peramivir (Rx)

Brand and Other Names:Rapivab
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 200mg/20mL (10mg/mL)
  • Dilute to recommended final volume before administering

Influenza

Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤2 days

600 mg IV as a single dose

Dosage Modifications

Renal impairment

  • CrCl ≥50 mL/min: No dosage adjustment necessary
  • CrCl 30-49 mL/min: 200 mg IV as a single dose
  • CrCl 10-29 mL/min: 100 mg IV as a single dose
  • Hemodialysis: Administer after dialysis

Dosing Considerations

Limitations of use

  • Efficacy based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled
  • Influenza viruses change over time and emergence of resistance substitutions could decrease drug effectiveness
  • Efficacy not established in patients with serious influenza requiring hospitalization

Dosage Forms & Strengths

IV solution

  • 200mg/20mL (10mg/mL)
  • Dilute to recommended final volume according to age and weight before administering

Influenza

Indicated for treatment of acute uncomplicated influenza in patients aged ≥6 months who have been symptomatic ≤2 days

<6 months: Safety and efficacy not established

≥6 months

6 months to 12 years: 12 mg/kg IV as a single dose; not to exceed 600 mg/dose

≥13 years: 600 mg IV as a single dose

Dosage Modifications

Renal impairment

  • 6 months to 2 years
    • CrCl >50 mL/min: No dosage adjustment necessary
    • CrCl <50 mL/min: Data are not available
  • 2-12 years
    • CrCl >50 mL/min: No dosage adjustment necessary
    • CrCl 30-49 mL/min: 4 mg/kg IV as a single dose
    • CrCl 10-29 mL/min: 2 mg/kg IV as a single dose
  • ≥13 years
    • CrCl >50 mL/min: No dosage adjustment necessary
    • CrCl 30-49 mL/min: 200 mg IV as a single dose
    • CrCl 10-29 mL/min: 100 mg IV as a single dose

Dosing Considerations

Limitations of use

  • Efficacy based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled
  • Influenza viruses change over time and emergence of resistance substitutions could decrease drug effectiveness
  • Efficacy not established in patients with serious influenza requiring hospitalization
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Interactions

Interaction Checker

and peramivir

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Adults

            • Diarrhea (8%)
            • Neutrophils <1 x 109/L (8%)
            • Increased serum glucose (>160 mg/dL) (5%)
            • Creatine phosphokinase (≥6 xULN) (5%)
            • Constipation (4%)
            • Insomnia (3%)
            • AST and ALT increased (3%)
            • Hypertension (2%)

            Aged 6 months to 17 years

            • Generally, similar to adults, except for following
            • Vomiting (3%)
            • Proteinuria (3%)

            Postmarketing Reports

            Dermatologic: Stevens-Johnson syndrome, exfoliative dermatitis, rash

            General disorders and administration site conditions: Anaphylactic/anaphylactoid reactions

            Psychiatric: Abnormal behavior, hallucination

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            Warnings

            Contraindications

            Known serious hypersensitivity or anaphylaxis to peramivir or any component of the product; severe allergic reactions have included anaphylaxis, erythema multiforme, and Stevens-Johnson Syndrome

            Cautions

            Serious skin reactions reported including erythema multiforme and Stevens-Johnson syndrome; discontinue and initiate appropriate treatment

            Influenza can be associated with neurologic and behavioral symptoms including hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes; postmarketing surveillance has reported delirium and abnormal behavior leading to injury in patients receiving neuraminidase inhibitors

            Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza; peramivir has not been shown to prevent such complications

            Drug interaction overview

            • Inactivated influenza vaccine: May administered at any time relative to use of peramivir
            • Live attenuated influenza vaccine (LAIV; intranasal): Antiviral drugs may inhibit viral replication and reduce vaccine efficacy; avoid LAIV within 2 weeks before or 48 hr after peramivir unless medically indicated
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            Pregnancy & Lactation

            Pregnancy

            Limited available data with use in pregnant women are insufficient to determine a drug- associated risk of adverse developmental outcomes; there are risks to the mother and fetus associated with influenza in pregnancy

            Animal studies

            • Administered during organogenesis in rats
              • Dose 8 x human recommended dose
              • Single IV bolus injection: No adverse effects observed
              • Continuous IV infusion: Reduced renal papilla and dilated ureters were observed
            • Administered in rabits
              • Administration of drug during organogenesis at exposures 8 times those in humans at recommended dose resulted in developmental toxicity (abortion or premature delivery) at a maternally toxic dose

            Lactation

            There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in rat milk limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            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

            Elicits antiviral activity by inhibiting influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells

            Absorption

            Peak plasma concentration

            • 6 months to <2 years: 38,000 ng/mL
            • 2 to <7 years: 47,400 ng/mL
            • 7 to <13 years: 61,200 ng/mL
            • 13 to <18 years: 51,500 ng/mL
            • Adults: 45,700 ng/mL

            AUC

            • 6 months to <2 years: 46,200 ng⋅h/mL
            • 2 to <7 years: 62,700 ng⋅h/mL
            • 7 to <13 years: 76,300 ng⋅h/mL
            • 13 to <18 years: 65,500 ng⋅h/mL
            • Adults: 68,500 ng⋅h/mL

            Distribution

            Protein bound: <30%

            Vd: 12.56 L

            Metabolism

            Not significantly metabolized

            It is not a substrate for CYP enzymes, does not affect glucuronidation, and is not a substrate or inhibitor of P-gp

            Elimination

            Half-life: 20 hr (single 600-mg IV dose)

            Clearance: ~90% (renal)

            Excretion: Urine ~90%

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            Administration

            IV Compatibilities

            0.9% NaCl

            0.45% NaCl

            D5W

            Lactated Ringer solution

            Compatible with materials commonly used for administration (eg, PVC bags, PVC-free bags, polypropylene syringes, polyethylene tubing)

            IV Preparation

            Contains no preservatives or bacteriostatic agents; do not use if seal over vial opening is broken or missing

            Visually inspect vial for particulate matter and discoloration

            Dilute appropriate dose in 0.9% or 0.45% NaCl, D5W, or lactated Ringer solution to final concentration of 1-6 mg/mL as recommended by age and weight

            Maximum infusion volume by age and weight

            • Infants aged 6 months to 1 year (any weight): 25 mL

            Adults and pediatric patients aged ≥1 yr

            • 5 kg to <10 kg: 25 mL
            • 10 kg to <15 kg: 50 mL
            • 15 kg to <20 kg: 75 mL
            • ≥20 kg: 100 mL

            IV Administration

            Administer IV over 15-30 minutes

            Do not mix or infuse with other IV medications

            Storage

            Unopened vials: Store in original cartons at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Diluted solution: Administer immediately or refrigerate at 2-8°C (36-46°F) for up to 24 hr

            If refrigerated, allow diluted solution to reach room temperature then administer immediately

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            Formulary

            FormularyPatient Discounts

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            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.