Casodex is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Casodex is used to treat prostate cancer that has spread to other parts of the body (metastatic).

Casodex is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

Warnings

Casodex is used to treat prostate cancer. This medicine should never be taken by a woman or a child.

Bicalutamide can harm an unborn baby if you father a child while using this medicine. Use effective birth control to prevent pregnancy while using Casodex and for at least 130 days (about 19 weeks) after your last dose.

Casodex can harm your liver. Call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Casodex if you are allergic to bicalutamide.

Use effective birth control if your sex partner is able to get pregnant. Bicalutamide can harm an unborn baby if you father a child while using this medicine. Keep using birth control for at least 130 days (about 19 weeks) after your last dose.

Casodex is not for use by women or children.

This medicine can cause birth defects if a woman takes it during pregnancy.

To make sure Casodex is safe for you, tell your doctor if you have:

• liver disease; or
• diabetes.

How should I take Casodex?

Take Casodex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Casodex is usually taken once per day in the morning or evening.

Take the medicine at the same time each day, with or without food.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor’s instructions.

You should not stop using Casodex unless your doctor tells you to.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Prostate Cancer:

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:
-Therapy with this drug should be started at the same time as therapy with an LHRH analog.
-If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Use: For use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Casodex could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Casodex side effects

Get emergency medical help if you have signs of an allergic reaction to Casodex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• liver problems–nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
• (if you also take warfarin) unusual bruising or bleeding.

Common Casodex side effects may include:

• anemia;
• blood in your urine;
• fever, chills, flu-like symptoms;
• trouble breathing;
• hot flashes;
• pain in your back, pelvis, or stomach;
• swelling in your arms, ankles, legs, or feet;
• increased night-time urination;
• weakness, dizziness; or
• nausea, diarrhea, constipation.

Carvykti (ciltacabtagene autoleucel) is a personalized CAR T-cell therapy used to treat relapsed or refractory multiple myeloma (RRMM). It is used in adults whose multiple myeloma has returned or stopped responding to earlier treatments and may be used as early as the first relapse in certain patients.

Carvykti is a one-time infusion using a patient’s own genetically modified T cells to recognize and destroy multiple myeloma cells that express the BCMA protein.

For Carvykti treatment, T cells (a type of white blood cell) are collected from your blood and modified at the manufacturing site. A specialized receptor, called a chimeric antigen receptor (CAR), is added to the surface of the T cells. This enables it to recognize and attack multiple myeloma cells that carry the BCMA protein.

Once modified, the T cells are multiplied and infused back into your body as a personalized immunotherapy. After infusion, these CAR-T cells can seek out and kill BCMA-expressing multiple myeloma cells, helping improve disease control and clinical outcomes.

Carvykti is a BCMA-targeted CAR-T cell therapy.

Who Is Eligible for Carvykti Therapy?

Carvykti is FDA approved for the treatment of adults with relapsed or refractory multiple myeloma who meet all of the following criteria:

• Have multiple myeloma that has returned or stopped responding to treatment
• Have received at least one prior line of therapy
• Have been treated with:
  • A proteasome inhibitor, and
  • An immunomodulatory agent
• Have disease that is refractory to lenalidomide (no longer responds to lenalidomide treatment)

Carvykti may be used as early as the first relapse in appropriate patients when previous therapies have not been effective.

What is the Carvykti treatment process?

The Carvykti CAR T-cell therapy process is:

• T-cell collection: T cells, a type of white blood cell, are collected from your blood through a process called leukapheresis.
• Genetic modification: At a specialized manufacturing facility, a chimeric antigen receptor (CAR) is added to the surface of the T cells.
• Targeting BCMA: This CAR enables the T cells to recognize BCMA (B-cell maturation antigen), a protein found on multiple myeloma cells.
• Cell expansion: The modified CAR T cells are multiplied in the laboratory to create a sufficient number of cells for treatment.
• One-time infusion: The modified T cells are infused back into your body as a personalized immunotherapy.
• Cancer cell attack: After infusion, the CAR-T cells seek out and kill BCMA-expressing multiple myeloma cells, helping improve disease control and clinical outcomes.

How effective is Carvykti for RRMM?

New data from the Phase 3 CARTITUDE-4 study (NCT04181827) demonstrated that Carvykti was more effective than standard therapy.

• At 12 months, the estimated progression-free survival (PFS) rate was 75.9% with Carvykti compared to 49.5% with standard therapy. 
• In addition, 74.0% of patients treated with Carvykti achieved a complete response or better, while only 22.3% of patients on standard therapy reached that level of response. 
• An update to this study at a median follow-up of 33.6 months reported a statistically significant improvement in the overall survival rate with Carvykti compared to standard therapy.

These response rates were assessed by an Independent Review Committee (IRC) using the International Myeloma Working Group (IMWG) criteria.

Boxed Warnings

Carvykti has boxed warnings for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome (GBS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and/or recurrent cytopenias, immune-effector cell-associated enterocolitis (IEC-EC), and secondary hematological malignancies. 

A boxed warning is the strongest safety-related warning issued by the FDA. 

• Cytokine Release Syndrome (CRS). This includes fatal or life-threatening reactions, that have occurred in patients following treatment with Carvykti. Do not administer this medicine to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This may be fatal or life-threatening, and has occurred following treatment with Carvykti, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with Carvykti .  Supportive care and/or corticosteroids should be provided as needed.
• Parkinsonism and Guillain-Barré syndrome and their associated complications have occurred following Carvykti treatment resulting in fatal or life-threatening reactions.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, have occurred in patients following treatment with this medicine. HLH/MAS can occur with CRS or neurologic toxicities.
• Prolonged or recurrent cytopenias (low blood cell counts) have occurred after treatment with Carvykti and may be associated with bleeding, infection, and the need for stem cell transplantation to restore blood cell production.
• Immune Effector Cell–associated enterocolitis (IEC-EC), including fatal or life-threatening reactions, has been reported following treatment with Carvykti.
• Secondary blood cancers, such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), have occurred after treatment with Carvykti. T-cell malignancies have also been reported following treatment of blood cancers with BCMA- and CD19-directed genetically modified autologous T-cell therapies, including Carvykti. 

