Symfi Approved to Treat HIV
April 6, 2018 – The U.S. FDA has approved Symfi™ (efavirenz 600mg/lamivudine 300mg/tenofovir disoproxil fumarate 300mg), manufactured by Mylan, to treat HIV-1 in adults and pediatric patients who weigh at least 40kg (88lbs). Mylan received approval for a similar product, Symfi Lo™, in March to treat HIV-1 in patients who weigh at least 35kg (77lbs).
Both Symfi and Symfi Lo are expected to launch during the second quarter, along with a third HIV medication from Mylan, Cimduo™ (lamivudine 300mg/tenofovir disoproxil fumarate 300mg), also approved in March. Although the products are similar to brand name medications already on the market, they are not considered generics. However, they are expected to be priced lower than most other brand name HIV drugs currently on the market.
Recommended dosing with Symfi is one tablet per day. The medication carries a black box warning that discontinuing treatment with two of its components, lamivudine and tenofovir disoproxil fumarate, can reactivate hepatitis B virus (HBV) in patients who are co-infected with HIV and HBV. Healthcare providers should test patients for HBV before, during, and after treatment with Symfi.
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.