MIMRYLO™ (rusfertide) has a favorable safety profile as seen in the largest pivotal trial in PV^1-3

The safety of MIMRYLO was assessed in 285 adult patients in the VERIFY trial¹

Duration of exposure in the VERIFY trial^1,4:

87% of patients were exposed for ≥28 weeks
65% of patients were exposed ≥52 weeks

The safety of MIMRYLO was studied both alone and in combination with CRTs.^1,4-6

The most common (>15%) adverse reactions were injection site reactions (56%), and anemia (16%).¹

Common Adverse Reactions

In the VERIFY trial, most adverse reactions observed with MIMRYLO (Weeks 0-32) were low grade and did not lead to treatment discontinuation^1,4

Adverse reactions in ≥5% of patients with a difference of ≥5 percentage points between the MIMRYLO and control arms

Table: common adverse reactions ≥5% with MIMRYLO vs control; injection site reactions 56% vs 33%, anemia 16% vs 4.1%

*Includes anemia and hemoglobin decreased.¹
^†Includes thrombocytosis and platelet count increased.¹
^‡Includes dyspnea and dyspnea exertional.¹

5.5% taking MIMRYLO discontinued due to adverse reactions (Weeks 0-32) vs 2.7% with control arm; mild to moderate.

Serious adverse reactions and discontinuations

In the safety population of 285 patients, a serious adverse reaction of anemia occurred in one (0.4%) patient who received MIMRYLO. Five patients discontinued MIMRYLO due to adverse reactions: two (0.7%) due to injection site reactions, two (0.7%) due to thrombocytosis, and one (0.4%) due to anemia.¹

Across the whole trial (Weeks 0-52), the majority of common adverse reactions were mild to moderate^1,4

The most common (>15%) adverse reactions across the full 52-week trial of injection site reactions (47%) and anemia (26%) were consistent in occurrence and grading with Weeks 0-32.

ADDITIONAL SAFETY INFORMATION

Additional safety information in the VERIFY trial

Increases in platelet counts were observed in some patients within 4 weeks of treatment initiation. Generally, platelet counts plateaued on treatment by Week 8.¹

There was no evidence of increased cancer risk in patients treated with MIMRYLO (Weeks 0-32) compared with the control arm (2.1% vs 5.5%). For the MIMRYLO patients who stayed on treatment through Week 52, the rate was 3.0%.⁴

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CRT=cytoreductive therapy; PV=polycythemia vera.

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

New or Worsening Thrombocytosis: MIMRYLO may increase platelet counts in patients with PV. Platelet counts generally plateaued on treatment by Week 8. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation.

Injection-Site Reactions: Injection site reactions (including Grade 3 reactions) have been reported in patients treated with MIMRYLO. The most common injection site reactions reported were erythema, pruritus, pain, and swelling. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling.

Embryo-Fetal Toxicity: Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Advise patients to stop taking MIMRYLO if they become pregnant.

ADVERSE REACTIONS

The most common (>15%) adverse reactions were injection site reactions (56%) and anemia (16%).

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment.

Females and Males of Reproductive Potential

Pregnancy Testing: Prior to initiating MIMRYLO, pregnancy testing is recommended for females of reproductive potential.
Contraception: Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see MIMRYLO (rusfertide) full Prescribing Information.

MIMRYLO™ (rusfertide) has a favorable safety profile as seen in the largest pivotal trial in PV^1-3

The safety of MIMRYLO was assessed in 285 adult patients in the VERIFY trial¹

In the VERIFY trial, most adverse reactions observed with MIMRYLO (Weeks 0-32) were low grade and did not lead to treatment discontinuation^1,4

Across the whole trial (Weeks 0-52), the majority of common adverse reactions were mild to moderate^1,4

Additional safety information in the VERIFY trial

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

INDICATION

The safety of MIMRYLO was assessed in 285 adult patients in the VERIFY trial1

In the VERIFY trial, most adverse reactions observed with MIMRYLO (Weeks 0-32) were low grade and did not lead to treatment discontinuation1,4

Across the whole trial (Weeks 0-52), the majority of common adverse reactions were mild to moderate1,4

Additional safety information in the VERIFY trial

IMPORTANT SAFETY INFORMATION AND INDICATION

The safety of MIMRYLO was assessed in 285 adult patients in the VERIFY trial¹

In the VERIFY trial, most adverse reactions observed with MIMRYLO (Weeks 0-32) were low grade and did not lead to treatment discontinuation^1,4

Across the whole trial (Weeks 0-52), the majority of common adverse reactions were mild to moderate^1,4