Brukinsa

Brukinsa is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer. Brukinsa belongs to a group of drugs called BTK inhibitors. Bruton's tyrosine kinase (BTK) is a protein that signals to cancerous B cells, helping them to grow and spread. Blocking BTK can help stop this signaling.

This medication comes in capsule form. It is taken once or twice daily. Swallow Brukinsa capsules whole with a glass of water. Do not open, break, or chew the capsules.

Common side effects include decreased blood cell and platelet counts, rash, diarrhea, and upper respiratory infections.

Brukinsa is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Brukinsa may cause serious side effects. See the "Brukinsa Precautions" section.

Common side effects include:

• decreased white blood cells
• decreased red blood cells (anemia)
• decreased platelet count
• rash
• diarrhea
• upper respiratory infection 
• bruising
• cough

These are not all the possible side effects of Brukinsa.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Especially tell your healthcare provider if you take:

• anticoagulant medications ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), or ketoconazole
• aprepitant (Cinvanti, Emend) 
• clarithromycin (Biaxin, in Prevpac)
• digoxin (Lanoxin)
• diltiazem (Cardizem, Cartia, Tiazac, others)
• erythromycin (E.E.S., Erythrocin, others)
• certain medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as efavirenz (Sustiva, in Atripla), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase)
• nefazodone
• omeprazole (Prilosec)
• phenobarbital
• phenytoin (Dilantin, Phenytek) 
• pioglitazone (Actos)
• rifampin (Rifadin, Rifamate, Rimactane, others)
• midazolam
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)
• St. John's Wort

This is not a complete list of Brukinsa drug interactions. Ask your doctor or pharmacist for more information.

Brukinsa may cause serious side effects, including:

• Bleeding problems (hemorrhage) that 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
  • vomit blood or vomit that looks like coffee grounds 
  • cough up blood or blood clots
  • increased bruising 
  • dizziness
  • weakness
  • confusion
  • changes 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. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with Brukinsa, but can also be severe. 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. Use sun protection when you are outside in sunlight.
• Heart rhythm problems (atrial fibrillation and atrial flutter). Tell your healthcare provider if you have any of the following signs or symptoms:
  • your heartbeat is fast or irregular 
  • shortness of breath
  • feel lightheaded or dizzy 
  • chest discomfort
  • pass out (faint)

Grapefruit and grapefruit juice may interact with Brukinsa and lead to potentially dangerous effects, including muscle injury. Discuss the use of grapefruit products with your doctor.

Before taking 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.
• are pregnant or plan to become pregnant. Brukinsa can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with Brukinsa. Females should not become 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 doseof Brukinsa. 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 of Brukinsa.
• are breastfeeding or plan to breastfeed. It is not known if Brukinsa passes into your breast milk. Do not breastfeed during treatment with Brukinsa and for at least 2 weeks after your last dose of Brukinsa.

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 Brukinsa works and can cause side effects.

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

If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with Brukinsa. Females should not become 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 doseof Brukinsa. 

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 of Brukinsa.

Tell your healthcare provider if you are are breastfeeding or plan to breastfeed. It is not known if Brukinsa passes into your breast milk. Do not breastfeed during treatment with Brukinsa and for at least 2 weeks after your last dose of Brukinsa.

• Take Brukinsa exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking Brukinsa unless your healthcare provider tells you to.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking Brukinsa
• if you develop certain side effects.
• Take Brukinsa with or without food.
• Swallow Brukinsa capsules whole with a glass of water. Do not open, break, or chew the capsules.
• If you miss a dose of Brukinsa, take it as soon as you remember on the same day. Return to your normal schedule
• the next day.

Take Brukinsa exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Recommended dose: 160 mg orally twice daily or 320 mg orally once daily; swallow whole with water and with or without food.

If you take too much Brukinsa, call your local Poison Control Center or seek emergency medical attention right away.

• Store Brukinsa capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Brukinsa comes in a bottle with a child-resistant cap.
• Keep Brukinsa and all medicines out of the reach of children.