Kedrab Approved for Rabies
August 25, 2017 – The U.S. FDA has approved Kedrab™ [rabies immune globulin (human)], manufactured by Kamada, to be used to provide temporary, passive protection against rabies infection when administered immediately following contact with a rabid or potentially rabid animal. Patients must also receive a full course of rabies vaccine to provide active protection following treatment with Kedrab.
Recommended dosing for Kedrab is determined by body weight. Patients receive a one-time dose of 20 IU/kg, with as much injected into and around the animal bite as possible. The remaining dose is delivered intramuscularly at sites as far from the bite as practical.
Kedrab is made from human plasma, meaning there is a limited risk that it may carry infectious agents, such as viruses. Some patients may experience allergic reactions or blood-related side effects, including blood clots or ruptured red blood cells. Live vaccines, including those for measles and polio, should not be given for at least three months following treatment with Kedrab.
Distribution will begin in early 2018.
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.