VISIT WEBSITE FOR PATIENTS

Celgene Patient Support®

A single source for access support

Celgene Patient Support® provides:

  • A single Specialist assigned to help patients in your geographic area
  • Assistance with understanding patient insurance coverage for POMALYST
  • Information about financial assistance for POMALYST

FINANCIAL ASSISTANCE
Depending on the patient's insurance situation, there are programs and organizations that may help pay for POMALYST

celgene commercial co-pay programCelgene Commercial Co-pay Program*

Celgene Commercial Co-pay Program for eligible patients with commercial or private insurance (including healthcare exchanges)*

  • Provides assistance to help patients meet co-pay/co-insurance costs
  • Reduces co-pay responsibility to $25 for POMALYST

Eligibility criteria for patients include*:

  • Gross annual household income of $100,000 or less
  • Commercial or private insurance that does not cover the full cost of POMALYST
  • Residence in the United States or a US territory
  • Patients with government healthcare insurance (for example, Medicare [Parts B, C, and D], Medicaid, Medigap, TriCare) are not eligible

independent third party organizationsIndependent third-party organizations

Independent third-party organizations for patients who are unable to afford their medication (including patients with Medicare, Medicaid, or other government-sponsored insurance)

Celgene Patient Support® can provide you with information about independent third-party organizations that may be able to help patients with the cost of:

  • Deductibles
  • Co-payments/co-insurance
  • Insurance premiums

Transportation assistance

Celgene Patient Support® can provide information about financial assistance for transportation costs to and from medical appointments.

  • Independent third-party organizations may be able to help patients with transportation costs, such as gasoline, parking, tolls, and taxi, bus, or train fare, to and from medical appointments

celgene patient assistance programCelgene Patient Assistance Program (PAP)§

Celgene Patient Assistance Program (PAP) for qualified patients who are uninsured or underinsured

  • POMALYST may be available at no cost to patients who meet insurance and financial criteria

INSURANCE-RELATED ASSISTANCE
On behalf of the patient, our Specialists are available to assist with each of the following steps in the insurance approval process for POMALYSTII

celgene patient support benefits investigationBenefits investigation

  • Initiate a benefits investigation to determine co-payment and other out-of-pocket costs
  • Assess prior authorization requirements
  • Educate patients about insurance coverage or other programs for which they may qualify


celgene patient support prior authorization assistancePrior authorization assistance

  • Assist with the prior authorization process by providing the necessary forms for completion
  • Follow up with the insurance provider to determine the outcome


celgene patient support appeals assistanceAppeals assistance

  • Provide information about the appeals process after a denied prior authorization
  • Supply a checklist of the required documentation for submission to the insurance company
  • Submit the appeal to the insurance company at the request of the patient

*Other eligibility requirements and restrictions apply. Please see full Terms and Conditions.
Patients may be subject to a random audit to verify income.
Financial and medical eligibility requirements vary by organization.
§Patients must meet specified financial and eligibility requirements to qualify for assistance.
IICelgene cannot provide insurance advice or make insurance decisions.
Celgene provides a facilitation service and will not provide any medical input into a prior authorization or an appeal.

Enrolling in Celgene Patient Support®
There are 3 simple ways to enroll in Celgene Patient Support®. Choose the option that is easiest for you

celgene patient support online enrollmentEnroll online now
You can enroll patients in Celgene Patient Support® online. Click here to get started.


call celgene patient supportCall 1-800-931-8691
Patients can be enrolled over the phone at 1-800-931-8691, Monday–Thursday, 8 am–7 pm ET, and Friday, 8 am–6 pm ET (translation services available).


email or fax celgene patient supportE-mail or fax the enrollment form
Download the English or Spanish enrollment form and return it to us by e-mail at patientsupport@celgene.com or fax it to us at 1-800-822-2496.

Celgene Patient Support

Pomalidomide (POMALYST) + dex is a National Comprehensive Cancer Network® (NCCN®) Category 1 Option for Previously Treated Multiple Myeloma

Indicated for patients with multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma, V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • 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.
  • 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 and Arterial Thromboembolism

  • Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.

CONTRAINDICATIONS

  • Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.

WARNINGS AND PRECAUTIONS

  • Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS
  • 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 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
  • Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
  • POMALYST REMS® Program: See Boxed WARNINGS
  • Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
  • Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
  • Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors.
  • Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
  • Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
  • Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
  • Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe cutaneous reactions such as SJS, TEN or DRESS, and do not resume therapy.
  • Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
  • Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
  • Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
  • Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

ADVERSE REACTIONS

The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).

DRUG INTERACTIONS

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: See Boxed WARNINGS. 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. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436.
  • Lactation:  There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. 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 a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
  • Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
  • Renal Impairment: Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days.
  • Hepatic Impairment: Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment.
  • Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction.

Please see full Prescribing Information, including Boxed WARNINGS.

REFERENCE: 1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. Accessed May 30, 2017.

Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY and
VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • POMALYST is contraindicated in pregnancy.
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