Treating your patients with MIMRYLO™ (rusfertide)

Patient Identification

Finding the appropriate patient for MIMRYLO

Whether used alone or in combination with CRTs, MIMRYLO may be beneficial for your patients who^1,2:

Have frequent phlebotomies
Are impacted by low iron levels and resulting fatigue
Are receiving hydroxyurea but need more HCT control
Report a high symptom burden and interruptions to daily life that prevent normal activities due to treatment with phlebotomy or current therapy

Dosing & Administration

A once-weekly*, subcutaneous self-injection that can fit into your patients’ lives and is individualized to their needs

Start

All patients initiate with 19 mg, whether using MIMRYLO alone or in combination with concomitant therapies.¹

Adjust

Some patients may require dose escalation based on individual efficacy and safety response.¹

After two weeks, the dose can be adjusted to the next defined dosage increment. Continue to adjust dosing until the desired HCT level is reached.¹

For grade ≥2 anemia or for drug-related grade ≥3 toxicities, reduce the dose of MIMRYLO to the preceding defined dosage increment.¹

Maintain

Once HCT control is achieved, patients should continue to take their individualized dose of MIMRYLO once a week.¹

Monitor CBC every 2-4 weeks, or as clinically indicated, during dose modification¹

MIMRYLO is available as a lyophilized powder for reconstitution in single-dose vials.¹

After patients undergo training by a healthcare provider at first dose¹:

MIMRYLO can be self-administered at home and doses can be adjusted to help patients achieve optimal HCT stability
If patients cannot self-administer, they can continue treatment in office

*Dosing is one injection weekly from dosage increments of 9.5 mg up to 54 mg. Weekly dosages of 69 mg or 82 mg must be administered in two injections on the same day. Weekly dosages of 95 mg or 108 mg must be administered in two injections on separate days. Please see additional details on Dosing and Administration within the full Prescribing Information.¹

Flexible dosage adjustments for HCT control

Find your patient's ideal dose of MIMRYLO through a stepwise approach¹

Dosing table: 8 weekly dose levels from 9.5mg (dose reduction) to 108mg (maximum weekly dose); starting dose is 19mg as a single subcutaneous injection; doses 69mg and above require two injections, either same-day or split across the week.

^†Dosage colors correlate with dosage strength, as seen on the MIMRYLO prescription box.
^‡The median duration of exposure to MIMRYLO was 61 weeks (range; 2 weeks to 133 weeks) with 65% of patients exposed to ≥52 weeks.³

CBC=complete blood count; CRT=cytoreductive therapy; HCT=hematocrit; PV=polycythemia vera.

All individuals in images are actor portrayals.

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.

Treating your patients with MIMRYLO™ (rusfertide)

Finding the appropriate patient for MIMRYLO

Whether used alone or in combination with CRTs, MIMRYLO may be beneficial for your patients who^1,2:

A once-weekly*, subcutaneous self-injection that can fit into your patients’ lives and is individualized to their needs

After patients undergo training by a healthcare provider at first dose¹:

Flexible dosage adjustments for HCT control

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

INDICATION

Finding the appropriate patient for MIMRYLO

Whether used alone or in combination with CRTs, MIMRYLO may be beneficial for your patients who1,2:

A once-weekly*, subcutaneous self-injection that can fit into your patients’ lives and is individualized to their needs

After patients undergo training by a healthcare provider at first dose1:

Flexible dosage adjustments for HCT control

IMPORTANT SAFETY INFORMATION AND INDICATION

Whether used alone or in combination with CRTs, MIMRYLO may be beneficial for your patients who^1,2:

After patients undergo training by a healthcare provider at first dose¹: