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Savings are available through the Pomalidomide instant savings program†
Making Pomalidomide Capsules more affordable for patients†

Apotex is pleased to offer financial assistance with cost-sharing for Pomalidomide Capsules manufactured and distributed by Apotex to eligible commercially insured patients through the Pomalidomide instant savings† program:

Do you have commercial health insurance?

You may be eligible for the Pomalidomide instant savings† program

  • If eligible, commercially insured patients may pay as little as $0† out-of-pocket cost with the Pomalidomide instant savings card toward each fill, and the program will pay up to $1,250 per 30-day supply of the remaining cost after primary insurance coverage, up to $15,000 per calendar year.
  • Patients must deduct the savings received under this program from any reimbursement request submitted to their insurance plan, either directly by them or on their behalf.

Follow these simple steps for your Pomalidomide instant savings† program card:

Review the Pomalidomide instant savings† program Terms and Conditions here:

  • I understand this offer is not valid for patients who are uninsured or have no prescription drug coverage for Pomalidomide, or for patients whose prescriptions are paid for in whole or in part by either Medicaid, Medicare, TRICARE, the Federal Employee Health Benefits program, or any other Federal or State funded program.
  • I verify I have commercial health insurance and agree to the Terms and Conditions.
Enroll
†Click Enroll to agree to the Terms and Conditions and verify that you meet the eligibility requirements and get your printable Pomalidomide instant savings† program card.

If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, please call 1-833-694-7868.

Patient

  • Show the Pomalidomide instant savings† card with your Pomalidomide prescription at any participating pharmacy.
  • If eligible, commercially insured patients may pay as little as $0† with the Pomalidomide instant savings card toward each fill, and the program will pay up to $1,250 per 30-day supply of the remaining cost after primary insurance coverage, up to $15,000 per calendar year.
  • By using this card, the patient acknowledges meeting the eligibility requirements and complying with our Terms and Conditions.
  • For questions about eligibility or about using the card, please call toll free at 1-833-694-7868.

Pharmacist

  • For commercially insured patients presenting the Pomalidomide instant savings program card for whom you have dispensed Pomalidomide Capsules. (Refer to this document for applicable NDCs). Process a coordination of benefits claim (COB/split bill) by using the patient's prescription insurance for the PRIMARY claim.
  • Submit a SECONDARY claim to CapitalRx under BIN: 610852 and PCN: 2001.
  • For questions about processing the card, please call toll free at 1-833-694-7868.

Limitations apply

  • Offer not valid for patients who are uninsured or have no prescription drug coverage for Pomalidomide or those with prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program or any other federal or state health care program or if the patients receive full reimbursement for prescriptions from private insurance plans or other health or pharmacy benefit programs (i.e. there is no cost-sharing obligation).

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WARNING: EMBRYO-FETAL TOXICITY AND VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • Pomalidomide is contraindicated in pregnancy. Pomalidomide 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 pomalidomide treatment.
  • Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment. To avoid embryo-fetal exposure to pomalidomide, Pomalidomide Capsules are only available through a restricted distribution program, the PS-Pomalidomide REMS program.

Information about the PS-Pomalidomide REMS program is available at www.ps-pomalidomiderems.com or by calling the toll-free number 1-888-423-5436.

Venous and Arterial Thromboembolism

Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. 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.

 
 

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients:

  • in combination with dexamethasone, for patients with multiple myeloma (MM) 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.
  • with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.

WARNING: EMBRYO-FETAL TOXICITY AND VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • Pomalidomide is contraindicated in pregnancy. Pomalidomide 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 pomalidomide treatment.
  • Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment. To avoid embryo-fetal exposure to pomalidomide, Pomalidomide Capsules are only available through a restricted distribution program, the PS-Pomalidomide REMS program.

Information about the PS-Pomalidomide REMS program is available at www.ps-pomalidomiderems.com or by calling the toll-free number 1-888-423-5436.

