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Home > Drugs > Selective immunosuppressants > Tyruko > Tyruko Side Effects
Selective immunosuppressants

Tyruko Side Effects

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: parenteral concentrate for iv infusion.

Warning

  • Increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain; usually leads to death or severe disability.1 13 14 15 16

  • Risk factors include duration of therapy (e.g., >2 years), prior use of immunosuppressants, and presence of anti-JC virus (JCV) antibodies.1 When initiating and continuing treatment with natalizumab, consider these risk factors in the context of expected benefit.1

  • Because of risk of PML, available only through a restricted distribution program (TOUCH® Prescribing Program).1 2 3

  • Monitor patients during therapy for any new signs or symptoms suggestive of PML; immediately withhold the drug at first such sign or symptom.1

  • For diagnosis of PML, an evaluation that includes a gadolinium-enhanced MRI brain scan and, when indicated, CSF analysis for JC viral DNA recommended.1

REMS:

FDA approved a REMS for natalizumab to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of natalizumab and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]). (Also see Restricted Distribution Program under Dosage and Administration.)

Side effects include:

Patients with MS: Headache, fatigue, infusion-related reactions, arthralgia or extremity pain, depression, lower respiratory or urinary tract infections, gastroenteritis, rash, vaginitis, abdominal discomfort, diarrhea.

Patients with Crohn's disease: Headache, fatigue, upper respiratory infection, nausea.

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]

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