Elotuzumab- Empliciti (Nov 2015) - Anti-cancer
Drug Name:Elotuzumab- Empliciti (Nov 2015) - Anti-cancer
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
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 drug-drug 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 IgG. 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 .
Indication:
EMPLICITI· (elotuzumab) for injection, for intravenous use
Initial U.S. Approval: 2015
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.40
Drug Name - Elotuzumab
Active Ingredient- Empliciti
Date of approval - 11/30/2015
FDA-approved use - To treat People with Multiple Myloama
who have received one to three prior medications
Approved by US FDA on 11/30/2015- (Ref- FDA approved List- 2015)
Adverse Reaction:
Most common adverse reactions (20% or higher) are fatigue, diarrhea, pyrexia,
constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory
tract infection, decreased appetite, pneumonia.
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Infusion reactions: Premedication is required. Interrupt EMPLICITI for Grade 2
or higher and permanently discontinue for severe infusion reaction.
Infections: Monitor for fever and other signs of infection and treat promptly.
Second Primary Malignancies (SPM): Higher incidences of SPM were observed
in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI.
Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is
suspected.
Interference with determination of complete response: EMPLICITI can interfere
with assays used to monitor M-protein. This interference can impact the
determination of complete response.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in combination
with lenalidomide and dexamethasone for the treatment of patients with multiple
myeloma who have received one to three prior therapies.
DOSAGE AND ADMINISTRATION
With lenalidomide and dexamethasone: 10 mg/kg administered intravenously
every week for the first two cycles and every 2 weeks thereafter until disease
progression or unacceptable toxicity.
Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen.
DOSAGE FORMS AND STRENGTHS
For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for
reconstitution.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Infusion Reactions
EMPLICITI may cause infusion reactions. Advise patients to contact their healthcare
provider if they experience signs and symptoms of infusion reactions, including fever,
chills, rash, or breathing problems within 24 hours of infusion .
Advise patients that they will be required to take the following oral medications
prior to EMPLICITI dosing to reduce the risk of infusion reaction
1. Dexamethasone orally as prescribed
2.H1 blocker: diphenhydramine or equivalent (if oral)
3. H2 blocker: ranitidine or equivalent (if oral)
4. Acetaminophen (650-1000 mg orally)
Pregnancy
Advise patients that lenalidomide has the potential to cause fetal harm and has specific
requirements regarding contraception, pregnancy testing, blood and sperm donation,
and transmission in sperm. Lenalidomide is only available through a REMS program.
Infections
Inform patients of the risk of developing infections during treatment with EMPLICITI,
and to report any symptoms of infection
Second Primary Malignancies
Inform patients of the risk of developing SPM during treatment with EMPLICITI .
Hepatotoxicity
Inform patients of the risk of hepatotoxicity during treatment with EMPLICITI and to
report any signs and symptoms associated with this event to their healthcare
provider for evaluation
Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA
U.S. License No. 1713
1343639 Issued November 2015
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7
(Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is
expressed on myeloma cells independent of cytogenetic abnormalities.
SLAMF7 is also expressed on Natural Killer cells, plasma cells, and at lower levels
on specific immune cell subsets of differentiated cells within the hematopoietic lineage
2. Pharmacokinetics
Elotuzumab exhibits nonlinear pharmacokinetics (PK) resulting in greater than
proportional increases in area under the concentration-time curve (AUC) indicative
of target-mediated clearance.
The administration of the recommended 10 mg/kg EMPLICITI regimen in combination
with lenalidomide/dexamethasone is predicted to result in geometric mean (CV%)
steady-state trough concentrations of 194 g/mL (52%).
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
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.
2. Lactation
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.
3. Females and Males of Reproductive Potential
Pregnancy Testing
When EMPLICITI is used with lenalidomide, there is a risk of fetal harm, including severe
life-threatening human birth defects associated with lenalidomide, and the need
to follow requirements regarding pregnancy avoidance, including testing.
4. Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
5. Geriatric Use
Of the 646 patients across treatment groups in the randomized trial in multiple myeloma,
57% were 65 years of age or older; the number of patients 65 years or older was
similar between treatment groups.
No overall differences in efficacy or safety were observed between patients 65 years
or older and younger patients (less than 65 years of age).
