Important Safety Information

WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C - In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of...+

See More

Indications for PROMACTA® (eltrombopag)
PROMACTA is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.

PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Limitations of Use
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS).

Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Access

Novartis Oncology Patient Support

The right resources at the right time.

Novartis Oncology Patient Support is designed to help meet the needs of patients and caregivers by making it easier to access Novartis Oncology medicine(s). Our patient support programs include financial assistance, information about lifestyle support, and more.

 
To learn more about support for your patients, call 1-800-282-7630 or visit HCP.Novartis.com/Access

Patient Assistance Now Oncology

Assistance. Access. Answers.

  • Patient Assistance Now Oncology (PANO) is a support center consisting of dedicated case managers who provide information to patients and HCPs regarding coverage and costs of medicines specific to a patient’s insurance plan. These case managers also help direct callers to additional Novartis Oncology Patient Support programs that best fit their needs

Universal Co-pay Program

Novartis universal co-pay card

Patients may be eligible for co-pay savings on their next prescription of PROMACTA® (eltrombopag).

  • Eligible patients with private insurance may pay $0 per month
  • ~75% of PROMACTA commercial patients pay $50 or less, with ~57% paying $01*
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product*
  • Your patients can learn if they are eligible for the Novartis Oncology Universal Co-pay Program by visiting Copay.NovartisOncology.com or calling 1-877-577-7756

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756.

Based on 22,616 approved claims identified between January 1, 2020 and December 31, 2020 for all relevant payers, including commercial, government, and/or other third-party support. Patients with government insurance are not eligible for the Universal Co-pay Program; any information about these patients’ co-pay may be a function of their specific benefit design as applicable to the product.1

Medicare Patient Co-pay

Low to no co-pay for Medicare patients.

  • ~70% of PROMACTA Medicare patients pay $10 or less, with ~60% paying $01†

Free Trial Program

  • The PROMACTA 14-day free trial is designed to provide a temporary supply of medicine that will allow patients to begin therapy quickly for a US Food and Drug Administration–approved indication. Eligible patients with a valid prescription can receive a free trial supply via mail. (Eligibility may vary)
  • You can help your patients apply for this program by submitting the Novartis Service Request Form, available at HCP.Novartis.com/Access

Patient Navigator Program

  • The Novartis Patient Navigators are a dedicated team of specialists who support eligible patients during their treatment journeys
  • Patients receive a series of phone calls from a specially trained navigator who will support and guide them through various aspects of taking their prescribed medicines§

Patient Navigator services do not involve the practice of nursing or provide clinical advice and counseling. Medical inquiries will be directed to HCP or office staff.

§Must be prescribed a Novartis Oncology medicine for an approved indication that is offered within the Patient Navigator Program.

PROMACTA4U

Support for your patients when they need it most

Promacta for you patient support
 
Help your patients start on Day 12:
Contact your Novartis representative about our sample and voucher program

Financial Assistance

Financial assistance may be available for eligible underinsured or uninsured patients.

  • The Novartis Patient Assistance Foundation, Inc. (NPAF), an independent charitable organization, may provide financial assistance for Novartis Oncology medicine(s) to patients experiencing financial hardship with limited or no prescription coverage. Patients who meet the following eligibility requirements may be qualified to receive Novartis medicine(s) at no cost:
    • US resident
    • Proof of income that meets the financial eligibility requirement
    • Limited or no prescription coverage
  • New patients seeking NPAF assistance are required to submit the PANO Service Request Form
  • To learn more, call NPAF at 1-800-277-2254 or visit PAP.Novartis.com

Exceptions exist for individuals with limited prescription coverage. Please be advised that access to the medicines distributed through the Novartis Patient Assistance Foundation, Inc., is free of charge to all eligible patients.

HCP, health care professional.

References:

  1. Data on file. IQVIA, anonymized patient-level data. Novartis Pharmaceuticals Corp; January 2021.
  2. Promacta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

Indications and Important Safety Information

Indications for PROMACTA® (eltrombopag)
PROMACTA is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.

PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Limitations of Use
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS).

Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Important Safety Information for PROMACTA® (eltrombopag)

WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C
In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation.

RISK OF HEPATOTOXICITY
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.

Hepatotoxicity
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity.

Treatment of ITP, chronic hepatitis C, and refractory severe aplastic anemia

  • Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose-adjustment phase, and monthly following establishment of a stable dose
  • PROMACTA inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform fractionation
  • Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized
  • Discontinue PROMACTA if ALT levels increase to ≥3 times the upper limit of normal in patients with normal liver function or ≥3 times baseline in patients with pretreatment elevations in transaminases and are progressively increasing; or persistent for ≥4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation
  • If the potential benefit for reinitiating treatment with PROMACTA outweighs the risk for hepatotoxicity, then consider cautiously reintroducing PROMACTA and measure serum liver tests weekly during the dose-adjustment phase. Hepatotoxicity may reoccur if PROMACTA is reinitiated. If liver test abnormalities persist, worsen, or recur, then permanently discontinue PROMACTA

First-line treatment of severe aplastic anemia

  • ALT, AST, and bilirubin should be measured prior to initiation of PROMACTA
  • During treatment, increases in ALT levels should be managed based on recommendation in Dosing and Administration section for hepatic impairment  
Thrombotic/Thromboembolic Complications
  • Thrombotic/thromboembolic complications may result from increases in platelet counts with PROMACTA
  • Reported thrombotic/thromboembolic complications included both venous and arterial events, and were observed at low and at normal platelet counts
  • Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA
  • To minimize the risk for thrombotic/thromboembolic complications, do not use PROMACTA in an attempt to normalize platelet counts. Follow the dose-adjustment guidelines to achieve and maintain target platelet counts
Increased Risk of Death and Progression of Myelodysplastic Syndromes (MDS) to Acute Myeloid Leukemia (AML)
  • In a clinical trial of patients with intermediate- to high-risk MDS and thrombocytopenia receiving PROMACTA, an increased number of progressions from MDS to AML and deaths have been observed compared to placebo
  • PROMACTA is not indicated for the treatment of patients with MDS
Cataracts
  • Development or worsening of cataracts with PROMACTA has been reported with a frequency of 5% to 11% in 6 clinical studies
  • Perform a baseline ocular examination prior to initiating PROMACTA. Regularly monitor patients for signs and symptoms of cataracts while on PROMACTA
Laboratory Monitoring
  • Monitor serum liver tests
  • Monitor clinical hematology tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts
  • Hematologic response may take up to 16 weeks after starting PROMACTA. If no hematologic response has occurred after 16 weeks with PROMACTA, discontinue therapy
Drug/Drug and Drug/Food Interactions
  • PROMACTA must be taken at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods, and mineral supplements
  • Take PROMACTA without a meal or with a meal low in calcium (≤50 mg)

Adverse Reactions
Across all indications, the most common adverse reactions (≥20% in any indication) were anemia, nausea, pyrexia, ALT increased, cough, fatigue, headache, and diarrhea.

The most common adverse reactions (≥5%) in a single-arm trial of 92 patients 2 years and older with severe aplastic anemia (SAA) who had not received prior immunosuppressive therapy were increased ALT (29%) and AST (17%), blood bilirubin increased (17%), rash (8%), and skin discoloration including hyperpigmentation (5%). Upper respiratory infection, particularly in pediatric patients, was also reported. The most common adverse reactions (≥20%) in a single-arm, open-label trial in 43 patients with refractory SAA who received PROMACTA were nausea (33%), fatigue (28%), cough (23%), diarrhea (21%), and headache (21%). In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported, including 5 patients who had complex changes in chromosome 7. If new cytogenetic abnormalities are observed, consider discontinuation of PROMACTA.

Please see full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide.