Avatrombopag

Avatrombopag is a prescription medication used to treat the symptoms of thrombocytopenia. Avatrombopag is available under the following different brand names: Doptelet.

• What Are Side Effects Associated with Using Avatrombopag?

Common side effects of Avatrombopag include:

• Fever,
• Easy bruising,
• Unusual bleeding (nosebleeds, bleeding gums),
• Purple or red spots on the skin,
• Tiredness,
• Headache,
• Joint pain,
• Runny or stuffy nose,
• Sneezing,
• Sore throat,
• Nausea,
• Stomach pain, and
• Swelling in the hands or feet

Serious side effects of Avatrombopag include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Chest pain,
• Shortness of breath,
• Fast heartbeats,
• Pain, swelling, or redness in one or both legs,
• Stomach pain or tenderness,
• Sudden fever,
• Chills,
• Yellowing of the skin or eyes (jaundice),
• Bloody or tarry stools,
• Coughing up blood, and
• Vomit that looks like coffee grounds

Rare side effects of Avatrombopag include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 20 mg

Thrombocytopenia

Adult dosage

• Patients with chronic liver disease
• Initiate 10-13 days before the scheduled procedure.
• Patients should undergo their procedure 5-8 days after the last dose.
• Dose based on pre-procedure platelet count.
• Platelet count below 40 x109/L: 60 mg orally once a day for 5 days
• Platelet count 40 to below 50 x109/L: 40 mg orally once a day for 5 days
• Patients with chronic immune thrombocytopenia
• Use the lowest dose needed to achieve and maintain a platelet count above 50 x109/L to reduce the risk of bleeding.
• Initial dose: 20 mg orally once a day; not to exceed 40 mg orally once a day.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Avatrombopag has severe interactions with no other drugs.
• Avatrombopag has serious interactions with the following drugs:
  • abametapir
  • fexinidazole
  • lonafarnib
  • ritonavir
  • sotorasib
  • lapatinib
  • tucatinib
  • voxelotor
• Avatrombopag has moderate interactions with at least 27 other drugs.
• Avatrombopag has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • larotrectinib
  • ribociclib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Avatrombopag?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Avatrombopag?”

Cautions

• Thrombotic/thromboembolic complications
  • Thrombopoietin (TPO) receptor agonists are associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic ITP.
  • Portal vein thrombosis reported with chronic liver disease in patients treated with thrombopoietin (TPO) receptor agonists (ADAPT-1 and ADAPT-2 clinical trials)
  • Consider the potential increased thrombotic risk when administering to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (.g, factor V Leiden, prothrombin 20210A, antithrombin deficiency, or protein C or S deficiency)
  • Not to be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts; thromboembolic events (arterial or venous) reported.
  • Monitor platelet counts and follow dosing guidelines to achieve target platelet counts; monitor patients receiving therapy for signs and symptoms of thromboembolic events and institute treatment promptly.
• Drug interaction overview
  • Avatrombopag is a CYP2C9 and CYP3A4 substrate; it inhibits organic anion transporter (OAT) 3 and breast cancer resistance protein (BCRP)
  • Moderate or strong dual CYP2C9 and CYP3A4 inhibitors
  • Coadministration with a moderate or strong dual CYP2C9 and CYP3A4 inhibitor increases avatrombopag AUC, which may increase the risk of avatrombopag toxicities.
  • If starting a moderate or strong dual CYP2C9 and CYP3A4 inhibitor during treatment, monitor platelet counts and adjust the avatrombopag dose as necessary.
• Moderate or strong dual CYP2C9 and CYP3A4 inducers
  • Coadministration with a moderate or strong dual CYP2C9 and CYP3A4 inducers decreases avatrombopag AUC, which may reduce the efficacy of avatrombopag.
  • If starting a moderate or strong dual CYP2C9 and CYP3A4 inducer during treatment, monitor platelet counts and adjust the avatrombopag dose as necessary.

Pregnancy and Lactation

• Based on findings from animal reproduction studies, may cause fetal harm when administered to pregnant women
• Lactation
  • No data are available regarding the presence of the drug in human milk, the effects on the breastfed child, or the effects on milk production.
  • In studies, avatrombopag was present in the milk of lactating rats; when a drug is present in animal milk, it is likely the drug will be present in human milk
  • Owing to the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose
• Clinical considerations
  • Interrupt breastfeeding and pump and discard breast milk in lactating women receiving avatrombopag for brief periods (. g, before an invasive procedure) during treatment and for 2 weeks after the last dose to minimize exposure to a breastfed child.