RAPIVAB Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

BioCryst Pharmaceuticals, Inc.

Λέξεις κλειδιά

72769-181

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1. Indications and Usage

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days. Limitations of Use: Efficacy of RAPIVAB is ...

2. Dosage and Administration

2.1 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 ...

3. 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 How Supplied/Storage and Handling (16)].

4. Contraindications

RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme ...

5. Warnings and Precautions

5.1 Serious Skin/Hypersensitivity Reactions Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience. Cases ...

6. Adverse Reactions

The following adverse reactions are discussed in other sections of the labeling: Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1)] Neuropsychiatric Events [see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of RAPIVAB. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not ...

7. Drug Interactions

This section describes clinically relevant drug interactions with RAPIVAB. Drug-drug interaction studies are described elsewhere in the labeling [see Clinical Pharmacology (12.3)]. 7.1 Influenza ...

8. Use in Specific Populations

8.7 Patients with Serious Influenza Requiring Hospitalization The use of RAPIVAB was not shown to provide benefit in patients with serious influenza requiring hospitalization [see Indications and Usage ...

8.1. Pregnancy

Risk Summary Limited available data with RAPIVAB 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 ...

8.2. Lactation

Risk Summary There are no data on the presence of RAPIVAB in human milk, the effects on the breastfed infant, or the effects on milk production. Peramivir is present in rat milk [see Data]. Limited ...

8.4. Pediatric Use

The safety and effectiveness of RAPIVAB for the treatment of influenza has been established in pediatric patients 2 to 17 years of age. Use of RAPIVAB for this indication is supported by evidence from ...

8.5. Geriatric Use

Clinical trials of RAPIVAB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not ...

8.6. Renal Impairment

A reduced dose of RAPIVAB is recommended for patients with creatinine clearance below 50 mL/min [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. Dose adjustment is not required ...

10. Overdosage

There is no human experience of acute overdosage with RAPIVAB. Treatment of overdosage with RAPIVAB should consist of general supportive measures including monitoring of vital signs and observation of ...

11. 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)-2-hydroxycyclopentanecarboxylic acid, trihydrate. ...

12. Clinical Pharmacology

12.2 Cardiac Electrophysiology At twice the maximum recommended dose, RAPIVAB did not prolong the QTc interval to any clinically relevant extent.

12.1. Mechanism of Action

Peramivir is an antiviral drug with activity against influenza virus [see Microbiology (12.4)].

12.3. Pharmacokinetics

The pharmacokinetics of RAPIVAB was evaluated in Phase 1 trials in adults. The pharmacokinetic parameters following intravenous administration of RAPIVAB (0.17 to 2 times the recommended dose) showed a ...

12.4. Microbiology

Mechanism of Action Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells. The median neuraminidase inhibitory activities ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies by intravenous injection of peramivir were not performed. However, in an oral carcinogenicity study in Sprague-Dawley rats no drug-related neoplasms were observed ...

13.2. Animal Toxicology and/or Pharmacology

Peramivir caused renal tubular necrosis and abnormal renal function in rabbits. Toxicities included tubular dilatation and necrosis with protein casts in cortical areas, dilated tubules with mineralization ...

14. Clinical Studies

14.1 Acute Uncomplicated Influenza in Adults Study 621 was a randomized, multicenter, blinded trial conducted in Japan that evaluated a single intravenous administration of RAPIVAB 300 mg, RAPIVAB 600 ...

16.1. How Supplied

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 # 72769-181-01). RAPIVAB injection ...

16.2. Storage and Handling

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. ...

17. Patient Counseling Information

Advise patients of the following: There is a risk of severe allergic reactions (including anaphylaxis) or serious skin reactions with RAPIVAB use. Advise patients to seek immediate medical attention if ...