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.

What is Imfinzi?

Imfinzi (durvalumab) is an immunotherapy used to treat cancer, including certain non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bile duct and gallbladder cancer, hepatocellular carcinoma, endometrial cancer and muscle invasive bladder cancer (MIBC). Imfinzi may help increase overall survival, lower the chance of cancer spreading, and help shrink tumors, depending on the type of cancer. Imfinzi works by helping the immune system find, recognize, and fight cancer cells.

Imfinzi is given as an infusion into a vein every 2, 3, or 4 weeks, depending on your condition. Other medicines may be part of your treatment plan, depending on your cancer type.

Imfinzi FDA approval was granted on May 1, 2017, for the company AstraZeneca, originally for Advanced Bladder Cancer, but FDA approval has since be extended for use in more cancer types.

How does Imfinzi work?

Imfinzi works by binding and blocking the PD-L1 protein on the outside of cancer cells, which means your immune system can then find and attack the cancer cells to help slow cancer spreading and increase survival. Imfinzi’s class of medicines is called checkpoint inhibitors.

Imfinzi mechanism of action (MOA) is as a programmed death-ligand 1 (PD-L1) blocking antibody. It binds and blocks PD-L1, so there is no interaction with PD-1 and CD80. This means that the immune response is now activated to work against the cancer cells.

Imfinzi can be used for cancers that have a protein called PD-L1 on the outside of the cancer cell. The PD-L1 protein helps the cancer cells hide it from the immune system so cancer cells can survive and multiply. When Imfinzi blocks PD-L1 it means the immune system is able to find cancers and destroy them.

What is Imfinzi used for?

Imfinzi indications are non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, hepatocellular carcinoma, endometrial cancer, and muscle invasive bladder cancer (MIBC) in specific patients. Imfinzi is an FDA-approved prescription medicine to treat adults with:

Non-small cell lung cancer (NSCLC)

• Non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements who have with resectable (tumors ≥ 4 cm and/or node positive). To be used in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinizi continued as a single agent as adjuvant treatment after surgery.
• Unresectable Stage III NSCLC in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi is to be used as a single agent.
• Metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. Imfinzi, Imjudo (tremelimumab-actl) and platinum-based chemotherapy are to be used in combination for the treatment regime.

Small cell lung cancer (SCLC) 

• in combination with the chemotherapy medicines etoposide and carboplatin or cisplatin when cancer has spread within your lungs or to other parts of the body
• as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

Biliary tract cancer (including cancer of the bile ducts and gallbladder cancer) in combination with the chemotherapy medicines gemcitabine and cisplatin when cancer has spread to nearby tissues or other parts of the body

Hepatocellular carcinoma (unresectable) Imfinzi, Imjudo (tremelimumab-actl) are used in combination.

Endometrial cancer that has spread (advanced) or come back (recurrent) and tests show the tumor is mismatch repair deficient (dMMR), Imfinzi is used with carboplatin plus paclitaxel followed by single-agent Imfinzi.

Bladder cancer that has invaded the muscle. Imfinzi is used in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Imfinizi as adjuvant treatment following radical cystectomy.

Imfinzi side effects

Common Imfinzi side effects

Common Imfinzi side effects include shortness of breath (dyspnea), cough, rash, tiredness (fatigue), cold symptoms (respiratory tract infections) inflammation of the lungs (pneumonitis) when used as a single agent for Stage III NSCLC.

When used with other cancer treatments, common Imfinzi side effects may include nausea, constipation, decreased appetite, feeling weak or tired, bone or muscle pain, cough, feeling short of breath, cold symptoms such as stuffy nose, sneezing, sore throat, abdominal pain, fever, itchy skin, rash, painful urination, hair loss, vomiting, nerve inflammation (causing symptoms such as numbness, weakness, tingling, or burning), changes blood tests including decreased magnesium, increased ALT, and increased AST. Side effects profiles are dependent on the specific combination of therapies.

Immune-mediated hypothyroidism was reported in 14% of people receiving Imfinzi in combination with carboplatin and paclitaxel. Events resolved in some patients, but all required endocrine therapy.

Serious Imfinzi side effects

Imfinzi may cause serious side effects including severe allergic reactions. Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

This medicine causes your immune system to attack tumor cells, but it could also 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:

• chest pain, new or worsening cough, feeling short of breath;
• severe stomach pain, diarrhea, bloody or tarry stools;
• new or worsening skin rash, itching, or blistering;
• fever, flu-like symptoms;
• pain or burning when you urinate;
• problems in other organs – mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems;
• liver problems – loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urination, red or pink urine, swelling in your feet or ankles;
• transplant rejection – rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; or
• signs of a hormonal disorder – unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, feeling cold, weight gain, or weight loss.

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. You may report side effects to the FDA .

