nelfinavir (Rx)

Brand and Other Names:Viracept
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral powder for suspension

  • 50mg/1g scoopful

tablet

  • 250mg
  • 625mg

HIV Infection

750 mg PO q8hr, OR

1250 mg PO q12hr

Dosage Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment

  • Mild impairment (Child-Pugh class A): Dose adjustment not necessary
  • Severe impairment (Child-Pugh Class B or C): Not recommended

Multiple Myeloma (Orphan)

Orphan designation for treatment of multiple myeloma

Sponsor

  • Swiss Group for Clinical Cancer Research (SAKK); Effingerstrasse 33; Bern, Switzerland

Dosage Forms & Strengths

oral powder for suspension

  • 50mg/1g scoopful

tablet

  • 250mg
  • 625mg

HIV Infection

<2 years: Safety and efficacy not established

2-13 years: 45-55 mg/kg PO q12hr, OR 25-35 mg/kg PO q8hr  

Not to exceed adult dose of 2,500 mg/day (q12hr dosing) or 1,875 mg/day (q8hr dosing)

Adolescents: 1,250 mg PO q12hr, OR 750 mg PO q8hr

Also see Administration

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Interactions

Interaction Checker

and nelfinavir

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (14-20%)

            1-10%

            Nausea (3-7%)

            Flatulence (1-5%)

            Abdominal pain (1%)

            Anemia (1%)

            Allergic reaction (1%)

            Impaired concentration (1%)

            Lipodystrophy (1%)

            Metabolic acidosis (1%)

            Rash (1-3%)

            Leukopenia (1%)

            Thrombocytopenia (1%)

            Weakness (1%)

            <1%

            QTc prolongation

            Torsades de pointes

            Diabetes mellitus, new onset and exacerbation

            Hyperglycemia

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            Warnings

            Contraindications

            Hypersensitivity

            Coadministration with major CYP3A4 substrates and/or inducers

            Drugs that are contraindicated with nelfinavir include alpha1-adrenoreptor agonists (eg, alfuzosin), antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, quinidine), rifampin, voriconazole, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John’s wort, lovastatin, simvastatin, lurasidone, pimozide, sildenafil (when used for PAH), midazolam, and triazolam

            Cautions

            Risk to pregnant/ pediatric pts: EMS (ethyl methanesulfonate) impurity shown to be teratogenic, mutagenic & carcinogenic in animal studies

            Oral powder contains 11.2 mg of phenylalanine per gram of powder

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

            Caution in patients with hemophilia A or B (risk of bleeding); increased bleeding, including spontaneous skin hematomas and hemarthrosis reported with protease inhibitors; in more than half of cases, administration of protease inhibitors was continued or reintroduced

            Increased risks of fat redistribution, hemolytic anemia, hyperbilirubinemia if used in combination with other antiretroviral drugs

            Increases risk of developing new onset diabetes mellitus; exacerbation of DM & hyperglycemia

            Not for use in patients with moderate to- evere hepatic impairment

            In pediatrics, drug exposure is highly variable

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            Pregnancy & Lactation

            Pregnancy Category: B (Antiretroviral Pregnancy Registry established, register pts by calling (800) 258-4263)

            Lactation: HIV+ women are advised not to breastfeed

            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

            Protease Inhibitor; inhibits cleavage of Gag-Pol polyprotein precursors, which in turn causes the formation of immature, noninfectious viral particles.

            Pharmacokinetics

            Absorption: food increases AUC 2-3x

            Vd: 2-7 L/kg

            Protein Bound: >98%

            Metabolism: hepatic via CYP3A4 & CYP2C19; major metabolite has activity comparable to parent drug

            Half-life, plasma: 3.5-5 hr

            Peak Plasma Time: 2-4 hr

            Enzymes Inhibited: CYP3A4

            Excretion: Feces: (87%); urine: (1-2%)

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            Administration

            Oral Administration

            Mix oral powder with small amount of water, milk, formula or dietary supplement and consume entire dose

            Do not mix with acidic food or juice

            If not consumed immediately, refrigerate no more than 6 hr

            May use crushed 250 mg tablets instead of oral powder

            Take all doses with high-fat meals

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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.