Warnings and Precautions

• Prolonged and Recurrent Cytopenias: Cytopenia is low levels of red blood cells (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia). Cytopenia may occur after Carvykti infusion. Prolonged neutropenia has been associated with increased risk of infection. Blood counts should be monitored before and after the infusion.
• Infections: Patients should be monitored for signs and symptoms of infection and receive appropriate treament if necessary.
• Hypogammaglobulinemia (low levels of immunoglobulins):  Your immunoglobulin levels will be monitored and immunoglobulin replacement therapy may be considered if required.
• Hypersensitivity Reactions: Hypersensitivity reactions have occurred. Monitor for hypersensitivity reactions during infusion. ( 5.8)
• Secondary Malignancies: Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including this medicine. Contact Janssen Biotech, Inc. at 1-800-526-7736, if this occurs.
• Immune-effector cell-associated enterocolitis (IEC-EC): Carvykti can cause serious gastrointestinal side effects, including severe or persistent diarrhea or ruptured bowel, which can be life-threatening and may lead to death. Tell your healthcare provider right away if you develop diarrhea, abdominal pain, weight loss, fever, chills, or any signs or symptoms of an infection. 

Differences in survival rates in the first 10 months were found in a study comparing Carvykti to standard therapy.

• 14% in the Carvykti arm died compared to 12% in the standard therapy arm.
• The increased death rate occurred before and after receiving Carvykti treatment.
• The reasons for death were progression of multiple myeloma and side effects of the treatment. 

However, the FDA has determined that the overall benefit of Carvykti continues to outweigh the potential risks. 

Carvykti side effects

Carvykti common side effects

Carvykti Common side effects may include:

• confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;
• headache, dizziness;
• problems with speech;
• low blood cell counts;
• fever, chills, tiredness, or other signs of infection;
• decreased appetite, constipation, nausea, or diarrhea; or
• pain in your joints or muscles.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of Carvykti is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also, call your doctor at once if you have:

• confusion, loss of consciousness, seizures, problems with speech, reading, or writing, depression
• personality changes, including a reduced ability to express emotions, being less talkative,
  disinterest in activities, and reduced facial expression
• tingling and numbness of hands and feet, leg and arm weakness, facial numbness; or
• low blood cell counts – fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• persistent or severe diarrhea, abdominal pain, and weight loss.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

Tell your doctor if you have ever had:

• neurologic problems (such as stroke, seizures, memory loss);
• breathing problems;
• heart problems;
• liver or kidney disease;
• diarrhea;
• recent or active infection; or
• low blood counts.

Pregnancy

Carvykti is not recommended for women who are pregnant or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus. Pregnancy after this therapy should be discussed with the treating physician.

Women will need pregnancy testing before receiving this medicine. You will also need to use birth control to prevent pregnancy during treatment with this medicine. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How should I receive Carvykti?

The Carvykti treatment process involves:

1. T-cell collection – A patient’s white blood cells (T cells) are collected via leukapheresis.
2. Genetic modification – The T cells are engineered to express a CAR that recognizes BCMA, a protein highly expressed on multiple myeloma cells.
3. Expansion and conditioning – The modified T cells are multiplied in a lab, while the patient undergoes lymphodepleting chemotherapy to prepare for infusion.
4. One-time infusion – The patient receives an intravenous (IV) infusion of Carvykti.
5. Post-treatment monitoring – Patients are closely monitored for cytokine release syndrome (CRS) and other potential side effects.

Dosing information

Recommended dose: 0.5-1.0×10⁶ CAR-positive viable T cells per kg, with a maximum dose of 1×10⁸ CAR-positive viable T cells per infusion.

Pre-medication required: Acetaminophen and an H1-antihistamine before infusion.

General dosing information:

• Administered intravenously at an authorized facility.
• Patients should stay within 2 hours of the treatment facility for at least 4 weeks post-infusion for monitoring.

What should I avoid after receiving this medicine?

• Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert for at least 8 weeks after you get Carvykti. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects, as discussed by your healthcare provider.
• You must not be given certain vaccines called live vaccines for some time before and after Carvykti treatment. Talk to your healthcare provider if you need to have any vaccinations.
• Do not donate blood, organs, tissues, or cells for transplantation.

What other drugs will affect Carvykti?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some commercial Human Immunodeficiency Virus (HIV) tests may incorrectly give you an HIV-positive result while you are receiving treatment with Carvykti.

Carvykti Package Insert

HCPs and patients often use the Carvykti Package Insert (PI) for more detailed information about this medicine. The Carvykti Package Insert contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the FDA label, or Carvykti Prescribing Information (PI).

Ingredients

Active ingredient: ciltacabtagene autoleucel

Inactive ingredients: DMSO

Manufacturer Information

Carvykti Manufacturer Janssen Biotech, Inc., Horsham, PA, USA.

Marketing Partner Legend Biotech, Somerset, NJ, USA.

Carvykti Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Carvykti.Carvykti (ciltacabtagene autoleucel) – Janssen Biotech, Inc.

Calquence (acalabrutinib) is a targeted cancer treatment used for chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL), in certain patients.

Calquence is a Bruton tyrosine kinase (BTK) inhibitor that works by blocking BTK, a protein that plays a key role in cancer cell growth and division. By inhibiting BTK, Calquence helps to slow the progression of cancer and helps extend patients’ lives

Calquence capsules and tablets are taken twice daily.

Calquence FDA approval was granted on October 31, 2017, for treating MCL. Its approval was later expanded to include CLL and SLL. Calquence is manufactured by AstraZeneca Pharmaceuticals.

How does Calquence work? 

Some cancer cells get signals to grow and divide from a protein called Bruton tyrosine kinase (BTK). The Calquence mechanism of action is by blocking Bruton tyrosine kinase (BTK), which helps to stop cancer cells from growing and multiplying, to help reduce cancer growth. The Calquence class of medications is called BTK inhibitors and is a targeted therapy.

Is Calquence chemotherapy?

No, Calquence is not chemotherapy; it is a targeted therapy, specifically a Bruton’s tyrosine kinase (BTK) inhibitor.

What is Calquence used for?

Calquence is used for adult patients with:

• chronic lymphocytic leukemia (CLL)
• small lymphocytic lymphoma (SLL) 
• mantle cell lymphoma (MCL)  in patients
  • who have received at least one prior therapy, or
  • who are previously untreated, and
    • are ineligible for autologous hematopoietic stem cell transplantation (HSCT), and
    • used in combination with bendamustine and rituximab.

