Treating multiple myeloma with REVLIMID REVLIMID® (lenalidomide) is a prescription medicine, used to treat people with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). Attachment 1: Product information for AusPAR Lenalidomide (Revlimid) Celgene Pty Ltd PM-2014-02792-1-4 Final 5 February 2016. This Product Information was approved at the time this AusPAR was published. Revlimid® (lenalidomide) capsules Product Information Teratogenic Effects: Revlimid (lenalidomide) is structurally related to thalidomide. Lenalidomide (Revlimid®) is used to treat adult patients with certain types of blood cancers, including mantle cell lymphoma, multiple myeloma, and myelodysplastic syndrome. It may be used in combination with another medication, dexamethasone. REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide REVLIMID is only available through a restricted distribution program, REVLIMID REMS®. WARNING: REVLIMID can cause harm to an unborn baby, blood clots, and low blood cell counts. Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, for REVLIMID, and Important Safety Information on pages ?-??. Revlimid® (lenalidomide), an immunomodulatory drug (IMiD®), is the first oral medication that was developed for treatment of multiple myeloma. It is used in the newly diagnosed, maintenance therapy, and relapsed and/or refractory settings. Revlimid 2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 15 mg/ 20 mg/ 25 mg hard capsules Pack size of 7 or 21 capsules. Not all pack sizes may be available. 6.6 Special precautions for disposal and other handling Capsules should not be opened or crushed. If powder from lenalidomide makes contact with the skin, the Revlimid is only available through the Revlimid REMS program [see Warnings and Precautions (5.2)]. Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning Revlimid therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. and full Prescribing Information, including Boxed WARNINGS, for REVLIMID. The REVLIMID REMS® program Indications REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM). 1. REVLIMID [package insert]. Summit, NJ: Celgene Corporation; 2017. 2. Kotla V, Goel S, Nischal S, et al. Mechanism of action of lenalidomide in hematological Lenalidomide, an oral immunomodulatory agent, has received approval in the USA from the Food and Drug Administration (FDA) for the management of myelodysplastic syndromes (MDS) classified by the International Prognostic Scoring System (IPSS) as low risk or intermediate-1 risk and with a deletion 5q (del(5q)) cytogenetic abnormality. 1 1 2 3 HIGHLIGHTS OF PRESCRIBING INFORMATION 4 These highlights do not include all the information needed to use REVLIMID®safely and effectively. See full prescribing information for REVLIMID. 5 REVLIMID(lenalidomide) capsules, for oral use 6 7 WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THOMBOSIS AND PULMONARY EMBOLISM 1 1 2