Brentuximab vedotin is used to treat classical Hodgkin lymphoma.

Brentuximab vedotin is also used to treat anaplastic large cell lymphoma that affects organs throughout the body (systemic) or that is confined only to the skin (primary cutaneous).

Brentuximab vedotin is sometimes given after other treatments have failed.

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

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

Brentuximab vedotin may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

Brentuximab vedotin is given as an infusion into a vein. A healthcare provider will give you this injection.

Brentuximab vedotin is usually given once every 2 to 3 weeks. Follow your doctor's dosing instructions very carefully.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Brentuximab vedotin can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Brentuximab vedotin doses are based on weight. Your dose needs may change if you gain or lose weight.

If you need surgery, tell your surgeon you currently use brentuximab vedotin. You may need to stop for a short time.

You should not be treated with brentuximab vedotin if you are allergic to it, or:

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

Tell your doctor if you have ever had:

• diabetes;

• liver disease;

• kidney disease; or

• peripheral vascular disease such as Raynaud's syndrome.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Brentuximab vedotin can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 6 months after your last dose of brentuximab vedotin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using brentuximab vedotin.

You should not breast-feed while you are using brentuximab vedotin.

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

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

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

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).

Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver right away if you feel dizzy, nauseated, chilled or feverish, or if you have itching or trouble breathing.

Brentuximab vedotin may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor if you have any of these other serious side effects, even if they occur several months after you receive brentuximab vedotin:

• 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;

• pain or burning when you urinate;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or

• 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;

• 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;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes); or

• stomach problems--severe constipation, new or worsening stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of brentuximab vedotin may include:

• numbness or tingling;

• fever;

• low blood cell counts;

• nausea, vomiting, diarrhea, constipation; or

• feeling tired.

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.

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.

Other drugs may affect brentuximab vedotin, 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.