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Tysabri

Generic Name: natalizumab (nat ta LIZ yoo mab)
Brand Names: Tysabri
Tysabri is used to treat multiple sclerosis and Crohn's disease. Learn about side effects, interactions and indications.
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Drug Information:
Tysabri (natalizumab) is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Tysabri is used to treat relapsing forms of multiple sclerosis. Tysabri is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other medicines have been tried without success. Tysabri may cause serious viral infections of the brain or spinal cord that can lead to disability or death. Call your doctor right away if you have a sudden fever, severe headache, confusion, memory problems, vision changes, eye pain, weakness on one side of your body, or problems with using your arms or legs. These symptoms may start gradually and get worse quickly. Learn more

Tysabri Side Effects

Tysabri Side Effects

Note: This document contains side effect information about natalizumab. Some of the dosage forms listed on this page may not apply to the brand name Tysabri.

For the Consumer

Applies to natalizumab: intravenous solution

Warning

Intravenous route (Solution)

Natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), which may lead to death or severe disability. Risk factors for PML include therapy duration, prior immunosuppressant use, and presence of anti-JC virus antibodies. Because of the risk of PML, natalizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program. Monitor patients for any new sign or symptom that may be suggestive of PML and interrupt therapy at the first sign or symptom suggestive of PML. For diagnosis, a gadolinium-enhanced MRI scan of the brain and, if indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Along with its needed effects, natalizumab (the active ingredient contained in Tysabri) 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

  • Back, leg, or stomach pains
  • bleeding gums
  • chills
  • dark urine
  • drowsiness
  • general body swelling
  • headache
  • loss of appetite
  • nosebleeds
  • pale skin
  • seizures
  • vomiting

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

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

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

Psychiatric

Very common (10% or more): Depression (19%)

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

Immunologic

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

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

Hepatic

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

Postmarketing reports: Serious liver injuries, increased liver enzymes, hyperbilirubinemia

Other

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

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

Frequency not reported: Flushing, feeling cold, pyrexia

Local

Frequency not reported: Localized hypersensitivity reactions

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

Musculoskeletal

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

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

Dermatologic

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

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

Hypersensitivity

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

Frequency not reported: anaphylaxis/anaphylactoid reaction

Hematologic

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

Metabolic

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

Cardiovascular

Common (1% to 10%): Chest discomfort

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Tysabri (www.drugs.com/tysabri.html).