Hematology
Polycythemia vera: Mimrylo, for prescribers
Mimrylo on what its first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for polycythemia vera. 2 other FDA-approved medicines for polycythemia vera have no prescribing guide here yet and are listed below.
The polycythemia vera prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drug with a prescribing guide
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Mimrylorusfertide | |
|---|---|
| Label dated | August 28, 2026 |
| Starting dose | 19mg subcutaneously once weekly. One single-dose vial of lyophilized powder per carton, co-packaged with a diluent prefilled syringe. |
| Dispensing gate | No REMS; pregnancy testing recommended for females of reproductive potential, injection training before initiation, the Here2Assist enrollment form with original prescriber and patient signatures faxed to 1-844-269-3038 (the form's prescription is valid only by fax), and routing to Biologics by McKesson, Onco360 or in-office dispensing |
| Required monitoring | CBC every 2 to 4 weeks after initiation and during dose modifications, or as clinically indicated; titrate to hematocrit below 45%; platelets generally plateau by week 8 |
| Example PA threshold | No public payer policy found as of November 9, 2026; label indication is erythrocytosis in adults with PV; VERIFY enrolled patients with at least 3 phlebotomies in 28 weeks or 5 in a year despite standard care |
| Support line | Takeda Oncology Here2Assist, 1-844-817-6468, Option 2, Monday to Friday 8 AM to 8 PM Eastern; fax 1-844-269-3038; benefits verification within 1 business day; free nurse-led injection training; co-pay as little as $0 for commercial plans; PAP; a 2-month Bridge Program for patients already on therapy |
- Label dated
- August 28, 2026
- Starting dose
- 19mg subcutaneously once weekly. One single-dose vial of lyophilized powder per carton, co-packaged with a diluent prefilled syringe.
- Dispensing gate
- No REMS; pregnancy testing recommended for females of reproductive potential, injection training before initiation, the Here2Assist enrollment form with original prescriber and patient signatures faxed to 1-844-269-3038 (the form's prescription is valid only by fax), and routing to Biologics by McKesson, Onco360 or in-office dispensing
- Required monitoring
- CBC every 2 to 4 weeks after initiation and during dose modifications, or as clinically indicated; titrate to hematocrit below 45%; platelets generally plateau by week 8
- Example PA threshold
- No public payer policy found as of November 9, 2026; label indication is erythrocytosis in adults with PV; VERIFY enrolled patients with at least 3 phlebotomies in 28 weeks or 5 in a year despite standard care
- Support line
- Takeda Oncology Here2Assist, 1-844-817-6468, Option 2, Monday to Friday 8 AM to 8 PM Eastern; fax 1-844-269-3038; benefits verification within 1 business day; free nurse-led injection training; co-pay as little as $0 for commercial plans; PAP; a 2-month Bridge Program for patients already on therapy
Other FDA-approved medicines for polycythemia vera
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
FDA decisions for polycythemia vera
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- August 28, 2026Mimrylo (rusfertide), NDA, Takeda / Protagonist TherapeuticsApproved
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- November 2026Mimrylo. DailyMed's history shows a new version of the Mimrylo listing posted on November 4, 2026. The label text DailyMed served on November 9 still carried the August 2026 revision date, so we could not see what changed. DailyMed history
- August 2026Mimrylo. This first label, revised in August 2026, has no boxed warning, no contraindications and no recent major changes. FDA label
- August 2026Mimrylo. The approval letter requires a clinical study of long-term safety with at least 3 years of follow-up. It covers platelet counts, blood clots, progression to myelofibrosis or acute myeloid leukemia, and JAK2 allele burden, with a final report due in June 2029. FDA letter
- August 2026Mimrylo. The FDA approved Mimrylo on August 28, 2026, for erythrocytosis in adults with polycythemia vera. Drugs@FDA lists it as a new molecular entity with priority review and orphan status. Drugs@FDA
Open trials
Questions prescribers ask about Polycythemia vera
Does Mimrylo require a REMS?
No. Mimrylo has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Mimrylo require?
CBC every 2 to 4 weeks after initiation and during dose modifications, or as clinically indicated; titrate to hematocrit below 45%; platelets generally plateau by week 8.
What do insurers require before covering Mimrylo?
This is one public insurer policy, an example rather than every plan. No public payer policy found as of November 9, 2026; label indication is erythrocytosis in adults with PV; VERIFY enrolled patients with at least 3 phlebotomies in 28 weeks or 5 in a year despite standard care.
Which support program starts Mimrylo patients on therapy?
Takeda Oncology Here2Assist, 1-844-817-6468, Option 2, Monday to Friday 8 AM to 8 PM Eastern; fax 1-844-269-3038; benefits verification within 1 business day; free nurse-led injection training; co-pay as little as $0 for commercial plans; PAP; a 2-month Bridge Program for patients already on therapy.
A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Polycythemia vera page and the first 90 days pages for Mimrylo.