New Dosage and Delivery System for Enbrel
November 17, 2017 – Amgen has launched Enbrel Mini™ cartridges with the AutoTouch™ reusable auto-injector, a new dosage form and delivery system for Enbrel® (etanercept) injection. The new AutoTouch device and Enbrel Mini cartridges were approved by the U.S. FDA in September of 2017. AutoTouch carries an Arthritis Foundation Ease of UseSM Commendation.
The AutoTouch auto-injector is designed to allow patients to easily self-administer subcutaneous injections of prefilled Enbrel Mini single-dose prefilled cartridges, which contain 50mg/mL of Enbrel in a new formulation that was found to be associated with less injection site pain than previous versions of the drug. The AutoTouch features three injection speeds, a progress bar, and a sensor that indicates proper placement for injection. It also has an ergonomic handle created to allow ease of use for patients with limited hand strength, sound cues to indicate the proper installation of cartridges, and a needle that remains hidden during injection.
Enbrel is a tumor necrosis factor (TNF) inhibitor approved to treat chronic inflammatory conditions, including ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and rheumatoid arthritis. Recommended dosing with Enbrel Mini cartridges is one cartridge per week. Like other drugs of its type, Enbrel carries a black box warning that cautions there is a risk for severe infections, including tuberculosis (TB), and that the use of TNF inhibitors in children and teens has been associated with the development of lymphoma and other cancers. Patients should be tested for tuberculosis before starting Enbrel, and continue to be monitored for TB throughout their course of treatment, and for several months following the cessation of treatment with the drug.
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.