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Brentuximab Side Effects

In Summary

More frequently reported side effects include: peripheral motor neuropathy. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to brentuximab: intravenous powder for solution

Along with its needed effects, brentuximab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking brentuximab:

More Common

  • Back pain
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • bone pain
  • burning, numbness, tingling, or painful sensations
  • chills
  • cough
  • difficult or labored breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • lower back or side pain
  • pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet

Less Common

  • Anxiety
  • bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cloudy urine
  • confusion
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • fainting
  • fast heartbeat
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • irregular heartbeat
  • itching
  • joint pain, stiffness, or swelling
  • muscle pain
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • severe pain in the chest
  • stomach pain
  • sudden onset of severe breathing difficulty
  • thickening of bronchial secretions
  • unusual weight gain or loss

Incidence Not Known

Some side effects of brentuximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Decreased appetite or weight
  • difficulty having a bowel movement
  • difficulty with moving
  • hair loss or thinning of the hair
  • muscle spasm or stiffness
  • night sweats
  • pain in the arms or legs
  • rash
  • trouble sleeping

Less Common

For Healthcare Professionals

Applies to brentuximab: intravenous powder for injection

Dermatologic

Very common (10% or more): Rash (up to 31%), pruritus (up to 19%), alopecia (up to 14), night sweats (up to 12%), dry skin (up to 10%)

Rare (less than 0.1%): : Stevens-Johnson syndrome (SJS) (including fatal outcomes), toxic epidermal necrolysis (including fatal outcomes)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 42%), diarrhea (up to 36%), abdominal pain (up to 25%), vomiting (up to 22%), constipation (up to 19%)

Postmarketing reports: Pancreatitis (including fatal outcomes)[Ref]

Hematologic

Very common (10% or more): Neutropenia (any grade) (up to 78%), anemia (up to 52%), thrombocytopenia (up to 41%), lymphadenopathy (up to 11%)

Postmarketing reports: Febrile neutropenia[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction[Ref]

Metabolic

Very common (10% or more): Weight decreased (up to 19%), decreased appetite (up to 11%)

Common (1% to 10%): Hyperglycemia[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 19%), myalgia (up to 17%), back pain (up to 14%), pain in extremity (up to 10%)

Common (1% to 10%): Muscle spasms[Ref]

Nervous system

Very common (10% or more): Peripheral sensory neuropathy (up to 56%), peripheral motor neuropathy (up to 23%), headache (up to 19%), dizziness (up to 16%)

Common (1% to 10%): Demyelinating polyneuropathy

Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]

Other

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

Psychiatric

Very common (10% or more): Insomnia (up to 16%), anxiety (up to 11%)[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (up to 47%), cough (up to 25%), dyspnea (up to 17%), oropharyngeal pain (up to 11%)

Postmarketing reports: Noninfectious pulmonary toxicity (including fatal outcomes)[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased

Postmarketing reports: Hepatotoxicity[Ref]

Immunologic

Very common (10% or more): Infection

Common (1% to 10%): Sepsis/septic shock, pneumonia, herpes zoster

Uncommon (0.1% to 1%): Oral candidiasis, pneumocystis jiroveci pneumonia, staphylococcal bacteremia

Postmarketing reports: Serious opportunistic infections[Ref]

Oncologic

Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Adcetris (brentuximab vedotin)." Seattle Genetics Inc, Bothell, WA.

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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