Celgene Corporation is pleased to announce that POMALYST®
(pomalidomide) capsules is now approved and available for patients with
multiple myeloma who have received at least 2 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.
CONTRAINDICATIONS: Pregnancy
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POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If this drug
is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to a fetus |
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Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when
administered during the period of organogenesis |
ICD-9 Diagnostic Codes
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The ICD-9 diagnostic codes for the approved indication of POMALYST in multiple myeloma are
203.00 and 203.02 |
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Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when
administered during the period of organogenesis |
Dosage and Administration
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The recommended starting dose of POMALYST is 4 mg once daily orally on Days 1‑21 of
repeated 28-day cycles (21/28 days) until disease progression |
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POMALYST may be given in combination with dexamethasone. In the study, dexamethasone
was given on days 1, 8, 15, and 22, and dosed at 40 mg per day for patients 75 years or
younger, or 20 mg per day for patients older than 75 years |
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POMALYST may be taken with water |
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Inform patients not to break, chew, or open the capsules |
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POMALYST should be taken without food (at least 2 hours before or 2 hours after a meal) |
Dosage Forms and Strengths
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POMALYST is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules |
Dose Modification Instructions for POMALYST for Hematologic Toxicities
Toxicity
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Dose Modification
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Neutropenia
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ANC* < 500 per mcL or Febrile neutropenia (fever more than or equal to 38.5°C and ANC < 1,000 per mcL) |
Interrupt POMALYST treatment, follow CBC weekly |
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ANC return to more than or equal to 500 per mcL |
Resume POMALYST at 3 mg daily |
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For each subsequent drop < 500 per mcL |
Interrupt POMALYST treatment |
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Return to more than or equal to 500 per mcL |
Resume POMALYST at 1 mg less than the previous dose |
Thrombocytopenia
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Platelets < 25,000 per mcL |
Interrupt POMALYST treatment, follow CBC weekly |
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Platelets return to > 50,000 per mcL |
Resume POMALYST treatment at 3 mg daily |
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For each subsequent drop < 25,000 per mcL |
Interrupt POMALYST treatment |
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Return to more than or equal to 50,000 per mcL |
Resume POMALYST at 1 mg less than previous dose |
*ANC = Absolute Neutrophil Count
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For other Grade 3 or 4
toxicities hold treatment and restart treatment at 1 mg less than the
previous dose when toxicity has resolved to less than or equal to Grade 2
at the physician's discretion |
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To initiate a new
cycle of POMALYST, the neutrophil count must be at least 500 per mcL,
the platelet count must be at least 50,000 per mcL |
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If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST |
Important Dosing Information
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Pomalidomide may be given in combination with dexamethasone |
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Pomalidomide may be taken with water |
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Inform patients not to break, chew or open the capsules |
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Pomalidomide should be taken without food (at least 2 hours before or 2 hours after a meal) |
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Monitor CBCs every week for the first 8 weeks and monthly thereafter |
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Patients may require dose interruption and/or modification |
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No dosage adjustment is required for pomalidomide based on age |
Important Information about POMALYST and POMALYST REMS™
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To avoid embryo-fetal exposure, POMALYST is only available under a restricted distribution program called "POMALYST REMS™" |
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POMALYST is
contraindicated in pregnant females and females capable of becoming
pregnant. Females of reproductive potential may be treated with POMALYST
provided adequate precautions are taken to avoid pregnancy |
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Only prescribers and
pharmacists certified by the POMALYST REMS™ program can prescribe and
dispense POMALYST to patients who are enrolled and meet all the
conditions of the POMALYST REMS™ program |
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Information about POMALYST and the POMALYST REMS™ program can be obtained by visiting www.CelgeneRiskManagement.com, or by calling the Celgene Customer Care Center toll free at 1-888-423-5436 |
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Effective contraception
must be used by female patients of reproductive potential for at least 4
weeks before beginning POMALYST therapy, during therapy, during dose
interruptions and for 4 weeks following discontinuation of POMALYST
therapy |
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Females of reproductive
potential must have 2 negative pregnancy tests (sensitivity of at least
50 mIU/mL). The first test should be performed within 10-14 days, and
the second test within 24 hours prior to writing an initial prescription |
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Once treatment has started
and during dose interruptions, pregnancy testing for females of
reproductive potential should occur weekly during the first 4 weeks of
use, then pregnancy testing should be repeated every 4 weeks in females
with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks |
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If pregnancy does occur during treatment, POMALYST must be discontinued immediately |
Access Assistance
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Celgene Patient Support®
can offer assistance with access to POMALYST for both insured and
uninsured patients. This includes benefits investigations, co-pay
assistance or free drug to those patients who qualify, as well as
appeals support |
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For assistance or more information, contact your dedicated Celgene Patient Support® Specialist at 1-800-931-8691 or visit www.CelgenePatientSupport.com |
For a list of pharmacies registered in the POMALYST REMS™ program, visit www.Celgene.com/PharmacyNetwork.
POMALYST®
(pomalidomide) is 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.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM
Embryo-Fetal Toxicity
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POMALYST
is contraindicated in pregnancy. POMALYST is a thalidomide analogue.
Thalidomide is a known human teratogen that causes severe birth defects
or embryo-fetal death. In females of reproductive potential, obtain 2
negative pregnancy tests before starting POMALYST treatment |
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Females
of reproductive potential must use 2 forms of contraception or
continuously abstain from heterosexual sex during and for 4 weeks after
stopping POMALYST treatment |
POMALYST is only available through a restricted distribution program called POMALYST REMS™.
Venous Thromboembolism
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Deep
Venous Thrombosis (DVT) and Pulmonary Embolism (PE) occur in patients
with multiple myeloma treated with POMALYST. Prophylactic
anti-thrombotic measures were employed in the clinical trial. Consider
prophylactic measures after assessing an individual patient’s underlying
risk factors |
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CONTRAINDICATIONS: Pregnancy
|
POMALYST
can cause fetal harm and is contraindicated in females who are pregnant.
If this drug is used during pregnancy or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the
potential hazard to a fetus |
|
Pomalidomide
is a thalidomide analogue and is teratogenic in both rats and rabbits
when administered during the period of organogenesis |
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
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Females of Reproductive Potential:
Must avoid pregnancy while taking POMALYST and for at least 4 weeks
after completing therapy. Must commit either to abstain continuously
from heterosexual sexual intercourse or to use 2 methods of reliable
birth control, beginning 4 weeks prior to initiating treatment with
POMALYST, during therapy, during dose interruptions and continuing for 4
weeks following discontinuation of POMALYST therapy. Must obtain 2
negative pregnancy tests prior to initiating therapy
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Males:
Pomalidomide is present in the semen of patients receiving the drug.
Males must 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. Males must not donate sperm
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Blood Donation:
Patients must not donate blood during treatment with POMALYST and for 1
month following discontinuation of the drug because the blood might be
given to a pregnant female patient whose fetus must not be exposed
to POMALYST
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POMALYST REMS Program
Because of the
embryo-fetal risk, POMALYST is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called "
POMALYST REMS."
Prescribers and pharmacists must be certified with the program;
patients must sign an agreement form and comply with the requirements.
Further information about the
POMALYST REMS program is available at [
celgeneriskmanagement.com] or by telephone at 1‑888‑423‑5436.
Venous Thromboembolism:
Patients receiving POMALYST have developed venous thromboembolic events
reported as serious adverse reactions. In the trial, all patients were
required to receive prophylaxis or antithrombotic treatment. The rate of
DVT or PE was 3%. Consider anticoagulation prophylaxis after an
assessment of each patient’s underlying risk factors.
Hematologic Toxicity: Neutropenia
of any grade was reported in 50% of patients and was the most
frequently reported Grade 3/4 adverse event, followed by anemia and
thrombocytopenia. Monitor patients for hematologic toxicities,
especially neutropenia, with complete blood counts weekly for the first 8
weeks and monthly thereafter. Treatment is continued or modified for
Grade 3 or 4 hematologic toxicities based upon clinical and laboratory
findings. Dosing interruptions and/or modifications are recommended to
manage neutropenia and thrombocytopenia.
Hypersensitivity Reactions: Patients
with a prior history of serious hypersensitivity associated with
thalidomide or lenalidomide were excluded from studies and may be at
higher risk of hypersensitivity.
Dizziness and Confusional State: 18%
of patients experienced dizziness and 12% of patients experienced a
confusional state; 1% of patients experienced grade 3/4 dizziness, and
3% of patients experienced grade 3/4 confusional state. Instruct
patients to avoid situations where dizziness or confusion may be a
problem and not to take other medications that may cause dizziness or
confusion without adequate medical advice.
