Doptelet is a prescription medicine used to help treat low blood platelet counts in children with persistent or chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough.

FAST ACTING AND LONG LASTING

Doptelet and Doptelet Sprinkle are once-a-day oral medications that help raise your child’s platelet counts with no treatment injections and no extra doctor’s visits for treatment. Also, the type of food they eat won’t impact how treatment works. Doptelet and Doptelet Sprinkle are not used to make platelet counts normal.

Doptelet and Doptelet Sprinkle

Doptelet Sprinkle is indicated for patients aged ≥1 and <6 years. Doptelet tablets are indicated for patients aged 6 and older. Doptelet Sprinkle oral granules that come in a bottle are not the same dosage form as Doptelet tablets that come in a blister card and cannot be directly substituted for each other.

What makes Doptelet or Doptelet Sprinkle different?

Doptelet and Doptelet Sprinkle are oral treatments that can give pediatric patients with persistent or chronic ITP a platelet count lift anytime, anywhere, and with any food

Your child’s doctor will adjust the dose of Doptelet or Doptelet Sprinkle based on platelet levels reached and will check your child’s platelet counts weekly until their platelet counts reach 50,000 per microliter, then monthly after that, and for at least 4 weeks after stopping treatment. Before starting Doptelet or Doptelet Sprinkle, tell your child’s doctor about all the medicines they take, as their doctor may adjust the starting dose.

No food restrictions

No food-type restrictions

Doptelet tablet is a thrombopoietin receptor agonist (TPO-RA) that must be taken with food and can be taken at any time. Because food won’t impact the effectiveness of treatment, your child may have more flexibility with meal choices and schedules.

The effectiveness of Doptelet Sprinkle also isn’t impacted by food, but it must be taken with a soft food or liquid like applesauce or orange juice.

See the Instructions for Use for a full list of recommended soft foods and liquids.

No food restrictions

No additional risk of liver damage

Doptelet and Doptelet Sprinkle don’t require additional liver function monitoring because in clinical trials they were not shown to lead to liver damage (or “hepatotoxicity,” in medical terms).

No food restrictions

No treatment injections or infusions

Doptelet is a TPO-RA available in oral form (as a tablet or oral granules) that can be taken anywhere.

No food restrictions

No eye exams

Doptelet and Doptelet Sprinkle don’t require eye exams before starting or during treatment.

No food restrictions

Fits their schedule

As long as it’s at the same time each day, Doptelet or Doptelet Sprinkle can be taken at any time that works best for your child and your family. Before starting Doptelet or Doptelet Sprinkle, tell your child’s doctor about all the medicines they take, as their doctor may adjust the starting dose.

The safety of Doptelet has been established over 7 years in adult patients*

*Doptelet is approved for use in adults with chronic ITP (FDA approved in 2019). See full indication details below.

Choose Doptelet or Doptelet Sprinkle for a platelet count lift that works fast and lasts

In the 3-month clinical trial, Doptelet and Doptelet Sprinkle were shown to:

LIFT PLATELETS

Raise platelet counts to 50,000 per microliter or more for at least 2 consecutive weeks of the 3-month trial.

This was seen in 44 of 54 children taking Doptelet or Doptelet Sprinkle, compared to 0 of 21 on placebo.

ACT FAST

Lift platelet counts to 50,000 per microliter or more in as few as 8 days.

By Day 8, 30 of 54 children on Doptelet or Doptelet Sprinkle had platelet counts of 50,000 per microliter or more, compared with 0 of 21 people in the placebo group.

AND LAST

In at least 6 out of the last 8 weeks, 15 of 54 children on Doptelet or Doptelet Sprinkle had a platelet count of 50,000 per microliter or more without the need for rescue treatment, compared with 0 of 21 on placebo.