Venous and Arterial Thromboembolism

Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. 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: Pomalidomide capsules can cause fetal harm when administered to a pregnant female and are contraindicated in females who are pregnant [see Boxed Warning]. 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 risk to a fetus.

Severe Hypersensitivity Reactions: Pomalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See BOXED WARNINGS.

  • 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 pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Male patients taking lenalidomide must not donate sperm while taking pomalidomide and for up to 4 weeks after discontinuing lenalidomide.
  • Blood Donation: Patients must not donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide.

PS-Pomalidomide REMS Program: See Boxed WARNINGS. Because of the embryo-fetal risk, pomalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the PS-Pomalidomide REMS program. Prescribers and pharmacies must be certified with the PS-Pomalidomide REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive Pomalidomide Capsules. 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.

Venous and Arterial Thromboembolism: Venous thromboembolic events (deep venous thrombosis (DVT) and pulmonary embolism (PE)) and arterial thromboembolic events (myocardial infarction and stroke) have been observed in patients treated with pomalidomide. Patients with known risk factors, including prior thrombosis, may be at greater risk. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors.

Increased Mortality in Patients with MM with Pembrolizumab: In two randomized clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality.

Hematologic Toxicity:

  • MM: In patients receiving pomalidomide + low-dose Dex, neutropenia was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia. Neutropenia of any grade was reported in 51% of patients, and Grade 3 or 4 neutropenia in 46%. The rate of febrile neutropenia was 8%. Monitor patients for hematologic toxicities, especially neutropenia. Monitor CBC weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification
  • KS: Hematologic toxicities were the most common (all grades and Grade 3 or 4) adverse reactions. 50% of patients had Grade 3 or 4 neutropenia. Monitor patients for hematologic toxicities, especially decreased neutrophils. Monitor CBC every 2 weeks for the first 12 weeks and monthly thereafter. Withhold, reduce the dose, or permanently discontinue pomalidomide based on the severity of the reaction.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with pomalidomide, as well as elevated levels of alanine aminotransferase and bilirubin. Monitor liver function tests monthly. Stop pomalidomide upon elevation of liver enzymes and evaluate. After return to baseline values, consider restarting treatment at a lower dose.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive pomalidomide. Consider pomalidomide interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue pomalidomide for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with pomalidomide. At-risk patients include those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

Dizziness and Confusional State: 14% of patients who received pomalidomide + low-dose dex experienced dizziness and 7% experienced a confusional state; 1% experienced Grade 3 or 4 dizziness, and 3% experienced Grade 3 or 4 confusional state.

Neuropathy: In patients who received pomalidomide + low-dose dex, 18% experienced neuropathy, with approximately 12% experiencing peripheral neuropathy. 2% experienced Grade 3 neuropathy in one trial.

Risk of Secondary Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving pomalidomide as an investigational therapy outside MM.

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to pomalidomide have been reported. Permanently discontinue for angioedema or anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

  • In MM: Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.
  • In KS: Serious adverse reactions occurred in 18% (5/28) of patients who received pomalidomide. Most common adverse reactions including laboratory abnormalities (≥30%) are decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea.

DRUG INTERACTIONS

Co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased Cmax and AUC of pomalidomide by 24% and 125% respectively. Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). If co-administration is unavoidable, reduce the pomalidomide dose. Smoking tobacco reduces pomalidomide AUC due to CYP1A2 induction. Smoking may reduce the efficacy of pomalidomide.

USE IN SPECIFIC POPULATIONS

  • Pregnancy - See Boxed WARNINGS: If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Apotex Corp. at 1-800-706-5575.
  • Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of pomalidomide on the breastfed infant, or the effects of pomalidomide on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from pomalidomide, advise women not to breastfeed during treatment with pomalidomide.
  • Renal Impairment: Starting dose adjustment is recommended for patients with severe renal impairment requiring dialysis. Hepatic Impairment: Dose adjustment is recommended in patients with hepatic impairment.
  • Hepatic Impairment: Dose adjustment is recommended in patients with hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact Apotex, Inc. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including BOXED WARNINGS.