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PROMACTA FOR ORAL SUSPENSION
Anemias
Bleeding disorders
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Drug Name:

PROMACTA FOR ORAL SUSPENSION Rx

Generic Name and Formulations:
Eltrombopag (as olamine) 25mg; per pkt; pwd for reconstitution; contains mannitol.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for PROMACTA FOR ORAL SUSPENSION:

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

Pharmacological Class:

Thrombopoietin receptor agonist.

Adverse Reactions:

Nausea, diarrhea, upper RTI, vomiting, increased ALT, myalgia, UTI, nasopharyngitis, anemia, pyrexia, fatigue, headache, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, alopecia, peripheral edema; hepatotoxicity, hemorrhage, thrombotic/thromboembolic complications, cataracts.

How Supplied:

Tabs—30; Oral susp kit—1 (30 pkts w. supplies)

Indications for PROMACTA FOR ORAL SUSPENSION:

Thrombocytopenia in adult and pediatric patients ≥1year with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Thrombocytopenia in adults with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy.

Limitations Of use:

Should be used only in ITP whose degree of thrombocytopenia and clinical condition increase the risk of bleeding; or, in chronic hepatitis C whose degree of thrombocytopenia prevents starting or limiting ability to maintain interferon-based therapy. Safety and efficacy not established in combination with direct-acting antiviral agents without interferon for chronic hepatitis C infection.

Adults and Children:

Take on empty stomach. ITP: <1yr: not established; 1–5yrs: initially 25mg once daily; ≥6yrs: initially 50mg once daily. Hepatic impairment or East Asian ancestry: initially 25mg once daily. East Asian ancestry with hepatic impairment: consider initiating at 12.5mg once daily. Titrate to maintain platelet count ≥50x109/L; max 75mg once daily. Chronic hepatitis C-associated thrombocytopenia: initially 25mg once daily. Titrate dose by 25mg every 2 weeks as needed to achieve target platelet counts; max 100mg/day. Monitoring, dose adjustment, and discontinuation: see full labeling.

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

Pharmacological Class:

Thrombopoietin receptor agonist.

Adverse Reactions:

Nausea, diarrhea, upper RTI, vomiting, increased ALT, myalgia, UTI, nasopharyngitis, anemia, pyrexia, fatigue, headache, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, alopecia, peripheral edema; hepatotoxicity, hemorrhage, thrombotic/thromboembolic complications, cataracts.

How Supplied:

Tabs—30; Oral susp kit—1 (30 pkts w. supplies)

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