Calquence side effects

Common Calquence side effects

Common Calquence side effects include:

• Infection (65%)
• Upper respiratory tract infection – URTI (35%)
• Lower respiratory tract infection – LRTI (18%)
• Urinary tract infection – UTI (15%)
• Headache (39%)
• Dizziness (20%)
• Diarrhea (35%)
• Nausea (22%)
• Musculoskeletal pain (32%)
• Joint pain (16%)
• Tiredness (23%)
• Bruising (21%)
• Rash (25%)
• Hemorrhage (20%).

There were also changes in blood test levels neutropenia 23% (low white blood cells), anemia 53% (low red blood cells), thrombocytopenia 32% (low platelet levels, and lymphocytosis 16% (high white blood cells).

The above common side effects occurred in patients being treated with Calquence CLL as monotherapy and occurred in 15% or more of patients.

Serious side effects

Calquence may cause serious side effects. Call your doctor at once if you have:

• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop
• bleeding inside your body – weakness, dizziness, confusion; problems with speech, prolonged headache, bloody or tarry stools, pink or brown urine; coughing up blood or vomit that looks like coffee grounds
• heart rhythm disorders – dizziness, chest pain, shortness of breath, fast or irregular heart rate, or feeling light-headed. Serious cardiac arrhythmias have occurred in patients treated with Calquence
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• signs of infection – fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing.

Get emergency medical help if you have signs of an allergic reaction to Calquence hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

This medicine may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Liver toxicity, which may be severe or fatal, has been reported with Bruton tyrosine kinase inhibitors, including this medicine. Your healthcare provider will monitor your liver function tests before starting treatment with this medicine and while you are taking it. Tell your healthcare provider immediately if you experience abdominal discomfort, dark urine, or yellowing of the skin.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Bleeding problems. Calquence can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

Your healthcare provider may stop this medicine for any planned medical, surgical, or dental procedure

Infections: Monitor for signs and symptoms of infection and treat promptly. 

Change in blood tests. It may cause low levels of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia). You will have complete blood counts regularly.

Second Primary Cancer: Other cancers have occurred, including skin cancers and other solid tumors. Always use sun protection. 

Heart rhythm changes: You will be monitored for symptoms of problems with the rate or rhythm of your heart (arrhythmias).

Severe hepatic impairment. This medicine should be avoided in patients with severe liver impairment and liver problems that have occurred in patients taking this medicine. If you have symptoms of stomach pain, dark-colored urine of dark color, or yellowing of your skin, you should contact your healthcare provider, who will monitor your liver function.

Before taking this medicine

To make sure Calquence is safe for you, tell your doctor if you have ever had:

• an active or chronic infection, including hepatitis B;
• a heart rhythm disorder;
• bleeding problems;
• recent surgery or plan to have surgery, medical or dental procedure; or
• liver problems

Taking Calquence may increase your risk of developing other cancers. Ask your doctor about this risk.

Pregnancy

Tell your healthcare professional if you are pregnant or plan to become pregnant, as Calquence may harm your unborn baby and problems during childbirth (dystocia). Your healthcare provider may do a pregnancy test before you start treatment, if you are able to become pregnant.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with this medicine and for at least 1 week after the last dose.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Calquence passes into your breast milk. Do not breastfeed during treatment with this medicine and for at least 2 weeks after your final dose.

How should I take Calquence?

Calquence directions

• Calquence tablet and capsules is usually taken twice per day (about 12 hours apart) with or without food, with a glass of water. Swallow the tablet and capsule whole, and do not crush, chew, break, open, or dissolve it.
• If you need to take an antacid medicine, take it either 2 hours before or 2 hours after you take Calquence.  If you need to take certain other medicines called acid reducers (H-2 receptor blockers), take Calquence 2 hours before the acid reducer medicine.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking this medicine if you develop certain side effects. 
• Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
• If you need surgery, tell the surgeon beforehand that you are using this medication. You may need to stop using the medicine for a short time.
• While taking this medicine, you may need frequent blood tests.
• If you’ve had hepatitis B, it may come back. You may need liver function tests while using this medicine.

Calquence dosing information

Usual monotherapy adult dose of Calquence for CLL,  SLL, or MCL

Dose: Calquence 100 mg capsule or tablet orally every 12 hours until the cancer progresses or there is unacceptable toxicity.

Usual adult dose in combination with obinutuzumab 

For patients with previously untreated CLL or SLL. The recommended dose of Calquence 100 mg taken orally approximately every 12 hours. Start Calquence at Cycle 1 (each cycle is 28 days). Start obinutuzumab (Gazyva) at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing. 

Administer Calquence prior to obinutuzumab when given on the same day. 

Usual adult Calquence dose in combination with bendamustine and rituximab 

For patients with previously untreated MCL. The recommended dosage of 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity

Start Calquence on Day 1 of Cycle 1 (each cycle is 28 days) 

Administer bendamustine 90 mg/m2 on Days 1 and 2 and rituximab 375 mg/m2 on Day 1 of Cycle 1 and continue for a total of 6 cycles. 

Patients achieving a response (PR or CR) after the first 6 cycles may receive maintenance rituximab on Day 1 of every other cycle for a maximum of 12 additional doses, starting on Cycle 8 up to Cycle 30 

General dose information

How long do you take Calquence? Calquence treatment should be continued until the cancer progresses or there is unacceptable toxicity.

Formulations available: 

• Calquence 100mg capsules.
• Calquence 100mg tablets.

Hepatic Impairment. You should not take this medicine if you have severe hepatic impairment. Dose modifications are not required for patients with mild or moderate hepatic impairment.

Dose modifications for drug interactions. See detailed dosing information for dose modifications required for drug interactions.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 3 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Calquence?

Avoid taking an antacid such as Tums or calcium carbonate within 2 hours before or after you take Calquence.

Calquence could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Calquence?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Drug interactions with groups:

• Strong CYP3A Inhibitors: Avoid co-administration of strong CYP3A Inhibitors with Calquence.
• Moderate CYP3A Inhibitors: Reduce the dosage of Calquence if these medicines are used together.
• Strong CYP3A Inducers: Avoid co-administration of strong CYP3A Inducers with Calquence. If co-administration is unavoidable, then the dosage of Calquence should be increased.

