Select therapeutic use:

Colorectal disorders:

Indications for TYSABRI:

In moderately-to-severely active Crohn's disease: to induce and maintain clinical response and remission in adult patients with evidence of inflammation who have had inadequate response to or are intolerant to conventional therapy and TNF-α inhibitors.

Adult Dosage:

≥18yrs: Give by IV infusion over 1hr; monitor during and for 1hr post-infusion. 300mg every 4 weeks. Discontinue after 12 weeks of induction therapy if no therapeutic response, or if unable to taper off chronic concomitant steroids within 6 months of starting therapy. May continue with aminosalicylates.

Children Dosage:

<18yrs: not established.

TYSABRI Contraindications:

Progressive multifocal leukoencephalopathy (PML).

Boxed Warning:

Progressive multifocal leukoencephalopathy.

TYSABRI Warnings/Precautions:

Increased risk of PML with longer treatment duration (>2yrs), prior treatment with immunosuppressants, and/or presence of anti-JCV antibodies. Monitor for signs/symptoms of PML; withhold if develops. Test patients for anti-JCV antibody status prior to or during treatment if status unknown; patients with negative status should be retested periodically. Reevaluate periodically (at 3 months and 6 months post-infusion, every 6 months thereafter, and for at least 6 months after discontinuation). MS: obtain MRI scan prior to initiating therapy. Risk of JCV granule cell neuronopathy; manage similarly to PML if develops. Monitor for signs/symptoms of herpes encephalitis and meningitis; discontinue and treat if occurs. Refer for retinal screening if eye symptoms develop; consider discontinuing therapy if acute retinal necrosis is confirmed. Discontinue if jaundice or liver injury occurs, or if thrombocytopenia is suspected. Immunosuppression. Monitor for infections. Vaccinations. Elderly. Pregnancy. Nursing mothers.

TYSABRI Classification:

Immunomodulator (integrin receptor antagonist).

TYSABRI Interactions:

Concomitant other immunosuppressants or TNF-α inhibitors: not recommended.

Adverse Reactions:

Headache, fatigue, arthralgia, infections, depression, pain in extremity, abdominal discomfort, diarrhea NOS, nausea, rash; immune reconstitution syndrome (monitor), hypersensitivity reactions (discontinue if occurs; do not restart), hepatotoxicity, inj site reactions, antibody formation (if persistent, may substantially reduce efficacy), changes in blood cell counts.

Note:

This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-use vial—1

Pricing for TYSABRI

15ml of 300mg/15ml vial (Qty: 1)
Appx. price $7676
GoodRx

Multiple sclerosis:

Indications for TYSABRI:

Monotherapy for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult Dosage:

≥18yrs: Give by IV infusion over 1hr; monitor during and for 1hr post-infusion. 300mg every 4 weeks.

Children Dosage:

<18yrs: not established.

TYSABRI Contraindications:

Progressive multifocal leukoencephalopathy (PML).

Boxed Warning:

Progressive multifocal leukoencephalopathy.

TYSABRI Warnings/Precautions:

Increased risk of PML with longer treatment duration (>2yrs), prior treatment with immunosuppressants, and/or presence of anti-JCV antibodies. Monitor for signs/symptoms of PML; withhold if develops. Test patients for anti-JCV antibody status prior to or during treatment if status unknown; patients with negative status should be retested periodically. Reevaluate periodically (at 3 months and 6 months post-infusion, every 6 months thereafter, and for at least 6 months after discontinuation). MS: obtain MRI scan prior to initiating therapy. Risk of JCV granule cell neuronopathy; manage similarly to PML if develops. Monitor for signs/symptoms of herpes encephalitis and meningitis; discontinue and treat if occurs. Refer for retinal screening if eye symptoms develop; consider discontinuing therapy if acute retinal necrosis is confirmed. Discontinue if jaundice or liver injury occurs, or if thrombocytopenia is suspected. Immunosuppression. Monitor for infections. Vaccinations. Elderly. Pregnancy. Nursing mothers.

TYSABRI Classification:

Immunomodulator (integrin receptor antagonist).

TYSABRI Interactions:

Concomitant other immunosuppressants: not recommended.

Adverse Reactions:

Headache, fatigue, arthralgia, infections, depression, pain in extremity, abdominal discomfort, diarrhea NOS, nausea, rash; immune reconstitution syndrome (monitor), hypersensitivity reactions (discontinue if occurs; do not restart), hepatotoxicity, inj site reactions, antibody formation (if persistent, may substantially reduce efficacy), changes in blood cell counts.

Note:

This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-use vial—1

Pricing for TYSABRI

15ml of 300mg/15ml vial (Qty: 1)
Appx. price $7676
GoodRx