Imcivree

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to:

• Bardet-Biedl syndrome (BBS)
  
  
  [see Dosage and Administration (
  
  

  2.1 Patient Selection

  BBS

  • Select patients for treatment with IMCIVREE who have a clinical diagnosis of BBS
    [see Clinical Studies ].
    Consider genetic confirmation in pediatric patients aged <6 years.

  POMC, PCSK1, or LEPR Deficiency

  • Select patients for treatment with IMCIVREE who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR
    [see Clinical Studies ].
  • Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient
    [see Clinical Studies ].
  • Information on an FDA-approved test for the detection of variants in the
    POMC, PCSK1,
    or
    LEPR
    is available at
    http://www.fda.gov/CompanionDiagnostics.

  )]
  
  
• Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in
  
  
  POMC, PCSK1, or LEPR
  genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS)
  
  
  [see Dosage and Administration (
  
  

  2.1 Patient Selection

  BBS

  • Select patients for treatment with IMCIVREE who have a clinical diagnosis of BBS
    [see Clinical Studies ].
    Consider genetic confirmation in pediatric patients aged <6 years.

  POMC, PCSK1, or LEPR Deficiency

  • Select patients for treatment with IMCIVREE who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR
    [see Clinical Studies ].
  • Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient
    [see Clinical Studies ].
  • Information on an FDA-approved test for the detection of variants in the
    POMC, PCSK1,
    or
    LEPR
    is available at
    http://www.fda.gov/CompanionDiagnostics.

  )].
  
  

IMCIVREE is

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency with
  
  
  POMC
  ,
  
  
  PCSK1
  , or
  
  
  LEPR
  variants classified as benign or likely benign
  
• Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

• Select patients for treatment who have a clinical diagnosis of BBS or who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR. (
  
  
  2.1 Patient Selection

  BBS

  • Select patients for treatment with IMCIVREE who have a clinical diagnosis of BBS
    [see Clinical Studies ].
    Consider genetic confirmation in pediatric patients aged <6 years.

  POMC, PCSK1, or LEPR Deficiency

  • Select patients for treatment with IMCIVREE who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR
    [see Clinical Studies ].
  • Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient
    [see Clinical Studies ].
  • Information on an FDA-approved test for the detection of variants in the
    POMC, PCSK1,
    or
    LEPR
    is available at
    http://www.fda.gov/CompanionDiagnostics.
  )
  
• Recommended starting dosage injected subcutaneously for:
  
  
  • Adults and pediatric patients aged 12 years and older is 2 mg (0.2 mL) once daily for 2 weeks. (
    
    
    2.2 Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older

    • The recommended starting dosage is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks in adults and pediatric patients aged 12 years and older.
    • Monitor patients for gastrointestinal (GI) adverse reactions during dosage initiation and titration
      [see Adverse Reactions ]
      .
    • If the starting dosage is:
      • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily. If the 1 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 2 mg (0.2 mL) once daily.
      • Tolerated for 2 weeks, increase the dosage to 3 mg (0.3 mL) once daily. If the 3 mg once daily dosage is not tolerated, decrease the dosage to 2 mg (0.2 mL) once daily.
    • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
    )
    
    
  • Pediatric patients aged 6 to less than 12 years is 1 mg (0.1 mL) once daily for 2 weeks. (
    
    
    2.3 Recommended Dosage in Pediatric Patients Aged 6 to Less Than 12 Years

    • The recommended starting dosage is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years.
    • Monitor patients for GI adverse reactions during dosage initiation and titration
      [see Adverse Reactions ]
      .
    • If the starting dosage is:
      • Not tolerated, reduce the dosage to 0.5 mg (0.05 mL) once daily. If the 0.5 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 1 mg (0.1 mL) once daily.
      • Tolerated for 2 weeks, increase the dosage to 2 mg (0.2 mL) once daily. If the 2 mg daily dosage is:
        • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily.
        • Tolerated, increase the dosage to 3 mg (0.3 mL) once daily.
    • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
    )
    
    
  • Pediatric patients aged 2 to less than 6 years is 0.5 mg (0.05 mL) once daily for 2 weeks. (
    
    
    2.4 Recommended Dosage in Pediatric Patients Aged 2 to Less Than 6 Years

    • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years.
    • Monitor patients for GI adverse reactions during dosage initiation and titration
      [see Adverse Reactions ]
      .
    • If the starting dosage is:
      • Not tolerated, discontinue the product.
      • Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 1.

