Brentuximab Vedotin, Injection

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KEY POINTS

• This medicine is given by IV to treat certain kinds of lymphoma.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine increases the risk of a brain infection that can lead to death or severe disability. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: brentuximab vedotin, injection; Adcetris

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma

It is used to treat people whose cancer has come back or progressed under other treatment.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease
• Progressive multifocal leukoencephalopathy (PML)

Females of childbearing age: Talk with your healthcare provider if you pregnant or plan to become pregnant. This medicine may harm an unborn baby. Do not become pregnant during treatment with this medicine. Use an effective method of birth control while you are receiving this medicine and for at least 6 months after your therapy is completed. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider’s approval.

How do I use it?

The infusions are given by your healthcare provider. You will be watched carefully after you receive each dose to make sure that you do not have a serious reaction. Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects you.

Your provider may tell you to take certain medicines before each infusion to help reduce any side effects. Follow your healthcare provider's directions exactly.

What if I miss a dose?

Do not miss an appointment for an infusion. If you miss an appointment for an infusion, contact your healthcare provider to reschedule your appointment.

What should I watch out for?

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. Tell your healthcare provider right away if you have:

• Changes in mood or behavior
• Confusion, thinking problems, loss of memory
• Changes in vision, speech, or walking
• Decreased strength or weakness on one side of the body

You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause an infusion reaction. Tell your healthcare provider right away if you have fever, chills, rash, or breathing problems within 24 hours of receiving this medicine.

This medicine may cause ulcers and bleeding in the stomach and intestines. If you have stomach pain, or bloody or black tarry bowel movements, contact your healthcare provider right away.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

This medicine may lower the number of certain types of blood cells in your body. You may get infections or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever or other signs of infection, or have any unusual bruising or bleeding, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Numbness or tingling of your hands or feet; unusual tiredness or weakness; dark urine; yellowing of your skin or eyes; light-colored bowel movements; unexplained loss of appetite; severe nausea, vomiting, or stomach pain; bloody or black tarry bowel movements; unusual bruising or bleeding; pain when urinating; decreased urination; fever; cough; sore throat; chest pain; trouble breathing; severe irritation, rash, peeling, or blisters; severe dizziness or fainting; swollen lymph glands; unexplained swelling in arms or legs; confusion; loss of memory or problems thinking; unusual mood or behavior changes; decreased strength or weakness on one side of the body; changes in vision, speech, or walking.

Other: Constipation, diarrhea, nausea, vomiting, mild stomach pain, headache, back pain, joint or muscle pain, dry skin, night sweats, weight loss, trouble sleeping, dizziness, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), bleomycin, ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), irinotecan (Camptosar), mitotane (Lysodren), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Conivaptan (Vaprisol)
• Dexamethasone
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Nefazodone
• Simeprevir (Olysio)
• St. John's wort
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.