Clinical Pharmacology Details


Eltrombopag Olamine


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Indications & Dose:

For the treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduces of prevents bleeding. In patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to initiate and optimise interferon based therapy.


DOSAGE AND ADMINISTRATION:


Idiopathic Thrombocytopenic Purpura: The recommended starting dose in adults is 50 mg once daily and adjust to maintain a platelet count > 50,000/ul. Do not exceed a dose of 75 mg, daily. Discontinue treatment if the platelets count does not increase to a sufficient level after 4 weeks of therapy.
HCV associated Thrombocytopenia: The recommended starting dose in adults is 25 mg once daily and adjust to achieve a platelet count required to initiate antiviral therapy. Do not exceed a dose of 100 mg once daily. Discontinue treatment if the platelets count does not increase to a sufficient level after 24 weeks of therapy. Hepatic impairment: Exercise caution when administering Eltrombopag Olamine to ITP patients with hepatic impairment (Child-Pugh score >5).
Elderly:
Limited data on the use of Eltrombopag Olamine in patients aged 65 years and older is available.
Children
: The safety and efficacy have not been established. 

Contraindications:

Not known. 

Side Effects:

Cautions:

Precautions:

Interaction:

Rosuvastatin and liponavir/ ritonavir may cause a change in plasma concentration of eltrombopag. When coadministered with Eltrombopag Olamine., a reduced dose of rosuvastatin should be considered and careful monitoring should be undertaken. Caution should be used when co-administration of Eltrombopag Olamine. with LPV/RTV takes place. Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of Eltrombopag Olamine. when lopinavir/ ritonavir therapy is initiated or discontinued. Take at least four hours before or after any product containing polyvalent cation or food to prevent malabsorption. 

Warnings:

Exercise caution when administering to patients with hepatic disease or to patients with known risk factors for thromboembolism. Monitor platelets count for 4 weeks following discontinuation of Eltrombopag Olamine. HCV patients should be closely monitored for signs and symptoms of hepatic decompensation. Eltrombopag Olamine. may increase the risk for development or progression of reticulin fibers within the bone marrow. Routine monitoring of patients for cataracts is recommended. 


 

Adverse Effects:

Lactations:

Eltrombopag olamine. should be used in pregnant women and nurshing mothers only if the expected benefit justifies the potential risk to the foetus. 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Very Common: Nausea, diarrhea, fatigue, pyrexia, chills, asthenia, oedema peripheral, myalgia, pruritus, alopecia, cough, headache, insomnia, decreased appetite, influenza like illness and anaemia. Common: pharyngitis, urinary tract infection, dry mouth, vominting, alopecia, rash, back pain, musculoskeletal pain, hyperbilirubinaemia and myalgia,


 

Patient And Carer Advice: