POMALYT CAPSULES*
Manufacturer DetailsCELGENE CORP
Celgene Corp.
Compositions:
Pomalidomide -mg capsules,
Pomalidomide -mg capsules,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit capsules |
List of Related Indications:
- Multiple Myleloma Patients who have received at least two prior therapies, including Lenalidomide and Bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy
List Of Drugs:
- Pomalidomide -(Pomalyst)- @- (Feb 2013) Chemotherapeutic Agents
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 interaction studies have been conducted with POMALYST.
Pomalidomide is primarily metabolized by CYP1A2 and CYP3A.
Pomalidomide is also a substrate for P-glycoprotein (P-gp).
1. Drugs That May Increase Pomalidomide Plasma Concentrations
CYP3A, CYP1A2 or P-gp inhibitors: Co-administration of POMALYST with drugs
that are strong inhibitors of CYP1A2, CYP3A (e.g. ketoconazole) or P-gp could
increase exposure and should be avoided.
2. Drugs That May Decrease Pomalidomide Plasma Concentrations
CYP3A, CYP1A2 or P-gp inducers: Co-administration of POMALYST with drugs
that are strong inducers of CYP1A2, CYP3A (e.g. rifampin) or P-gp could
decrease exposure and should be avoided.
Smoking: Cigarette smoking may reduce pomalidomide exposure due to
CYP1A2 induction. Patients should be advised that smoking may reduce the
efficacy of pomalidomide.
Dexamethasone: Co-administration of multiple doses of 4 mg POMALYST
with 20 mg to 40 mg dexamethasone (a weak inducer of CYP3A) to patients
with multiple myeloma had no effect on the pharmacokinetics of
pomalidomide compared with pomalidomide administered alone.
Indication:
POMALYST (pomalidomide) capsules, for oral use
Initial US Approval: 2013
WARNING: EMBRYO-FETAL TOXICITY and VENOUS
THROMBOEMBOLISM
See full prescribing information for complete boxed warning
EMBRYO-FETAL TOXICITY
POMALYST is contraindicated in pregnancy. POMALYST is
a thalidomide analogue. Thalidomide is a known human
teratogen that causes severe life-threatening birth defects.
For females of reproductive potential: Exclude pregnancy
before start of treatment. Prevent pregnancy during treatment
by the use of two reliable methods of contraception
POMALYST is available only through a restricted program called the
POMALYST REMS program
Drug Name- Pomalyst
Active Ingredient - Pomalidomide
To treat patients with multiple myeloma whose disease progressed
after being treated with other cancer drugs
Indication-
Multiple myeloma
Approved by FDA on 8-2-2013 (Ref- FDA approved List- 2013)
Proprietary Name- POMALYST CAPSULES*
Established Name- Pomalidomide
Applicant- CLEGENE CORPORATION
Indication- For treatment of patients with multiple myleloma who have
received at least two prior therapies, including lenalidomide
and bortezomib and have demonstrated disease progression
on or wihin 60 days of completion of the last therapy
Approval Date- February 8,2013
Approved by US FDA (Ref- FDA approved list- 2013)
Adverse Reaction:
Most common adverse reactions (.30%) included fatigue and asthenia,
neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upperrespiratory
tract infections, back pain and pyrexia
Contra-Indications:
CONTRAINDICATIONS
Pregnancy
WARNINGS AND PRECAUTIONS
Hematologic Toxicity: Neutropenia was the most frequently reported
Grade 3/4 adverse event. Monitor patients for hematologic toxicities,
especially neutropenia
Dosages/ Overdosage Etc:
Indication-
Multiple myeloma
INDICATIONS AND USAGE
POMALYST is a thalidomide analogue indicated for patients with multiple
myeloma who have received at least two prior therapies including
lenalidomide and bortezomib and have demonstrated disease progression on
or within 60 days of completion of the last therapy. Approval is based on
response rate. Clinical benefit, such as improvement in survival or symptoms,
has not been verified
VENOUS THROMBOEMBOLISM
Deep Venous Thrombosis (DVT) and Pulmonary Embolism
(PE) occur in patients with multiple myeloma treated with
POMALYST
DOSAGE AND ADMINISTRATION
4 mg per day taken orally on days 1-21 of repeated 28-day cycles until disease
progression.
DOSAGE FORMS AND STRENGTHS
Capsules: 1 mg, 2 mg, 3 mg and 4 mg
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA- approved Patient labeling (Medication Guide)
1. Embryo-Fetal Toxicity Advise patients that POMALYST is contraindicated in
pregnancy.
2. POMALYST is a thalidomide analog and may cause serious birth defects
or death to a developing baby
3. Advise females of reproductive potential that they must avoid pregnancy
while taking POMALYST and for at least 4 weeks after completing
therapy
4. Initiate POMALYST treatment in females of reproductive potential only
following a negative pregnancy test.
5. Advise females of reproductive potential of the importance of monthly
pregnancy tests and the need to use two different forms of contraception
including at least one highly effective form simultaneously during
POMALYST therapy, during therapy interruption and for 4 weeks after
she has completely finished taking POMALYST.
6.Highly effective forms of contraception other than tubal ligation include
IUD and hormonal (birth control pills, injections, patch or implants)
and a partners vasectomy. Additional effective contraceptive methods
include latex or synthetic condom, diaphragm and cervical cap.
7. Instruct patient to immediately stop taking POMALYST and contact her doctor
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.
8. Advise patient that if her doctor is not available, she can call 1-888-668-2528
for information on emergency contraception
9. Advise males to always use a latex or synthetic condom during any sexual
contact with females of reproductive potential while taking POMALYST
and for up to 28 days after discontinuing POMALYST, even if they have undergone
a successful vasectomy.
10. Advise male patients taking POMALYST that they must not donate sperm
11. All patients must be instructed to not donate blood while taking POMALYST
and for 1 month following discontinuation of POMALYST
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of action
Pomalidomide, an analogue of thalidomide, is an immunomodulatory agent with
antineoplastic activity. In in vitro cellular assays, pomalidomide inhibited
proliferation and induced apoptosis of hematopoietic tumor cells.
Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant
multiple myeloma cell lines and synergized with dexamethasone in both
lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor
cell apoptos.
2. Pharmacokinetics
Absorption - Following administration of single oral doses of POMALYST, the Cmax
for pomalidomide occurs at 2 and 3 hours post dose. The systemic exposure
(AUC) of pomalidomide increases in an approximately dose proportional manner
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category X
Risk Summary
POMALYST can cause embryo-fetal harm when administered to a pregnant
female and is contraindicated during pregnancy.
POMALYST is a thalidomide analogue.
Thalidomide is a human teratogen, inducing a high frequency of severe and
life-threatening birth defects such as amelia (absence of limbs), phocomelia
(short limbs), hypoplasticity of the bones, absence of bones, external ear
abnormalities (including anotia, micropinna, small or absent
2. Nursing mothers
It is not known if pomalidomide is excreted in human milk. Pomalidomide was
excreted in the milk of lactating rats. Because many drugs are excreted in
human milk and because of the potential for adverse reactions in nursing
infants from POMALYST, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the
drug to the mother.
3. Pediatric use
Safety and effectiveness of POMALYST in patients below the age of 18 have not
been established
.
4. Geriatric use
No dosage adjustment is required for POMALYST based on age.