  • 75 children with persistent or chronic immune thrombocytopenia (aged 1 to <18 years) were evaluated in a 3-month clinical trial for Doptelet or Doptelet Sprinkle (clinical trials for a rare disease usually have smaller sample sizes than non-rare disease trials). During the trial (core phase), 54 patients received Doptelet or Doptelet Sprinkle, while 21 did not receive Doptelet or Doptelet Sprinkle
  • 27.8% (15/54) of patients taking Doptelet or Doptelet Sprinkle achieved an increase in platelet counts during at least 6 of the last 8 weeks of the core study in the absence of rescue therapy vs 0% of patients not taking Doptelet or Doptelet Sprinkle
  • 81.5% (44/54) of patients taking Doptelet or Doptelet Sprinkle reached at least 2 consecutive platelet counts of 50,000 per microliter or more in the absence of rescue therapy vs 0% of patients not taking Doptelet or Doptelet Sprinkle
  • Most of the patients included in the trial (>65%) had tried 3 or more ITP treatments, and the trial also involved both patients who had and had not used a thrombopoietin receptor agonist (TPO-RA), which is the same type of medicine as Doptelet and Doptelet Sprinkle
  • During the trial, there were children taking Doptelet or Doptelet Sprinkle who were compared with those not taking Doptelet or Doptelet Sprinkle. Those taking Doptelet or Doptelet Sprinkle were able to keep platelet counts at or above 50,000 platelets per microliter for an average of half of the weeks (48.9%) in the absence of rescue therapy vs those not taking Doptelet or Doptelet Sprinkle (1.2%)
  • On Day 8 of the trial, 55.6% (30/54) of patients taking Doptelet or Doptelet Sprinkle reached at least 50,000 platelets per microliter or more in the absence of rescue therapy. Those who were not taking Doptelet or Doptelet Sprinkle did not reach 50,000 platelets per microliter
  • 7% of children who received Doptelet or Doptelet Sprinkle needed rescue therapy, while 43% of children who did not receive Doptelet or Doptelet Sprinkle needed rescue therapy

With Doptelet or Doptelet Sprinkle, your child may experience side effects

Serious side effects

Doptelet or Doptelet Sprinkle may cause serious side effects including blood clots. People with persistent or chronic ITP and people with certain blood clotting conditions may have an increased risk of developing blood clots. Tell your healthcare provider right away if you get signs and symptoms of a blood clot, including:

  • Swelling, pain, or tenderness in their legs
  • Shortness of breath
  • Chest pain
  • Fast heartbeat
  • Stomach (abdominal) pain or tenderness

Common side effects

The most common side effects of Doptelet or Doptelet Sprinkle in children with persistent or chronic ITP are viral infection, runny nose, cough, fever, and pain in the mouth or throat.

These are not all the possible side effects of Doptelet and Doptelet Sprinkle. Talk to your child’s doctor if any side effect bothers your child or does not go away.

Learn how to take Doptelet and Doptelet Sprinkle

See how to prepare and administer the medicine.

Find a persistent or chronic ITP specialist near you

One of the most important steps in getting care for your child is finding the right provider in your area.

Find a specialist

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Indication & Important Safety Information

What are DOPTELET (avatrombopag) and DOPTELET Sprinkle (avatrombopag)?

DOPTELET is a prescription medicine used to treat low blood platelet counts in:

  • Adults with long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure
  • Adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough.
  • Children 1 year and older with persistent or chronic ITP when other treatments have not worked well enough

DOPTELET tablets and DOPTELET Sprinkle are different dosage forms of DOPTELET.

DOPTELET and DOPTELET Sprinkle are not used to make platelet counts normal.

It is not known if DOPTELET or DOPTELET Sprinkle are safe and effective in children younger than 1 year of age.

IMPORTANT SAFETY INFORMATION

Before you take DOPTELET or DOPTELET Sprinkle, tell your doctor about all your medical conditions, including if you:

  • Have ever had a blood clot
  • Are pregnant or plan to become pregnant. DOPTELET or DOPTELET Sprinkle may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with DOPTELET or DOPTELET Sprinkle
  • Are breastfeeding or plan to breastfeed. It is not known if DOPTELET or DOPTELET Sprinkle passes into your breast milk. Do not breastfeed during your treatment with DOPTELET and DOPTELET Sprinkle for at least 2 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. DOPTELET or DOPTELET Sprinkle may affect the way other medicines work, and other medicines may affect the way DOPTELET or DOPTELET Sprinkle works.

