Rapivab
(Peramivir)Dosage & Administration
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Rapivab Prescribing Information
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.
- Administer RAPIVAB as a single dose within 2 days of onset of influenza symptoms ()
2.1 Dosage in Acute Uncomplicated InfluenzaAdminister 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.
Pediatric Patients (6 months to 12 years of age)The recommended dosage of RAPIVAB in pediatric patients 6 months to 12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), administered via intravenous infusion for 15 to 30 minutes.
- Administer RAPIVAB by intravenous infusion for a minimum of 15 minutes ()
2.1 Dosage in Acute Uncomplicated InfluenzaAdminister 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.
Pediatric Patients (6 months to 12 years of age)The recommended dosage of RAPIVAB in pediatric patients 6 months to 12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), administered via intravenous infusion for 15 to 30 minutes.
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 patientsa
(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 Dosing in Patients with Renal ImpairmentSignificantly increased drug exposures were observed when RAPIVAB was administered to adult subjects with renal dysfunction
[see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dosage should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1 and Table 2. No dosage adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher[see Clinical Pharmacology (12.3)].In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1 and Table 2)
[see Clinical Pharmacology (12.3)].Table 1. Dosage Adjustment for Adults and Adolescents (13 Years and Older) with Altered Creatinine Clearance Creatinine Clearancea(mL/min) ≥50 30 to 49 10 to 29 aCalculated using the Cockcroft and Gault equation. Recommended Dose (mg) 600 mg 200 mg 100 mg Table 2. Dosage Adjustment for Pediatric Patients (2 to 12 Years of Age) with Altered Creatinine Clearance Creatinine Clearancea(mL/min) ≥50 30 to 49 10 to 29 aCalculated using the Cockcroft and Gault equation.bUp to maximum dose of 600 mg. Recommended Dose (mg/kg)b 12 mg/kg 4 mg/kg 2 mg/kg No data are available to inform a recommendation for dosage adjustment with RAPIVAB in pediatric patients 6 months to less than 2 years of age with creatinine clearance less than 50 mL/min
[see Use in Specific Populations (8.4, 8.6), Clinical Pharmacology (12.3)]. - Hemodialysis: Administer after dialysis ()
2.2 Dosing in Patients with Renal ImpairmentSignificantly increased drug exposures were observed when RAPIVAB was administered to adult subjects with renal dysfunction
[see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dosage should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1 and Table 2. No dosage adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher[see Clinical Pharmacology (12.3)].In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1 and Table 2)
[see Clinical Pharmacology (12.3)].Table 1. Dosage Adjustment for Adults and Adolescents (13 Years and Older) with Altered Creatinine Clearance Creatinine Clearancea(mL/min) ≥50 30 to 49 10 to 29 aCalculated using the Cockcroft and Gault equation. Recommended Dose (mg) 600 mg 200 mg 100 mg Table 2. Dosage Adjustment for Pediatric Patients (2 to 12 Years of Age) with Altered Creatinine Clearance Creatinine Clearancea(mL/min) ≥50 30 to 49 10 to 29 aCalculated using the Cockcroft and Gault equation.bUp to maximum dose of 600 mg. Recommended Dose (mg/kg)b 12 mg/kg 4 mg/kg 2 mg/kg No data are available to inform a recommendation for dosage adjustment with RAPIVAB in pediatric patients 6 months to less than 2 years of age with creatinine clearance less than 50 mL/min
[see Use in Specific Populations (8.4, 8.6), Clinical Pharmacology (12.3)]. - RAPIVAB must be diluted prior to administration ()
2.3 Preparation of RAPIVAB for Intravenous InfusionUse aseptic technique during the preparation of RAPIVAB to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.
Follow the steps below to prepare a diluted solution of RAPIVAB:
(a) Do not use if seal over bottle opening is broken or missing.(b) Visually inspect RAPIVAB for particulate matter and discoloration prior to administration.(c) Dilute an appropriate dose of RAPIVAB 10 mg/mL solution[see Dosage and Administration (2.1, 2.2)]in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's. The maximum infusion volume is provided in Table 3. The final concentration of diluted RAPIVAB for administration should be between 1 mg/mL and 6 mg/mL.Table 3. Maximum Infusion Volume by Age and Weight Age Weight (kg) Maximum Infusion Volumea(mL) aInfusion volume is the total volume of RAPIVAB 10 mg/mL solution and diluent. The final concentration of diluted RAPIVAB for administration should be between 1 mg/mL and 6 mg/mL.Infants 6 months to 1 year of age Any 25 mL Adults and pediatric patients 1 year and older 5 kg to less than 10 kg 25 mL 10 kg to less than 15 kg 50 mL 15 kg to less than 20 kg 75 mL At least 20 kg 100 mL (d) Administer the diluted solution via intravenous infusion for 15 to 30 minutes.(e) Discard any unused diluted solution of RAPIVAB after 24 hours.
Once a diluted solution of RAPIVAB has been prepared, administer immediately or store under refrigerated conditions (2° to 8°C or 36° to 46°F) for up to 24 hours. If refrigerated, allow the diluted solution of RAPIVAB to reach room temperature then administer immediately.
- See the Full Prescribing Information for drug compatibility information ()
2.4 Drug CompatibilityRAPIVAB injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's. Do not mix or co-infuse RAPIVAB with other intravenous medications.
RAPIVAB injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing.
Each vial of RAPIVAB injection contains 200 mg per 20 mL (10 mg per mL) as a clear, colorless solution
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 is supplied in cartons containing 3 single-use vials (NDC # 72769-181-03).
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).
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
Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, stillbirths, birth defects, preterm delivery, low birthweight, and small for gestational age.
Reproductive toxicity studies have been performed in rats and rabbits. In rats, peramivir was administered once daily by intravenous bolus injection at doses of 200, 400, and 600 mg/kg/day on Gestational Days 6 to 17. No treatment-related fetal toxicities were observed when peramivir was administered by intravenous bolus injection at the maximum feasible dose of 600 mg/kg, resulting in exposures approximately 8 times those in humans at the recommended dose.
Peramivir was also administered by continuous intravenous infusion to rats at daily doses of 50, 400, and 1000 mg/kg/day on Gestational Days 6 to 17. Dose related increases in the incidence of fetal abnormalities of reduced renal papilla and dilated ureters were observed at 400 and 1000 mg/kg/day. The systemic drug exposure in rats at a dose without fetal effects was less than the exposures in humans at the recommended dose.
In rabbits, peramivir was administered once daily by intravenous bolus injection at doses of 25, 50, 100, and 200 mg/kg/day on Gestational Days 7 to 19. Developmental toxicity (abortion or premature delivery) was observed at maternally toxic dose levels (100 and 200 mg/kg/day) resulting in exposures approximately 8 times those in humans at the recommended dose. The exposure in rabbits at doses without developmental toxicity was less than the exposure in humans at the recommended dose.
A pre/post-natal developmental toxicity study was performed in pregnant rats administered peramivir once daily by intravenous infusion at doses of 50, 200, 400, and 600 mg/kg/day on Gestational Day 6 through Lactation Day 20. No significant effects of peramivir on developmental outcomes were observed in nursing pups at up to the highest dose tested.
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.
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
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
- 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 Serious Skin/Hypersensitivity ReactionsRare 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)]. - 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 Neuropsychiatric EventsInfluenza 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.
There have been postmarketing reports of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including RAPIVAB. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of RAPIVAB to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.