New Indication for Enbrel
November 4, 2016 - The US FDA approved a new indication for Enbrel® (etanercept) injection Enbrel has become the first biological anti-inflammatory drug indicated to treat moderate-to-severe chronic plaque psoriasis among teens and children as young as four years of age. Enbrel is a tumor necrosis factor (TNF) inhibitor, manufactured by Amgen, and was first FDA approved in 1998 for treating adults who have rheumatoid arthritis (RA). Six years later, it received an indication to treat adults with moderate-to-severe plaque psoriasis. According to the Psoriasis Research Institute, approximately 30% to 45% of psoriasis patients are children and adolescents. For adults with psoriasis, the recommended dose is 50mg, injected subcutaneously (SQ) once a week. Enbrel dosing for patients between four and 17 years of age is based on their weight (0.8mg/Kg/week SQ), with a weekly limit of 50mg. Enbrel’s labeling carries a boxed warning that using it may be associated with severe infections and that patients should be checked for tuberculosis (TB) before beginning it, while undergoing therapy and for several months after Enbrel treatment ends. All recommended vaccinations should be given before treatment with it Enbrel starts. Additionally, some children and teens who used Enbrel or drugs like it developed lymphoma or other forms of cancer. Enbrel is supplied in multi-dose vials as well as in two prefilled forms -- syringes and SureClick® auto-injectors. Among its other indications are treating ankylosing spondylitis, polyarticular juvenile arthritis and psoriatic arthritis.
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
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.