TREAT ACUTE UNCOMPLICATED INFLUENZA IN 15-30 MINUTES1

The first full-course antiviral influenza therapy in a single intravenous dose approved for people 2 years and older.1

Ordering Information

Deliver full-course influenza therapy to patients in your care with RAPIVAB.

in a study, up to 55%

of adults were noncompliant when prescribed an oral antiviral medication3

Nearly 75%

of adults are nonadherent — from not filling prescriptions to taking fewer than the recommended dosages3

nearly one third

of patients stop taking their medicine earlier than instructed3

When oral influenza therapy is not appropriate, consider RAPIVAB.

Review RAPIVAB information here.

RAPIVAB is the first full course of antiviral influenza therapy in a single intravenous dose. RAPIVAB is FDA approved for people aged 2 and older and helps to treat acute uncomplicated influenza with just one 15- to 30-minute IV infusion.1

RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days.

  • 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. RAPIVAB injection is supplied in cartons containing 3 single-use vials.

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.

Ask about RAPIVAB® today.

Please call customer service at (855) 358-8966 for more information.

Please call customer service at (855) 358-8966 to order RAPIVAB® today

Important Safety Information

INDICATIONS

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.

LIMITATIONS OF USE

  • Efficacy of RAPIVAB 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 RAPIVAB.
  • The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization.

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.

WARNINGS AND PRECAUTIONS

  • 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.
  • 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. There have been postmarketing reports (from Japan) 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. The contribution of RAPIVAB to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.
  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. RAPIVAB has not been shown to prevent such complications.

ADVERSE REACTIONS

The most common adverse reaction in adults(18 years of age and older) was diarrhea (8% RAPIVAB vs 7% placebo). Lab abnormalities (incidence ≥ 2%) occurring more commonly with RAPIVAB than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose > 160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils < 1.0 x 109/L (8% vs 6%). In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).

The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated with RAPIVAB (occurring in >2% of subjects) and not reported in adults included vomiting (3% versus 9% for oseltamivir), fever and tympanic membrane erythma (2% versus 0%, respectively, for each of these events). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in >2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).

CONCURRENT USE WITH LIVE ATTENUATED INFLUENZA VACCINE

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV). The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of RAPIVAB within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

Please see full prescribing information for RAPIVAB.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates.

References

1. RAPIVAB [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc, 2018. 2. Singer AC, Järhult JD, Grabic R, et al. Compliance to oseltamivir among two populations in Oxfordshire, United Kingdom affected by influenza A(H1N1)pdm09, November 2009-a waste water epidemiology study. PLoS One. 2013; 8(4):e60221. 3.Improving prescription medicine adherence is key to better health care. PhRMA website. http://phrma.org/sites/default/files/pdf/PhRMA_Improving%20Medication%20Adherence_Issue%20Brief.pdf .Published January 2011. Accessed October 17, 2016.

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