• Persistent or chronic immune thrombocytopenic in patients who have had an inadequate response to corticosteroids, immunoglobulins or splenectomy (should only be used in patients with an ↑ risk of bleeding).
• Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
• Severe aplastic anemia in patients who have had an inadequate response to immunosuppressive therapy.
• First-line treatment of severe aplastic anemia (in combination with standard immunosuppressive therapy).

Contraindicated in:

• Lactation: Lactation.

Use Cautiously in:

• Myelodysplastic syndromes (may ↑ risk of hematologic malignancy)
• Hepatic impairment (lower initial dose required)
• Patients of East-/Southeast-Asian ancestry (may require lower doses)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Pedi: Children <1 yr (safety and effectiveness not established)
• Geri: Older adults may be more sensitive to drug effects; ↑ dose cautiously, consider age-related ↓ in renal and hepatic function, concurrent disease states and drug therapy.

CV: THROMBOEMBOLISM.

EENT: development/worsening of cataracts.

GI: HEPATOTOXICITY.

Drug-Drug:

• ↓availability and absorption of iron, calcium, aluminum, magnesium, selenium and zinc by chelation; give eltrombopag 2 hr before or 4 hr after medications containing these and other polyvalent cations.
• Concomitant use with ribavirin and interferon may ↑ risk of hepatic decompensation

Drug-Food:

• ↓availability and absorption of iron, calcium, aluminum, magnesium, selenium, and zinc by chelation; do not administer within 4 hr of foods containing these and other polyvalent cations.

• Powder for oral suspension: 12.5 mg/pkt; 25 mg/pkt;
• Tablets: 12.5 mg; 25 mg; 50 mg; 75 mg;

Persistent or Chronic Immune Thrombocytopenia

• PO (Adults and Children 6 yr): 50 mg once daily, may be ↑ to achieve a platelet count of 50 × 10⁹/L (not to exceed 75 mg/day); Patients of East-/Southeast-Asian ancestry — 25 mg once daily initially, may be ↑ to achieve a platelet count of 50 × 10⁹/L (not to exceed 75 mg/day).
• PO (Children 1–5 yr): 25 mg once daily, may be ↑ to achieve a platelet count of 50 × 10⁹/L (not to exceed 75 mg/day).

Chronic Hepatitis C-Associated Thrombocytopenia

• PO (Adults): 25 mg once daily; may be ↑ by 25 mg every 2 wk to achieve the target platelet count required to initiate antiviral therapy; during antiviral therapy, adjust dose to avoid dose ↓ of peginterferon (not to exceed 100 mg/day).

First-Line Treatment of Severe Aplastic Anemia

• PO (Adults and Children 12 yr): 150 mg once daily for 6 mo; Patients of East-/Southeast-Asian ancestry — 75 mg once daily for 6 mo.
• PO (Children 6–11 yr): 75 mg once daily for 6 mo; Patients of East-/Southeast-Asian ancestry — 37.5 mg once daily for 6 mo.
• PO (Children 2–5 yr): 2.5 mg/kg once daily for 6 mo; Patients of East-/Southeast-Asian ancestry — 1.25 mg/kg once daily for 6 mo.

Refractory Severe Aplastic Anemia

• PO (Adults): 50 mg once daily; may be ↑ by 50 mg every 2 wk to achieve a platelet count of 50 × 10⁹/L (not to exceed 150 mg/day);Patients of East-/Southeast-Asian ancestry — 25 mg once daily; may be ↑ by 50 mg every 2 wk to achieve a platelet count of 50 × 10⁹/L (not to exceed 150 mg/day).

Promacta

• Increases platelet production by initiating proliferation and differentiation of megakaryocytes from bone marrow progenitor cells.

• Increased blood counts.

Therapeutic Classification: antithrombocytopenics

Pharmacologic Classification:

Absorption: 52% absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >99%.

Metabolism/Excretion: Extensively metabolized; 59% eliminated in feces, 20% as unchanged drug; 31% excreted in urine as metabolites.

Half-life: 21–35 hr.

Revolade

(effect on platelet count)

• Instruct patient to take eltrombopag as directed. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes. Explain purpose, risks and benefits of therapy to patient. Risks or long term therapy are unknown.
• Instruct patient to avoid taking eltrombopag within 4 hr of foods, mineral supplements, and antacids containing iron, calcium, aluminum, magnesium, zinc, and selenium.
• Advise patients to avoid activities and medications that may increase risk of bleeding.
• Advise patient of need for baseline ocular exam before starting therapy and monitoring for signs and symptoms of cataracts during therapy.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Instruct patient to notify health care professional if symptoms of liver problems (yellowing of skin or whites of eyes, unusual darkening of urine, unusual tiredness, pain in right upper stomach, confusion, swelling of abdomen) occur.
• Rep: May cause fetal harm. Advise females of reproductive potential use effective contraception during and for at least 7 days after therapy ended and to notify health care professional promptly if pregnancy is planned or suspected and to avoid breastfeeding.
• Emphasize the importance of routine lab tests to determine effectiveness and monitor for side effects.

el-TROM-bo-pag

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0684- PROMACTA
    • 0078-0684-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0685- PROMACTA
    • 0078-0685-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0686- PROMACTA
    • 0078-0686-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0687- PROMACTA
    • 0078-0687-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0687-15)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0972- PROMACTA
    • 0078-0972-61- 1 CARTON in 1 KIT (0078-0972-61) > 30 PACKET in 1 CARTON (0078-0972-23) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)