Zomacton

Warning and Precautions, Slipped Capital Femoral Epiphysis in Pediatric Patients (5.10)                 07/2025                                                                                                                                              

ZOMACTON is a recombinant human growth hormone indicated for:

• Pediatric:
  Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years. (
  1.1 Pediatric Patients

  ZOMACTON is indicated for the treatment of pediatric patients with:

  • growth failure due to inadequate secretion of endogenous growth hormone (GH),
  • short stature associated with Turner syndrome,
  • idiopathic short stature (ISS), height standard deviation score (HSDS) ≤-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range,
  • short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency,
  • short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
  )
• Adult:
  Replacement of endogenous GH in adults with GH deficiency (
  1.2 Adult Patients

  ZOMACTON is indicated for the replacement of endogenous GH in adults with GH deficiency.
  )

• Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites (
  2.1 Administration and Use Instructions

  • Therapy with ZOMACTON should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which ZOMACTON is indicated
    [see Indications and Usage (1)].
  • Fundoscopic examination should be performed routinely before initiating treatment with ZOMACTON to exclude preexisting papilledema, and periodically thereafter
    [see Warnings and Precautions (5.5)].
  • Administer ZOMACTON by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.
  • ZOMACTON 5 mg and 10 mg can be administered using a standard sterile disposable syringe. For proper use, please refer to the Instructions for Use provided with the administration device. The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
  )
• Pediatric dosage:
  Divide the calculated weekly dosage into equal doses given either 3, 6, or 7 days per week (
  2.2 Pediatric Dosage

  • Individualize dosage for each patient based on the growth response.
  • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
  • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
    • Pediatric GH Deficiency:
      0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
    • Turner syndrome:
      Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
    • Idiopathic short stature:
      Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
    • SHOX Deficiency:
      0.35 mg/kg/week (0.05 mg/kg/day)
    • Small for Gestational Age (SGA):
      Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
      • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
  • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
  • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
    [see Contraindications (4)].
  )
  • GH deficiency

    :
    0.18 mg/kg/week to 0.3 mg/kg/week (
    2.2 Pediatric Dosage

    • Individualize dosage for each patient based on the growth response.
    • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
    • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
      • Pediatric GH Deficiency:
        0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
      • Turner syndrome:
        Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
      • Idiopathic short stature:
        Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
      • SHOX Deficiency:
        0.35 mg/kg/week (0.05 mg/kg/day)
      • Small for Gestational Age (SGA):
        Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
        • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
    • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
    • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
      [see Contraindications (4)].
    )
  • Turner syndrome:
    Up to 0.375 mg/kg/week (
    2.2 Pediatric Dosage

    • Individualize dosage for each patient based on the growth response.
    • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
    • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
      • Pediatric GH Deficiency:
        0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
      • Turner syndrome:
        Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
      • Idiopathic short stature:
        Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
      • SHOX Deficiency:
        0.35 mg/kg/week (0.05 mg/kg/day)
      • Small for Gestational Age (SGA):
        Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
        • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
    • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
    • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
      [see Contraindications (4)].
    )
  • ISS

    :
    Up to 0.37 mg/kg/week (
    2.2 Pediatric Dosage

    • Individualize dosage for each patient based on the growth response.
    • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
    • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
      • Pediatric GH Deficiency:
        0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
      • Turner syndrome:
        Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
      • Idiopathic short stature:
        Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
      • SHOX Deficiency:
        0.35 mg/kg/week (0.05 mg/kg/day)
      • Small for Gestational Age (SGA):
        Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
        • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
    • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
    • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
      [see Contraindications (4)].
    )
  • SHOX deficiency:
    0.35 mg/kg/week (
    2.2 Pediatric Dosage

    • Individualize dosage for each patient based on the growth response.
    • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
    • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
      • Pediatric GH Deficiency:
        0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
      • Turner syndrome:
        Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
      • Idiopathic short stature:
        Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
      • SHOX Deficiency:
        0.35 mg/kg/week (0.05 mg/kg/day)
      • Small for Gestational Age (SGA):
        Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
        • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
    • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
    • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
      [see Contraindications (4)].
    )
  • SGA:
    Up to 0.47 mg/kg/week (
    2.2 Pediatric Dosage

    • Individualize dosage for each patient based on the growth response.
    • Divide the calculated weekly ZOMACTON dosage into equal doses given either 3, 6, or 7 days per week.
    • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
      • Pediatric GH Deficiency:
        0.18 mg/kg/week to 0.3 mg/kg/week (0.026 mg/kg/day to 0.043 mg/kg/day)
      • Turner syndrome:
        Up to 0.375 mg/kg/week (up to 0.054 mg/kg/day)
      • Idiopathic short stature:
        Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day)
      • SHOX Deficiency:
        0.35 mg/kg/week (0.05 mg/kg/day)
      • Small for Gestational Age (SGA):
        Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
        • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of ZOMACTON (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
    • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
    • Discontinue ZOMACTON for stimulation of linear growth once epiphyseal fusion has occurred
      [see Contraindications (4)].
    )
• Adult dosage:
  Either of the following two dosing regimens may be used:
  • Non-weight based dosing
    : Initiate with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1 to 2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements (
    2.3 Adult Dosage

    • Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
    • Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with ZOMACTON than younger individuals
      [see Use in Specific Populations (8.5)]
      .
    • Estrogen-replete women and patients receiving oral estrogen may require higher doses
      [see Drug Interactions (7)].
    • Administer the prescribed dose daily
    • Either of two ZOMACTON dosing regimens may be used:
      • Non-weight based
        • Initiate ZOMACTON with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1 to 2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
        • Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range.
        • Maintenance dosages will vary considerably from person to person, and between male and female patients.
      • Weight-based
        • Initiate ZOMACTON at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily.
        • Use the patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
        • Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen.
    )
  • Weight-based dosing (Not recommended for obese patients)
    : Initiate at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily (
    2.3 Adult Dosage

    • Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
    • Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with ZOMACTON than younger individuals
      [see Use in Specific Populations (8.5)]
      .
    • Estrogen-replete women and patients receiving oral estrogen may require higher doses
      [see Drug Interactions (7)].
    • Administer the prescribed dose daily
    • Either of two ZOMACTON dosing regimens may be used:
      • Non-weight based
        • Initiate ZOMACTON with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1 to 2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
        • Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range.
        • Maintenance dosages will vary considerably from person to person, and between male and female patients.
      • Weight-based
        • Initiate ZOMACTON at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily.
        • Use the patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
        • Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen.
    )
• See Full Prescribing Information for reconstitution instructions (
  2.4 Reconstitution

  • Reconstitute ZOMACTON 5 mg with 1 mL to 5 mL of diluent, Bacteriostatic Sodium Chloride Injection, USP with 0.9% benzyl alcohol as a preservative. Do not use diluent if the patient has a known hypersensitivity to benzyl alcohol
    [see Contraindications (4)]
    or in neonates
    [see Warnings and Precautions (5.13)]
    , or pregnant or lactating women
    [see Use in Specific Populations (8.1, 8.2)]
    instead reconstitute with 0.9% Sodium Chloride Injection, USP, use only one dose per vial, and discard the unused portion.
  • Reconstitute ZOMACTON 10 mg with 1 mL syringe of diluent, Bacteriostatic Water for Injection, USP with 0.33% metacresol as a preservative. Do not use diluent if the patient has a known hypersensitivity to metacresol
    [see Contraindications (4)]
    .
  • Aim the stream of diluent against the side of the vial to prevent foaming and gently swirl the vial with a rotary motion until the contents are completely dissolved and the solution is clear. Do not shake the vial since shaking or vigorous mixing will cause the solution to be cloudy.
  • Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use.
  • Occasionally, after refrigeration, some cloudiness may occur. Allow the product to warm to room temperature. If cloudiness persists or particulate matter is noted do not use.
  )

ZOMACTON is a white, lyophilized powder available as:

• For injection: 5 mg in a single-patient-use vial
• For injection: 10 mg in a single-patient-use vial

• Pregnancy and Lactation
  : If ZOMACTON 5 mg is needed, reconstitute with 0.9% sodium chloride injection or use the ZOMACTON 10 mg benzyl alcohol-free formulation. (
  8.1 Pregnancy

  Risk Summary

  The ZOMACTON 5 mg diluent contains benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus 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 (5.13)and Use in Specific Populations (8.4)].

  Therefore, if ZOMACTON 5mg is needed during pregnancy, reconstitute with 0.9% sodium chloride injection, use only one dose per vial, and discard the unused portion, or use a ZOMACTON 10 mg benzyl alcohol-free formulation.

  Limited published data do not report an association with somatropin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when somatropin is used in pregnancy. Published reports indicate that somatropin does not cross the placenta. Animal reproduction studies have not been conducted with ZOMACTON.

  The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  ,
  8.2 Lactation

  Risk Summary

  The ZOMACTON 5mg diluent contains 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 (5.13)and Use in Specific Populations (8.4)].

  If ZOMACTON 5mg is needed during lactation, reconstitute with 0.9% sodium chloride injection, use only one dose per vial, and discard after use or use a ZOMACTON 10 mg benzyl alcohol-free formulation

  .

  There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects on the breastfed infant have been reported with somatropin. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZOMACTON and any potential adverse effects on the breastfed child from ZOMACTON or from the underlying maternal condition.
  )