Intelence Receives Expanded Pediatric Indication
July 16, 2018 – The U.S FDA has approved an expanded pediatric indication for Intelence® (etravirine) tablets, manufactured by Janssen. The drug, previously indicated for use in adults and children at least six years of age, may now be used to treat children as young as two years of age. Intelence is approved to treat HIV-1 infection in treatment-experienced individuals, in conjunction with other antiretrovirals.
In a clinical trial to assess product safety and efficacy in the new age group, patients received Intelence along with a ritonavir-boosted protease inhibitor, one to two nucleoside reverse transcriptase inhibitors (NRTIs), and/or an integrase inhibitor. Study participants had confirmed HIV-1 RNA plasma viral loads of greater than 1000 copies/mL, and a history of virologic failure while on an antiretroviral regimen. By Week 24, 88% of patients had achieved a viral load of less than 400 HIV-1 RNA copies/mL.
Intelence is available in 25mg, 100mg, and 200mg dosage strengths, and can be dissolved in water for patients who are unable to swallow tablets. It should be taken after a meal, with recommended dosing based on weight in patients under 18 years of age. Recommended dosing for adults is 200mg twice daily.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.