Biocryst Pharmaceuticals, Inc.

Biocryst Pharmaceuticals, Inc. Drugs

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  2.1 Dosage in Acute Uncomplicated Influenza

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

  The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

  2.2 Dosing in Patients with Renal Impairment

  Significantly increased drug exposures were observed when RAPIVAB was administered to subjects with renal dysfunction [see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see Clinical Pharmacology (12.3)].

  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) [see Clinical Pharmacology (12.3)].

  Table 1. Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance* (mL/min) ≥50 30-49 10-29 * Calculated using the Cockcroft and Gault equation. Recommended Dose (mg) 600 200 100

  2.3 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:

  (a) Do not use if seal over bottle opening is broken or missing. (b) Visually inspect RAPIVAB for particulate matter and discoloration prior to administration. (c) Dilute an appropriate dose of RAPIVAB 10 mg/mL solution [see Dosage and Administration (2)] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's to a maximum volume of 100 mL. (d) Administer the diluted solution via intravenous infusion for 15 to 30 minutes. (e) 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.

  2.4 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.

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