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PROMACTA
Overview
What is PROMACTA?
PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production.
Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula CHNO•2(CHNO). The molecular weight is 564.65 for eltrombopag olamine and 442.5 for eltrombopag free acid. Eltrombopag olamine has the following structural formula:
Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.
PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg, or 100 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate. hypromellose (12.5-mg, 25-mg, 50-mg, and 75-mg tablets) or polyvinyl alcohol and talc (100-mg tablet), polyethylene glycol 400, titanium dioxide, polysorbate 80 (12.5-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), FD&C Blue No. 2 aluminum lake (50-mg tablet), Iron Oxide Red and Iron Oxide Black (75-mg tablet), or Iron Oxide Yellow and Iron Oxide Black (100-mg tablet).
PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each 25-mg packet delivers eltrombopag olamine equivalent to 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.
What does PROMACTA look like?
What are the available doses of PROMACTA?
What should I talk to my health care provider before I take PROMACTA?
How should I use PROMACTA?
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
Use the lowest dose of PROMACTA to achieve and maintain a platelet count greater than or equal to 50 x 10/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use PROMACTA to normalize platelet counts In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting PROMACTA and decreased within 1 to 2 weeks after discontinuing PROMACTA.
Initial Dose Regimen:
Adult and Pediatric Patients 6 Years and Older with ITP:
For patients of East Asian ancestry with ITP, initiate PROMACTA at a reduced dose of 25 mg once daily
For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate PROMACTA at a reduced dose of 25 mg once daily .
For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A, B, C), consider initiating PROMACTA at a reduced dose of 12.5 mg once daily .
Pediatric Patients with ITP Aged 1 to 5 Years:
[see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)]
Monitoring and Dose Adjustment:
When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, and then follow standard monthly monitoring.
In patients with ITP and hepatic impairment (Child-Pugh Class A, B, C), after initiating PROMACTA or after any subsequent dosing increase, wait 3 weeks before increasing the dose.
Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during therapy with PROMACTA. Do not administer more than one dose of PROMACTA within any 24-hour period.
Discontinuation:
[see Warnings and Precautions (5.2)]
What interacts with PROMACTA?
Sorry No Records found
What are the warnings of PROMACTA?
Sorry No Records found
What are the precautions of PROMACTA?
Sorry No Records found
What are the side effects of PROMACTA?
Sorry No records found
What should I look out for while using PROMACTA?
None.
What might happen if I take too much PROMACTA?
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
In one report, a subject who ingested 5,000 mg of PROMACTA had a platelet count increase to a maximum of 929 x 10/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations, and fatigue. The patient was treated with gastric lavage, oral lactulose, intravenous fluids, omeprazole, atropine, furosemide, calcium, dexamethasone, and plasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months’ follow-up, all events had resolved without sequelae.
In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with PROMACTA in accordance with dosing and administration recommendations .
How should I store and handle PROMACTA?
Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16Terbutaline sulfate tablets, USP are packaged in bottles of 4 tablets. Descriptions of the 5 mg tablets follow:TabletsBottles of 4 NDC 43063-558-04Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closureRev. 02/16
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells.
Non-Clinical Toxicology
None.The concomitant use of terbutaline sulfate with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with terbutaline sulfate.
In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. In two controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, ascites and encephalopathy occurred more frequently on the arm receiving treatment with PROMACTA plus antivirals (7%) than the placebo plus antivirals arm (4%). Patients with low albumin levels (less than 3.5 g/dL) or Model for End-Stage Liver Disease (MELD) score greater than or equal to 10 at baseline had a greater risk for hepatic decompensation on the arm receiving treatment with PROMACTA plus antivirals. Discontinue PROMACTA if antiviral therapy is discontinued.
The following serious adverse reactions associated with PROMACTA are described in other sections.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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