Warnings

Imfinzi works by causing your immune system to attack tumor cells but it may also 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, pituitary, or adrenal glands.

Call your doctor at once if you have new or unusual symptoms, such as: tiredness, mood changes, headaches, vision problems, muscle weakness, stomach problems, weight changes, skin rash, hair loss, bleeding or bruising, yellowing of your skin or eyes, increased or decreased urination, dark urine, bloody or tarry stools, worsening cough, chest pain, or trouble breathing.

Infusion-Related Reactions. Your infusion may be slowed, interrupted or permanently discontinued if you have an infusion-related reaction, depending on the severity of the reaction.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Embryo-Fetal Toxicity: This medicine can cause fetal harm. Females of reproductive potential should be advised of the potential risk to a fetus and should use effective contraception.

Before taking this medicine

You should not use this infusion if you are allergic to the active ingredient, durvalumab, or any of the inactive ingredients.

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

• an organ transplant or a stem cell transplant (recent or planned);
• lung disease or breathing problems;
• liver disease;
• radiation treatment of your chest area;
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome, or
• an autoimmune disorder such as lupus, ulcerative colitis, or Crohn’s disease.

Pregnancy

Imfinzi may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

Do not breastfeed while using medicine, and for at least 3 months after your last dose.

How is Imfinzi given?

Imfinzi is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 hour to complete.

Imfinzi Dosing information

Usual Adult Dose for Small Cell Lung Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 4 weeks as a single agent until disease progression, unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Use: First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin.

Usual Adult Dose for Biliary Tract Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent until disease progression or until unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or until unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Use: Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.

Usual Adult Dose for Unresectable Hepatocellular Carcinoma:

Less than 30 kg:
20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Greater than or equal to 30 kg:
1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Use: The treatment of adult patients with unresectable hepatocellular carcinoma in combination with tremelimumab-actl.

Usual Adult Dose for dMMR endometrial cancer

30 kg or less:
15 mg/kg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by Imfinzi 20 mg/kg every 4 weeks as a single agent Until disease progression or unacceptable toxicity.

Greater than 30 kg:

1,120 mg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by Imfinzi 1,500 mg every 4 weeks as a single agent.

What is Jemperli?

Jemperli is a cancer immunotherapy used to treat types of endometrial cancer and solid tumors. Jemperli belongs to the class of drugs called programmed death receptor-1 (PD-1)–blocking antibodies. In tumors, a protein (PD-1) on immune cells (T-cells) makes them inactive, preventing them from killing cancer cells. Jemperli works by binding to PD-1, which activates the T-cells, and then they can find, attack, and kill the cancer cells.

Jemperli (dostarlimab-gxly) is given as an intravenous infusion into your vein over 30 minutes every 3 to 6 weeks, depending on your treatment regime. Jemperli can be used as a single medicine or used with carboplatin and paclitaxel to treat certain cancers.

Jemperli is FDA-approved to treat adult patients with:

• Primary advanced or recurrent endometrial cancer, regardless of biomarker status. To be used in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has been confirmed with an FDA-approved test. Endometrial cancer must have progressed on or following prior treatment with a platinum-containing regimen in any setting, and patients are not candidates for curative surgery or radiation. It is to be used as a single agent.
• Mismatch repair deficient (dMMR) recurrent or advanced solid tumors confirmed with an FDA-approved test. Solid tumors must have progressed on or following prior treatment, and there are no satisfactory alternative treatment options. It is to be used as a single agent.

Jemperli side effects

Common Jemperli side effects

Common Jemperli side effects when used alone in people with dMMR solid tumors (including endometrial cancer) include:

• tiredness and weakness
• low red blood cell count (anemia)
• diarrhea
• nausea
• constipation
• vomiting.

The most Jemperli common side effects when given with carboplatin and paclitaxel in people with endometrial cancer include:

• nerve problems in your arms, hands, legs, and feet
• joint pain
• shortness of breath
• rash
• decreased appetite
• tiredness
• constipation
• urinary tract infections
• nausea
• diarrhea
• vomiting
• hair loss
• stomach-area (abdomen) pain.

Serious Jemperli side effects

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

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, chilled, feverish, itchy, or short of breath.

Jemperli strengthens your immune system to help it attack cancer cells, but it may also attack healthy cells, and you could develop serious or fatal side effects.

Also, see the Important Information section.

This is not a complete list of Jemperli’s side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Important information

Jemperli can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment with Jemperli has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

• cough
• chest pain
• shortness of breath

Intestinal problems (colitis) can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• diarrhea or more bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems, including hepatitis. Signs and symptoms of liver problems may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

• change in the amount or color of your urine
• blood in your urine
• swelling in your ankles
• loss of appetite

Skin problems. Signs of skin problems may include:

• rash
• itching
• skin blistering or peeling
• swollen lymph nodes
• painful sores or ulcers in your mouth or your nose, throat, or genital area
• fever or flu-like symptoms

Problems in other organs and tissues. These are not all of the signs and symptoms of immune system problems. Call or see your healthcare provider right away for any new or worse signs or symptoms. Signs and symptoms of these problems may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Jemperli. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach area (abdominal) pain, and diarrhea.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare provider may also need to delay or completely stop treatment.