What are the side effects of DOPTELET or DOPTELET Sprinkle?

DOPTELET or DOPTELET Sprinkle may cause serious side effects including blood clots. People with CLD or persistent or chronic ITP and people with certain blood clotting conditions may have an increased risk of developing blood clots. Tell your healthcare provider right away if you get signs and symptoms of a blood clot, including:

  • Swelling, pain, or tenderness in your legs
  • Shortness of breath
  • Chest pain
  • Fast heartbeat
  • Stomach (abdominal) pain or tenderness

The most common side effects of DOPTELET in adults with CLD are fever, stomach (abdominal) pain, nausea, headache, tiredness, and swelling of hands and feet.

The most common side effects of DOPTELET in adults with chronic ITP are headache, tiredness, bruising, nosebleed, upper respiratory infection, joint pain, bleeding gums, purple or red spots on your skin, and runny nose.

The most common side effects of DOPTELET or DOPTELET Sprinkle in children with persistent or chronic ITP are viral infection, runny nose, cough, fever, and pain in the mouth or throat.

These are not all of the possible side effects of DOPTELET or DOPTELET Sprinkle. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the DOPTELET and DOPTELET Sprinkle full Prescribing Information.

What are DOPTELET (avatrombopag) and DOPTELET Sprinkle (avatrombopag)?

DOPTELET is a prescription medicine used to treat low blood platelet counts in:

  • Adults with long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure
  • Adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough.
  • Children 1 year and older with persistent or chronic ITP when other treatments have not worked well enough

What are DOPTELET (avatrombopag) and DOPTELET Sprinkle (avatrombopag)?

DOPTELET is a prescription medicine used to treat low blood platelet counts in:

  • Adults with long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure
  • Adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough.
  • Children 1 year and older with persistent or chronic ITP when other treatments have not worked well enough

DOPTELET tablets and DOPTELET Sprinkle are different dosage forms of DOPTELET.

DOPTELET and DOPTELET Sprinkle are not used to make platelet counts normal.

It is not known if DOPTELET or DOPTELET Sprinkle are safe and effective in children younger than 1 year of age.

IMPORTANT SAFETY INFORMATION

Before you take DOPTELET or DOPTELET Sprinkle, tell your doctor about all your medical conditions, including if you:

  • Have ever had a blood clot
  • Are pregnant or plan to become pregnant. DOPTELET or DOPTELET Sprinkle may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with DOPTELET or DOPTELET Sprinkle
  • Are breastfeeding or plan to breastfeed. It is not known if DOPTELET or DOPTELET Sprinkle passes into your breast milk. Do not breastfeed during your treatment with DOPTELET and DOPTELET Sprinkle for at least 2 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. DOPTELET or DOPTELET Sprinkle may affect the way other medicines work, and other medicines may affect the way DOPTELET or DOPTELET Sprinkle works.

What are the side effects of DOPTELET or DOPTELET Sprinkle?

DOPTELET or DOPTELET Sprinkle may cause serious side effects including blood clots. People with CLD or persistent or chronic ITP and people with certain blood clotting conditions may have an increased risk of developing blood clots. Tell your healthcare provider right away if you get signs and symptoms of a blood clot, including:

  • Swelling, pain, or tenderness in your legs
  • Shortness of breath
  • Chest pain
  • Fast heartbeat
  • Stomach (abdominal) pain or tenderness

The most common side effects of DOPTELET in adults with CLD are fever, stomach (abdominal) pain, nausea, headache, tiredness, and swelling of hands and feet.

The most common side effects of DOPTELET in adults with chronic ITP are headache, tiredness, bruising, nosebleed, upper respiratory infection, joint pain, bleeding gums, purple or red spots on your skin, and runny nose.

The most common side effects of DOPTELET or DOPTELET Sprinkle in children with persistent or chronic ITP are viral infection, runny nose, cough, fever, and pain in the mouth or throat.

These are not all of the possible side effects of DOPTELET or DOPTELET Sprinkle. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the DOPTELET and DOPTELET Sprinkle full Prescribing Information.

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