Neuropathy: 18%
of patients experienced neuropathy (approximately 9% peripheral
neuropathy). There were no cases of grade 3 or higher neuropathy adverse
reactions reported.
Risk of Second Primary Malignancies: Cases
of acute myelogenous leukemia have been reported in patients receiving
POMALYST as an investigational therapy outside of multiple myeloma.
ADVERSE REACTIONS In
the clinical trial of 219 patients who received POMALYST alone (n=107)
or POMALYST + low-dose dexamethasone (low-dose dex) (n=112), all
patients had at least one treatment-emergent adverse reaction.
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In the POMALYST
alone versus POMALYST + low dose dexamethasone arms, respectively, most
common adverse reactions (≥30%) included fatigue and asthenia
(55%, 63%), neutropenia (52%, 47%), anemia (38%, 39%), constipation
(36%, 35%), nausea (36%, 22%), diarrhea (34%, 33%), dyspnea (34%, 45%),
upper respiratory tract infection (32%, 25%), back pain (32%, 30%), and
pyrexia (19%, 30%)
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90% of patients
treated with POMALYST alone and 88% of patients treated with POMALYST +
low-dose dex had at least one treatment-emergent NCI CTC Grade 3 or 4
adverse reaction
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In the
POMALYST alone versus POMALYST + low dose dexamethasone arms,
respectively, most common Grade 3/4 adverse reactions (≥15%) included
neutropenia (47%, 38%), anemia (22%, 21%), thrombocytopenia (22%, 19%),
and pneumonia (16%, 23%). For other Grade 3 or 4 toxicities besides
neutropenia and thrombocytopenia, hold treatment and restart treatment
at 1 mg less than the previous dose when toxicity has resolved to less
than or equal to Grade 2 at the physician’s discretion
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67% of patients
treated with POMALYST and 62% of patients treated with POMALYST +
low-dose dex had at least one treatment-emergent serious adverse
reaction
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In the
POMALYST alone versus POMALYST + low dose dexamethasone arms,
respectively, most common serious adverse reactions (≥5%) were pneumonia
(14%, 19%), renal failure (8%, 6%), dyspnea (5%, 6%), sepsis (6%, 3%),
pyrexia (3%, 5%) dehydration (5%, 3%), hypercalcemia (5%, 2%), urinary
tract infection (0%, 5%), and febrile neutropenia (5%, 1%)
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DRUG INTERACTIONSNo
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). Coadministration of
POMALYST with drugs that are strong inhibitors or inducers of CYP1A2,
CYP3A, or P‑gp should be avoided. Cigarette smoking may reduce
pomalidomide exposure due to CYP1A2 induction. Patients should be
advised that smoking may reduce the efficacy of pomalidomide.
USE IN SPECIFIC POPULATIONS
Pregnancy:
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. Report any suspected fetal exposure
to POMALYST to the FDA via the MedWatch program at 1‑800‑332‑1088 and
also to Celgene Corporation at 1‑888‑423‑5436.
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.
Pediatric Use: Safety and effectiveness of POMALYST in patients under the age of 18 have not been established.
Geriatric Use: No
dosage adjustment is required for POMALYST based on age. Patients
greater than or equal to 65 years of age were more likely than patients
less than or equal to 65 years of age to experience pneumonia.
Renal and Hepatic Impairment: Pomalidomide
is metabolized in the liver. Pomalidomide and its metabolites are
primarily excreted by the kidneys. The influence of renal and hepatic
impairment on the safety, efficacy, and pharmacokinetics of pomalidomide
has not been evaluated. Avoid POMALYST in patients with a serum
creatinine >3.0 mg/dL. Avoid POMALYST in patients with serum
bilirubin >2.0 mg/dL and AST/ALT >3.0 x ULN.
Please see full
Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
POMALYST is only available under a restricted distribution program, POMALYST REMS™.
Sent on behalf of Celgene Corporation.
POMALYST® and Celgene Patient Support® are registered trademarks of Celgene Corporation. POMALYST REMS™ is a trademark of Celgene Corporation.
| ©2013 Celgene Corporation. |
02/13 |
US-POM120061a |
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