Indications
R-Pag Tablet is used for:
Adult chronic immune (idiopathic) thrombocytopenic purpura (ITP), Hepatitis C Virus (HCV) related, Thrombocytopenia, Aplastic anemia
Adult Dose
Adult
Chronic ITP: Initial dose 50 mg once daily. Adjust to maintain platelet count greater than or equal to 50×109 /L
Chronic hepatitis C associated thrombocytopenia: Initial recommended dose is 50 mg once daily and do not exceed a daily dose of 100 mg.
Severe aplastic anemia: Initial recommended dose is 50 mg once daily, adjust to maintain platelet count greater or equal 50×109 /L. Do not exceed 150 mg per day
Max: 75 mg daily.
After adjustment, platelet counts should be monitored at least weekly for 2-3 weeks. Wait for at least 2 weeks to see the effect of any dose adjustment on the patient’s platelet response prior to considering another dose adjustment.
Hepatic Impairment: Should not be used in ITP patients with liver cirrhosis (hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Child Dose
Child 6 years or older
Chronic ITP: Initial dose 50 mg once daily.
Child 1 to 5 year
The initial dose is 25 mg once daily.
Adjust to maintain platelet count greater than or equal to 50×109 /L
Renal Dose
Renal Impairment: No dose adjustment is necessary in ITP patients with renal impairment.
Administration
Should be taken on an empty stomach: Take at least 4 hr before or after antacids, dairy products or other Ca-containing food products or mineral supplements containing polyvalent cations.
Contra Indications
Eltrombopag is contraindicated in patients with severe hepatic impairment and who are hypersensitive to any of its excipients.
Precautions
Regularly monitor clinical haematology, platelet counts & serum liver test throughout therapy. Renal & hepatic impairment; hepatic disease. Thrombotic/thromboembolic complications. Increased risk of bleeding upon discontinuation of treatment. Bone marrow reticulin formation & risk of bone marrow fibrosis. Malignancies & progression of malignancies. Pregnancy & lactation. Childn <18 yr, elderly.
Pregnancy-Lactation
Pregnancy
Available data from published case reports and postmarketing experience with use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses
Effects were observed at doses resulting in exposures that were 6 times the human clinical exposure based on AUC in patients with chronic ITP at 75 mg/day, and 3 times the AUC in patients with chronic hepatitis C at 100 mg/day
Contraception
Based on animal reproduction studies, fetal harm may occur when administered to a pregnant woman
Use effective contraception in sexually-active females of reproductive during treatment and for at least 7 days after stopping treatment
Lactation
No data available regarding presence of eltrombopag or metabolites in human milk, effects on breastfed child, or on milk production
However, drug was detected in pups of lactating rats 10 days postpartum suggesting potential for transfer during lactation; due to potential for serious adverse reactions in a breastfed child from drug, breastfeeding is not recommended during treatment
Interactions
Increased plasma Cmax & AUC of HMG-CoA reductase inhibitors. Caution w/ methotrexate, topotecan. Increased conc w/ fluvoxamine; decreased conc w/ rifampicin & lopinavir/ritonavir. Reduced absorption by antacids, dairy products & other products containing polyvalent cations (eg Fe, Ca, Mg, Al, Se, Zn). Reduced plasma AUC & Cmax w/ high-calorie & -fat meal. Monitor platelet counts when used in combination w/ lopinavir/ritonavir & other drugs for treatment of idiopathic thrombocytopenic purpura (ITP).
Side Effects
Side effects of Eltrombopag Olamine :
Most common adverse reactions are nausea diarrhea, upper respiratory tract infection, increased ALT, mayalgia, urinanry tract infection, fatigue, headache, Insomnia; headache, paraesthesia; cataract, dry eye; GI & hepatobiliary disorders; rash, pruritus, alopecia; arthralgia, muscle spasm, bone pain; fatigue, peripheral oedema; thromboembolic events.
Mode of Action
Small-molecule thrombopoietin (TPO)-receptor agonist that interacts with human TPO receptor transmembrane domain of human TPO-receptor & initiates signaling cascades that induce proliferation & differentiation of megakaryocytes from bone marrow progenitor cells.
Note
R-Pag 12.5 mg Tablet generic name is Eltrombopag Olamine. R-Pag 12.5 mg Tablet is manufactured by Renata LimitedR-Pag is availble in all over Bangladesh.
Mes BD drug index information on R-Pag Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.