Before receiving Jemperli

Before you receive Jemperli, tell your healthcare provider if you have any medical conditions, including if you:

• have immune system problems, such as Crohn’s disease, ulcerative colitis, or lupus.
• have received an organ transplant.
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic).
• have received radiation treatment to your chest area.
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Jemperli can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment.
• You should use effective birth control during treatment and for 4 months after your last dose. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Jemperli.

Breastfeeding

Tell your healthcare provider you are breastfeeding or plan to breastfeed. It is not known if Jemperli passes into your breast milk.

• Do not breastfeed during treatment and for 4 months after your last dose.

How will I receive Jemperli?

• Your healthcare provider will give you Jemperli into your vein through an intravenous (IV) line over 30 minutes.
• When Jemperli is used in combination with carboplatin and paclitaxel, Jemperli is usually given every 3 weeks for the first 6 doses. Beginning 3 weeks later, it is usually given alone every 6 weeks.
• When Jemperli is used alone to treat dMMR recurrent or advanced endometrial cancer and dMMR recurrent or advanced solid tumors, it is usually given every 3 weeks for the first 4 doses. Beginning 3 weeks later, it is usually given every 6 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Jemperli Dosing information

Usual adult Jemperli dose for primary advanced or recurrent endometrial cancer.

Dose: Jemperli dose (in combination with carboplatin and paclitaxel) 500 mg every 3 weeks for 6 cycles followed by 1,000 mg monotherapy every 6 weeks for all cycles thereafter.

Usual adult dose for dMMR recurrent or advanced endometrial cancer

Dose: Jemperli (as a single agent) 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.

Usual adult dose for dMMR recurrent or advanced solid tumors

Dose: Jemperli (as a single agent) 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.

General Dosing Information

• Jemperli is given as an intravenous infusion over 30 minutes.
• Click on the link below for more detailed dosing information.

What other drugs will affect Jemperli?

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

Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

Jemperli Package Insert

Review the Jemperli Package Insert for more detailed information about this medicine. 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.

What are the ingredients in Jemperli?

Active ingredient: dostarlimab-gxly

Inactive ingredients: citric acid monohydrate, L-arginine hydrochloride, polysorbate 80, sodium chloride, trisodium citrate dihydrate, and Water for Injection

What is Keytruda?

Keytruda is used to treat multiple types of cancer such as melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin Lymphoma, urothelial carcinoma, gastric cancer, and many others. It is given as an infusion into your vein (IV infusion) every 3 to 6 weeks depending on the type of cancer you have.

Keytruda (pembrolizumab) is an immunotherapy treatment, not chemotherapy, although it is often used with other medicines, including chemotherapy. It works by enhancing the body’s natural immune response against cancer cells. 

Keytruda infusion first gained FDA approval on September 4, 2014.

Types of cancer treated with Keytruda

Keytruda is FDA-approved to treat numerous cancers, including certain types of:

• Biliary tract cancer
• Certain types of colorectal cancer
• Cervical cancer
• Classical Hodgkin Lymphoma
• Cutaneous squamous cell carcinoma (cSCC)
• Endometrial cancer
• Esophageal cancer
• Gastric cancer
• Head and neck squamous cell cancer (HNSCC)
• Kidney cancer (renal cell carcinoma)
• Liver cancer (Hepatocellular carcinoma [HCC]) secondary to hepatitis B
• Malignant pleural mesothelioma (MPM)
• Melanoma
• Merkel cell carcinoma (MCC)
• Microsatellite instability-high (MSI-H) or mismatch repair deficient cancers 
• Non-small cell lung cancer (NSCLC)
• Primary Mediastinal Large B-cell lymphoma (PMBCL)
• Triple-negative breast cancer
• Tumor mutational burden-high (TMB-H) cancer
• Urothelial cancer including some types of Bacillus Calmette-Guerin (BCG)-unresponsive urothelial cancers.

Some cancers may need to be tested for genetic markers such as PD-L1, dMMR, TMB, or pMMR to determine if Keytruda is right for you.

Note that this is just a summary, see the Keytruda Prescribing Information for specific criteria and prior treatment requirements that may apply for each indication. 

Mechanism

Keytruda works through a sophisticated mechanism of action called immune checkpoint inhibition:

• It blocks the PD-1 protein found on T cells
• This prevents PD-1 from interacting with PD-L1 on cancer cells
• This inhibition “takes the brakes off” the immune system, allowing T cells to recognize and attack cancer cells more effectively
• Keytruda enhances the immune system response against cancer.

