DopteletGeneric Name: avatrombopag
Date of Approval: May 21, 2018
Dosage Form: Tablets
Company: Dova Pharmaceuticals, Inc.
Treatment for: Thrombocytopenia in Chronic Liver Disease Patients who are Scheduled to Undergo a Procedure
FDA Approves Doptelet
The U.S. Food and Drug Administration (FDA) has approved Doptelet (avatrombopag), a second generation, once daily, orally administered thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.
Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is Doptelet?
Doptelet is a prescription medicine used to treat low blood platelet counts in adults with long-lasting (chronic) liver disease who are scheduled to have a medical or dental procedure.
Doptelet is not used to make platelet counts normal in adults with chronic liver disease.
It is not known if this medicine is safe and effective in children.
Before taking Doptelet
Before you take Doptelet, tell your healthcare provider about all of your medical conditions, including if you:
- have ever had a blood clot.
- are pregnant or plan to become pregnant. Doptelet may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment.
- are breastfeeding or plan to breastfeed. It is not known if Doptelet passes into your breast milk. Do not breastfeed during your treatment, and for at least two weeks after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take Doptelet?
- Take Doptelet exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much to take, and when to start taking it.
- Take your prescribed dose one time per day for five days in a row as instructed by your healthcare provider.
- Take Doptelet with food.
- Your healthcare provider will check your platelet count before treatment, and on the day of your scheduled procedure.
- If you forget to take a dose, take it as soon as you remember. Do not take two doses at one time to make up for a missed dose. Take your next dose at your usual time the next day and complete all five days of dosing.
- If you take too much Doptelet, call your healthcare provider or go to the nearest hospital emergency room right away.
Doptelet side effects
Doptelet may cause serious side effects, including:
- Blood clots. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots. Tell your healthcare provider right away if you have signs and symptoms of a blood clot, including:
- swelling, pain, or tenderness in your leg
- shortness of breath
- chest pain
- fast heartbeat
- stomach (abdominal) pain or tenderness
The most common side effects include:
- stomach (abdominal) pain
- swelling of the hands or feet
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
How should I store Doptelet?
- Store Doptelet at room temperature between 68°F to 77°F (20°C to 25°C).
- Store the tablets in the original package.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Doptelet.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in Doptelet?
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.