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Tyruko Side Effects

Generic name: natalizumab

Medically reviewed by Drugs.com. Last updated on Apr 18, 2023.

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

Applies to natalizumab: intravenous solution.

Warning

Intravenous route (Solution)

Progressive Multifocal LeukoencephalopathyNatalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.Risk factors for PML include the presence of anti-JC virus antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab.Monitor patients, and withhold natalizumab immediately at the first sign or symptoms suggestive of PML.Because of the risk of PML, natalizumab is available only through a restricted distribution program called the TOUCH® Prescribing Program.

Intravenous route (Solution)

Progressive Multifocal Leukoencephalopathy Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab-sztn. Healthcare professionals should monitor patients on natalizumab-sztn for any new sign or symptom that may be suggestive of PML. Natalizumab-sztn dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. Because of the risk of PML, natalizumab-sztn is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYRUKO REMS Program.

Serious side effects of Tyruko

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

Rare

Incidence not known

Other side effects of Tyruko

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

Less common

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]

Frequently asked questions

References

1. Product Information. Tysabri (natalizumab). Elan Pharmaceutical/Athena Neurosciences Inc. 2004.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. 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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