About the REVLIMID REMS™ program
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM).
REVLIMID is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
To avoid embryo-fetal exposure, REVLIMID is only available under a restricted distribution program called "REVLIMID Risk Evaluation and Mitigation Strategy (REMS)™" (formerly known as the RevAssist® program). Only certified prescribers can prescribe REVLIMID and only certified pharmacies can dispense REVLIMID in the REVLIMID REMS™ program.
In order to receive REVLIMID, all patients must be enrolled in the REVLIMID REMS™ program and agree to comply with the requirements of the REVLIMID REMS™ program.
Key points of the REVLIMID REMS™ program
The prescriber enrolls and becomes certified with Celgene for the REVLIMID REMS™ program
The prescriber counsels patient on benefits and risks of REVLIMID
The prescriber provides contraception and emergency contraception counseling
The prescriber verifies negative pregnancy test for all female patients of reproductive potential
The prescriber completes a REVLIMID® (lenalidomide) Patient-Physician Agreement Form with each patient and sends to Celgene
The prescriber/patient completes applicable mandatory confidential survey
The prescriber obtains an authorization number from Celgene and writes it on every prescription, along with
the patient risk category
The prescriber writes no more than a 4-week (28-day) supply, with no automatic refills or telephone prescriptions
The prescriber sends REVLIMID prescription to certified pharmacy
The pharmacy certifies with Celgene for the REVLIMID REMS™ program
The certified pharmacy must obtain a confirmation number from Celgene before dispensing
The certified pharmacy counsels the patient, and completes an Education and Counseling Checklist
The certified pharmacy dispenses REVLIMID to patient along with a Medication Guide
REVLIMID® is a registered trademark of Celgene Corporation.
REVLIMID REMS™ is a trademark of Celgene Corporation.
©2015 year of origin. Celgene Corporation, www.celgene.com.
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