Getting your patient started on IMCIVREE

Prescribing IMCIVREE for your patients

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1. Download the IMCIVREE Prescription Start Form (preferred method)

Use the Start Form to initiate the prescription and help connect your patient with Rhythm InTune.

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2. Complete all fields in the Start Form

Select the appropriate indication and choose the titration and maintenance dose by age and, for ages 4 to <6, by weight.

To enroll in Rhythm InTune, your patient should complete and sign pages 2 and 3.

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3. Sign and submit the Start Form

Fax the completed form to 1-877-805-0130 or email patientsupport@rhythmtx.com.

To help avoid unnecessary delays during the insurance approval process:

  • Use the IMCIVREE Prescription Start Form
  • Complete all fields in the form
  • Ensure the appropriate indication and dosage are selected

If e-prescribing, please be sure to:

  • Select PANTHERx Rare Pharmacy in the US, or Special Care Pharmacy Services in Puerto Rico
  • Consider also submitting the Prescription Start Form, which includes the Rhythm InTune patient consent form and additional information fields often required for insurance approval, as these are not typically included when e-prescribing

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Personalized patient support

Helping patients stay on track along their IMCIVREE journey:

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Patient Access

Financial Assistance: The majority of patients, regardless of coverage type, have obtained approval for IMCIVREE. Financial assistance programs are available for eligible patients.
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Starting Treatment

Injection Training and Treatment Education: Patients and caregivers may choose to receive injection training through on-demand videos, live virtual training, or in-person instruction, as well as education on what to expect in the first 90 days.
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Ongoing Treatment

Adherence, Wellness, and Community: Rhythm InTune Patient Education Managers* help patients and their caregivers with ongoing wellness tips, disease education, and help connecting with others living with acquired HO.

Patients can enroll in Rhythm InTune by completing the consent section of the IMCIVREE Prescription Start Form or can learn more by visiting RhythmInTune.com.

*Patient Education Managers are employees of Rhythm Pharmaceuticals and do not provide medical care or advice. We encourage your patients to always speak to their healthcare providers regarding their medical care.

Learn more about Patient Education Managers

See how they can help your patient along their IMCIVREE journey.

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Questions?

For more information about Rhythm InTune, contact us at 1-855-206-0815 (M-F, 8am-6pm ET) or by emailing patientsupport@rhythmtx.com

Find resources for your patients starting IMCIVREE, including injection training.

Learn more about the causes and symptoms of acquired HO.

HO=hypothalamic obesity.

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to acquired hypothalamic obesity or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, nausea, vomiting, and headache

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.

Indication and Important Safety Information

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to acquired hypothalamic obesity or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, nausea, vomiting, and headache

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.