Generic Name and Formulations:
Eltrombopag (as olamine) 12.5mg, 25mg, 50mg, 75mg, 100mg; tabs.
Company:
Novartis Pharmaceuticals Corp
Indications for PROMACTA:
Severe aplastic anemia in adults who have had insufficient response to immunosuppressive therapy.
Adult:
Take on empty stomach. Initially 50mg once daily. Hepatic impairment or East Asian ancestry: initially 25mg once daily. Titrate dose by 50mg every 2 weeks as needed to maintain platelet count ≥50x109/L; max 150mg daily. Monitoring, dose adjustment, and discontinuation: see full labeling.
Children:
Not established.
Warnings/Precautions:
Increased risk of hepatic decompensation in patients with chronic hepatitis C in combination with interferon and ribavirin; discontinue Promacta if antiviral therapy is discontinued. Increased risk of severe hepatotoxicity; monitor liver function prior to initiation, every 2 weeks during dose adjustments, and monthly after stabilized (see full labeling); discontinue if ALT ≥3xULN in those with normal liver function or ≥3x baseline (or >5xULN, whichever is lower) in those with pre-treatment transaminase elevations and are progressive or persistent for ≥4 weeks, or if occurs with increased bilirubin, or symptoms/evidence of hepatic injury/decompensation; reinitiate therapy if benefit outweighs risk; if restarted, monitor carefully. Increased risk of thromboembolism; do not use to normalize platelet counts. Do baseline eye exam; monitor for cataracts. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Potentiates substrates of OATP1B1 (eg, most statins, bosentan, ezetimibe, glyburide, olmesartan, valsartan, repaglinide, rifampin) or BCRP (eg, imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, sulfasalazine, topotecan); monitor and consider reducing their doses. Antagonized by lopinavir/ritonavir. Separate dosing by at least 2hrs before or 4hrs after food/drugs containing polyvalent cations (eg, Fe+2, Ca+2, Al+3, Mg+2, Se+2, Zn+2).
See Also:
PROMACTA FOR ORAL SUSPENSION
Pharmacological Class:
Thrombopoietin receptor agonist.
Adverse Reactions:
Nausea, diarrhea, fatigue, cough, headache, pain, dyspnea, pyrexia, dizziness, febrile neutropenia, ecchymosis, muscle spasms, arthralgia, rhinorrhea; hepatotoxicity, hemorrhage, thrombotic/thromboembolic complications, cataracts.
How Supplied:
Tabs—30; Oral susp kit—1 (30 pkts w. supplies) |
