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Avatrom 20

Rx

20 mg • Tablet

Avatrombopag • Jenphar Bangladesh Ltd.

Available as: 20 mg

Indications & Uses

Avatrombopag is used for thrombocytopenia in adults with chronic liver disease (CLD) who are scheduled to undergo a procedure. It is also used for thrombocytopenia in people with chronic immune thrombocytopenia (ITP). Treatment of thrombocytopenia in patients with chronic liver disease (CLD): the medicine is indicated for adult patients with chronic liver disease who are scheduled to undergo a procedure. Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP): avatrombopag is indicated for adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Pharmacology

Mechanism of Action

Avatrombopag is a small molecule TPO receptor agonist, and it is well absorbed when taken by mouth. It stimulates bone marrow progenitor cells to multiply and mature into megakaryocytes, so the body makes more platelets. It does not compete with TPO for binding to the TPO receptor, and its effect on platelet production adds to the effect of TPO.

Pharmacodynamics: Platelet Response

In adults, avatrombopag raised platelet counts, and the rise depended on both the dose and the exposure. The count began to go up within 3 to 5 days of the start of a 5-day treatment course, and the peak came after 10 to 13 days. After that, platelet counts fell gradually and returned to near baseline values after 35 days.

Pharmacodynamics: Cardiac Electrophysiology

At exposures similar to those reached with the 40 mg and 60 mg doses, it did not prolong the QT interval to any clinically relevant extent. Data from the pooled clinical trials in patients were analysed, and based on that, mean QTc prolongation effects of more than 20 ms are not anticipated with the highest recommended therapeutic dosing regimen.

Dosage Reference

Reference Information Only

Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.

Adults:

Recommended dosage for patients with chronic liver disease

The recommended dose and duration for patients with chronic liver disease who are scheduled to undergo a procedure depend on the platelet count. If the count is less than 40X109/L, the dose is 60 mg (3 tablets) for 5 days. If it is 40 to less than 50X109/L, the dose is 40 mg (2 tablets) for 5 days.

Recommended dosage for patients with chronic immune thrombocytopenia

For the initial dose regimen, begin Avatrombopag at a starting dose of 20mg (1tablet) once daily with food.

Dose adjustments for patients with chronic immune thrombocytopenia are based on the platelet count. If it is less than 50 x 109/L after at least 2 weeks of Avatrombopag, increase one dose level. Then wait 2 weeks to assess the effects of this regimen and any later dose adjustments. If the count is between 200 and 400 x 109/L, decrease one dose level, and again wait 2 weeks to assess the effects of this regimen and any later dose adjustments.

If the count is greater than 400 x 109/L, stop Avatrombopag and increase platelet monitoring to twice weekly. When the platelet count falls below 150 x10 9 /L, decrease one dose level per Table 3 and restart therapy.

Stop Avatrombopag if the count is still less than 50 x 109/L after 4 weeks of Avatrombopag 40 mg once daily. Stop it as well if the count is greater than 400 x 109/L after 2 weeks of Avatrombopag 20 mg weekly.

Or, as directed by the registered physician.

Side Effects

People with chronic liver disease who take avatrombopag most often report fever, abdominal pain, nausea, headache, tiredness and swelling in the arms or legs (peripheral edema). In people with chronic immune thrombocytopenia, the most common reactions are headache, tiredness, confusion, nosebleeds, upper respiratory tract infection, joint pain, bleeding gums, petechiae and nasopharyngitis.

Cautions & Contraindications

Warnings & Precautions

Thrombotic and thromboembolic complications Avatrombopag is a thrombopoietin (TPO) receptor agonist, and TPO receptor agonists have been linked with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in these patients when they were treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, one patient (n=1/430) with chronic liver disease and thrombocytopenia had a treatment-emergent event of portal vein thrombosis while on Avatrombopag. Think about the possible extra risk of thrombosis when giving Avatrombopag to patients who already have known risk factors for thromboembolism. These include genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency, or Protein C or S deficiency). Avatrombopag should not be given to patients with chronic liver disease in an attempt to normalize platelet counts.

Contraindications

Avatrombopag must not be given to anyone who is allergic to it, or to any other component of the product.

Pregnancy & Breastfeeding

Pregnancy

Animal reproduction studies suggest that Avatrombopag may cause harm to the fetus when a pregnant woman takes it. There isn't enough data on Avatrombopag in pregnant women to say whether it carries a risk of adverse developmental outcomes. Pregnant women should be told about the possible risk to the fetus.

Lactation

Nothing is known about whether Avatrombopag passes into human milk, what effect it has on a breastfed child, or what effect it has on milk production. Because Avatrombopag could cause serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Use in Special Populations

Pediatric Use: Safety and effectiveness of avatrombopag in children have not been established.

Geriatric Use: Clinical experience reported so far has not shown any difference in response between elderly and younger patients.

Overdose

If someone takes too much Avatrombopag, the platelet count can rise too far and lead to thrombotic or thromboembolic complications. The patient and the platelet count should be watched closely. Any thrombotic complications are treated according to standard of care. There is no known antidote for Avatrombopag overdose. Hemodialysis is not expected to help clear Avatrombopag from the body, because only approximately 6% of it is excreted through the kidneys and it is highly bound to plasma proteins.

⚠️ In an emergency call 999 or go to the nearest hospital emergency department.

Storage

Store Avatrombopag below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.

Common questions about Avatrom 20 20 mg

What is Avatrom 20 20 mg Tablet?

Avatrom 20 20 mg Tablet is a medicine that contains Avatrombopag. It is made by Jenphar Bangladesh Ltd.

What is Avatrom 20 used for?

Avatrombopag is used for thrombocytopenia in adults with chronic liver disease (CLD) who are scheduled to undergo a procedure. It is also used for thrombocytopenia in people with chronic immune thrombocytopenia (ITP).

What are the side effects of Avatrom 20?

People with chronic liver disease who take avatrombopag most often report fever, abdominal pain, nausea, headache, tiredness and swelling in the arms or legs (peripheral edema). In people with chronic immune thrombocytopenia, the most common reactions are headache, tiredness, confusion, nosebleeds, upper respiratory tract infection, joint pain, bleeding gums, petechiae and nasopharyngitis.

Can I take Avatrom 20 during pregnancy or while breastfeeding?

Pregnancy Animal reproduction studies suggest that Avatrombopag may cause harm to the fetus when a pregnant woman takes it. There isn't enough data on Avatrombopag in pregnant women to say whether it carries a risk of adverse developmental outcomes. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

What happens if I take too much Avatrom 20?

If someone takes too much Avatrombopag, the platelet count can rise too far and lead to thrombotic or thromboembolic complications. The patient and the platelet count should be watched closely. In an emergency call 999 or go to the nearest hospital emergency department.

How should I store Avatrom 20?