Keytruda belongs to the drug class called immune checkpoint inhibitors and may also be called a monoclonal antibody.

Clinical trials have shown most people respond to Keytruda within 2-4 months of starting treatment .

Keytruda side effects

The most common side effects of Keytruda when it is used alone are:

• fatigue or excessive tiredness
• pain, including pain in the stomach, muscles, bones, or joints
• rash or itching
• diarrhea
• fever
• cough
• decreased appetite
• shortness of breath
• constipation
• nausea
• low levels of thyroid hormone.

Clinical trials have reported Keytruda side effects that are more common in children than adults are:

• fever
• vomiting
• headache
• stomach area pain
• low levels of white blood cells.

The most common side effects of Keytruda when it is used in combination with chemotherapy or radiotherapy treatments include:

• fatigue or excessive tiredness
• nausea
• constipation
• diarrhea
• decreased appetite
• rash
• vomiting
• cough
• trouble breathing
• fever
• hair loss
• inflammation of the nerves that may cause pain
• weakness and paralysis in the arms and legs
• swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
• mouth sores
• headache
• weight loss
• stomach-area (abdominal), joint, or muscle pain,
• trouble sleeping
• bleeding
• blisters, or rash on the palms of your hands and soles of your feet
• urinary tract infection
• low levels of thyroid hormone.
• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, weight loss
• low blood sodium levels, abnormal thyroid, liver and kidney function tests
• low blood cell counts
• tingling or numbness in your hands or feet, loss of movement in the arms and legs
• bleeding
• pain and burning when you urinate
• fever, headache, feeling weak or tired, dizziness, trouble sleeping
• cough, hoarse voice, feeling short of breath
• changes in your sense of taste, dry skin, and dry eyes
• itching, hair loss, rash, or blisters on your hands or feet
• increased blood pressure
• pain in your muscles, bones, or joints
• mouth sores or swelling around your mouth, nose, eyes, throat, intestines, or vagina
• tingling or numbness in your arms or legs.

Prompt medical attention to these side effects is crucial. Your doctor will monitor you during Keytruda treatment. 

Serious side effects and warnings

Keytruda is a medicine that works with your immune system to treat certain cancers. Keytruda can cause your immune system to attack normal organs and tissues in any area of your body and can cause serious side effects.

• These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time.
• These problems may happen anytime during treatment or even after your treatment has ended

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems, such as cough, shortness of breath, or chest pain
• Intestinal problems, such as:
  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems such as
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems, such as
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • eye sensitivity to light
  • hair loss
  • eye problems feeling cold
  • rapid heartbeat
  • constipation
  • increased sweating
  • your voice gets deeper
  • extreme tiredness
  • dizziness or fainting
  • weight gain or weight loss
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems, such as
  • decrease in your amount of urine
  • swelling of your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems, such as
  • rash
  • painful sores or ulcers in your mouth or your nose, throat, or genital area
  • itching
  • fever or flu-like symptoms
  • skin blistering or peeling
  • swollen lymph nodes.
• any new or worsening signs or symptoms in other organs, which may include:
  • chest pain, irregular heartbeat, shortness of breath, swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or
  • numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, and bruising.
• Infusion reactions can sometimes be severe or life-threatening. Signs and symptoms may include:
  • chills or shaking dizziness
  • itching or rash
  • feeling like passing out
  • flushing
  • fever
  • shortness of breath or wheezing
  • back pain.

For people who have had an organ transplant, Keytruda may cause rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death.

• These complications may happen if you underwent transplantation either before or after being treated with Keytruda.
• Your healthcare provider will monitor you for these complications.

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

Keytruda may cause harm to an unborn baby. Females of reproductive potential should use effective contraception.

Getting medical treatment right away for these side effects may help keep these problems from becoming more serious. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

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

• an autoimmune disorder such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, lupus, or psoriasis
• received or plan to receive a stem cell transplant that uses donor stem cells
• had an organ transplant
• had radiation to your chest
• a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy

Keytruda may harm an unborn baby. Your healthcare provider will give you a pregnancy test to make sure you are not pregnant. Use effective birth control while using Keytruda and for at least 4 months after your last dose. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during
treatment with Keytruda.

Breastfeeding

It is not known if Keytruda passes into breast milk. Do not breastfeed while using this medicine and for at least 4 months after your last dose.

How is Keytruda administered?

Keytruda is administered as an infusion into your vein through an intravenous line over 30 minutes.

• In adults, a Keytruda infusion is usually given every 3 weeks or 6 weeks depending on the cancer type being treated and your dosage.
• In children, Keytruda is usually given every 3 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

You will need frequent medical tests to help your doctor determine if you are tolerating Keytruda. Do not miss any follow-up visits.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda infusion.