If you use a stomach acid reducer such as cimetidine, ranitidine, Tagamet, Pepcid, or Zantac, take the Calquence dose 2 hours before taking any of these other medicines.

Tell your doctor about all your current medicines. Many drugs can affect acalabrutinib, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);
• an antibiotic or antifungal medicine (itraconazole, fluconazole, erythromycin, rifampin);
• antiviral medicine to treat hepatitis C or HIV/AIDS;
• heart medication (diltiazem) ; or
• a proton pump inhibitor stomach acid medicine – such as omeprazole, lansoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Calquence Copay Card and Calquence Cares

The Calquence Copay Card can help you pay as little as $0 per month for out-of-pocket costs if you have commercial insurance plans.

AstraZeneca has a support program called AstraZeneca Access 360, which can help with questions about insurance, costs, affordability options, and other patient resources.

For patients with Medicare or no insurance facing affordability challenges, there is also an AstraZeneca Prescriptions Savings plan called AZ&ME.

Calquence Package Insert 

Review the Calquence Package Insert (PI) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Brukinsa is used to treat adults with mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma. It is an oral capsule or tablet that is taken once or twice a day.

Brukinsa (zanubrutinib) was first approved in 2019. There is no generic.

FDA approvals and indications

Brukinsa is a prescription oral capsule or tablet used to treat adults with:

• Chronic lymphocytic leukemia (CLL)
• Small lymphocytic lymphoma (SLL)
• Follicular lymphoma (FL), in combination with obinutuzumab, whose disease has come back or did not respond to treatment (relapsed or refractory) and who have received at least 2 prior treatments
• Mantle cell lymphoma (MCL), who have received at least 1 prior treatment for their cancer.
• Waldenström’s macroglobulinemia (WM)
• Marginal zone lymphoma (MZL), when the disease has come back or did not respond to treatment (relapsed or refractory), and who have received at least one anti-CD20-based regimen.

It is not known if this medicine is safe and effective in children.

How does Brukinsa work?

Brukinsa is a targeted treatment, not a chemotherapy drug, and works by directly blocking an enzyme, called Bruton’s tyrosine kinase (BTK), preventing its activity.

• BTK is a signaling molecule for pathways that cause an increase in B cells, a type of white blood cell that makes infection-fighting antibodies.
• Inhibition of BTK reduces the growth and spread of malignant B cells.

Brukinsa belongs to the drug class called BTK inhibitors.

Side effects

The most common side effects of Brukinsa are:

• diarrhea or constipation
• low platelet or other blood cell counts
• easy bruising or bleeding
• musculoskeletal pain
• high blood pressure
• a rash
• cold or flu symptoms, such as stuffy nose, sneezing, sore throat, or cough.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Brukinsa. Symptoms may include hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Brukinsa can cause the following serious or life-threatening side effects:

• Severe bleeding. Bleeding problems are common with Brukinsa, and can be serious and may
  lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
  • blood in your stools or black stools (looks like tar)
  • pink or brown urine
  • unexpected bleeding, or bleeding that is severe or you cannot control
  • increased bruising
  • dizziness
  • weakness
  • confusion
  • vomit blood or vomit that looks like coffee grounds
  • cough up blood or blood clots
  • change in speech
  • headache that lasts a long time.
• Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms
• Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with Brukinsa to check your blood counts.
• Second primary cancers. New cancers have happened in people during treatment with Brukinsa, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment. Use sun protection when you are outside in sunlight.
• Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
  • your heartbeat is fast or irregular
  • feel lightheaded or dizzy
  • pass out (faint)
  • shortness of breath
  • chest discomfort.
• Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with Brukinsa. Your healthcare provider will do blood tests to check your liver before and during treatment. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

Brukinsa can cause fetal harm when administered to a pregnant woman, including malformations. Women should use effective contraception and avoid becoming pregnant while taking Brukinsa and for 1 week after the last dose. Men should avoid fathering a child during treatment and for 1 week after the last dose.

It is not known if Brukinsa is safe and effective in children.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking

Before you start treatment with Brukinsa, tell your healthcare provider about all of your medical conditions, including if you:

• have bleeding problems
• have had recent surgery or plan to have surgery. Your healthcare provider may stop Brukinsa for any planned medical, surgical, or dental procedure
• have an infection
• have or had heart rhythm problems
• have high blood pressure
• have liver problems, including a history of hepatitis B virus (HBV) infection
• take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Brukinsa can harm your unborn baby. If you can become pregnant, your healthcare provider may do a pregnancy test before starting treatment with this medicine.

You may need to have a negative pregnancy test before you start using Brukinsa. Females should not become pregnant during treatment and for at least 1 week after the last dose. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.

Males should avoid getting female partners pregnant during treatment and for at least 1 week after the last dose of Brukinsa. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.

Breastfeeding

It is not known if Brukinsa passes into your breast milk. Do not breastfeed during treatment and for at least 2 weeks after your last dose.

How should I take Brukinsa?

Take exactly as directed by your healthcare provider. 

• Take the capsules/tablets once or twice daily as directed.
• Swallowed the capsules whole with a full glass of water. Do not open, break, or chew the capsules.
• The tablets can be split in half down the score line as prescribed by your healthcare provider. Do not chew or crush the tablets.
• May be taken with or without food. 
• The dosage may need to be reduced in those with severe liver disease.
• Take until disease progression or unacceptable toxicity occurs.

Dosing information

Adult dose of Brukinsa for MCL, WM, MZL, CLL, SLL, and FL:

• 160 mg twice a day or 320 mg once a day.
• May be taken with or without food.

Available as 80 mg capsules and 160 mg tablets.

Dosage reduction

The recommended dosage in severe liver disease is 80 mg twice daily.

• No dosage reduction is necessary in patients with mild or moderate hepatic impairment (Child-Pugh class A or B).

The dose also needs to be reduced when used with CYP3A Inhibitors or Inducers .

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Brukinsa?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Common medications that may interact with Brukinsa include:

• Moderate to strong CYP3A Inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, ritonavir, grapefruit juice, erythromycin, or verapamil
• Moderate to strong CYP3A inducers, such as glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid coadministration.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Brukinsa with certain other medications may affect how zanubrutinib works and can cause side effects.

Breyanzi is used to treat 5 types of non-Hodgkin lymphoma, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), with relapsed or refractory (R/R) marginal zone lymphoma (MZL) in specific patients.

