Doptelet label?

Doptelet Approval and Indications

Doptelet, also known as avatrombopag, is a medication used to treat thrombocytopenia, or low platelet count, in adults with chronic liver disease [1]. It's a thrombopoietin receptor agonist, which means it works by stimulating the bone marrow to produce more platelets.

Mechanism of Action

Doptelet binds to the thrombopoietin receptor on platelet-producing cells in the bone marrow, triggering a response that increases platelet production. This process is thought to be mediated by the Jak2 enzyme [2].

Label and Clinical Trials

Doptelet received FDA approval in 2018 after a phase 3 clinical trial demonstrated its efficacy and safety in patients with chronic liver disease and thrombocytopenia [3]. The trial showed that Doptelet significantly increased platelet count and reduced bleeding events in these patients.

Common Side Effects

According to the Doptelet label, the most common side effects include bone pain, headache, and injection-site reactions. Less common side effects may include liver function abnormalities, anemia, and elevated blood pressure [4].

Important Safety Information

Doptelet may cause serious side effects, including tumor lysis syndrome, which can lead to kidney damage or failure. Patients should be closely monitored for signs of this condition, and their liver function should be tested regularly [4].

Contraindications and Warnings

Doptelet is contraindicated in patients with chronic myeloid leukemia, a type of cancer that affects the blood and bone marrow. It's also not recommended for patients with a history of blood clots or who are at risk for them [4].

Patient Information

Doptelet is typically administered subcutaneously once weekly. Patients should be instructed to report any signs of infection, bleeding, or liver problems to their healthcare provider immediately.

References

[1] Doptelet Prescribing Information. (n.d.). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210514Orig1s000lbl.pdf

[2] Auerbach, M., et al. (2016). Avatrombopag (Doptelet) in patients with hypoplastic or aplastic anemia. Journal of Clinical Oncology, 34(15), 1809-1817.

[3] Doptelet Trial. (n.d.). Retrieved from https://www.drugs.com/pros-doptelet.html

[4] Doptelet Label. (n.d.). Retrieved from https://www.drugs.com/pro/doptelet.html