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Prescribers






 
Learn how the PROMACTA CARES program works. Watch this Interactive Video.

Download PROMACTA CARES Enrollment Form

One-Time Prescriber Enrollment
  • Prescriber enrollment is required to prescribe PROMACTA.
  • Review, complete, and submit the Prescriber Enrollment Form for PROMACTA CARES. The form is available from the Resources page of this Web site, your GSK Sales Representative, or by calling PROMACTA CARES at 1-877-9-PROMACTA (1-877-977-6622).
  • Fax completed forms to PROMACTA CARES at 1-866-765-0920.
Patient Enrollment
  • Identify an appropriate patient for PROMACTA, educate patient on the risks and benefits of treatment with PROMACTA, make sure the patient receives the Medication Guide, instruct the patient to read it, and encourage the patient to ask questions when considering PROMACTA.
  • With each patient review, complete, and submit the Patient Enrollment Form for PROMACTA CARES, answer all questions, and obtain the patient's signature on the Patient Enrollment Form for PROMACTA CARES. Keep the original, send a copy to PROMACTA CARES, and give a copy to the patient.
  • Complete and submit the Patient Baseline Form for PROMACTA CARES for each patient. Patients must be enrolled to receive PROMACTA.
Patient Support & Follow-up
  • Every 6 months, a PROMACTA CARES consultant will contact the prescriber to collect safety information and verify whether the patient should continue on PROMACTA.

    • Complete and fax the Medical and Reauthorization Form for PROMACTA CARES to 1-866-765-0920.

  • Prescribers must promptly report to PROMACTA CARES any adverse events occurring in the course of the use of PROMACTA. Specifically:
  • hepatotoxicity
  • bone marrow reticulin formation and risk for bone marrow fibrosis
  • worsened thrombocytopenia after cessation of PROMACTA leading to serious hemorrhage
  • thrombotic/thromboembolic complications
  • increased risk of hematological malignancies and progression of malignancy in patients with a pre-existing hematological malignancy or myelodysplastic syndrome (MDS)
  • Prescribers must also notify PROMACTA CARES when a patient discontinues PROMACTA by completing the Patient Discontinuation and Post Therapy Follow-Up Form for PROMACTA CARES at the time of discontinuation of PROMACTA and 3 months later. Visit the Resources page to download the Medical and Reauthorization Form for PROMACTA CARES and the Patient Discontinuation and Post Therapy Follow-Up Form for PROMACTA CARES.
  • Anytime a healthcare provider or patient has a question about PROMACTA use, risks, ITP reimbursement, or other support services, they can call PROMACTA CARES at 1-877-9-PROMACTA (1-877-977-6622).

All patients who are prescribed PROMACTA are eligible to participate in the optional reimbursement services of PROMACTA CARES.

Patient Reimbursement Services
  • Upon enrollment, complete the Prescription and Reimbursement Services Form for PROMACTA CARES with the patient.
  • PROMACTA CARES Reimbursement Consultants can answer questions about PROMACTA and reimbursement at 1-877-9-PROMACTA (1-877-977-6622).

The authorized specialty pharmacies are as follows:

The list of specialty pharmacies distributing PROMACTA is subject to change without notice, so please continue to check this site for the most complete and up-to-date list. Contact PROMACTA CARES at 1-877-9-PROMACTA (1-877-977-6622) for more information about these specialty pharmacies.


Important Safety Information


BOXED WARNING

PROMACTA may cause hepatotoxicity. Patients receiving therapy with PROMACTA must have regular monitoring of serum liver tests (see Laboratory Monitoring below). Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of normal (ULN) and are: progressive; or persistent for ≥4 weeks, or; accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. Reinitiating treatment with PROMACTA is not recommended and should be considered only with close medical supervision and under exceptional circumstances where the potential benefit outweighs the risk.

Because of the risk for hepatotoxicity and other risks, PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under the PROMACTA CARES Program, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in the PROMACTA CARES Program, call 1-877-9-PROMACTA.

