ASH Clinical News Hematology Pipeline Update: Drug Updates from the | Page 15

Other clinically important adverse reactions reported in patients treated with
EMPLICITI (elotuzumab) that did not meet the criteria for inclusion in Table 1 but
occurred at a frequency of 5% or greater in the EMPLICITI group and at a frequency
at least twice the control rate for the randomized trial in multiple myeloma are
listed below:
General disorders and administration site conditions: chest pain
Immune system disorders: hypersensitivity
Nervous system disorders: hypoesthesia
Psychiatric disorders: mood altered
Skin and subcutaneous tissue disorders: night sweats
Laboratory abnormalities worsening from baseline and occurring at a frequency of
10% or higher in the EMPLICITI group and 5% or higher than the lenalidomide and
dexamethasone group (criteria met for all Grades or Grade 3/4) for the randomized
trial in multiple myeloma are presented in Table 2.
Table 2:

Laboratory Abnormalities Worsening from Baseline and with a
10% or Higher Incidence for EMPLICITI-Treated Patients and a 5%
Higher Incidence than Lenalidomide and Dexamethasone-Treated
Patients [Criteria met for All Grades or Grade 3/4]

Laboratory Parameter

EMPLICITI +
Lenalidomide and
Lenalidomide and
Dexamethasone
Dexamethasone
N=318
N=317
All Grades Grade 3/4 All Grades Grade 3/4

randomized trial in multiple myeloma. The detection of antibody formation is highly
dependent on the sensitivity and specificity of the assay. Additionally, the observed
incidence of antibody (including neutralizing antibody) positivity in an assay may
be influenced by several factors including assay methodology, sample handling,
timing of sample collection, concomitant medications, and underlying disease. For
these reasons, comparison of incidence of antibodies to EMPLICITI (elotuzumab)
with the incidences of antibodies to other products may be misleading.
DRUG INTERACTIONS
Drug Interactions
No formal drug-drug interaction studies have been conducted with EMPLICITI.
However, EMPLICITI is used in combination with lenalidomide and dexamethasone.
Refer to the prescribing information for those products for important drugdrug interactions.
Laboratory Test Interference
EMPLICITI may be detected in the SPEP and serum immunofixation assays of
myeloma patients and could interfere with correct response classification. A small
peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation
may potentially be attributed to EMPLICITI, particularly in patients whose
endogenous myeloma protein is IgA, IgM, IgD, or lambda light chain restricted.
This interference can impact the determination of complete response and possibly
relapse from complete response in patients with IgG kappa myeloma protein
[see Warnings and Precautions].
USE IN SPECIFIC POPULATIONS

Hematology

Pregnancy

Lymphopenia

99.4

76.7

98.4

48.7

Leukopenia

90.6

32.4

88.3

25.6

Thrombocytopenia

83.6

19.2

77.8

20.3

Hypoalbuminemia

73.3

3.9

65.6

2.3

Elevated Alkaline
Phosphatase

38.7

1.3

29.8

0

Hyperglycemia

89.3

17.0

85.4

10.2

Risk Summary
There are no studies with EMPLICITI with pregnant women to inform any
drug associated risks. Animal reproduction studies have not been conducted
with elotuzumab.
EMPLICITI is administered in combination with lenalidomide and dexamethasone.
Lenalidomide can cause embryo-fetal harm and is contraindicated for use in
pregnancy. Refer to the lenalidomide and dexamethasone prescribing information
for additional information. Lenalidomide is only available through a REMS program.
The background risk in the U.S. general population of major birth defects is
2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Hypocalcemia

78.0

11.3

76.7

4.7

Lactation

Low Bicarbonate

62.9

0.4

45.1

0

Hyperkalemia

32.1

6.6

22.2

1.6

Liver and Renal Function Tests

Chemistry

Vital sign abnormalities were assessed by treatment arm for the randomized trial
in multiple myeloma and are presented in Table 3. Percentages are based on
patients who had at least one on-treatment vital sign abnormality any time during
the course of therapy.
Table 3:

Vital Sign Abnormalities
EMPLICITI +
Lenalidomide and
Dexamethasone
N=318
%

Lenalidomide and
Dexamethasone

Systolic Blood Pressure ≥160 mmHg

33.3

20.9

Diastolic Blood Pressure ≥100 mmHg

17.3

11.7

Systolic Blood Pressure <90 mmHg

28.9

8.2

Heart Rate ≥100 bpm

47.8

29.7

Heart Rate <60 bpm

66

31.3

Vital Sign Parameter

N=317
%

Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity to EMPLICITI.
Of 390 patients across four clinical studies who were treated with EMPLICITI
and evaluable for the presence of anti-product antibodies, 72 patients
(18.5%) tested positive for treatment-emergent anti-product antibodies by an
electrochemiluminescent (ECL) assay. In 63 (88%) of these 72 patients, antiproduct antibodies occurred within the first 2 months of the initiation of EMPLICITI
treatment. Anti-product antibodies resolved by 2 to 4 months in 49 (78%) of these
63 patients. Neutralizing antibodies were detected in 19 of 299 patients in the

Risk Summary
There is no information on the presence of EMPLICITI in human milk, the
effect on the breast-fed infant, or the effect on milk production. Because
of the potential for serious adverse reactions in breast-fed infants from
elotuzumab administered with lenalidomide/dexamethasone, breastfeeding is
not recommended. Refer to the lenalidomide and dexamethasone prescribing
information for additional information.
Females a