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November 15, 2021 – PharmaEssentia's Besremi® (ropeginterferon alfa-2b-njft) has been approved to treat polycythemia vera (PV) in adults. It is the only interferon drug FDA approved for this indication.
- PV is a rare blood cancer that occurs when the bone marrow makes too many red blood cells.
- Besremi is a subcutaneous injection that can be administered by a healthcare provider, caregiver,
or the patient. Recommended initial dosing is 100mcg given by subcutaneous injection with a
dosing schedule of once every two weeks. The dose is increased by 50mcg every two weeks, up
to a maximum of 500mcg, until specific blood test values (hematocrit, platelets, and leukocytes)
have stabilized (hematologic stability).
- If the patient maintains hematologic stability for at least one year on a stable dose of Besremi, dose frequency may be reduced to once every four weeks.
- If the patient is taking hydroxyurea, the initial dose of Besremi should be reduced to 50mcg, and the patient should discontinue hydroxyurea by Week 13 of taking Besremi.
- PharmaEssentia has launched Besremi at a wholesale acquisition cost (WAC) of $6,988 per syringe.