Emergency Use Authorization Issued for Treating Novel 2009 H1N1 Flu
By Melinda Young
Editor Melinda Young, Senior Managing Editor Gary Evans, Associate Publisher Coles McKagen report no financial relationships relevant to this field of study. Physician Reviewer Morris Harper, MD, reports consulting work with Agouron Pharmaceuticals, Gilead Sciences, Abbott Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb. Nurse Planner Kay Ball, RN, is a consultant and stockholder with Steris Corp. and is on the speaker's bureau for the Association of periOperative Nurses.
This article originally appeared in the June 2009 issue of AIDS Alert.
On April 26, 2009, the Acting Secretary of Health and Human Services (HHS) declared a public health emergency related to the current outbreak of "swine flu" (now designated "novel 2009 H1N1").
In response to this public health emergency, the CDC requested Emergency Use Authorization (EUA) for the use of oseltamivir (Tamiflu®) and zanamivir (Relenza®) for treatment and prophylaxis of influenza for broader populations than currently are included in the product labeling, including pediatric populations, and others who fall outside of the indicated uses.
Influenza viruses cause serious, sometimes fatal, disease in immunocompromised patients, including HIV-infected infants, toddlers, and young children.
Currently, zanamivir is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Oseltamivir is approved for the treatment and prevention of influenza in patients 1 year and older.
The EUAs allow for oseltamivir also to be used to treat and prevent influenza in children younger than 1 year, and to provide alternative dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They also may be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.
These temporary extensions of the indication, which will terminate when the emergency no longer exists, are summarized below:
1. Use of oseltamivir for treatment and prophylaxis of influenza in infants younger than 1 year of age. Oseltamivir currently is approved for use in patients 1 year of age and older. New dosing recommendations in infants younger than 1 year were based on expedited review of safety and pharmacokinetic data submitted by Roche and the Collaborative Antiviral Study Group of NIAID/NIH. In addition, age-based dose recommendations in older children were included in these new recommendations. These EUA recommendations are intended for use with Tamiflu for Oral Suspension and are shown here:
Expanded EUA Tamiflu Dose Recommendations for Treatment of Influenza in Pediatric Patients Body Weight (kg) Body Weight (lbs) Dose by Age Recommended Treatment Dose for 5 Days:
- Greater than 40 kg, greater than 88 lbs, and 10 years of age or older: 75 mg twice daily;
- Greater than 23 kg to 40 kg, greater than 51 lbs to 88 lbs, 6-9 years: 60 mg twice daily;
- Greater than 15 kg to 23 kg, greater than 33 lbs to 51 lbs, 3-5 years: 45 mg twice daily;
- 15 kg or less, 33 pounds or less, 1-2 years: 30 mg twice daily;
- Dosing for infants younger than 1 year is not based on weight: 6-11 months: 25 mg twice daily; 3-5 months: 20 mg twice daily; Less than 3 months: 12 mg twice daily.
The Tamiflu Oral Suspension bottle comes with a dispenser marked for 30, 45, or 60 mg. For children who weigh more than 40 kg (or 88 lbs) or adults who can't swallow capsules, you will need to measure out a dose of 30 mg plus another dose of 45 mg. For infants less than 1 year old, a different measuring device must be used that will dispense 2 mL (about 25 mg), 1.6 mL (about 20 mg), or 1 mL (12 mg).
Doses for prevention of the novel 2009 H1N1 are the same for each weight group but doses are administered only once per day rather than twice. Prevention dosages should be taken for 10 days following close contact with an infected person or during a community outbreak.
2. Use of oseltamivir and zanamivir in patients not included in the current labeling. These drugs are currently indicated for use in patients with acute, uncomplicated influenza who have had symptoms for less than 48 hours. The EUA allows for use of Tamiflu and Relenza in patients who have more severe influenza disease or who have been ill for longer than 48 hours based on limited published data and the understanding that the novel 2009 H1N1 may have different presentations. Depending on available products and susceptibility data, clinicians may wish to make individual risk-benefit assessments regarding the appropriate use of the products.
More detailed information about Influenza Antiviral Drugs is available on the FDA web site at http://www.fda.gov/cder/drug/antivirals/influenza/default.htm. The TAMIFLU® FACT SHEET FOR HEALTH CARE PROVIDERS contains information specific to the expanded pediatric dosing recommendations for Tamiflu.
On April 26, 2009, the Acting Secretary of Health and Human Services (HHS) declared a public health emergency related to the current outbreak of "swine flu" (now designated "novel 2009 H1N1").You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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