Breyanzi is a one-time infusion of CAR T cell therapy that may help you have complete and lasting remission. 

Breyanzi is a cancer treatment created using immune cells, called T cells, collected from the patient’s own blood. The T cells are modified to become CAR T cells and are then infused back into the patient’s body. The CART T cells can attach to the cancer cells and kill them, helping clear the cancer from the body.  Before your infusion, you will have chemotherapy to prepare your body for your treatment. 

Breyanzi FDA approval was first received on February 5, 2021, for the company Bristol Myers Squibb (BMS).  It contains lisocabtagene maraleuce. The most recent approval was for relapsed or refractory marginal zone lymphoma (MZL) on December 4, 2025.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat five types of non-Hodgkin lymphoma: large B-cell lymphoma, relapsed or refractory chronic CLL/SLL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL)  in specific patients.

Large B-cell lymphoma

Breyanzi is used to treat large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in adults. You can only be treated with Breyanzi if:

• your first treatment has not worked, or your cancer returned within a year of your first treatment, OR
• your first treatment has not worked, or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR
• two or more kinds of treatment have not worked or stopped working.

It is not indicated for the treatment of primary central nervous system lymphoma.

Relapsed or refractory chronic CLL/SLL

Breyanzi is used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have:

• received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. 
• This is an accelerated FDA approval.

Relapsed or refractory follicular lymphoma (FL) 

Breyanzi is used to treat relapsed or refractory follicular lymphoma (FL) in adults who have:

• received 2 or more prior lines of systemic therapy. 
• This is an accelerated FDA approval.

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

It is approved for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Relapsed or refractory (R/R) marginal zone lymphoma (MZL)

Breyanzi is approved for adult patients who have received at least two prior lines of systemic therapy.

Breyanzi side effects

Common Breyanzi side effects

Common Breyanzi side effects may include:

• headache, dizziness;
• confusion, problems with speech or thinking;
• fever, chills, shaking;
• nausea, vomiting, stomach pain;
• diarrhea, constipation;
• fast or irregular heartbeats;
• cough, trouble breathing;
• swelling; or
• pain in your bones, joint, or muscles.

Serious Bryanzi side effects

Get emergency medical help if you have signs of an allergic reaction, hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to treat CRS if it occurs.

Breyanzi may cause other serious side effects. Call your doctor at once if you have:

• problems with speech;
• confusion, trouble concentrating, memory problems;
• decreased consciousness;
• tremors, or a seizure; or
• signs of infection – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online .

How will I receive Breyanzi?

Breyanzi is a one-time cancer treatment made from your own white blood cells. The process takes several weeks and involves collecting, modifying, and then infusing those cells back into your body, with close monitoring for side effects.

Breyanzi is a liquid medicine given intravenously (into a vein) by a doctor or nurse. It is usually given as two infusions over about 30 minutes total as a one-time dose.

Breyanzi treatment process

Step 1: T Cell collection

• T cells, which are a type of white blood cell, are collected using a procedure called leukapheresis (a process that removes white blood cells from the body).

Step 2: T Cell activation

• The collected T cells are sent away and modified so they can better recognize and attack cancer cells.
• This modification process takes about 3–4 weeks.

Step 3: Preparation for infusion

• You will receive chemotherapy medicines a few days before Breyanzi to prepare your body; this is called lymphodepleting chemotherapy.

Step 4: Breyanzi infusion

• The modified cells are then infused back into your body as Breyanzi. Because the treatment is made from your own cells, it must only be given to you.

Step 5: Follow-up

• Your healthcare provider will check if the treatment is working and monitor for side effects.
  You should plan to stay near the treatment center for at least 4 weeks after receiving Breyanzi.

It is very important not to miss your cell collection or treatment appointment

Before taking this medicine

Tell your doctor if you have ever had:

• hepatitis B or C; or
• if you have received a vaccine within the past 6 weeks.

Using Breyanzi may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Warnings

Breyanzi has a boxed warning for cytokine release syndrome(CRS), neurologic toxicity, and secondary hematological malignancies.

Cytokine release syndrome (CRS): This is a common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to treat this condition if it occurs.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including this therapy.

What should I avoid after receiving Breyanzi?

 Avoid driving or operating machinery for at least 2 weeks after receiving this treatment. This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures.

Do not donate blood, organs, tissues, or cells for transplantation.

Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you your immune system has recovered

What other drugs will affect Breyanzi?

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. You should keep a written list of all the prescription and nonprescription (over-the-counter) medicines you take, along with any products such as vitamins, minerals, or other dietary supplements. Remember to bring this list with you each time you see a doctor or are hospitalized. This information is important to have on hand for emergencies.

Blincyto (blinatumomab) is an injectable immunotherapy treatment that may be used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 month and older. It is a biologic treatment that is usually given after other cancer treatments have been tried without success.

Blincyto’s mechanism of action is to connect the protein CD3 found on the surface of T cells (a type of white blood cell that is an essential part of our immune system) to another protein, CD19 found on cancerous and non-cancerous B-cells. This activates the T-cell and Blincyto works by causing the destruction (lysis) of CD19 cells. Blincyto is a bispecific CD19-directed CD3 T-cell engager. In one study, 81% of patients with B-cell precursor ALL with minimal residual disease receiving Blincyto had no detectable cancer after 4 weeks.

Blincyto was FDA-approved on December 3, 2014. There is no generic Blincyto available.

What is Blincyto used for?

Blincyto is used to treat adults and children 1 month and older with:

• B-cell precursor ALL in remission when only a small number of cancer cells remain in the body (minimal residual disease [MRD])
• B-cell precursor ALL that has come back or did not respond to previous treatments
• Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase of chemotherapy treatment with multiple phases.

It is not known if Blincyto is safe and effective in children under 1 month of age.

Blincyto side effects

The most common side effects of Blincyto include:

• fever
• infusion-related reactions (see below)
• headache
• infections
• muscle, joint, and bone pain
• low white or red blood cell counts (neutropenia or anemia)
• low platelet count (thrombocytopenia)
• diarrhea.

