ETP 50 Tablet

ETP 50 is used to treat low platelet count due to chronic immune (idiopathic) thrombocytopenic purpura (ITP) or chronic hepatitis C virus (HCV) infection. It is also used to treat severe aplastic anemia. ETP 50 is a thrombopoietin agonist. It works by stimulating the formation of new platelets in the blood. The function of platelets is to help reduce bleeding. It should be taken in a dose and duration as advised by the doctor. You may take it on an empty stomach. This medicine is to be swallowed as a whole. Do not chew, crush or break it. Inform your doctor if you have any known allergy from this medication. The common side effects include nausea, vomiting or diarrhea. Inform your doctor if you are pregnant or breastfeeding or suffering from liver diseases as a dose adjustment may be required. It is safe to use in patients suffering from kidney diseases. It is not advised to drive after taking this medicine as you may feel dizzy making you less alert.

Uses of ETP 50

• Low platelet count due to ITP or HCV infection

Side effects of ETP 50

Common

• Nausea
• Diarrhea
• Upper respiratory tract infection
• Vomiting
• Increased liver enzymes
• Muscle pain
• Urinary tract infection

How to use ETP 50

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. ETP 50 is to be taken empty stomach.

How ETP 50 works

ETP 50 is a thrombopoietin agonist. It works by stimulating the formation of new platelets in the blood. Platelets help to reduce or prevent bleeding.

What if you forget to take ETP 50?

If you miss a dose of ETP 50, skip it and continue with your normal schedule. Do not double the dose.

Quick Tips

• Take ETP 50 on an empty stomach, either 1 hour before or 2 hours after meals.
• Take ETP 50 at least 2 hours before or 4 hours after eating dairy products and calcium-fortified juices.

Brief Description

Indication

Adult chronic immune (idiopathic) thrombocytopenic purpura (ITP), Hepatitis C Virus (HCV) related, Thrombocytopenia, Aplastic anemia

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.

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.

Contraindication

Eltrombopag is contraindicated in patients with severe hepatic impairment and who are hypersensitive to any of its excipients.

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.

Precaution

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.

Side Effect

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.

Pregnancy Category Note

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

Interaction

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).