    Table 1:Recommended Maintenance Dosage Based on Baseline Body Weight in Pediatric Patients Aged 2 to Less Than 6 Years

    Patient Weight/Treatment Week	Daily Dose	Volume to be Injected
    15 kg to less than 20 kg
    Week 1 and onward	0.5 mg once daily	0.05 mL once daily
    20 kg to less than 30 kg
    Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
    Week 3 and onward	1 mg once daily	0.1 mL once daily
    30 kg to less than 40 kg
    Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
    Weeks 3‑4	1 mg once daily	0.1 mL once daily
    Week 5 and onward	1.5 mg once daily	0.15 mL once daily
    Greater than or equal to 40 kg
    Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
    Weeks 3‑4	1 mg once daily	0.1 mL once daily
    Weeks 5‑6	1.5 mg once daily	0.15 mL once daily
    Weeks 7 and onward	2 mg once daily	0.2 mL once daily
    )
    
    
• Recommended maintenance dosage for adults and pediatric patients aged 6 years and older is 3 mg (0.3 mL) injected subcutaneously once daily. (
  
  
  2.2 Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older

  • The recommended starting dosage is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks in adults and pediatric patients aged 12 years and older.
  • Monitor patients for gastrointestinal (GI) adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily. If the 1 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 2 mg (0.2 mL) once daily.
    • Tolerated for 2 weeks, increase the dosage to 3 mg (0.3 mL) once daily. If the 3 mg once daily dosage is not tolerated, decrease the dosage to 2 mg (0.2 mL) once daily.
  • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
  ,
  
  
  2.3 Recommended Dosage in Pediatric Patients Aged 6 to Less Than 12 Years

  • The recommended starting dosage is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, reduce the dosage to 0.5 mg (0.05 mL) once daily. If the 0.5 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 1 mg (0.1 mL) once daily.
    • Tolerated for 2 weeks, increase the dosage to 2 mg (0.2 mL) once daily. If the 2 mg daily dosage is:
      • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily.
      • Tolerated, increase the dosage to 3 mg (0.3 mL) once daily.
  • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
  )
  
• Recommended maintenance dose for pediatric patients aged 2 to less than 6 years is determined by body weight. (
  
  
  2.4 Recommended Dosage in Pediatric Patients Aged 2 to Less Than 6 Years

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, discontinue the product.
    • Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 1.

  Table 1:Recommended Maintenance Dosage Based on Baseline Body Weight in Pediatric Patients Aged 2 to Less Than 6 Years

  Patient Weight/Treatment Week	Daily Dose	Volume to be Injected
  15 kg to less than 20 kg
  Week 1 and onward	0.5 mg once daily	0.05 mL once daily
  20 kg to less than 30 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily
  30 kg to less than 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Weeks 3‑4	1 mg once daily	0.1 mL once daily
  Week 5 and onward	1.5 mg once daily	0.15 mL once daily
  Greater than or equal to 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Weeks 3‑4	1 mg once daily	0.1 mL once daily
  Weeks 5‑6	1.5 mg once daily	0.15 mL once daily
  Weeks 7 and onward	2 mg once daily	0.2 mL once daily
  )
  
• For recommended dosage in patients with renal impairment, see Full Prescribing Information. (
  
  
  2.5 Recommended Dosage in Patients with Renal Impairment

  Recommended Dosage in Adults and Pediatric Patients Aged 2 Years and Older with End Stage Renal Disease [estimated glomerular filtration (eGFR) less than 15 mL/min/1.73 m²]

  IMCIVREE is not recommended for use in patients with end stage renal disease.

  Recommended Dosage in Patients with Severe Renal Impairment (eGFR of 15 to 29 mL/min/1.73 m²)

  Adults and Pediatric Patients Aged 12 Years and Older

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in adults and pediatric patients aged 12 years and older with severe renal impairment.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) once daily. If the 1 mg daily dosage is tolerated for at least 1 week, increase the dosage to 1.5 mg (0.15 mL) once daily. The recommended maintenance dosage is 1.5 mg (0.15 mL) injected subcutaneously once daily
      [see Use in Specific Populations and Clinical Pharmacology ]
      .

