ZOMACTON somatropin Kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Recombinant Human Growth Hormone class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Somatropin injection is used to treat growth failure caused by growth hormone deficiency and certain other conditions to increase body weight and endurance in certain people with human immunodeficiency virus (HIV) infection to treat short bowel syndrome in adults who need special nutrition therapy Somatropin is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body, which may result in increased growth, body weight, and improved absorption of nutrients and fluids from the intestines.
Read the full MedlinePlus article ↗- Somatropin is a lab-made version of the growth hormone your body naturally produces. Your doctor has likely prescribed it because your body — or your child's body — isn't making en...
- What exactly is somatropin and why has my doctor prescribed it?
- You'll inject it just under the skin — not into a vein or deep muscle. Common spots are the belly, thigh, upper arm, or buttock. The most important habit to get into is rotating yo...
- How do I give the injection, and does it hurt?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $278.604 | — |
| Medicaid paysCMS SDUD · 12 mo | $294.33 | — |
| Medicare drug plans payPart D · Q2 2026 | $296.17 | — |
| Medicare Part B allowsASP · J2941 | No ASP payment limit on file for J2941 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Genotropin 00013-2649-02 | Pfizer | 7 cartridges | $30.899 | — | Availability likely | save 89% |
| Genotropin 00013-2650-02 | Pfizer | 7 cartridges | $61.640 | — | Availability likely | save 78% |
| Genotropin 00013-2651-02 | Pfizer | 7 cartridges | $93.050 | — | FDA listed | save 67% |
| Zomactonthis 55566-1801-01 | Ferring | 1 kit | $278.604 | — | Availability likely | — |
| Omnitrope 00781-4004-36 | Sandoz | 1 kit | $326.117 | — | Availability likely | +17% |
| Genotropin 00013-2626-81 | Pfizer | 1 cartridge | $752.224 | — | Availability likely | +170% |
| Genotropin 00013-2646-81 | Pfizer | 1 cartridge | $1,810.400 | — | Availability likely | +550% |
| Genotropin 00013-2656-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2653-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2654-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2652-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2655-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2657-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
| Genotropin 00013-2658-02 | Pfizer | 7 cartridges | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55566-1801-01 You're viewing this | 1 KIT in 1 CARTON (55566-1801-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 5 mL in 1 VIAL | 2015-05-07 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 ) Adult: Replacement of endogenous GH in adults with GH deficiency ( 1.2 )
1.1Pediatric 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.
1.2Adult Patients ZOMACTON is indicated for the replacement of endogenous GH in adults with GH deficiency.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites ( 2.1 ) Pediatric dosage: Divide the calculated weekly dosage into equal doses given either 3, 6, or 7 days per week ( 2.2 ) GH deficiency : 0.18 mg/kg/week to 0.3 mg/kg/week ( 2.2 ) Turner syndrome: Up to 0.375 mg/kg/week ( 2.2 ) ISS : Up to 0.37 mg/kg/week ( 2.2 ) SHOX deficiency: 0.35 mg/kg/week ( 2.2 ) SGA: Up to 0.47 mg/kg/week ( 2.2 ) 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 ) 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 ) See Full Prescribing Information for reconstitution instructions ( 2.4 )
2.1Administration 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.
2.2Pediatric 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) ].
2.3Adult 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 Popu…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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 For injection: 5 mg lyophilized powder in a single-patient-use vial ( 3 ) 10 mg lyophilized powder in a single-patient-use vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS ZOMACTON is contraindicated in patients with: Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1) ] . Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.2) ] .
Active malignancy [see Warnings and Precautions (5.3) ] . Known hypersensitivity to somatropin or to any excipients of ZOMACTON. Systemic hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with postmarketing use of somatropins [see Dosage and Administrations (2.4) , Warnings and Precautions (5.6) ] .
Active proliferative or severe non-proliferative diabetic retinopathy. Pediatric patients with closed epiphyses. Acute critical illness ( 4 , 5.1 ) Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death ( 4 , 5.2 ) Active malignancy ( 4 ) Hypersensitivity to ZOMACTON, its excipients, or diluents ( 4 ) Active proliferative or severe non-proliferative diabetic retinopathy ( 4 ) Pediatric patients with closed epiphyses ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Increased Risk of Neoplasm: Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence. ( 5.3 ) Glucose Intolerance and Diabetes Mellitus: ZOMACTON may decrease insulin sensitivity, particularly at higher doses.
Monitor glucose levels periodically in all patients receiving ZOMACTON, especially in patients with existing diabetes mellitus or at risk for development. ( 5.4 ) Intracranial Hypertension (IH): Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter.
If papilledema occurs, stop treatment. ( 5.5 ) Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.
( 5.6 ) Fluid Retention: May occur in adults and may be dose dependent. ( 5.7 ) Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.8 ) Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin.
( 5.9 ) Slipped Capital Femoral Epiphysis in Pediatric Patients: May occur; evaluate patients with onset of a limp or hip/knee pain. ( 5.10 ) Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with scoliosis for progression. ( 5.11 ) Pancreatitis: Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients.
