Rapivab(peramivir injection)获美国食品药品管理局FDA批准抗病毒药物Rapivab用于治疗成年流感患者。Rapivab是BioCryst制药公司研制的一种神经氨酸苷酶抑制剂（NI）。它是FDA批准的第三种治疗流感的NI. 
RAPIVAB Rx 
Pharmacological Class:
Neuraminidase inhibitor.

Active Ingredient(s):
Peramivir 10mg/mL; per vial; solution for IV injection after dilution; preservative-free.

Company
BioCryst Pharmaceuticals, Inc.
Indication(s):
Treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤2 days. Limitations of use: Efficacy based on predominantly influenza A virus infections; limited number of influenza B virus subjects enrolled. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. Efficacy not established in serious influenza requiring hospitalization.

Pharmacology:
Peramivir inhibits influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells. The antiviral activity of peramivir against laboratory strains and clinical isolates of influenza virus was determined in cell culture. The concentrations of peramivir required for inhibition of influenza virus in cell culture varied depending on the assay method used and the virus tested.

The relationship between the antiviral activity in cell culture, inhibitory activity in the neuraminidase assay, and the inhibition of influenza virus replication in humans has not been established.

Clinical Trials:
Study 621 was a randomized, multi-center, blinded trial conducted in Japan that eva luated a single IV administration of Rapivab 300mg, 600mg, or placebo given over 30 minutes in patients 18–65 years of age with acute uncomplicated influenza. Treatment was initiated within 48 hours of onset of symptoms.

The primary endpoint, time to alleviation of symptoms, was defined as the number of hours from study drug initiation until the start of the 24-hour period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, headache, feverishness, myalgia, and fatigue) were either absent or present at a level no greater than mild for at least 21.5 hours.

Overall, patients receiving Rapivab 600mg experienced alleviation of their combined influenza symptoms a median of 21 hours earlier than those receiving placebo. The median time to recovery to normal temperature (<37°C) in the Rapivab 600mg group was about 12 hours earlier as compared with placebo.

Study 301 was a randomized, double-blind, multi-center, placebo-controlled trial in patients with serious influenza requiring hospitalization (n=398). Patients were randomized to receive Rapivab 600mg daily for 5 days plus standard of care (which could include other neuraminidase inhibitors [eg, oseltamivir]) vs. placebo plus standard of care within 72 hours of symptom onset.

The primary endpoint was time to clinical resolution defined as the time in hours from initiation of study treatment until resolution of at least 4 of 5 signs (temperature, oxygen saturation, respiration rate, heart rate, or systolic blood pressure), maintained for at least 24 hours. Rapivab plus standard of care did not improve median time to clinical resolution compared with standard of care alone.

For more clinical trial data, see full labeling.

Legal Classification:
Rx

Adults:
Start within 2 days of symptom onset. Give as IV infusion over 15–30 minutes. ≥18 years: 600mg as a single dose. Renal impairment (CrCl 30–49mL/min): 200mg; (CrCl 10–29mL/min): 100mg; (on hemodialysis): administer after dialysis.

Children:
<18 years: not established.

Warnings/Precautions:
Serious skin/hypersensitivity reactions (eg, erythema multiforme, Stevens-Johnson syndrome): treat as appropriate if occur or is suspected. Monitor closely for signs of abnormal behavior. Risk of secondary bacterial infections; treat as appropriate. Pregnancy (Category C). Nursing mothers.

Interaction(s)
Do not administer live attenuated influenza vaccine within 2 weeks prior or 48 hours after treatment.

Adverse Reaction(s)
Diarrhea; neuropsychiatric events (eg, hallucinations, delirium, abnormal behavior); serious skin reactions.

How Supplied:
Single-use vials (20mL)—3

LAST UPDATED:
3/19/2015