natalizumab

REMS

Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease (as monotherapy).
Moderately to severely active Crohn's disease in patients who have been unresponsive to conventional therapies, including tumor-necrosis factor inhibitors.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Concurrent use of immunosuppressants or tumor-necrosis factor inhibitors;
History of progressive multifocal leukoencephalopathy (PML).

Use Cautiously in:

Anti-JC virus (JCV) antibody positive (↑ risk of PML);
Prior use of immunosuppressants (↑ risk of PML);
OB: Neonatal thrombocytopenia and anemia may occur in newborns with in utero exposure;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: MELANOMA

EENT: acute retinal necrosis (caused by herpes simplex virus and varicella zoster virus)

GI: cholelithiasis, HEPATOTOXICITY

Hemat: immune thrombocytopenic purpura, thrombocytopenia

Neuro: depression, ENCEPHALITIS (CAUSED BY HERPES SIMPLEX VIRUS AND VARICELLA ZOSTER VIRUS), fatigue, JC virus granule cell neuronopathy, MENINGITIS (CAUSED BY HERPES SIMPLEX VIRUS AND VARICELLA ZOSTER VIRUS), PML

Misc: hypersensitivity reactions (including anaphylaxis), INFECTION, infusion-related reactions

Interactions ⬆ ⬇

Drug-drug:

↑risk of infection with immunosuppressants (avoid concurrent use).

Availability ⬆ ⬇

Solution for injection: 20 mg/mL

Route/Dosage ⬆ ⬇

Multiple Sclerosis

IV (Adults ): 300 mg every 4 wk.

Crohn's Disease

IV (Adults ): 300 mg every 4 wk; if no response after 12 wk, or if patient cannot be tapered off corticosteroid therapy after 6 mo, discontinue therapy.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to integrin receptors on non-neutrophil leukocytes, which may alter adhesion and migration characteristics involved in the crossing of activated inflammatory cells into the CNS.

Therapeutic effects:

Fewer exacerbations of relapsing MS.
Induction and maintenance of remission in Crohn's disease.

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents, gastrointestinal anti-inflammatories

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 7–15 days.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Inform patient of purpose of medication. Patients must visit their health care professional/prescriber 3 and 6 mo after first infusion and every 6 mo thereafter for follow-up exam.
REMS: Instruct patient to read the Medication Guide before starting the infusion. Natalizumab is available only through a special restricted distribution program called the TOUCH® Prescribing Program, MS-TOUCH for multiple sclerosis and CD-TOUCH for Crohn's Disease, and must be administered only to patients enrolled in this program.
Instruct patient to report symptoms of PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes), hypersensitivity reactions, hepatotoxicity (yellowing of the skin and eyes, unusual darkening of the urine, nausea, feeling tired or weak, vomiting), thrombocytopenia (easy bruising, prolonged bleeding from cuts, petechiae, abnormally heavy menstrual periods, or new bleeding from the nose or gums), or worsening of symptoms (new or sudden change in thinking, eyesight, balance, or strength or other problems) that persist over several days to health care professional immediately.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to inform all health care professionals about treatment with natalizumab.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Neonatal thrombocytopenia and anemia may occur in newborns exposed to natalizumab during pregnancy. Monitor CBC in newborns exposed to natalizumab in utero.

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Indications ⬇