What happens if I overdose?

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

What should I avoid while receiving Keytruda?

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

What is Loqtorzi?

Loqtorzi (toripalimab-tpzi) is an immunotherapy used to treat advanced nasopharyngeal carcinoma (NPC), a rare type of cancer of the nose or throat. Loqtorzi works by blocking the PD-1 receptor on tumor cells, which helps the immune system find and kill cancer cells. Loqtorzi is a monoclonal antibody that blocks PD-L1 and PD-L2, allowing the immune system to activate and kill the tumor. Loqtorzi is called a PD-1 inhibitor.

Loqtorzi is given as an intravenous infusion every two or three weeks, depending on your treatment regime.

Loqtorzi FDA approval was granted to Coherus BioSciences, Inc, on October 27, 2023, based on positive results from the Phase II clinical study POLARIS-02 and the Phase 3 clinical trial JUPITER-02  (NCT03581786).

Who can use Loqtorzi?

Loqtorzi FDA-approved indications are to treat adults as:

First-Line Treatment

• In combination with cisplatin and gemcitabine,
• When nasopharyngeal carcinoma cancer has spread to other parts of your body (metastatic) or,
• When cancer has returned (recurrent) in nearby tissues (locally advanced).

Subsequent Treatment: 

• As a single agent ,
• You have received chemotherapy that contains platinum, and it did not work or is no longer working and,
• NPC has returned and cannot be removed with surgery or,
• Metastatic NPC that has progressed.

How well does Loqtorzi work?

In the JUPITER-02 Phase 3 clinical trial, Loqtorzi with gemcitabine/cisplatin was compared to placebo with gemcitabine/cisplatin treatment. It was a Phase 3, randomized, double-blind, placebo-controlled trial with 289 patients.

Key Findings:

Median Progression-Free Survival:

• 11.7 months in the Loqtorzi group
•  8.0 months in the placebo group
• 48% risk reduction for disease progression, hazard ratio (HR) for disease progression or death: 0.52 (95% CI, 0.36-0.74; P < .001)

Overall Survival (OS):

• 37% reduced the risk of death in the Loqtorzi +gemcitabine-cisplatin-treated groups compared to the placebo +gemcitabine-cisplatin-treated group in the  3-year survival follow-up of JUPITER-02

How does Loqtorzi work?

Usually, your immune system protects you by using T cells to detect and destroy germs and cells like cancer cells. Some cells including cancer cells can hide from the T cells, so they are not killed. These cells have proteins  (PD-L1 and PD-L2) on the cell surface that bind to a protein (PD-1) on the T cells, which stops the T cells from killing it. 

Loqtorzi works (mechanism of action) by binding to PD-1 on T cells which stops it from binding to PD-L1 and PD-L2 on the cancer cells, this leaves T cells and the immune system free to find and kill cancer cells.

Loqtorzi is a humanized IgG4 monoclonal antibody.

What is nasopharyngeal carcinoma?

Nasopharyngeal carcinoma (NPC) is an aggressive cancer that starts in the nasopharynx, which is the upper part of the throat behind the nose and near the base of the skull. Because of where the cancer is, surgery is rarely an option, so most patients whose cancer is localized are treated mainly with radiation and chemotherapy

Loqtorzi side effects

Common Loqtorzi side effects

The most common Loqtorzi side effects when Loqtorzi is used as a single therapy are tiredness, hypothyroidism, and musculoskeletal pain these side effects occur in 20% or more of patients.

The most common Loqtorzi side effects when used in combination with cisplatin and gemcitabine are nausea, vomiting, decreased appetite, constipation, low thyroid levels, rash, fever, diarrhea, peripheral neuropathy, cough, muscle and joint pain, upper respiratory infection, trouble sleeping, dizziness, and malaise, these side effects affected 20% or more of patients in the clinical trial JUPITER-02.

Serious Loqtorzi 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 eyes, skin pain, red or purple skin rash with 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, skin sores, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

Toripalimab causes your immune system to attack tumor cells, but it could also 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.

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

• intestinal problems  – severe stomach pain, diarrhea, bloody or tarry stools;
• liver problems – loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• immune system problems – confusion, problems with thinking or memory, balance problems, trouble breathing, weakness, muscle cramps, irregular heart rhythm or swelling of ankles;
• signs of organ transplant rejection – feeling sick or uneasy, with pain or swelling near your transplanted organ;
• signs of a hormonal disorder – unusual headaches, vision problems, feeling light-headed, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;
• lung problems – cough, shortness of breath, chest pain;
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• low red blood cells (anemia) – pale skin, tiredness, feeling light-headed, cold hands and feet.

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

These are not all the possible side effects of Loqtorzi. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Before taking this medicine

Tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Loqtorzi can harm your unborn baby.

