Promacta (Eltrombopag Tablets) Drug Information: Overdosage and Contraindications

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May 27, 2012

Promacta

Thrombocytopenia (Low Platelet Count) »

What is thrombocytopenia?

Thrombocytopenia is a lower than normal number of platelets in the blood.

Platelets are one of the components of the blood along with white and red blood cells. Platelets play an important role in clotting and bleeding. Platelets are made in the bone marrow similar to other cells in the blood such as, white blood cells and red blood cells. Platelets originate from megakaryocytes which are large cells found in the bone marrow. The fragments of these megakaryocytes are platelets that are released into the blood stream. The circulating platelets make up about two third of the platelets that are released from the bone marrow. The other one third is typically stored (sequestered) in the spleen.

Platelets, in general, have a brief 7 to 10 days life in the blood, after which they are removed from the blood circulation. The number of platelets in the blood is referred to as the platelet count and is normally betw...

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OVERDOSE

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 10⁹/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 [see DOSAGE AND ADMINISTRATION].