  Pediatric Patients Ages 6 Years to Less Than 12 Years

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years with severe renal impairment.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) injected subcutaneously once daily. The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily

  Pediatric Patients Aged 2 to Less Than 6 Years Weighing at Least 20 kg

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years with severe renal impairment and weight of at least 20 kg.
    • The use of IMCIVREE in pediatric patients aged 2 to less than 6 years with weight less than 20 kg and severe renal impairment is not recommended
      [see Use in Specific Populations and Clinical Pharmacology ]
      .
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 2
      [see Use in Specific Populations and Clinical Pharmacology ]
      .

  Table 2: Recommended Maintenance Dosage Based on Baseline Body Weight in Pediatric Patients 2 to Less Than 6 Years of Age Weighing at Least 20 kg and with Severe Renal Impairment

  Patient Weight/Treatment Week	Daily Dose	Volume to be Injected
  20 kg to less than 30 kg
  Week 1 and onward	0.5 mg once daily	0.05 mL once daily
  30 kg to less than 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily
  Greater than or equal to 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily

  • The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily
    [see Use in Specific Populations and Clinical Pharmacology ]
    . Monitor patients for adverse reactions
    [see Adverse Reactions ]
    .

  Recommended Dosage in Adults and Pediatric Patients Aged 2 Years and Older with Mild (eGFR of 60 to 89 mL/min/1.73 m²) or Moderate (eGFR of 30 to 59 mL/min/1.73 m²) Renal Impairment

  The recommended dosage in patients with mild or moderate renal impairment is the same as in those with normal kidney function

  [see Dosage and Administration ]

  .
  )
  
• For titration and administration recommendations, see Full Prescribing Information. (
  
  
  2.2 Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older

  • The recommended starting dosage is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks in adults and pediatric patients aged 12 years and older.
  • Monitor patients for gastrointestinal (GI) adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily. If the 1 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 2 mg (0.2 mL) once daily.
    • Tolerated for 2 weeks, increase the dosage to 3 mg (0.3 mL) once daily. If the 3 mg once daily dosage is not tolerated, decrease the dosage to 2 mg (0.2 mL) once daily.
  • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
  ,
  
  
  2.3 Recommended Dosage in Pediatric Patients Aged 6 to Less Than 12 Years

  • The recommended starting dosage is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, reduce the dosage to 0.5 mg (0.05 mL) once daily. If the 0.5 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 1 mg (0.1 mL) once daily.
    • Tolerated for 2 weeks, increase the dosage to 2 mg (0.2 mL) once daily. If the 2 mg daily dosage is:
      • Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily.
      • Tolerated, increase the dosage to 3 mg (0.3 mL) once daily.
  • The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
  ,
  
  
  2.4 Recommended Dosage in Pediatric Patients Aged 2 to Less Than 6 Years

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the starting dosage is:
    • Not tolerated, discontinue the product.
    • Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 1.

  Table 1:Recommended Maintenance Dosage Based on Baseline Body Weight in Pediatric Patients Aged 2 to Less Than 6 Years

  Patient Weight/Treatment Week	Daily Dose	Volume to be Injected
  15 kg to less than 20 kg
  Week 1 and onward	0.5 mg once daily	0.05 mL once daily
  20 kg to less than 30 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily
  30 kg to less than 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Weeks 3‑4	1 mg once daily	0.1 mL once daily
  Week 5 and onward	1.5 mg once daily	0.15 mL once daily
  Greater than or equal to 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Weeks 3‑4	1 mg once daily	0.1 mL once daily
  Weeks 5‑6	1.5 mg once daily	0.15 mL once daily
  Weeks 7 and onward	2 mg once daily	0.2 mL once daily
  ,
  
  
  2.5 Recommended Dosage in Patients with Renal Impairment

  Recommended Dosage in Adults and Pediatric Patients Aged 2 Years and Older with End Stage Renal Disease [estimated glomerular filtration (eGFR) less than 15 mL/min/1.73 m²]

  IMCIVREE is not recommended for use in patients with end stage renal disease.

  Recommended Dosage in Patients with Severe Renal Impairment (eGFR of 15 to 29 mL/min/1.73 m²)

  Adults and Pediatric Patients Aged 12 Years and Older

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in adults and pediatric patients aged 12 years and older with severe renal impairment.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) once daily. If the 1 mg daily dosage is tolerated for at least 1 week, increase the dosage to 1.5 mg (0.15 mL) once daily. The recommended maintenance dosage is 1.5 mg (0.15 mL) injected subcutaneously once daily
      [see Use in Specific Populations and Clinical Pharmacology ]
      .

  Pediatric Patients Ages 6 Years to Less Than 12 Years

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years with severe renal impairment.
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) injected subcutaneously once daily. The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily

  Pediatric Patients Aged 2 to Less Than 6 Years Weighing at Least 20 kg

  • The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years with severe renal impairment and weight of at least 20 kg.
    • The use of IMCIVREE in pediatric patients aged 2 to less than 6 years with weight less than 20 kg and severe renal impairment is not recommended
      [see Use in Specific Populations and Clinical Pharmacology ]
      .
  • Monitor patients for GI adverse reactions during dosage initiation and titration
    [see Adverse Reactions ]
    .
  • If the recommended starting dosage is
    [see Use in Specific Populations ]
    :
    • Not tolerated, discontinue IMCIVREE.
    • Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 2
      [see Use in Specific Populations and Clinical Pharmacology ]
      .

  Table 2: Recommended Maintenance Dosage Based on Baseline Body Weight in Pediatric Patients 2 to Less Than 6 Years of Age Weighing at Least 20 kg and with Severe Renal Impairment

  Patient Weight/Treatment Week	Daily Dose	Volume to be Injected
  20 kg to less than 30 kg
  Week 1 and onward	0.5 mg once daily	0.05 mL once daily
  30 kg to less than 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily
  Greater than or equal to 40 kg
  Weeks 1‑2	0.5 mg once daily	0.05 mL once daily
  Week 3 and onward	1 mg once daily	0.1 mL once daily

  • The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily
    [see Use in Specific Populations and Clinical Pharmacology ]
    . Monitor patients for adverse reactions
    [see Adverse Reactions ]
    .

  Recommended Dosage in Adults and Pediatric Patients Aged 2 Years and Older with Mild (eGFR of 60 to 89 mL/min/1.73 m²) or Moderate (eGFR of 30 to 59 mL/min/1.73 m²) Renal Impairment

  The recommended dosage in patients with mild or moderate renal impairment is the same as in those with normal kidney function

  [see Dosage and Administration ]

  .
  ,
  
  
  2.6 Administration Instructions

  • Prior to initiation of IMCIVREE, train patients or their caregivers on proper injection technique. Instruct patients to use a 1-mL syringe with a 28-gauge or 29-gauge needle appropriate for subcutaneous injection.
  • Remove IMCIVREE from the refrigerator approximately 15 minutes prior to administration. Alternatively, warm IMCIVREE prior to administration by rolling the vial gently between the palms of the hands for 60 seconds.
  • Inspect IMCIVREE visually before use. It should appear clear to slightly opalescent, colorless to slightly yellow. Do not use if particulate matter or discoloration is seen.
  • Administer IMCIVREE once daily, at the beginning of the day, without regard to meals.
  • Inject IMCIVREE subcutaneously in the abdomen, thigh, or arm, rotating to a different site each day. Do not administer IMCIVREE intravenously or intramuscularly.
  • If a dose is missed, resume the once daily regimen as prescribed with the next scheduled dose.
  )
  

Injection: 10 mg/mL, clear to slightly opalescent, colorless to slightly yellow solution in a 1-mL multiple-dose vial for single patient use.

• Lactation:
  not recommended when breastfeeding (
  
  
  8.2 Lactation

  Risk Summary

  Treatment with IMCIVREE is not recommended for use while breastfeeding.

  IMCIVREE from multiple-dose vials contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs

  [see Warnings and Precautions and Use in Specific Populations ]

  .

  There is no information on the presence of setmelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. However, setmelanotide is present in the milk of rats (

  see Data

  ). When a drug is present in rat milk, it is likely that the drug will be present in human milk.

  Data

  Dose-related setmelanotide concentrations were observed in milk 2 hours after subcutaneous injection in the preweaning phase of a pre- and post-natal development study in rats. No quantifiable setmelanotide concentrations were detected in plasma from nursing pups on post-natal Day 11.
  )