CLINICAL NEWS
• Donor parity: Male vs. nulliparous
female vs. parous female
• Donor–recipient race match
• Donor–recipient cytomegalovirus
serostatus: donor-negative/
recipient-negative vs. donorpositive/recipient-negative vs.
donor-negative/recipient-positive vs.
donor-positive/recipient-positive
• ABO blood match: Match versus
minor mismatch versus major
mismatch
• Donor–recipient HLA match: 8/8 vs.
7/8 vs. 6/8 vs. 5/8 or lower
For the 1988 to 2006 cohort, the risk of mor-
tality was higher when donors were older
than 32 years of age, mismatched for ABO
blood group, or mismatched at one or more
HLA-loci (p<0.001). The findings were
similar in the 2007 to 2011 cohort.
“A similar trend was observed when
comparing donors older than 50 years to
donors aged 33 to 50 years (hazard ratio
[HR] = 1.15; 95% CI 1.02-1.29; p=0.02),” the
authors reported. While other donor char-
acteristics were not associated with mortality, several patient, disease, and transplant
characteristics were associated with higher
mortality (TABLE 3, page 45).
In the validation cohort, donor age acted
as a continuous variable for overall survival;
for each 10-year increment in donor age,
there was a 5.5-percent increase in mortality risk. After adjustment for recipient age,
disease, disease status, performance score,
T:7”
4.2 Allergic Reactions
REVLIMID is contraindicated in patients who have demonstrated
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide [see Warnings and Precautions
(5.8)].
5.2 REVLIMID REMS™ Program
Because of the embryo-fetal risk [see Warnings and Precautions (5.1)],
REVLIMID is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS), the REVLIMID REMS™
program (formerly known as the “RevAssist®” program).
Required components of the REVLIMID REMS™ program include the
following:
• Prescribers must be certified with the REVLIMID REMS™ program by
enrolling and complying with the REMS requirements.
• Patients must sign a Patient-Physician agreement form and comply
with the REMS requirements. In particular, female patients of
reproductive potential who are not pregnant must comply with the
pregnancy testing and contraception requirements [see Use in Specific
Populations (8.6)] and males must comply with contraception
requirements [see Use in Specific Populations (8.6)].
• Pharmacies must be certified with the REVLIMID REMS™ program,
must only dispense to patients who are authorized to receive REVLIMID
and comply with REMS requirements.
Further information about the REVLIMID REMS™ program is available at
www.celgeneriskmanagement.com or by telephone at 1-888-423-5436.
5.3 Hematologic Toxicity
REVLIMID can cause significant neutropenia and thrombocytopenia.
Monitor patients with neutropenia for signs of infection. Advise patients to
observe for bleeding or bruising, especially with use of concomitant
medication that may increase risk of bleeding. Patients taking REVLIMID
should have their complete blood counts assessed periodically as
described below [see Dosage and Administration (2.1, 2.2, 2.3)].
Patients taking REVLIMID in combination with dexamethasone for MM
should have their complet H