brentuximab vedotin

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Pronunciation: bren TUX i mab ve DOE tin

Brand: Adcetris

What is the most important information I should know about brentuximab vedotin?

You should not receive brentuximab vedotin if you are also receiving another cancer medicine called bleomycin (Blenoxane).

Brentuximab vedotin may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

What is brentuximab vedotin?

Brentuximab vedotin is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Brentuximab vedotin is used to treat Hodgkin's lymphoma or anaplastic large cell lymphoma.

Brentuximab vedotin is given after a stem cell transplant or other cancer medications have been tried without successful treatment.

Brentuximab vedotin was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, brentuximab vedotin produced complete or partial remission in many people. However, further studies are needed to determine if this medicine can lengthen survival time.

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

What should I discuss with my healthcare provider before receiving brentuximab vedotin?

You should not receive brentuximab vedotin if you are allergic to it, or:

  • if you are also receiving another cancer medicine called bleomycin (Blenoxane).

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

  • liver disease;
  • kidney disease; or
  • peripheral vascular disease such as Raynaud's syndrome.

Brentuximab vedotin can harm an unborn baby. Use birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Brentuximab vedotin use by either parent may cause birth defects.

If you are a woman, do not use brentuximab vedotin if you are pregnant. Use effective birth control while using this medicine and for at least 6 months after your last dose.

If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is using brentuximab vedotin. Keep using birth control for at least 6 months after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using brentuximab vedotin.

It is not known whether brentuximab vedotin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using brentuximab vedotin.

How is brentuximab vedotin given?

Brentuximab vedotin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Before you receive brentuximab vedotin, you may be given other medications to prevent certain side effects that brentuximab vedotin can cause.

Brentuximab vedotin is usually given once every 3 weeks for up to 16 treatment cycles, or until your body no longer responds to the medication. Follow your doctor's dosing instructions very carefully.

Brentuximab vedotin can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using brentuximab vedotin. You may need to stop using the medicine for a short time.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your brentuximab vedotin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while receiving brentuximab vedotin?

Do not receive a "live" vaccine while using brentuximab vedotin. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of brentuximab vedotin?

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, chilled or feverish, or if you have itching or trouble breathing. Infusion reactions often occur within the first 24 hours after the start of your brentuximab vedotin infusion.

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

Brentuximab vedotin may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have any of these other side effects, even if they occur several months after you receive brentuximab vedotin, or after your treatment ends.

  • numbness, weakness, burning pain, tingly feeling, or loss of feeling in your arms or legs;
  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
  • low red blood cells (anemia) --pale skin, easy bruising or bleeding, feeling light-headed or short of breath, trouble concentrating;
  • signs of infection --fever, chills, mouth or throat pain, skin sores, cough, pain or burning when you urinate;
  • signs of tumor cell breakdown --lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, confusion, fainting;
  • liver or pancreas problems --severe pain in your upper stomach (may spread to your back), nausea and vomiting, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • stomach problems --severe constipation, new or worsening stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • fever, infections, easy bruising or bleeding;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • numbness or tingling;
  • nausea, vomiting, diarrhea;
  • feeling tired;
  • cough; or
  • skin rash.

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 FDA at 1-800-FDA-1088.

What other drugs will affect brentuximab vedotin?

Many drugs can interact with brentuximab vedotin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with brentuximab vedotin, especially:

  • St. John's wort;
  • an antibiotic or antifungal medicine;
  • antiviral medicine to treat hepatitis, HIV, or AIDS;
  • heart medication;
  • seizure medicine; or
  • tuberculosis medications.

This list is not complete and many other drugs can interact with brentuximab vedotin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your doctor or pharmacist can provide more information about brentuximab vedotin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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