Tell you healhcare providers if you are pregnant or plan to become pregnant.

Females who are able to become pregnant should have a negative pregnancy test before you start treatment with Loqtorzi. You should use an effective method of birth control during your treatment and for 4 months after your last dose of this medicine. Talk to your healthcare provider about the best birth control methods that you can use during this time. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Loqtorzi.

Breastfeeding

Do not breastfeed during treatment and for 4 months after the last dose of Loqtorzi.

Tell you healhcare providers if you are breastfeeding or plan to breastfeed. It is not known if Loqtorzi passes into your breast milk.

How will I receive Loqtorzi?

Loqtorzi is as a intravenous (IV) infusion into your vein through an intravenous (IV) line which takes 30 or 60 minutes. The IV infusion will be given to you by your healthcare provider.

Loqtorzi is usually given every two or three weeks.

Your healthcare provider will decide how many treatments you need.

You will need to have regular blood tests to check for certain side effects. If you miss any appointments, call your healthcare provider as soon as possible to reschedule.

Dosing information

Recommended adult Loqtorzi dose for First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine: 240 mg every three weeks.

Recommended adult Loqtorzi dose Previously Treated Unresectable or Metastatic NPC: 3 mg/kg every two weeks.

What happens if I miss a dose?

If you miss any appointments, call your healthcare provider as soon as possible to reschedule.

What is nivolumab?

Nivolumab (brand name Opdivo) is an immunotherapy treatment that treats multiple types of cancer by interfering with the growth and spread of cancer cells in the body. It is given as an intravenous infusion (infusion into your vein; IV) over 30 minutes, every 2 to 4 weeks, depending on the type of cancer you have. Nivolumab can be used alone or with other medicines, such as ipilimumab (Yervoy) or chemotherapy.

Nivolumab was first approved by the FDA in 2014, under the brand Opdivo. There are no generics or biosimilars.

Types of cancer treated with nivolumab

Nivolumab is FDA-approved to treat the following cancers, either alone or in combination with other treatments such as ipilimumab (Yervoy):

• Melanoma
• Bladder cancer (urothelial carcinoma)
• Cancer of the stomach and esophagus
• Classical Hodgkin lymphoma (cHL)
• Gastric cancer, gastroesophageal junction cancer, and esophageal cancer
• Kidney cancer (renal cell carcinoma)
• Malignant pleural mesothelioma (cancer that affects the lining of the lungs and chest wall)
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, including cases that have progressed following prior treatment for metastatic disease
• Non-small cell lung cancer (NSCLC)
• Squamous cell cancer of the head and neck
• Unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.

For some cancers, such as melanoma and colorectal cancer, nivolumab is approved for children aged 12 years and older. .

Nivolumab is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Common combination therapies

Primary combination: ipilimumab (Yervoy)

Nivolumab and ipilimumab are commonly used together to improve survival for people with the following cancers:

• Metastatic melanoma
• Advanced renal cell carcinoma
• Non-small cell lung cancer
• Malignant pleural mesothelioma
• Colorectal cancer
• Hepatocellular carcinoma.

Clinical trials have shown nivolumab and ipilimumab work better when taken together for some types of cancer .

Chemotherapy combinations

Nivolumab is used with various chemotherapy treatments for:

• Non-small cell lung cancer
• Gastric cancer
• Esophageal cancer
• Pleural mesothelioma

Other targeted therapy combinations

Clinical trials have also reported enhanced benefits when nivolumab is used with:

• Cabometyx for kidney cancer
• Herceptin for certain gastric cancers.

Treatment selection factors

The choice of the combination treatment depends on:

• Cancer type and stage
• Biomarker testing results
• Patient’s overall health
• Prior treatments
• Side effect considerations.

Specific combinations will be determined by your oncologist based on individual factors and current FDA approvals.

How does nivolumab work?

Nivolumab works through a sophisticated mechanism called immune checkpoint inhibition:

• It blocks the PD-1 protein found on T cells
• This prevents PD-1 from interacting with PD-L1 on cancer cells
• This inhibition helps prevent cancer cells from “hiding” from the immune system, enhancing our immune system’s response against cancer.

Nivolumab belongs to the drug class called immune checkpoint inhibitors. It may also be called a monoclonal antibody or a PD-1-blocking antibody.

Side effects

The most common side effects of nivolumab when used alone are:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• mouth sores, altered sense of taste;
• itching, rash, redness, or blisters on your hands or feet;
• hormonal problems;
• liver problems;
• numbness, tingling, or burning pain in your hands or feet;
• fever, body aches;
• feeling weak, tired, or short of breath;
• cold symptoms such as runny or stuffy nose, cough, sore throat;
• headache, dizziness, increased blood pressure; or
• weight loss.

