Peramivir
Generic Name: peramivir
Brand Names:
Rapivab
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. The chemical formula is C 15 H 28 N 4 O 4 ∙ 3H 2 O , representing a molecular weight of 382.45.
Overview
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. The chemical formula is C 15 H 28 N 4 O 4 ∙ 3H 2 O , representing a molecular weight of 382.45.
Uses
1 INDICATIONS AND USAGE RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days. RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months 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. ( 1 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.
Dosage
2 DOSAGE AND ADMINISTRATION Administer RAPIVAB as a single dose within 2 days of onset of influenza symptoms ( 2.1 ) Administer RAPIVAB by intravenous infusion for a minimum of 15 minutes ( 2.1 ) Recommended Dosage Single Dose Adults and adolescents (13 years and older) 600 mg Pediatric patients (6 months to 12 years of age) 12 mg/kg (up to 600 mg) Recommended Dosage Adjustments in Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min) ≥50 30-49 10-29 a Up to maximum dose of 600 mg.
Side Effects
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 Warnings and Precautions (5.2) ] Most common adverse reaction (incidence >2%) is diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 drug and may not reflect the rates observed in practice.
Interactions
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) ]. 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 ) 7.1 Influenza Vaccines Inactivated influenza vaccine can be administered at any time relative to use of RAPIVAB. For live attenuated influenza vaccine (LAIV), antiviral drugs may inhibit viral replication and thus may reduce vaccine efficacy. The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated.
Warnings
5 WARNINGS AND PRECAUTIONS Cases of anaphylaxis and serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. Discontinue RAPIVAB and initiate appropriate treatment if anaphylaxis or serious skin reaction occurs or is suspected. ( 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) 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. 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, and Stevens-Johnson syndrome [see Warnings and Precautions (5.1) ] .
Pregnancy
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 with influenza in pregnancy [see Clinical Considerations ] . In animal reproduction studies, no adverse developmental effects were observed in rats when peramivir was administered by intravenous bolus injection during organogenesis at the maximum feasible dose, resulting in systemic drug exposures (AUC) approximately 8 times those in humans at the recommended dose.
Storage
Store vials of RAPIVAB injection in original cartons at 20°C to 25°C (68°F to 77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). Do not use if seal over bottle opening is broken or missing.
Frequently Asked Questions
What is Peramivir used for?▼
1 INDICATIONS AND USAGE RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days. RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months 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. ( 1 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.
What are the side effects of Peramivir?▼
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 Warnings and Precautions (5.2) ] Most common adverse reaction (incidence >2%) is diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 drug and may not reflect the rates observed in practice.
Can I take Peramivir during pregnancy?▼
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 with influenza in pregnancy [see Clinical Considerations ] . In animal reproduction studies, no adverse developmental effects were observed in rats when peramivir was administered by intravenous bolus injection during organogenesis at the maximum feasible dose, resulting in systemic drug exposures (AUC) approximately 8 times those in humans at the recommended dose.
What are the important warnings for Peramivir?▼
5 WARNINGS AND PRECAUTIONS Cases of anaphylaxis and serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. Discontinue RAPIVAB and initiate appropriate treatment if anaphylaxis or serious skin reaction occurs or is suspected. ( 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) 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. 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, and Stevens-Johnson syndrome [see Warnings and Precautions (5.1) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.