Some side effects may occur during the Blincyto injection. Tell your healthcare provider right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Blincyto such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Blincyto may cause serious side effects, including:

Cytokine release syndrome (CRS) and infusion reactions. CRS can occur when your immune system responds to immunotherapy medications such as Blincyto more aggressively than it should and symptoms may be similar to infusion reactions. Tell your healthcare provider right away if you develop a fever, chills, wheezing or difficulty breathing, dizziness, headache, low blood pressure, nausea or vomiting, body aches, diarrhea, facial swelling, a skin rash, or feel tired or light-headed.

Neurologic problems. Blincyto may affect your nerves and can cause some serious neurological disorders including a potentially life-threatening neurotoxicity called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your healthcare provider right away if you experience:

• seizures
• difficulty in speaking or slurred speech
• loss of consciousness
• trouble sleeping
• confusion and disorientation
• loss of balance
• headache
• difficulty with facial movements, hearing, vision, or swallowing
• tremors.

People with Down Syndrome over the age of 10 years may have a higher risk of seizures with Blincyto.

Life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.

Tumor Lysis Syndrome (TLS) is caused by the fast breakdown of cancer cells. It can be life-threatening
and may lead to death. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with Blincyto, including:

• nausea and vomiting
• confusion
• shortness of breath
• irregular heartbeat
• dark or cloudy urine
• reduced amount of urine
• unusual tiredness
• muscle cramps.

Low white blood cell counts (neutropenia) are common with Blincyto treatment and may sometimes be life-threatening. They can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell counts during treatment. Tell your healthcare provider right away if you get a fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands or feet, or feel light-headed or short of breath.

Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start Blincyto and during treatment.

Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with Blincyto and
corticosteroids. It may be severe and lead to death. Tell your healthcare provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.

People receiving Blincyto are at risk of seizures or losing consciousness and should not drive or engage in hazardous activities.

Blincyto may harm an unborn baby and should not be taken by females who are pregnant.

Before taking this medicine

You should not use Blincyto if you are allergic to blinatumomab, Blincyto, or any inactive ingredients in the injection.

To make sure Blincyto is safe for you, tell your doctor if you have:

• nerve problems or a neurologic disorder, such as seizures, confusion, trouble speaking, or problems with balance
• Down syndrome
• a history of chemotherapy or radiation treatment to your brain
• an infection
• have recently received a vaccine or if you are scheduled for a booster dose
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy

Blincyto may harm an unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Blincyto. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with Blincyto, and for 48 hours after their last dose. Do not use Blincyto if you are pregnant. If you inadvertently become pregnant while receiving Blincyto, tell your healthcare provider right away.

Breastfeeding

It is not known if Blincyto passes into your breast milk. You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

How is Blincyto administered?

Blincyto will be given to you by a continuous intravenous (IV) infusion into your vein using a small portable infusion pump. This means you can still carry out daily activities as normal, although you should be careful not to drive or engage in hazardous tasks while receiving the infusion.

• One induction treatment cycle is usually 4 weeks (28 days) of continuous infusion followed by 2 weeks (14 days) break without infusion.
• For the first 3 to 9 days of the first cycle and the first 2 days of the second cycle, you will usually receive this in a hospital under the care of your healthcare provider.
• For the rest of the cycle, your healthcare provider will decide if you receive your treatment at home or through an outpatient clinic or infusion center.
• Your healthcare provider will decide the number of treatment cycles of Blincyto but a treatment course for MRD is usually 1 cycle of Blincyto for induction followed by up to 3 additional cycles for consolidation (continued therapy). This usually consists of one IV infusion for 4 weeks (28 days), followed by an 8-week (56 days) break during which you will not receive Blincyto. This is 1 consolidation treatment cycle (84 days).
• Your healthcare provider may change your dose of Blincyto, delay, or completely stop treatment if you have certain side effects, and do blood tests during treatment to check you for side effects.

Before receiving Blincyto, you will be given a corticosteroid medicine to help reduce infusion reactions.

Before and during treatment, you may be given chemotherapy as an injection into the space that
surrounds the spinal cord and the brain (intrathecal injection) to help prevent central nervous system relapse of ALL.

• It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.

Receiving Blincyto at home

If your healthcare provider has decided you can receive Blincyto at home, your infusion bag will be changed at an outpatient center or by your home healthcare provider.

• Blincyto is available in 24-hour, 48-hour, and 7-day infusion bags. Your bag will need to be changed every day, every 2 days, or once a week based on what your doctor decides is best for you.
• Call your doctor if you experience any problems or side effects.
• Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given.
• Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
• Keep Blincyto out of reach of children or pets in the household.

What happens if I miss a dose?

Call your healthcare provider if you do not receive your IV bags on time or if your home healthcare provider does not change the infusion bag in time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include fever, tremors, and headache.

What should I avoid while using Blincyto?

Do not receive a “live” vaccine while using Blincyto, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Ask your doctor how soon it is safe for you to receive a vaccine after you stop using this medicine.

Avoid driving or hazardous activity until you know how Blincyto will affect you. Blincyto increases your risk of seizures, losing consciousness, and a serious nerve toxicity syndrome called ICANS (see above).

What other drugs will affect Blincyto?

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

No formal drug interaction studies have been conducted with Blincyto. The highest drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle. People receiving medications with a narrow therapeutic index metabolized by the cytochrome p450 system, such as warfarin or cyclosporin should be monitored for increases in side effects and the dosage of the interacting drug adjusted if needed.

No formal drug interaction studies have been conducted with Blincyto, but starting Blincyto treatment causes the short-lived release of cytokines that may suppress CYP450 enzymes and affect medications with a narrow therapeutic index, such as warfarin.

Storage

Intravenous (IV) bags containing Blincyto for infusion will arrive in a special package.

• Do not open the package.
• Do not freeze the package.

The package containing Blincyto will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C).

The prepared preservative-free Blincyto infusion bag lasts for 48 hours at room temperature 73°F to 81°F (23°C to 27°C) or 8 days when refrigerated at 36°F to 46°F (2°C to 8°C).

The prepared preservative-containing Blincyto infusion bag lasts for 7 days at room temperature 73°F to 81°F (23°C to 27°C) or 14 days when refrigerated at 36°F to 46°F (2°C to 8°C).

Do not throw away (dispose of) any Blincyto in your household trash. Talk with your healthcare provider about the disposal of Blincyto and used supplies.

Keep out of reach of children.

