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On Location 2018 ASH Annual Meeting A significantly lower proportion of patients in the apixaban group experienced recurrent VTE, com- pared with the dalteparin group. The recurrent VTE in the apixaban group was a cerebral VTE; while there were four lower-extremity DVTs, two upper-extremity DVTs, one PE, and one splanchnic VTE in the dalteparin group. Six-month mortality rates also were similar between the two treat- ment arms (hazard ratio [HR] = 1.40; 95% CI 0.82-2.43; p=0.31). Patients appeared to prefer the oral administration of apixaban, compared with subcutaneous injec- tions of dalteparin. According to surveys conducted each month dur- ing follow-up, the lower treatment burden of apixaban was associated with better quality of life, and pa- TABLE 3. Secondary Clinical Outcomes During Treatment Apixaban (n=145) Dalteparin (n=142) Hazard ratio (95% CI; p value) Major plus clinically relevant non-major bleeding 9 (6.2%) 9 (6.3%) 0.88 (0.41-1.94; p=0.882) Recurrent venous thromboembolism 1 (0.7%) 9 (6.3%) 0.21 (0.09-0.47; p=0.03) tients reported a lower concern for excess bruising, irritation, and stress, REVLIMID [lenalidomide] capsules, for oral use • • • • • control pills, injections, patch or implants) and a partner’s vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm and cervical cap. Instruct patient to immediately stop taking REVLIMID and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant. Advise patient that if her healthcare provider is not available, she should call Celgene Customer Care Center at 1-888-423-5436 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)]. Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Advise male patients taking REVLIMID that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)]. All patients must be instructed to not donate blood while taking REVLIMID, during dose interruptions and for 4 weeks following discontinuation of REVLIMID [see Warnings and Precautions (5.1)]. REVLIMID REMS program Because of the risk of embryo-fetal toxicity, REVLIMID is only available through a restricted program called the REVLIMID REMS program [see Warnings and Precautions (5.2)]. • Patients must sign a Patient-Physician agreement form and comply with the requirements to receive REVLIMID. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.3)]. • REVLIMID is available only from pharmacies that are certified in REVLIMID REMS program. Provide patients with the telephone number and website for information on how to obtain the product. Pregnancy Exposure Registry Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to REVLIMID during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations (8.1)]. Hematologic Toxicity Inform patients that REVLIMID is associated with significant neutropenia and thrombocytopenia [see Boxed Warning and Warnings and Precautions (5.3)]. Second Primary Malignancies Inform patients of the potential risk of developing second primary malignancies during treatment with REVLIMID [see Warnings and Precautions (5.6)]. Hepatotoxicity Inform patients of the risk of hepatotoxicity, including hepatic failure and death, and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.8)]. Severe Cutaneous Including Hypersensitivity Reactions Inform patients of the potential for severe reactions including hypersensitivity, angioedema, Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms if they had such a reaction to thalidomide and report symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.9)]. Tumor Lysis Syndrome Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.10)]. and higher overall satisfaction with the therapy (p<0.05). Dr. McBane also noted that premature discon- tinuation was lower in the apixaban arm than the LMWH group (4% vs. 15%; p=0.0012). Limitations of the study include the relatively small number of enrolled patients, its open-label design, as well as the reliance on self-reported ques- tionnaire data to evaluate secondary outcomes. The authors report financial rela- tionships with Bristol-Myers Squibb and Pfizer Alliance. REFERENCE McBane RD, Wysokinski WE, Le-Rademacher J, et al. Apixaban, dalteparin, in active cancer associated venous thromboembolism, the ADAM VTE trial. Abstract #421. Presented at the 2018 ASH Annual Meeting, December 2, 2018; San Diego, CA. Tumor Flare Reaction Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.11)]. Early Mortality in Patients with MCL Inform patients with MCL of the potential for early death [see Warnings and Precautions (5.14)]. Dosing Instructions Inform patients how to take REVLIMID [see Dosage and Administration (2)] • REVLIMID should be taken once daily at about the same time each day, • REVLIMID may be taken either with or without food. • The capsules should not be opened, broken, or chewed. REVLIMID should be swallowed whole with water. • Instruct patients that if they miss a dose of REVLIMID, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take REVLIMID at the usual time. Warn patients to not take 2 doses to make up for the one that they missed. Venous and Arterial Thromboembolism Inform patients of the risk of thrombosis including DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Boxed Warning and Warnings and Precautions (5.4)]. Manufactured for: Celgene Corporation Summit, NJ 07901 Increased Mortality in Patients with CLL Inform patients that REVLIMID had increased mortality in patients with CLL and serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure [see Warnings and Precautions (5.5)]. Pat. www.celgene.com/therapies REVLIMID ® and REVLIMID REMS ® are registered trademarks of Celgene Corporation. ©2005-2017 Celgene Corporation, All Rights Reserved. REV_MM_ALL_HCP_BSv.24 12_2017 Outside the 2018 ASH Annual Meeting in San Diego. January 2019 Annual Meeting Edition Cosmos Communications 1 Q1 Q2

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