FDA Approves New Pediatric Indication for Emend Capsule
September 2, 2015 – The U.S. Food and Drug Administration (FDA) approved the capsule form of Emend (aprepitant) which is an antiemetic (anti-nausea) for a new pediatric indication. Emend capsules were previously approved for adults only, Manufactured by Merck, Emend is a substance P/neurokinin 1 (NK-1) inhibitor indicated to prevent both immediate (acute) and late (delayed) chemotherapy-induced nausea and vomiting (CINV).
Emend capsules are now the only NK-1 inhibitor approved for use by children 12 years of age and older or children under 12 years who weigh 30kg (about 66 pounds) or more. However, the use of Emend’s intravenous (IV) formulation remains limited to adult patients. Emend capsules are available in three strengths, 125mg, 80mg and 40mg and should be taken once a day for the first three days of each chemotherapy cycle – 125mg on Day 1 and 80mg on Days 2 and 3 – in combination with dexamethasone and a 5HT3 inhibitor. The use of dexamethasone (or another corticosteroid) in children is optional.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.