HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RAPIVAB safely and effectively. See full prescribing information for RAPIVAB.
RAPIVAB™ (peramivir injection), for intravenous use
Initial U.S. Approval: [2014]
INDICATIONS AND USAGE
RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. (1)
Limitations of Use:
•Efficacy based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled.
•Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1)
•Efficacy could not be established in patients with serious influenza requiring hospitalization. (1)
DOSAGE AND ADMINISTRATION
•Administer as a single dose within 2 days of onset of influenza symptoms (2.1)
•Recommended dose is 600 mg, administered by intravenous infusion for a minimum of 15 minutes (2.1)
•Renal Impairment: Recommended dose for patients with creatinine clearance 30-49 mL/min is 200 mg and the recommended dose for patients with creatinine clearance 10-29 mL/min is 100 mg (2.2)
•Hemodialysis: Administer after dialysis (2.2)
•RAPIVAB must be diluted prior to administration (2.3)
•See the Full Prescribing Information for drug compatibility information (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg in 20 mL (10 mg/mL) in a single-use vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•Serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. (5.1)
•Neuropsychiatric events: Patients with influenza may be at an increased risk of hallucinations, delirium and abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2)
ADVERSE REACTIONS
Most common adverse reaction (incidence >2%) is diarrhea (6)
To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-844-273-2327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Live attenuated influenza vaccine (LAIV), intranasal: Avoid use of LAIV within 2 weeks before or 48 hours after administration of RAPIVAB, unless medically indicated (7.1)
USE IN SPECIFIC POPULATIONS
•Pregnancy: Use if benefit outweighs risk.(8.1)
•Nursing mothers: Caution should be exercised when administered to a nursing woman. (8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Acute Uncomplicated Influenza
2.2 Dosing in Patients with Renal Impairment
2.3 Preparation of RAPIVAB for Intravenous Infusion
2.4 Drug Compatibility
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Skin/Hypersensitivity Reactions
5.2 Neuropsychiatric Events
5.3 Risk of Bacterial Infections
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Influenza Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers 8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients with Impaired Renal Function
8.7 Patients with Serious Influenza Requiring Hospitalization
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Cardiac Electrophysiology
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Acute Uncomplicated Influenza in Adults
14.2 Serious Influenza Requiring Hospit |
