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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 15.05.2022
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Peramivir is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.
Limitations of Use:
- Efficacy of Peramivir is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Peramivir.
- The efficacy of Peramivir could not be established in patients with serious influenza requiring hospitalization.
Peramivir injection is used to treat acute uncomplicated influenza in adults who have flu symptoms (weakness, headache, fever, cough, runny or stuffy nose, and sore throat) for no more than 2 days. Peramivir belongs to the family of medicines called antivirals, which are used to treat infections caused by viruses.
Peramivir is to be given only by or under the direct supervision of your doctor.
Dosage In Acute Uncomplicated Influenza
Administer Peramivir within 2 days of onset of symptoms of influenza. The recommended dose of Peramivir in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.
Dosing In Patients With Renal Impairment
Significantly increased drug exposures were observed when Peramivir was administered to subjects with renal dysfunction. Therefore, the Peramivir dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. No dose adjustment is required for single administration of Peramivir in patients with creatinine clearance of 50 mL/min or higher.
In patients with chronic renal impairment maintained on hemodialysis, Peramivir should be administered after dialysis at a dose adjusted based on renal function (Table 1).
Table 1. Dosage Adjustment for Patients with Altered Creatinine Clearance
Creatinine Clearance* (mL/min) | |||
≥50 | 30-49 | 10-29 | |
Recommended Dose (mg) | 600 | 200 | 100 |
* Calculated using the Cockcroft and Gault equation. |
Preparation Of Peramivir For
Intravenous Infusion
Use aseptic technique during the preparation of Peramivir 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 Peramivir:
- Do not use if seal over bottle opening is broken or missing.
- Visually inspect Peramivir for particulate matter and discoloration prior to administration.
- Dilute an appropriate dose of Peramivir 10 mg/mL solution in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s to a maximum volume of 100 mL.
- Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
- Discard any unused diluted solution of Peramivir after 24 hours.
Once a diluted solution of Peramivir 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 Peramivir to reach room temperature then administer immediately.
Drug Compatability
Peramivir injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s. Do not mix or co-infuse Peramivir with other intravenous medications. Peramivir injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing.
How supplied
Dosage Forms And Strengths
Each vial of Peramivir injection contains 200 mg per 20 mL (10 mg per mL) as a clear, colorless solution.
Storage And Handling
Peramivir 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 # 61364- 181-01). Peramivir injection is supplied in cartons containing three single-use vials (NDC # 61364-181-03).
Store vials of Peramivir 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.
Distributed by: BioCryst Pharmaceuticals, Inc. Durham, NC 27703. Revised: Aug 2016
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What is the most important information I should know about Peramivir?
Peramivir 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.
Use Peramivir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Peramivir is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
- If you miss a dose of Peramivir, call your doctor to find out what to do.
Ask your health care provider any questions you may have about how to use Peramivir.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Influenza: Treatment of acute, uncomplicated influenza in patients ≥2 years of age who have been symptomatic ≤2 days.
Limitations of use: Efficacy is based on clinical trials in which influenza A was the predominant virus; a limited number of subjects with influenza B have been studied.
Off Label Uses
Influenza (hospitalized, high-risk patients)
Data from a multicenter, double-blind study conducted in Japan suggest that daily dosing of Peramivir compared to a single dose may be beneficial (shorter duration of illness) in high-risk hospitalized patients with influenza A or B and moderate to severe symptoms. Additional data may be necessary to further define the role of daily Peramivir in hospitalized high-risk patients.
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What other drugs will affect Peramivir?
This section describes clinically relevant drug interactions with Peramivir. Drug-drug interaction studies are described elsewhere in the labeling.
Influenza Vaccines
Inactivated influenza vaccine can be administered at any time relative to use of Peramivir. For live attenuated influenza vaccine (LAIV), antiviral drugs may inhibit viral replication and thus may reduce vaccine efficacy. The concurrent use of Peramivir with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of LAIV within 2 weeks before or 48 hours after administration of Peramivir unless medically indicated.
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What are the possible side effects of Peramivir?
The following adverse reactions are discussed in other sections of the labeling:
- Serious skin and hypersensitivity reactions
- Neuropsychiatric Events
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. In five randomized, double-blind, controlled trials, 1,399 subjects with acute uncomplicated influenza received a single dose of Peramivir, administered intravenously or intramuscularly, at doses up to 600 mg. Among the 664 subjects receiving Peramivir 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 Peramivir 600 mg experienced a serious adverse event and less than 1% discontinued study because of an adverse reaction.
Clinically significant laboratory abnormalities (DAIDS Grade 2-4) listed in Table 2 occurred more frequently in subjects treated with Peramivir 600 mg (intravenous or intramuscular) than placebo. Only events occurring at ≥2% are included.
Table 2: Laboratory Abnormalities Occurring in ≥2% of Subjects Treated with Peramivir 600 mg
Laboratory Parameter Abnormality * | Peramivir 600 mg | Placebo |
Alanine Aminotransferase (> 2.5 x ULN) | (N=654) 3% | (N=430) 2% |
Serum Glucose (> 160 mg/dL) | (N=660) 5% | (N=433) 3% |
Creatine Phosphokinase (≥ 6.0 x ULN) | (N=654) 4% | (N=431) 2% |
Neutrophils (< 1.000 x109/L) | (N=654) 8% | (N=430) 6% |
* Frequencies based on treatment-emergent laboratory abnormalities |
In a subset of subjects with serious influenza requiring hospitalization treated with Peramivir 600 mg as monotherapy (N=101) the following adverse reactions were also reported more frequently with Peramivir as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).
Postmarketing Experience
The following additional adverse reactions have been identified during postapproval use of Peramivir in Japan. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic
Stevens-Johnson syndrome, exfoliative dermatitis, rash
General disorders and administration site conditions: anaphylactic/anaphylactoid reactions
Psychiatric
abnormal behavior, hallucination
Peramivir is an experimental antiviral drug being developed by Biocryst Pharmaceuticals to treat influenza A/B. The development of Peramivir is supported by the US Department of Health and Human Services as part of the government's effort to prepare for a flu pandemic. The drug has had a long history. An oral formulation was abandoned by Johnson and Johnson due to poor bioavailability. BioCryst is now developing a injectable version, in partnership with Green Cross Pharmaceuticals in South Korea and with Shionogi Pharmaceuticals in Japan. The drug is in Phase II studies.