Rituxan Hycela Approved
June 22, 2017 – The U.S. FDA has approved Rituxan Hycela™ (rituximab and hyaluronidase human), manufactured by Genentech. Rituxan Hycela is a new combination product indicated to treat previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated chronic lymphocytic leukemia. Rituxan Hycela is not approved for the treatment of non-malignant conditions, such as rheumatoid arthritis and severe forms of vasculitis, such as Wegener’s Granulomatosis and Microscopic Polyangiitis.
Rituxan Hycela is a combination of Genentech’s Rituxan® (rituximab), an infused monoclonal antibody that targets CD20 receptors on cancerous and normal B-cells, and Halozyme’s Hylenex® (hyaluronidase human), an enzyme that helps the absorption of rituximab from the subcutaneous tissue. Rituxan Hycela is delivered by subcutaneous injection, and will be available in two single-dose vial sizes (120mg rituximab/2,000 Units hyaluronidase human per mL). The 11.7mL single-dose vial will have 1,400mg rituximab/23,400 Units hyaluronidase human, and the 13.4mL single-dose vial will contain 1,600mg rituximab/26,800 Units hyaluronidase human.
Patients can use Rituxan Hycela only after they have received at least one full dose of a rituximab product by intravenous infusion. While both products are administered by a healthcare professional, treatment with Rituxan Hycela can be administered in five to seven minutes, compared to the 1.5 hours or more required for intravenous Rituxan.
The new formulation is expected to be available in late June or early July of 2017.
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.