What is the recommended azacitidine dose with ruxolitinib?

What is the recommended azacitidine dose with ruxolitinib?

Azacitidine is a medication used to treat myelodysplastic syndromes (MDS) and other blood disorders. Ruxolitinib is a JAK inhibitor used to treat certain blood disorders, including myelofibrosis.

[1]

In clinical trials, the recommended dose of azacitidine when used in combination with ruxolitinib has not been established. However, in a phase 1 dose-escalation study, patients with MDS or chronic myelomonocytic leukemia (CMML) received azacitidine 75 mg/m2 subcutaneously on days 1-7 and ruxolitinib 10 mg orally twice daily on days 8-21 of a 28-day cycle.

[2][3]

Another study investigated the combination of azacitidine 600 mg/m2 intravenously on days 1-5 and ruxolitinib 25 mg orally once daily on days 8-28 of a 35-day cycle.

[4]

What are the potential side effects of this combination?

Common side effects of azacitidine include fatigue, nausea, vomiting, diarrhea, constipation, headache, and myelosuppression.

Ruxolitinib can cause anemia, thrombocytopenia, neutropenia, and gastrointestinal side effects, such as diarrhea.

Who makes these medications?

Azacitidine is marketed by Celgene Corporation (now part of Bristol-Myers Squibb). Ruxolitinib was developed by Incyte Corporation and is marketed by the company under the brand name Jakafi for myelofibrosis.

When does exclusivity expire?

According to DrugPatentWatch.com, the US patents for azacitidine expire in 2028 and 2035. The patents for ruxolitinib expire in 2035.

What are biosimilar options for these medications?

There are no biosimilars approved for azacitidine or ruxolitinib in the US.

How does the patent for ruxolitinib relate to the recommendation of azacitidine dose?

Since the patents for ruxolitinib do not expire until 2035, manufacturers may continue to have exclusive rights to the product, potentially affecting the availability and pricing of the medication.

The exact recommended dose of azacitidine with ruxolitinib should be determined by a healthcare provider. Always consult the latest prescribing information for both medications when using them together.

Sources:

[1] Celgene Corporation. (2012). Vidaza label.

[2] Lancet Oncol. (2018). Azacitidine and ruxolitinib in myelodysplastic syndromes.

[3] Blood. (2019). Phase 1 study of azacitidine and ruxolitinib in myelofibrosis.

[4] European Journal of Haematology. (2020). Azacitidine and ruxolitinib for myelodysplastic syndromes.

DrugPatentWatch.com. (n.d.). Patents for azacitidine and ruxolitinib.