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...+

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Indication for PROMACTA® (eltrombopag)
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

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

$0 co-pay with commercial insurance

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
  • 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.

Medicare Patient Co-pay

Low to no co-pay for Medicare patients

  • ~72% pay $10 or less—and ~63% have a $0 co-pay1†

Medicare patients are not eligible for the Universal Co-pay Program. The information about Medicare patients’ co-pay is a function of the Medicare benefit design applicable to the product.

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:
Ask 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 Patient Assistance Now Oncology 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.

APLD, anonymous patient-level data; FY, fiscal year; HCP, health care professional.

References:

  1. Data on file. IQVIA APLD FY 2020. Novartis Pharmaceuticals Corp; April 2021.
  2. Promacta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

Indication and Important Safety Information

Indication for PROMACTA® (eltrombopag)
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

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

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
  • During therapy with PROMACTA, assess complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Monitor platelet counts monthly thereafter
  • Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation of PROMACTA
  • When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, then follow standard monthly monitoring

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 in 3 placebo-controlled clinical trials in patients with persistent or chronic ITP (≥3% and greater than placebo) for PROMACTA were nausea (9%), diarrhea (9%), upper respiratory tract infection (7%), vomiting (6%), increased ALT (5%), myalgia (5%), urinary tract infection (5%), oropharyngeal pain (4%), increased AST (4%), pharyngitis (4%), back pain (3%), influenza (3%), paresthesia (3%), and rash (3%).

The most common adverse reactions in 2 placebo-controlled clinical trials in patients with persistent or chronic ITP 1 year and older (≥3% and greater than placebo) for PROMACTA were upper respiratory tract infection (17%), nasopharyngitis (12%), cough (9%), diarrhea (9%), pyrexia (9%), abdominal pain (8%), oropharyngeal pain (8%), toothache (6%), ALT increased (6%), rash (5%), AST increased (4%), and rhinorrhea (4%).

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