Avatrombopag

What is Avatrombopag?

Avatrombopag is a thrombopoietin receptor agonist.

What are the uses of this medicine?

• This medication is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure or with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

How does this medicine work?

• Avatrombopag is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist that results in an increased production of platelets.
• This medication does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.

Who should not use this medicine?

This medicine cannot be used for:

• Patients with chronic liver disease in an attempt to normalize platelet counts.
• Patients with chronic immune thrombocytopenia in an attempt to normalize platelet counts.

Is this medicine FDA approved?

• Avatrombopag was approved for use in the United States in 2018.

How should this medicine be administered?

For patients with chronic liver disease:

• Begin DOPTELET dosing based upon platelet count 10 to 13 days prior to the scheduled procedure.
• Take DOPTELET orally once daily for 5 consecutive days with food.
• For platelet count less than 40x10⁹/L, the dose is 60 mg (3 tablets) once daily; for platelet count 40 to less than 50x10⁹/L the dose is 40 mg (2 tablets) once daily.
• In the case of a missed dose, patients should take the next dose of DOPTELET as soon as they remember. Patients should not take two doses at one time to make up for a missed dose, and should take the next dose at the usual time the next day; all 5 days of dosing should be completed.

For patients with chronic immune thrombocytopenia:

• Initiate DOPTELET at 20 mg (1 tablet) once daily.
• Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50x10⁹/L.
• Do not exceed 40 mg per day.

What are the dosage forms and brand names of this medicine?

This medicine is available in the following dosage form:

• 20 mg tablets

This medicine is available in the following brand nameː DOPTELET

What side effects can this medication cause?

Common possible side effects of this medicine when used to treat low blood platelet counts in adults with chronic liver disease(CLD) who are scheduled to have a medical or dental procedure include:

• fever

• headache

• stomach pain

• tiredness

• nausea

• swelling of hands or feet

Common possible side effects of this medicine when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) include:

• headache

• joint pain

• tiredness

• bleeding gums

• bruising

• purple or red spots on your skin

• nosebleed

• runny nose

• upper respiratory tract infection

Serious possible side effects of this medicine include blood clots and may cause symptoms such as:

• swelling, pain, or tenderness in your legs

• fast heartbeat

• shortness of breath

• stomach pain or tenderness

• chest pain

What special precautions should I follow?

• Follow the dosing guidelines to achieve target platelet counts.
• DOPTELET is a thrombopoietin (TPO) receptor agonist, which is associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic immune thrombocytopenia.
• Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and institute treatment promptly.

What to do in case of emergency/overdose?

• In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications. Closely monitor symptoms and platelet count. Treat thrombotic complications in accordance with standard of care.
• No antidote for DOPTELET overdose is known.

Can this medicine be used in pregnancy?

• Avatrombopag may cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Avatrombopag in pediatric patients have not been established.

What should I know about storage of this medication?

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
• Store tablets in the original package.

What are the active and inactive ingredients in this medicine?

• Active ingredient: avatrombopag

• Inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Tablet coating film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide and ferric oxide yellow.

Who manufactures and distributes this medicine?

• DOPTELET is a registered trademark of AkaRx, Inc.
• Manufactured for AkaRx, Inc., Durham, North Carolina 27707
• Marketed by Sobi, Inc., Waltham, Massachusetts 02451

• Dailymed label info on Avatrombopag
• FDA Avatrombopag

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