Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 300mg/15mL
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Multiple Sclerosis

Indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations; when initiating and continuing treatment, physicians should consider whether expected benefit is sufficient to offset risk of PML

300 mg IV infusion over 1hr q4Weeks

Crohn Disease

Indicated for moderate-to-severe Crohn disease in adults who had inadequate/intolerent response to conventional treatment and TNF-alpha inhibitors

300 mg IV q4wk; infuse over 1 hr

Dosing Considerations

No information on safety/efficacy in chronic progressive multiple sclerosis

Because natalizumab increases risk of progressive multifocal leukoencephalopathy (PML), it is recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy

Additional or previous immunosuppressive therapy increases risk for PML; therefore, do not administer concomitantly with immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or TNF-alpha inhibitors

See Black Box Warnings

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and natalizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abdominal discomfort

            Arthralgia

            Depression

            Fatigue

            Headache

            Lower respiratory infection

            UTI

            1-10%

            Abnnormal LFTs

            Allergic reaction

            Chest discomfort

            Dermatitis

            Gastroenteritis

            Local bleeding

            Menstrual disorder

            Pruritus

            Rash

            Rigors

            Syncope

            Tonsillitis

            Tremor

            Urinary urgency/frequency

            Vaginitis

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            Warnings

            Black Box Warnings

            Increased risk of progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain caused by the JC virus in immunocompromised patients that usually leads to death or severe disability

            Immune reconstitution inflammatory syndrome may occur in patients who have developed PML; IRIS is a rare condition characterized by severe inflammatory response

            Because of the risk of PML, natalizumab is available only through a special restricted distribution program; prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program, are able to prescribe, distribute, or infuse the product to patients who are enrolled in and meet all the conditions of the TOUCH Prescribing Program

            Healthcare professionals should monitor patients on natalizumab for any new sign or symptom that may be suggestive of PML

            Withhold dose immediately at the first sign or symptom suggestive of PML

            For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended

            Consider assessing anti-JCV antibody status prior to treatment or during treatment if antibody status is unknown; the Stratify JCV Antibody ELISA test (Focus Diagnostics) was cleared by FDA on January 20, 2012

            Factors known to increase risk of PML in natalizumab-treated patients

            • Longer treatment duration, especially beyond 2 years
            • Prior treatment with an immunosuppressant (eg, mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate)
            • Presence of anti-JCV antibodies
            • Patients with all 3 known risk factors have an estimated risk of PML of 11/1,000
            • The risks and benefits of continuing treatment with natalizumab should be carefully considered in patients who are found to be anti-JCV antibody positive and have 1 or more additional risk factors
            • PML has been reported following discontinuation in patients who did not have findings suggestive of PML at the time of discontinuation; continue to monitor for any new signs or symptoms that may be suggestive of PML for ~6 months following discontinuation

            Contraindications

            Hypersensitivity

            Active/history of progressive multifocal leukoencephalopathy

            Cautions

            Increased risk of PML with prolonged duration of therapy, prior treatment with immunosuppressants, or positive anti-JCV antibody status (see Black Box Warnings)

            Do not use with other immunosuppressives; may increase the risk for certain infections; monitor patients for development of infections

            Possibility of anaphylactic reaction; observe patients during and for 1 hr after infusion to see if symptoms of hypersensitivity-type reactions develop

            Increased risk of developing encephalitis and meningitis caused by HSV and VZV; serious, life-threatening, and sometimes fatal cases reported; discontinue therapy if this occurs and treat appropriately

            Severe hepatic injury reported as early as 6 days following therapy initiation, including markedly elevated LFTs and bilirubin; discontinue in patients with jaundice or with significant liver injury

            After plasma exchange, wait at least two weeks to test for anti-JCV antibodies to avoid false negative test results caused by the removal of serum antibodies; after infusion of intravenous immunoglobulin (IVIg), wait at least 6 months (5 half-lives) for the IVIg to clear in order to avoid false positive anti-JCV antibody test results

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant humanized monoclonal antibody that binds to the α4-subunit of α4β1 and α4β7 integrins, prevents leukocyte-endothelial adhesion and leukocyte extravasation

            Absorption

            Peak plasma concentration: 64-132 mcg/mL

            Distribution

            Vd: 5.7 L (multiple sclerosis); 5.2L (Crohn disease)

            Elimination

            Half-Life: 7-15 days (multiple sclerosis); 3-17 days (Crohn disease)

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            Administration

            IV Preparation

            Concentrate is a colorless opalescent solution

            Visually inspect for particulate matter or discoloration - do not use if either present

            Withdraw the 15 mL concentrate from the vial and dilute in 100 mL 0.9% NaCl; no other diluent should be used

            Gently invert to mix - do not shake

            Make sure no particulate matter is present

            After dilution, use immediately or within 8 hr (keep refrigerated at 2-8°C)

            If refrigerated, warm before using

            Do not freeze

            IV Administration

            Infuse over 1 hr

            After infusion is complete flush with 0.9% NaCl

            Do not coadminister any other drugs either through Y-site or dissolved in same solution

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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