Brentuximab Side Effects

Some side effects of brentuximab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to brentuximab: intravenous powder for injection

Some people receiving a brentuximab vedotin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, itchy, or if you have a fever, chills, cough, or trouble breathing during the infusion. Infusion reactions often occur within the first 24 hours after the start of your brentuximab vedotin infusion.

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

Brentuximab vedotin increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as a change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have any of these other serious 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;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• lower back pain, blood in your urine;

• pain or burning when you urinate, urinating less than usual or not at all;

• numbness or tingling around your mouth;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting; 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.

Less serious side effects of brentuximab may include:

• tired feeling;

• stomach pain, nausea, vomiting;

• diarrhea, constipation, weight loss;

• swelling in your hands or feet;

• mild rash or itching;

• dry skin, hair loss;

• headache, dizziness, anxiety;

• muscle spasm, muscle or joint pain; or

• night sweats, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to brentuximab: intravenous powder for injection

Dermatologic

Dermatologic side effects have included rash (less than 31%), pruritus (less than 19%, alopecia (less than 14%), night sweats (less than 12%), and dry skin (less than 10%).

Gastrointestinal

Gastrointestinal side effects have included nausea (less than 42%), diarrhea (less than 36%), abdominal pain (less than 25%), vomiting (less than 22%) and constipation (less than 19%).

General

General side effects have included fatigue (less than 49%), pyrexia (less than 38%), pain (less than 28%), peripheral edema (less than 16%), and chills (less than 13%).

Hematologic

Hematologic side effects have included neutropenia (less than 55%), anemia (less than 52%), thrombocytopenia (less than 28%), and lymphadenopathy (less than 11%).

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis (less than 2%).

Metabolic

Metabolic side effects have included decreased appetite (less than 16%) and decreased weight (less than 12%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (less than 19%), myalgia (less than 17%), back pain (less than 14%), pain in extremity (less than 10%), and muscle spasms (less than 10%).

Nervous system

Nervous system side effects have included peripheral sensory neuropathy (less than 53%), headache (less than 19%), peripheral motor neuropathy (less than 16%), and dizziness (less than 16%).

Other

Other side effects have included infusion related reactions (12%) including chills, nausea, dyspnea, pruritus, pyrexia and cough.

Psychiatric

Psychiatric side effects have included insomnia (less than 16%) and anxiety (less than 11%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (less than 47%), cough (less than 25%), dyspnea (less than 19%), and oropharyngeal pain (less than 11%).

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