Peramivir

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

• 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.ICD-10: J11.1

• 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) ] .contraindicated

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. Adults and adolescents (13 years and older) 600 mg 200 mg 100 mg Pediatric patients a (2 to 12 years of age) 12 mg/kg 4 mg/kg 2 mg/kg No recommendation for dosage adjustment can be made for pediatric patients 6 months to less than 2 years of age with creatinine clearance less than 50 mL/min ( 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 ) 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 dosage of RAPIVAB in adult and adolescent patients 13 years of age and older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

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. Cases of anaphylaxis and Stevens-Johnson syndrome have been reported in postmarketing experience with RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to RAPIVAB [see Contraindications (4) , Adverse Reactions (6.2) ]. 5.2 Neuropsychiatric Events Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur in uncomplicated influenza as well.

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. Adverse Reactions in Adults (18 years of age and older) In 5 randomized, double-blind, controlled trials, 1,399 subjects with acute uncomplicated influenza received a single dose of RAPIVAB, administered intravenously or intramuscularly, at doses up to 600 mg. Among the 664 subjects receiving RAPIVAB 600 mg (intravenous or intramuscular), the most commonly observed adverse reaction was diarrhea, occurring at a rate of 8% versus 7% in subjects receiving placebo. No subject receiving RAPIVAB 600 mg experienced a serious adverse event and <1% discontinued study because of an adverse reaction. Clinically significant laboratory abnormalities (DAIDS Grades 2 to 4) listed in Table 4 occurred more frequently in subjects treated with RAPIVAB 600 mg (intravenous or intramuscular) than placebo. Only events occurring at ≥2% are included.

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. However, when peramivir was administered to rats by continuous intravenous infusion during the same gestation period, fetal abnormalities of reduced renal papilla and dilated ureters were observed. In rabbits, administration of peramivir during organogenesis at exposures 8 times those in humans at the recommended dose resulted in developmental toxicity (abortion or premature delivery) at a maternally toxic dose [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

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 linear relationship between dose and exposure parameters (C max and AUC).

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 the clinical status of the patient. There is no specific antidote for overdose with RAPIVAB. RAPIVAB is cleared by renal excretion and can be cleared by hemodialysis.

• Dec 19, 2014NDANDA206426Biocryst

1. 1Off Label Use2214%
2. 2Drug Ineffective2013%
3. 3Drug Resistance159.7%
4. 4Condition Aggravated106.5%
5. 5Pneumonia95.8%
6. 6Acute Kidney Injury85.2%
7. 7Multiple Organ Dysfunction Syndrome85.2%
8. 8Dysbiosis74.5%
9. 9Intestinal Obstruction74.5%
10. 10Maternal Exposure During Pregnancy74.5%
11. 11Muscular Weakness74.5%
12. 12Viral Load Increased74.5%
13. 13Acute Respiratory Distress Syndrome63.9%
14. 14Influenza63.9%
15. 15Pathogen Resistance63.9%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Peramivir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
  Withdrawn · Phase 3 · Interventional · 0 enrolled · BioCryst Pharmaceuticals
  NCT01224795updated 2026-06-10
• Intramuscular Peramivir for the Treatment of Uncomplicated Influenza
  Withdrawn · Phase 3 · Interventional · 0 enrolled · BioCryst Pharmaceuticals
  NCT00486980updated 2026-06-01
• A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
  Recruiting · Phase 2 · Interventional · 3,000 enrolled · University of Oxford
  NCT05648448updated 2026-04-14
• A/Texas Flu Challenge
  Recruiting · Phase 1 · Interventional · 50 enrolled · Emory University
  NCT06753474updated 2026-03-03
• Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
  Completed · Phase 3 · Interventional · 137 enrolled · BioCryst Pharmaceuticals
  NCT02369159updated 2021-03-23
• Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
  Completed · Phase 3 · Interventional · 74 enrolled · BioCryst Pharmaceuticals
  NCT02635724updated 2021-03-23
• Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza
  Terminated · Phase 3 · Interventional · 82 enrolled · BioCryst Pharmaceuticals
  NCT00610935updated 2021-03-17
• Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
  Completed · Phase 3 · Interventional · 363 enrolled · Hoffmann-La Roche
  NCT03684044updated 2021-01-06
• ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
  Completed · Phase 4 · Interventional · 180 enrolled · Johns Hopkins University
  NCT02609399updated 2019-10-04
• Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy
  Withdrawn · Observational · 0 enrolled · Midwestern University
  NCT01146353updated 2018-03-20

Frequently asked questions

How does Peramivir work?

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

What is Peramivir used for?

According to FDA labeling, Peramivir carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Peramivir?

Peramivir is classified as Neuraminidase inhibitors, Neuraminidase Inhibitor, Neuraminidase Inhibitors, Cellular Activity Alteration.

What are the brand names for Peramivir?

Peramivir is marketed under brand names including Rapivab.

What are the contraindications for Peramivir?

Peramivir labeling lists contraindications including: 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) ] .. Always consult the full prescribing information and a clinician.