The most common side effects of nivolumab and ipilimumab in combination are:

• constipation
• cough
• decreased appetite
• decreased weight
• diarrhea
• dizziness
• feeling tired
• fever
• headache
• itching
• low thyroid hormone levels (hypothyroidism)
• nausea
• pain in muscles, bones, and joints
• rash
• shortness of breath
• stomach-area (abdominal) pain
• upper respiratory tract infection
• vomiting.

Serious side effects and warnings

Nivolumab can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Immune system problems. Nivolumab is a medicine that may treat certain cancers by working with your immune system. Nivolumab can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended and may be more common when nivolumab is used in combination with other treatments. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

• Lung problems
  • new or worsening cough
  • shortness of breath
  • chest pain.
• Intestinal problems
  • diarrhea (loose stools) or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • hair loss
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased
  • sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems
  • decrease in your amount of urine
  • swelling in your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes.

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with nivolumab. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising.

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Nivolumab. Your healthcare provider will monitor you for these complications.

Nivolumab can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

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

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with nivolumab. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with nivolumab if you have severe side effects.

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

Nivolumab may cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with nivolumab.

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

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

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are similar to nivolumab
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Nivolumab may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving nivolumab and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if nivolumab passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is nivolumab administered?

Nivolumab is given as an infusion into a vein (IV infusion) by a healthcare provider. This medicine must be given slowly over 30 minutes.

• Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• The dosage of nivolumab depends on the cancer being treated and the patient’s age.
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.
• Nivolumab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving nivolumab?

Follow your doctor’s instructions about restricting food, beverages, or activity.

What other drugs will affect nivolumab?

Other drugs may interact with Nivolumab, 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.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.

Storage

Your healthcare provider will store Nivolumab refrigerated at 2°C to 8°C (36°F to 46°F) and protect it from light by storing it in the original package until the time of use.

Nivolumab should not be frozen or shaken.

Nivolumab ingredients

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

Who makes nivolumab?

Nivolumab is only available under the brand name Opdivo, which is made by Bristol Myers Squibb (BMS), headquartered in New York City.

Nivolumab 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 nivolumab.Opdivo (nivolumab) – Bristol-Myers Squibb Company

What is Opdivo?

Opdivo is used to treat many cancers, such as melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, liver cancer, esophageal squamous cell carcinoma, gastric cancer, and gastroesophageal junction cancer. It is given as an intravenous infusion (infusion into your vein; IV) over 30 minutes, every 2 to 4 weeks, depending on the type of cancer.

Opdivo is not chemotherapy; it is an immunotherapy treatment that can be used by itself, with chemotherapy, or with other immunotherapy treatments, such as Yervoy, another checkpoint inhibitor. Opdivo targets the PD-1 protein, while Yervoy targets the CTLA-4 protein.

Opdivo first gained FDA approval in 2014. There is no generic or biosimilar.

Mechanism

Opdivo works by interfering with the growth and spread of cancer cells in the body through a process called immune checkpoint inhibition.

• Normally, cancer cells can evade the immune system by expressing proteins called PD-L1 (programmed death-ligand 1) on their surface, which bind to PD-1 receptors on T cells.
• When PD-L1 binds to PD-1, it sends a “stop” signal to T cells, preventing them from attacking the cancer cells – essentially creating an “off switch” for the immune response.
• Opdivo is a monoclonal antibody that specifically blocks the PD-1 receptors on T cells, preventing this binding from occurring.
• By blocking this interaction, Opdivo removes the “brake” on the immune system, allowing T cells to recognize and attack cancer cells.

This reactivation of the immune response can lead to tumor shrinkage and improved survival in patients with certain types of cancer, including melanoma, lung cancer, renal cell carcinoma, and various other malignancies.

Clinical trials have shown most people respond to Opdivo within 2-3 months of starting treatment .

The effectiveness of Opdivo varies depending on the cancer type and stage and other factors .

Opdivo Vs Opdivo Qvantig

Opdivo Qvantig is a formulation of Opdivo containing hyaluronidase, which allows it to be given subcutaneously (under the skin) over 3 to 5 minutes, instead of intravenously over 30 minutes. 

• Opdivo Qvantig offers faster administration but has more restricted approved uses.

FDA approvals and uses

Opdivo is approved to treat the following cancers:

• Melanoma in adults and children 12 years and older
  • Unresectable/metastatic melanoma (single agent or with ipilimumab)
  • Adjuvant treatment for completely resected Stage IIB-IV melanoma
• Non-small cell lung cancer (NSCLC) in adults
  • Neoadjuvant treatment for resectable tumors ≥4cm or node-positive (with platinum-doublet chemotherapy)
  • Metastatic NSCLC with PD-L1 ≥1%, no EGFR/ALK mutations (first-line with ipilimumab)
  • Metastatic/recurrent NSCLC, no EGFR/ALK mutations (first-line with ipilimumab + 2 cycles platinum-doublet chemotherapy)
  • Metastatic NSCLC with progression after platinum-based therapy
• Malignant pleural mesothelioma in adults
  • Unresectable disease (first-line with ipilimumab)
• Renal cell carcinoma (RCC) in adults
  • Intermediate/poor risk advanced RCC (first-line with ipilimumab)
  • Advanced RCC (first-line with cabozantinib)
  • Advanced RCC after prior anti-angiogenic therapy
• Classical Hodgkin Lymphoma in adults
  • Relapsed/progressed after autologous stem cell transplant and brentuximab vedotin
  • After ≥3 systemic therapy lines, including autologous stem cell transplant
• Squamous cell cancer of the head and neck in adults
  • Recurrent/metastatic disease with progression after platinum-based therapy
• Urothelial carcinoma in adults
  • Adjuvant treatment for high-risk recurrence after radical resection
  • Unresectable/metastatic disease (first-line with cisplatin and gemcitabine)
  • Locally advanced/metastatic with progression during/after platinum therapy or within 12 months of neoadjuvant/adjuvant platinum therapy
• Colorectal cancer in adults and children 12 years and older
  • Unresectable/metastatic MSI-H or dMMR colorectal cancer (with ipilimumab)
  • MSI-H or dMMR metastatic disease progressed after fluoropyrimidine, oxaliplatin, and irinotecan
• Hepatocellular carcinoma (HCC) in adults
  • Unresectable/metastatic HCC (first-line with ipilimumab)
  • Previously treated with sorafenib (with ipilimumab)
• Esophageal cancer in adults
  • Completely resected esophageal/gastroesophageal junction cancer with residual disease after neoadjuvant chemoradiotherapy
  • Unresectable advanced/metastatic esophageal squamous cell carcinoma, PD-L1 ≥1% (first-line with chemotherapy or ipilimumab)
  • Unresectable advanced/recurrent/metastatic esophageal squamous cell carcinoma after prior chemotherapy
• Gastric/gastroesophageal junction cancer and esophageal adenocarcinoma in adults
  • Advanced/metastatic disease with PD-L1 ≥1% (with fluoropyrimidine and platinum-containing chemotherapy).
  • This indication is under the accelerated approval designation meaning continued approval may be contingent upon a clinical benefit in confirmatory trials.

Opdivo is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Clinical trials have shown Opdivo and Yervoy work better when taken together for some types of cancer .

Side effects

The most common side effects of Opdivo when used alone are:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation
• mouth sores, altered sense of taste
• itching, rash, redness, or blisters on your hands or feet
• hormonal problems
• liver problems
• numbness, tingling, or burning pain in your hands or feet
• fever, body aches
• feeling weak, tired, or short of breath
• cold symptoms such as runny or stuffy nose, cough, sore throat
• headache, dizziness, increased blood pressure
• weight loss.

The most common side effects of Opdivo and Yervoy in combination are:

• constipation
• cough
• decreased appetite
• decreased weight
• diarrhea
• dizziness
• feeling tired
• fever
• headache
• itching
• low thyroid hormone levels (hypothyroidism)
• nausea
• pain in muscles, bones, and joints
• rash
• shortness of breath
• stomach-area (abdominal) pain
• upper respiratory tract infection
• vomiting.

Serious side effects and warnings

Opdivo can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Immune system problems. Opdivo is a medicine that may treat certain cancers by working with your immune system. Opdivo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended, and may be more common when Opdivo is used in combination with other treatments. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

• Lung problems
  • new or worsening cough
  • shortness of breath
  • chest pain.
• Intestinal problems
  • diarrhea (loose stools) or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • hair loss
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased
  • sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems
  • decrease in your amount of urine
  • swelling in your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes.

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with nivolumab. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising.

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), may occur in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you undergo transplantation either before or after being treated with Opdivo. Your healthcare provider will monitor you for these complications.

Opdivo can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

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

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Opdivo. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Opdivo if you have severe side effects.

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

Opdivo may cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with Opdivo.

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

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

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past, and have received other medicines that are similar to Opdivo
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Opdivo may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving Opdivo and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if Opdivo passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is Opdivo administered?

Opdivo is given as an infusion into a vein (IV infusion) by a healthcare provider. This medicine must be given slowly over 30 minutes.

• Opdivo is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• The dosage of Opdivo depends on the cancer being treated and the patient’s age (see the Opdivo Prescribing Information for complete Opdivo dosing information).
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo.
• Opdivo can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Opdivo?

Follow your doctor’s instructions about restricting food, beverages, or activity.

What other drugs will affect Opdivo?

Other drugs may interact with Opdivo, 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.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.