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Doptelet

Generic name: avatrombopag
Drug class: Platelet-stimulating agents

Medically reviewed by  A Ras MD.

What is Doptelet?

Doptelet is a prescription medicine that is used to raise platelet counts.

Description

The active ingredient in DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist. The chemical name of avatrombopag maleate is 4-piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]-, (2Z)-2-butenedioate (1:1). It has the molecular formula C29H34Cl2N6O3S2 · C4H4O4. The molecular weight is 765.73.

The structural formula is:

The structural formula for DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist. The chemical name of avatrombopag maleate is 4-piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]-, (2Z)-2-butenedioate (1:1). It has the molecular formula C29H34Cl2N6O3S2 · C4H4O4. The molecular weight is 765.73.

The aqueous solubility of avatrombopag maleate at various pH levels indicates that the drug substance is practically insoluble at pH 1 to 11.

DOPTELET is provided as an immediate-release tablet. Each DOPTELET tablet contains 20 mg avatrombopag (equivalent to 23.6 mg of avatrombopag maleate) and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Coating film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide and ferric oxide yellow.

 Mechanism of Action

Avatrombopag is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.

Before taking Doptelet, tell your doctor:

  • If you are allergic to Doptelet; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you are breast-feeding. Do not breast-feed while you take Doptelet and for 2 weeks after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Doptelet with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Doptelet?

  • Tell all of your health care providers that you take Doptelet. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Blood clots have happened with Doptelet. The chance of blood clots may be raised in people with long-term liver disease and people with some blood clotting problems. Tell your doctor if you have ever had a blood clot. If you have questions, talk with your doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Doptelet, call your doctor right away.

How is Doptelet best taken?

Use Doptelet as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all uses of Doptelet:

  • Take Doptelet with food.

For a procedure:

  • Be sure you know when to start taking Doptelet. If you are not sure when to start taking Doptelet, talk with your doctor.
  • Call your doctor if you are not able to finish all of your doses before your procedure.

What do I do if I miss a dose?

For a procedure:

  • Call your doctor to find out what to do.

For other reasons:

  • Take a missed dose as soon as you think about it, with food.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Doptelet that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Swelling in the arms or legs.
  • A fast heartbeat.
  • Any unexplained bruising or bleeding.
  • Purple spots or redness of the skin.
  • Stomach pain.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Doptelet?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Fever.
  • Upset stomach.
  • Headache.
  • Feeling tired or weak.
  • Signs of a common cold.
  • Joint pain.
  • Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Doptelet?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

PRINCIPAL DISPLAY PANEL

  • NDC 71369-020-30
    20 mg per tablet
  • Rx Only
  • Doptelet
    Two blister cards with 15 tablets each (30 tablets)
  • PRINCIPAL DISPLAY PANEL NDC 71369-020-30 20 mg per tablet Rx Only Doptelet Two blister cards with 15 tablets each (30 tablets)

 

SRC: NLM .

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