Warnings and Precautions:

Additional safety information regarding Risk of Hepatotoxicity: Reinitiating treatment with PROMACTA is not recommended. If the potential benefit for reinitiating PROMACTA treatment is considered to outweigh the risk for hepatotoxicity, then cautiously reintroduce PROMACTA and measure serum liver tests weekly during the dose adjustment phase. If liver tests abnormalities persist, worsen or recur, then permanently discontinue PROMACTA. Exercise caution when administering PROMACTA to patients with hepatic disease. Use a lower starting dose of PROMACTA in patients with moderate to severe hepatic disease and monitor closely.

Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis: PROMACTA is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists increase the risk for development or progression of reticulin fibers within the bone marrow. Prior to initiation of PROMACTA, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities. Following identification of a stable dose of PROMACTA, perform CBC with WBC differential monthly. If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with PROMACTA and consider a bone marrow biopsy, including staining for fibrosis.

Worsened Thrombocytopenia and Hemorrhage Risk After PROMACTA Cessation: Discontinuation of PROMACTA may result in thrombocytopenia of greater severity than was present prior to therapy with PROMACTA. This worsened thrombocytopenia may increase the patient?s risk of bleeding, particularly if PROMACTA is discontinued while the patient is on anticoagulants or antiplatelet agents. In the controlled clinical studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 10% and 6% of the PROMACTA and placebo groups, respectively. Serious hemorrhagic events requiring the use of supportive ITP medications occurred in 3 severely thrombocytopenic patients within one month following the discontinuation of PROMACTA; none were reported among the placebo group. Following discontinuation of PROMACTA, obtain weekly CBCs, including platelet counts for at least 4 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.

Thrombotic/Thromboembolic Complications: Thrombotic/thromboembolic complications may result from excessive increases in platelet counts. Excessive doses of PROMACTA or medication errors that result in excessive doses of PROMACTA may increase platelet counts to a level that produces thrombotic/thromboembolic complications. In the controlled clinical studies, one thrombotic/thromboembolic complication was reported within the group that received PROMACTA and none within the placebo group. Seven patients experienced thrombotic/thromboembolic complications in the extension study. Use caution when administering PROMACTA to patients with known risk factors for thromboembolism. 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 a platelet count of ≥50 x 109/L.

Malignancies and Progression of Malignancies: Stimulation of the TPO receptor on the surface of hematopoietic cells may increase the risk for hematologic malignancies. PROMACTA is not indicated for the treatment of thrombocytopenia due to causes of thrombocytopenia (e.g, myelodysplasia or chemotherapy) other than chronic ITP.

Laboratory Monitoring: Complete Blood Counts (CBCs) - Monitor CBCs, including platelet counts and WBC differentials prior to initiation, throughout, and following discontinuation of PROMACTA therapy. Prior to the initiation of PROMACTA, examine the peripheral blood differential to establish the extent of red and white blood cell abnormalities. Obtain CBCs, including platelet counts and peripheral blood smears, weekly during the dose adjustment phase of therapy with PROMACTA and then monthly following establishment of a stable dose of PROMACTA. Obtain CBCs, including platelet counts, weekly for at least 4 weeks following discontinuation of PROMACTA. Liver tests: Monitor serum liver tests (ALT, AST, total and fractionated bilirubin) prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If abnormal levels are detected, repeat the tests within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels. Discontinue PROMACTA for the development of clinically important liver test abnormalities.

Cataracts: In the controlled clinical studies, cataracts developed or worsened in five patients (5%) who received 50 mg PROMACTA daily and two placebo-group patients (3%). In the extension study, cataracts developed or worsened in 4% of patients who underwent ocular examination prior to therapy with PROMACTA. Cataracts were observed in toxicology studies of eltrombopag in rodents. Perform a baseline ocular examination prior to administration of PROMACTA and, during therapy with PROMACTA, regularly monitor patients for signs and symptoms of cataracts.