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.

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.