Blincyto infusion ingredients

Active ingredient: blinatumomab.
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide, and preservative-free sterile water for injection.
Inactive ingredients of IV solution stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for injection.

Due to the addition of bacteriostatic saline, 7-day bags of Blincyto solution for infusion with a preservative contain benzyl alcohol and are not recommended for use in patients weighing less than 22 kg.

Available as Blincyto 35 mcg in a single-dose vial for reconstitution.

Who makes Blincyto?

Amgen Inc. makes Blincyto 35 mcg single-dose vials for reconstitution.

Blincyto Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Blincyto.Blincyto (blinatumomab) – Amgen Inc.

Bicalutamide is a prescription medicine belonging to a class of medicines called non-steroidal androgen receptor inhibitors.

Bicalutamide is used to treat prostate cancer that has spread to other parts of the body (metastatic).

Bicalutamide is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

It is not known if bicalutamide tablets are safe and effective in children.

Warnings

Bicalutamide can harm an unborn baby if you father a child while using this medicine. Use effective birth control to prevent pregnancy while using bicalutamide and for at least 130 days (about 19 weeks) after your last dose.

Before taking this medicine

You should not use this medicine if you are allergic to bicalutamide.

Use effective birth control if your sex partner is able to get pregnant. Bicalutamide can harm an unborn baby if you father a child while using this medicine. Keep using birth control for at least 130 days (about 19 weeks) after your last dose.

Bicalutamide is not for use by women or children.

This medicine can cause birth defects if a woman takes it during pregnancy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease; or
• diabetes.

How should I take bicalutamide?

Take bicalutamide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Bicalutamide is usually taken once per day in the morning or evening.

Take the medicine at the same time each day, with or without food.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor’s instructions.

You should not stop using bicalutamide unless your doctor tells you to.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Prostate Cancer:

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:
-Therapy with this drug should be started at the same time as therapy with an LHRH analog.
-If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Use: For use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking bicalutamide?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Bicalutamide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Bicalutamide side effects

Get emergency medical help if you have signs of an allergic reaction to bicalutamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• liver problems – nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• (if you also take warfarin) unusual bruising or bleeding.

Common bicalutamide side effects may include:

• anemia;
• blood in your urine;
• fever, chills, flu-like symptoms;
• trouble breathing;
• hot flashes;
• pain in your back, pelvis, or stomach;
• swelling in your arms, ankles, legs, or feet;
• increased night-time urination;
• weakness, dizziness; or
• nausea, diarrhea, constipation.

Bevacizumab injection is a targeted cancer drug used to treat types of colon and rectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, renal cell cancer (RCC), cervical cancer, ovarian cancer, fallopian tube cancer, or peritoneal cancer. Avastin is also used to treat types of hepatocellular carcinoma (HCC).

Bevacizumab belongs to a class of medications called antiangiogenic agents. Bevacizumab works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.

Avastin was the first brand of bevacizumab to be approved by the FDA on February 26, 2004, and is called the reference product.  Biosimilars of Avastin are Alymsys, Jobevne, Mvasi, Vegzelma, and Zirabev.
Bevacizumab is used together with other chemotherapy medications.

Bevacizumab side effects

Common bevacizumab side effects may include increased blood pressure, headache, back pain, dry or watery eyes, dry or flaky skin, stuffy nose, runny nose, sneezing, or altered sense of taste.

Serious bevacizumab side effects 

Get emergency medical help if you have signs of an allergic reaction to bevacizumab, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Bevacizumab can cause a serious but rare neurologic disorder that affects the brain. Symptoms may occur within hours of your first dose or may not appear for up to a year after your treatment started. Call your doctor at once if you have extreme weakness or tiredness, headache, confusion, vision problems, fainting, or seizures (blackout or convulsions).

Bevacizumab can cause you to bleed more easily. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding, or any bleeding that will not stop;
• signs of bleeding in your digestive tract – severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of bleeding in the brain – sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

Some people taking bevacizumab have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) in the stomach, intestines, throat, lungs, gallbladder, kidney, bladder, or vagina. Call your doctor if you have severe stomach pain or if you feel like you are choking when you eat or drink.

Also call your doctor if you have:

• slow wound healing;
• skin infection or open sores;
• missed menstrual periods;
• kidney problems – swelling, urinating less, feeling tired or short of breath;
• signs of a blood clot – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg;
• heart problems – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating, swelling, rapid weight gain, feeling short of breath; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Bevacizumab can make it easier for you to bleed. Seek emergency medical attention if you have any bleeding that will not stop. You may also have bleeding on the inside of your body.

Call your doctor if you have: signs of bleeding in your digestive tract–feeling very weak or dizzy, severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or signs of bleeding in the brain–sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

Bevacizumab can also cause problems with wound healing, which could result in bleeding or infection. Do not use bevacizumab within 28 days before or after a planned surgery.

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling very weak or tired, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of bevacizumab, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

Some people receiving a bevacizumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Before taking this medicine

You may not be able to use bevacizumab if you are being treating with other cancer medicines such as doxorubicin, daunorubicin, or if you have or ever had:

• ovarian cancer with symptoms such as severe stomach pain or pelvic pain;
• slow healing of a skin wound or surgical incision;
• surgery within the past 4 weeks (28 days);
• you plan to have surgery within the next 4 weeks (28 days); or
• coughing up blood or vomit that looks like coffee grounds.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• diabetes;
• heart problems such as a heart attack, stroke, blood clot or blood clotting disorder;
• high blood pressure;
• bleeding problems or a perforation (a hole or tear) in your esophagus, stomach, or intestines; or
• kidney disease.

Pregnancy

Bevacizumab may harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using bevacizumab and for at least 6 months after your last dose. Tell your doctor at once if you become pregnant.

This medicine may cause a woman’s ovaries to stop working correctly. Symptoms of ovarian failure include 3 or more missed menstrual periods in a row. It may be harder for you to get pregnant while you are using this medicine and after this treatment. Talk to your doctor about your individual risk.

Breastfeeding

Do not breastfeed while using bevacizumab and for at least 6 months after your last dose.

How is bevacizumab given?

Bevacizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, shortness of breath, or chest pain during the injection.

Bevacizumab is usually given once every 2 or 3 weeks.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

For detailed bevacizumab dosing information, click the link below.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your bevacizumab injection.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving bevacizumab?

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

What other drugs will affect bevacizumab?

