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Savings are available through the Cladribine instant savings program†

Making Cladribine tablets more affordable for patients†

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

Do you have commercial health insurance?

You may be eligible for the Cladribine instant savings† program

  • If eligible, commercially insured patients may pay as little as $0† out-of-pocket cost with the Cladribine instant savings card and the program will pay up to $4,600 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 Cladribine instant savings† program card:

  • Review the Terms and Conditions below.
  • Click Enroll to agree to the Terms and Conditions.
  • Print your Cladribine instant savings† program card and bring it to a participating local pharmacy.

Review the Cladribine 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 Cladribine, 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 Cladribine instant savings† program card.

If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, please call 1-833-944-5688.

Patient

  • Present the Cladribine instant savings† card with your Cladribine prescription at any participating pharmacy.
  • If eligible, commercially insured patients may pay as little as $0† out-of-pocket cost with the Cladribine instant savings card and the program will pay up to $4,600 per calendar year.
  • By using this card, the patient acknowledges meeting the eligibility requirements and complying with the Terms and Conditions.
  • For questions about eligibility or about using the card, please call toll free at 1-833-944-5688.

Pharmacist

  • For commercially insured patients presenting the Cladribine instant savings program card for whom you have dispensed Cladribine tablets (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 1-833-944-5688.

Limitations apply

  • Offer not valid for patients who are uninsured or have no prescription drug coverage for Cladribine 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 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).

IMPORTANT SAFETY INFORMATION

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY

Treatment with CLADRIBINE may increase the risk of malignancy. CLADRIBINE is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of CLADRIBINE on an individual patient basis. Follow standard cancer screening guidelines in patients treated with CLADRIBINE.

CLADRIBINE is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals.

Exclude pregnancy before the start of treatment with CLADRIBINE in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during CLADRIBINE dosing and for 6 months after the last dose in each treatment course.

Stop treatment with CLADRIBINE if the patient becomes pregnant.

 
 

INDICATION

CLADRIBINE TABLETS are a purine antimetabolite indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of CLADRIBINE TABLETS are generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.

Limitations of Use: CLADRIBINE is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY

  • Treatment with CLADRIBINE may increase the risk of malignancy. CLADRIBINE is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of CLADRIBINE on an individual patient basis. Follow standard cancer screening guidelines in patients treated with CLADRIBINE.
  • CLADRIBINE is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with CLADRIBINE in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during CLADRIBINE dosing and for 6 months after the last dose in each treatment course. Stop treatment with CLADRIBINE if the patient becomes pregnant.

CONTRAINDICATIONS

  • Patients with current malignancy.
  • Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during and for 6 months after the last dose in each treatment course. May cause fetal harm.
  • Patients infected with human immunodeficiency virus (HIV).
  • Patients with active chronic infections (e.g., hepatitis or tuberculosis).
  • Patients with a history of hypersensitivity to cladribine.
  • Women intending to breastfeed on a CLADRIBINE treatment day and for 10 days after the last dose.

WARNINGS AND PRECAUTIONS

  • Malignancies: Treatment with CLADRIBINE may increase the risk of malignancy. After the completion of 2 treatment courses, do not administer additional CLADRIBINE treatment during the next 2 years. In clinical studies, patients who received additional CLADRIBINE treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy. The risk of malignancy with reinitiating CLADRIBINE more than 2 years after the completion of 2 treatment courses has not been studied. Follow standard cancer screening guidelines in patients treated with CLADRIBINE.
  • Risk of Teratogenicity: CLADRIBINE may cause fetal harm when administered to pregnant women. In females of reproductive potential, exclude pregnancy before initiation of each treatment course of CLADRIBINE and prevent by the use of effective contraception during CLADRIBINE dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with CLADRIBINE should discontinue treatment.
  • Lymphopenia: CLADRIBINE causes a dose-dependent reduction in lymphocyte count. Concomitant use of CLADRIBINE with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects. Monitor lymphocyte counts before, during, and after treatment.
  • Infections: Serious, including life-threatening or fatal, infections have occurred. CLADRIBINE reduces the body's immune defense, and an increased risk of infections has been observed in patients receiving CLADRIBINE. Infections occurred in 49% of CLADRIBINE-treated patients compared to 44% of patients treated with placebo in clinical studies; serious or severe infections occurred in 2.4% of CLADRIBINE-treated patients and 2.0% of placebo-treated patients. The most frequent serious infections included herpes zoster and pyelonephritis. Fungal infections were observed, including cases of coccidioidomycosis. Single fatal cases of tuberculosis and fulminant hepatitis B were reported in the clinical program.
    • Screen patients for active and latent infections (tuberculosis, hepatitis B or C). Delay treatment until infection is fully resolved or controlled.
    • Vaccinate patients who are seronegative for varicella zoster virus (VZV) prior to treatment. Vaccinate patients who are seropositive to VZV with recombinant, adjuvanted zoster vaccine either prior to or during treatment, including when their lymphocyte counts are less than or equal to 500 cells per microliter.
    • Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections.
    • Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with parenteral cladribine for oncologic indications. No case of PML has been reported in clinical studies of cladribine in patients with MS. Obtain a baseline magnetic resonance imaging (MRI) within 3 months before initiating the first treatment course of CLADRIBINE. At the first sign of PML, withhold CLADRIBINE and perform an evaluation.
    • Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting CLADRIBINE. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting CLADRIBINE due to risk of infection.
  • Hematologic Toxicity: In addition to lymphopenia, decreases in other blood cells and hematological parameters have been reported with CLADRIBINE in clinical studies. Obtain complete blood count (CBC) with differential including lymphocyte count before and during treatment, periodically thereafter, and when clinically indicated.
  • Graft-versus-Host Disease with Blood Transfusions: Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of nonirradiated blood in patients treated with cladribine for non-MS treatment indications. In patients who require blood transfusion, irradiation of cellular blood components is recommended.
  • Liver Injury: In clinical studies, 0.3% of CLADRIBINE-treated patients had liver injury (serious or causing treatment discontinuation) compared to 0 placebo patients. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment. Discontinue CLADRIBINE if clinically significant liver injury is suspected.
  • Hypersensitivity: If a hypersensitivity reaction is suspected, discontinue CLADRIBINE therapy. Do not use CLADRIBINE in patients with a history of hypersensitivity to cladribine.
  • Cardiac Failure: In clinical studies, one CLADRIBINE-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Cases of cardiac failure have also been reported with parenteral cladribine used for treatment indications other than multiple sclerosis. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling).

Adverse Reactions: The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia.

Drug Interactions: Concomitant use with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological profile with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of CLADRIBINE.

Use in Specific Populations: Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.

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 WARNING.