DOSING

IMCIVREE recommended dosing1

  • Periodically assess response to IMCIVREE therapy. In pediatric patients, evaluate the impact of weight loss on growth and maturation
  • Evaluate weight loss after 12 to 16 weeks of treatment
  • If a patient has not lost at least 5% of baseline body weight, or 5% of baseline BMI for patients with continued growth potential, discontinue IMCIVREE as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment

BMI=body mass index.
*If starting dose is not tolerated, decrease to 1 mg once daily.
If increased dose is not tolerated, revert to previous dose.
If 3-mg once-daily dose is not tolerated, maintain patient on 2 mg once daily.
§If starting dose is not tolerated, decrease to 0.5 mg once daily.

PREPARATION & ADMINISTRATION

MULTIPLE-DOSE VIAL FOR ONCE-DAILY SUBCUTANEOUS INJECTION1

  • IMCIVREE should be injected at the beginning of the day, without regard to meals
  • Patients who store their IMCIVREE in the refrigerator should remove it 15 minutes prior to administration, or warm the vial between their hands for 60 seconds before injecting
  • IMCIVREE should be injected subcutaneously in the abdomen, thigh, or arm, rotating to a different site each day
IMCIVREE treatment

See Instructions for Use for more information on administration

STORAGE

Storing IMCIVREE1,2

Storage
Protect from light. Do not freeze. Store in the original carton.

Unopened vial
Store unopened vials in refrigerator at 2°C to 8°C (36°F to 46°F).

Open (in-use) vial
Opened vials can be stored at temperatures ranging from refrigerated to room temperature [2°C to 25°C (36°F to 77°F)] with brief excursions permitted up to 30°C (86°F).

Discard unused portion 30 days after first opening or if stored above 30°C (86°F).

Supplied as a multiple-dose vial

*If necessary, IMCIVREE may be stored at room temperature (≤30°C [≤86°F]) and then returned to refrigerator.
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. IMCIVREE [patient information]. Boston, MA. Rhythm Pharmaceuticals, Inc.

Important Safety Information
WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE.

Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.

Indication

IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency obesity.