Tell your doctor about all other cancer treatments you are receiving.

Other drugs may interact with bevacizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Ingredients and manufacturer

Active ingredient: bevacizumab

Avastin (bevacizumab)
Inactive ingredients: a,a-trehalose dihydrate, polysorbate 20, sodium phosphate dibasic (anhydrous), sodium phosphate monobasic (monohydrate), and Water for Injection, USP.
Manufacturer: Genentech, Inc, 1 DNA Way South San Francisco, CA 94080, USA.

Alymsys (bevacizumab-maly)
inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, trehalose, and Water for Injection, USP.
Manufacturer: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Product of Spain 

Mvasi (bevacizumab-awwb)
Inactive ingredients: α,α-trehalose dihydrate, polysorbate 20, sodium phosphate dibasic, anhydrous, sodium phosphate monobasic, monohydrate, and Water for Injection, USP.
Manufacturer: Amgen, Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 

Vegzelma (bevacizumab-adcd)
Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, trehalose, and Water for Injection, USP.
Manufacturer: CELLTRION, Inc. 20, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea. 

Zirabev (bevacizumab-bvzr)
Inactive ingredients: edetate disodium dihydrate, polysorbate 80, succinic acid, sucrose, and Water for Injection, USP. Sodium hydroxide is added to adjust the pH.
Manufacturer: Pfizer Inc. NY, NY 10017.

Bevacizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for bevacizumab.Avastin (bevacizumab) – Genentech, Inc.

Bendeka is used to treat chronic lymphocytic leukemia. This medicine is also used to treat indolent B-cell non-Hodgkin lymphoma after other medicines have been tried without successful treatment of this condition.

Bendeka may also be used for purposes not listed in this medication guide.

Bendeka side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Bendeka may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Bendeka may cause serious side effects. Call your doctor at once if you have:

• fever, chills, or itching during or shortly after the injection;
• pain, swelling, redness, skin changes, or signs of infection where the medicine was injected;
• severe ongoing nausea, vomiting, or diarrhea;
• liver problems–right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• signs of tumor cell breakdown–confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed if you have certain side effects.

Common side effects of Bendeka may include:

• fever, cough, mouth sores, trouble breathing;
• low blood cell counts;
• nausea, vomiting, diarrhea, constipation;
• headache, tiredness;
• rash; or
• loss of appetite, weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Tell your caregivers right away if you have any type of skin rash after being treated with Bendeka.

Before taking this medicine

You should not be treated with Bendeka if you are allergic to Bendeka, polyethylene glycol, propylene glycol, or mannitol (Osmitrol).

Tell your doctor if you have ever had:

• a weak immune system;
• fever or other signs of infection;
• tuberculosis;
• herpes zoster (also called shingles)
• a metabolic disorder or electrolyte imbalance;
• liver disease;
• kidney disease; or
• if you smoke.

Using Bendeka may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

Bendeka can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Bendeka if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Bendeka.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because Bendeka can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How is Bendeka given?

Bendeka is given as an infusion into a vein. A healthcare provider will give you this injection.

Bendeka is usually given for 2 days in a row every 21 to 28 days. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent certain side effects of bendamustine.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Bendeka affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Bavencio is used to treat a type of skin cancer called Merkel cell carcinoma in adults and children at least 12 years old, when the cancer has spread to other parts of the body (metastatic).

What is Bavencio?

Bavencio is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. Bavencio is given for this condition after platinum cancer medicines did not work or have stopped working.

Bavencio is also used alone or in combination with another medicine called axitinib to treat advanced kidney cancer that has spread or cannot be removed with surgery.

Warnings

Bavencio works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have symptoms such as: fever, cough, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, swelling in your ankles, increased or decreased urination, blood in your urine or stools, weight changes, hair loss, unusual bleeding, dark urine, or jaundice (yellowing of your skin or eyes).

Before taking this medicine

To make sure Bavencio is safe for you, tell your doctor if you have ever had:

• a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome;
• an immune system disorder such as ulcerative colitis or Crohn’s disease;
• lung problems or a breathing disorder;
• liver or kidney disease;
• heart problems or high blood pressure;
• high cholesterol;
• diabetes;
• an organ transplant; or
• if you have received or will receive a transplant of stem cells from a donor.

You should not use avelumab if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

You should not breastfeed while using this medicine and for at least 1 month after your last dose.

How is Bavencio given?

Bavencio is given as an infusion into a vein, usually once every 2 weeks. A healthcare provider will give you this injection.

Bavencio must be given slowly and the IV infusion can take at least 60 minutes to complete.

You may be given other medication to prevent certain side effects that may occur during the infusion.

You may need frequent medical tests to check your heart or liver function, and to help your doctor determine how long to treat you with Bavencio.

Dosing information

Usual Adult Dose for Merkel Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Usual Adult Dose for Urothelial Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Uses:
-For maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy
-Previously treated urothelial carcinoma: For treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy OR have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Renal Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food
Duration of therapy: Until disease progression or unacceptable toxicity

Use: In combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

Usual Pediatric Dose for Merkel Cell Carcinoma:

12 years and older:
800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For metastatic Merkel cell carcinoma (MCC) in pediatric patients 12 years and older

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Bavencio side effects

Get emergency medical help if you have signs of an allergic reaction to Bavencio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have stomach or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

• sudden chest pain or discomfort;
• severe stomach pain, diarrhea, bloody or tarry stools;
• blistering or peeling skin rash;
• pounding heartbeats or fluttering in your chest;
• flu-like symptoms;
• pain or burning when you urinate;
• joint pain, weakness;
• vision changes;
• liver problems – loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• heart problems – chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
• kidney problems – little or no urination, red or pink urine, swelling in your feet or ankles; or
• signs of a hormonal disorder – feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, sweating, feeling cold, weight gain, or weight loss.

Common Bavencio side effects may include:

• hoarse voice;
• cough, shortness of breath;
• trouble speaking;
• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• severe headache, blurred vision, pounding in your neck or ears;
• painful urination;
• stomach pain, nausea, diarrhea, loss of appetite;
• feeling tired;
• chills, fever;
• muscle pain, back pain, bone pain;
• rash;
• swelling in your hands or feet;
• redness or swelling where the injection was given;
• liver problems; or
• symptoms of underactive thyroid – tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures.