ASH Clinical News ACN_5.2_digital | Page 26

Important Safety Information (continued)
Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths
(within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early
deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (≥10 x 10 9 /L)
ADVERSE REACTIONS
Multiple Myeloma
• In newly diagnosed: The most frequently reported Grade 3 or 4 reactions included neutropenia,
anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract,
lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia. The highest frequency of infections
occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%). There were more Grade 3 and
4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or Rd18
• The most common adverse reactions reported in ≥20% (Arm Rd Continuous): diarrhea (46%),
anemia (44%), neutropenia (35%), fatigue (33%), back pain (32%), asthenia (28%), insomnia (28%),
rash (26%), decreased appetite (23%), cough (23%), dyspnea (22%), pyrexia (21%), abdominal pain
(21%), muscle spasms (20%), and thrombocytopenia (20%)
• Maintenance Therapy Post Auto-HSCT: The most frequently reported Grade 3 or 4 reactions in ≥20%
(REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia. The serious adverse
reactions of lung infection and neutropenia (more than 4.5%) occurred in the REVLIMID arm
• The most frequently reported adverse reactions in ≥20% (REVLIMID arm) across both maintenance
studies (Study 1, Study 2) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia
(23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%),
nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash
(32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%, 21%)
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due to increased C max and AUC with
concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin
stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not
known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is
recommended in patients with MM taking concomitant warfarin
USE IN SPECIFIC POPULATIONS
• Pregnancy: See Boxed WARNINGS: If pregnancy does occur during treatment, immediately
discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive
toxicity for further evaluation and counseling. There is a REVLIMID pregnancy exposure registry that
monitors pregnancy outcomes in females exposed to REVLIMID during pregnancy as well as female
partners of male patients who are exposed to REVLIMID. This registry is also used to understand the
root cause for the pregnancy. Report any suspected fetal exposure to REVLIMID to the FDA via the
MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436
• Lactation: There is no information regarding the presence of lenalidomide in human milk, the effects
of REVLIMID on the breastfed infant, or the effects of REVLIMID on milk production. Because many
drugs are excreted in human milk and because of the potential for adverse reactions in breastfed
infants from REVLIMID, advise female patients not to breastfeed during treatment with REVLIMID
• Pediatric Use: Safety and effectiveness have not been established in pediatric patients
• Renal Impairment: Adjust the starting dose of REVLIMID based on creatinine clearance value and in
patients on dialysis
Please see additional Important Safety Information throughout and Brief Summary,
including Boxed WARNINGS, on the following pages.
REFERENCES: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Multiple
Myeloma V.1.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed July 20, 2018. To view the most
recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their
content, use, or application and disclaims any responsibility for their application or use in any way.
2. REVLIMID [package insert]. Summit, NJ: Celgene Corp; 2017. 3. Data on fi le. Celgene Corp; 2018.
REVLIMID ® and REVLIMID REMS ® are registered trademarks of Celgene Corporation.
© 2018 Celgene Corporation
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