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Natalizumab Side Effects

For the Consumer

Applies to natalizumab: intravenous solution

Along with its needed effects, natalizumab 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 natalizumab:

More Common

  • Body produces substance that can bind to drug making it less effective or cause side effects
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

Rare

  • Blurred vision
  • changes in behavior
  • chest pain
  • confusion
  • difficult or labored breathing
  • faintness or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • feeling unusually cold
  • fever
  • gaseous abdominal or stomach pain
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • shivering
  • sneezing
  • sore throat
  • stomach fullness
  • sweating
  • thoughts of killing oneself
  • yellow eyes or skin

Incidence Not Known

Some side effects of natalizumab 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

  • Bladder pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • cracked, dry, scaly skin
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • discouragement
  • feeling sad or empty
  • frequent, strong, or increased urge to urinate
  • irregular menstruation
  • irritability
  • itching of the vagina or genital area
  • loss of interest or pleasure
  • lower back or side pain
  • muscle pain or stiffness
  • pain during sexual intercourse
  • pain in the joints
  • pain, cramps, or heavy bleeding
  • passing urine more often
  • stomach soreness or discomfort
  • swollen glands
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble concentrating
  • trouble sleeping

Less Common

  • Absent, missed, or irregular menstrual periods
  • chest discomfort
  • fainting
  • local bleeding
  • shakiness in the legs, arms, hands, or feet
  • stopping of menstrual bleeding
  • trembling or shaking of the hands or feet

For Healthcare Professionals

Applies to natalizumab: intravenous concentrate

Ocular

Frequency not reported: Acute retinal necrosis (ARN), blindness, decreased visual acuity, redness, eye pain[Ref]

Nervous system

Very common (10% or more): Headache (38%)

Common (1% to 10%): Vertigo, somnolence, tremor, dizziness

Uncommon (0.1% to 1%): Progressive multifocal leukoencephalopathy (PML)

Frequency not reported: Tremor[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (22%), lower respiratory tract infection (17%)

Common (1% to 10%): Pharyngolaryngeal pain, cough, sinusitis, nasopharyngitis[Ref]

Psychiatric

Very common (10% or more): Depression (19%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (17%), gastroenteritis (11%), abdominal discomfort (11%), diarrhea (10%)

Common (1% to 10%): Dyspepsia, constipation, flatulence, aphthous stomatitis, tooth infection, tonsillitis

Frequency not reported: Vomiting[Ref]

Immunologic

Very common (10% or more): Influenza-like illness (12%)

Common (1% to 10%): Herpes, tonsillitis, viral infection, immunogenicity[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function test

Postmarketing reports: Serious liver injuries, increased liver enzymes, hyperbilirubinemia[Ref]

Other

Very common (10% or more): Fatigue (27%)

Common (1% to 10%): Tooth infections, toothache, rigors

Frequency not reported: Flushing, feeling cold, pyrexia[Ref]

Local

Frequency not reported: Localized hypersensitivity reactions[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (21%), vaginitis (10%)

Common (1% to 10%): Irregular menstruation, dysmenorrhea, amenorrhea, ovarian cyst, urinary incontinence, urinary urgency/frequency[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (19%), pain in extremity (16%), back pain (12%)

Common (1% to 10%): Rigors, muscle cramp, joint swelling[Ref]

Dermatologic

Very common (10% or more): Rash (12%)

Common (1% to 10%): Dermatitis, pruritus, night sweats, dry skin, urticaria[Ref]

Hypersensitivity

Common (1% to 10%): Immediate or delayed hypersensitivity reactions, seasonal allergy

Frequency not reported: anaphylaxis/anaphylactoid reaction[Ref]

Hematologic

Rare (less than 0.1%): Anemia, hemolytic anemia[Ref]

Metabolic

Common (1% to 10%): Weight increased, weight decreased, peripheral edema[Ref]

Cardiovascular

Common (1% to 10%): Chest discomfort[Ref]

References

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

2. "Product Information. Tysabri (natalizumab)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.

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

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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