Taltz Receives New Indication
December 1, 2017 – The U.S. FDA has approved a new indication for Taltz® (ixekizumab) injection, manufactured by Eli Lilly. Taltz is now approved for use as either a monotherapy or in conjunction with a conventional disease-modifying antirheumatic drug (cDMARD), such as methotrexate, to treat adult patients who have psoriatic arthritis (PsA).
Recommended dosing under the new indication for patients with psoriatic arthritis alone is 160mg delivered once in the first week, and 80mg once every four weeks thereafter. If the patient also has plaque psoriasis, recommended dosing is 160mg taken once in the first week, then 80mg taken once every two weeks through Week 12; subsequent doses should be taken once every four weeks. Taltz is delivered via subcutaneous injection, and is available in single-use, prefilled autoinjectors and syringes containing 80mg of the drug each. Patients can self-administer Taltz once they have been instructed on proper techniques by a qualified healthcare professional.
Patients should be tested for tuberculosis before beginning Taltz, as use of the medication may increase their risk of infection.
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.