PROMACTA FOR ORAL SUSPENSION Rx

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PROMACTA FOR ORAL SUSPENSION

Anemias
Bleeding disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Eltrombopag (as olamine) 25mg; per pkt; pwd for reconstitution; contains mannitol.

Select therapeutic use:

Indications for PROMACTA FOR ORAL SUSPENSION:

Severe aplastic anemia in adults who have had insufficient response to immunosuppressive therapy.

Limitations Of use:

Not indicated for the treatment of myelodysplastic syndromes (MDS).

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 death and progression of MDS to acute myeloid leukemia (AML). Increased risk of thromboembolism; do not use to normalize platelet counts. Do baseline eye exam; monitor for cataracts. Renal impairment. East Asians. 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. May be 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. Should be used only in ITP patients whose degree of thrombocytopenia and clinical condition increase the risk of bleeding. Thrombocytopenia in adults with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy. Should be used only in chronic hepatitis C patients whose degree of thrombocytopenia prevents starting or limiting ability to maintain interferon-based therapy.

Limitations Of use:

Not indicated for the treatment of myelodysplastic syndromes (MDS). 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 death and progression of MDS to acute myeloid leukemia (AML). Increased risk of thromboembolism; do not use to normalize platelet counts. Do baseline eye exam; monitor for cataracts. Renal impairment. East Asians. 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. May be 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)