Rapivab is a prescription medicine used to treat the symptoms of Influenza. Rapivab may be used alone or with other medications.

Rapivab belongs to a class of drugs called Antivirals, Influenza; Neuraminidase Inhibitors.

It is not known if Rapivab is safe and effective in children younger than 6 months of age.

What are the possible side effects of Rapivab?

Rapivab may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• fever,
• sore throat,
• burning in your eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• new or worsening flu symptoms,
• confusion,
• hallucinations, and
• unusual thoughts or behavior

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Rapivab include:

• diarrhea,
• constipation, and
• sleep problems (insomnia)

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Rapivab. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

RAPIVAB (peramivir) is an inhibitor of influenza virus neuraminidase. The chemical name is (1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-(carbamimidoylamino)-2hydroxycyclopentanecarboxylic acid, trihydrate. The chemical formula is C₁₅H₂₈N₄O₄ • 3H₂O, representing a molecular weight of 382.45. The molecular structure is as follows:

RAPIVAB injection is a clear, colorless, sterile, isotonic solution (200 mg per 20 mL) in glass vials fitted with rubber stoppers and royal blue flip-off seals. Each mL contains 10 mg peramivir (on an anhydrous basis) in 0.9% sodium chloride solution. The pH may have been adjusted with sodium hydroxide, USP and/or hydrochloric acid, USP. The pH is 5.5 - 8.5.

DOSAGE AND ADMINISTRATION

Dosage In Acute Uncomplicated Influenza

Administer RAPIVAB within 2 days of onset of symptoms of influenza.

Adults And Adolescents (13 Years Of Age And Older)

The recommended dose of RAPIVAB in adult and adolescent patients 13 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

Pediatric Patients (2 To 12 Years Of Age)

The recommended dose of RAPIVAB in pediatric patients 2 to 12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), administered via intravenous infusion for 15 to 30 minutes.

Dosing In Patients With Renal Impairment

Significantly increased drug exposures were observed when RAPIVAB was administered to adult subjects with renal dysfunction [see CLINICAL PHARMACOLOGY]. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1 and Table 2. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see CLINICAL PHARMACOLOGY].

In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1 and Table 2) [see CLINICAL PHARMACOLOGY].

Table 1: Dosage Adjustment for Adults and Adolescents (13 years and older) with Altered Creatinine Clearance

Table 2: Dosage Adjustment for Pediatric Patients (2 to 12 years of age) with Altered Creatinine Clearance

Preparation Of RAPIVAB For Intravenous Infusion

Use aseptic technique during the preparation of RAPIVAB to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.

Follow the steps below to prepare a diluted solution of RAPIVAB:

1. Do not use if seal over bottle opening is broken or missing.
2. Visually inspect RAPIVAB for particulate matter and discoloration prior to administration.
3. Dilute an appropriate dose of RAPIVAB 10 mg/mL solution [see above] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s to a maximum volume of 100 mL.
4. Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
5. Discard any unused diluted solution of RAPIVAB after 24 hours.

Once a diluted solution of RAPIVAB has been prepared, administer immediately or store under refrigerated conditions (2° to 8°C or 36° to 46°F) for up to 24 hours. If refrigerated, allow the diluted solution of RAPIVAB to reach room temperature then administer immediately.

Drug Compatibility

RAPIVAB injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s. Do not mix or co-infuse RAPIVAB with other intravenous medications.

RAPIVAB injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing.

HOW SUPPLIED

Dosage Forms And Strengths

Each vial of RAPIVAB injection contains 200 mg per 20 mL (10 mg per mL) as a clear, colorless solution [see Storage And Handling].

Storage And Handling

RAPIVAB injection is a clear, colorless sterile, isotonic solution. Each single-use vial contains 200 mg per 20 mL (10 mg/mL) of peramivir in a clear glass vial (NDC # 61364-181-01). RAPIVAB injection is supplied in cartons containing three single-use vials (NDC # 61364-181-03).

Store vials of RAPIVAB injection in original cartons at 20° to 25°C (68° to 77°F). Excursions are permitted to 15° to 30°C (59° to 86°F).

Do not use if seal over bottle opening is broken or missing.

Manufactured for and distributed by: BioCryst Pharmaceuticals, Inc. Durham, NC 27703. Revised: Apr 2018