( 5.12 ) Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including the diluent for ZOMACTON 5 mg. If administering ZOMACTON 5 mg to infants, reconstitute with 0.9% sodium chloride injection. ( 5.13 )
5.1Increased Mortality in Patients with Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin [see Contraindications (4) ] . Two placebo-controlled clinical trials in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs.
19%) among somatropin-treated patients (doses 5.3 mg/day-8 mg/day) compared to those receiving placebo. The safety of continuing ZOMACTON treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. ZOMACTON is not indicated for the treatment of non-GH deficient adults.
5.2Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin.
If, during treatment with somatropin, patients show signs of upper airway obstruction (including onset of, or increased, snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4) ] . ZOMACTON is not indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome.
5.3 Increase…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] Fatalities in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.2) ] Neoplasms [see Warnings and Precautions (5.3) ] Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] Intracranial hypertension [see Warnings and Precautions (5.5) ] Severe hypersensitivity [see Warnings and Precautions (5.6) ] Fluid retention [see Warnings and Precautions (5.7) ] Hypoadrenalism [see Warnings and Precautions (5.8) ] Hypothyroidism [see Warnings and Precautions (5.9) ] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10) ] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11) ] Pancreatitis [see Warnings and Precautions (5.12) ] Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative [see Warnings and Precautions (5.13) ] Lipoatrophy [see Warnings and Precautions (5.14) ] Common adverse reactions reported in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose tolerance.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a different approved somatropin formulation and may not reflect the adverse reaction rates observed in practice. Pediatric Patients Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone ZOMACTON was evaluated in 164 pediatric patients with short stature due to GHD in an open-label study for 24 weeks.
The subjects ranged in age from 2.1 to 17.7 years with a mean of 10.8 years. One hundred twenty (73%) of the subjects were male and 44 (27%) were female. Two subjects were Asian, 12 were Black, 130 were Caucasian, and 20 were categorized as 'other'.
Table 1: Adverse Reactions ≥ 5% in Pediatric Patients with Growth Failure Due to GHD Treated with ZOMACTON through 24 Weeks Adverse Reaction 24 Week Exposure to ZOMACTON (n=164) Upper respiratory infection 32% Fever 16% Pharyngitis 12% Headache 11% Otitis Media 10% Increased cough 9% Abdominal pain 7% Anemia 6% Maculopapular rash 6% Diarrhea 5% Pain 5% Rhinitis 5% All pediatric patients were carefully observed for signs or laboratory abnormalities of hypothyroidism. Fifteen patients had T4 values which occasionally fell below the central laboratory's lower limit of normal; T4 levels rose to normal when tested during the next visit for all patients except one who continued to be monitored.
Six of the 15 patients received thyroxine therapy before and throughout the study period, and thyroxine dose adjustments were made during the study in 3/6 subjects. In studies with GH deficient pediatric patients, injection site pain was reported in 1.6% of patients. A mild and transient edema, which appeared in 1.6% of patients, was observed early during the course of treatment.
Short Stature Associated with Turner Syndrome In a randomized, concurrent-controlled, open-label study, there was an increase in the occurrence of otitis media, ear disorders and surgical procedures in patients receiving another somatropin product at a dose of 0.3 mg/kg/week, compared with untreated control patients (Table 2). A similar increase in otitis media was observed in an 18-month placebo-controlled study. Table 2: Adverse Reactions Occurring in Patie…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 7 includes a list of drugs with clinically important drug interactions when administered concomitantly with ZOMACTON and instructions for preventing or managing them. Table 7: Clinically Important Drug Interactions with ZOMACTON Glucocorticoids Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. ZOMACTON inhibits 11βHSD-1.
Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of ZOMACTON may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of ZOMACTON [seeWarnings and Precautions (5.8)].
Examples: Cortisone acetate and prednisone may be affected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment Clinical Impact: Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of ZOMACTON in pediatric patients. Intervention: Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.
Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. ZOMACTON may alter the clearance of compounds known to be metabolized by CP450 liver enzymes. Intervention: Careful monitoring is advisable when ZOMACTON is administered in combination with drugs metabolized by CP450 liver enzymes.
Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to ZOMACTON. Intervention: Patients receiving oral estrogen replacement may require greater ZOMACTON dosages [seeDosage and Administration (2.2)] . Insulin and/or Other Hypoglycemic Agents Clinical Impact: Treatment with ZOMACTON may decrease insulin sensitivity, particularly at higher doses.
Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [seeWarnings and Precautions (5.4)]. Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of ZOMACTON ( 7 ) Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth.
( 7 ) Cytochrome P450-Metabolized Drugs: ZOMACTON may alter the clearance. Monitor carefully if used with ZOMACTON ( 7 ) Oral Estrogen: Larger doses of ZOMACTON may be required ( 7 ) Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required ( 5.4 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS 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 , 8.2 )
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness of ZOMACTON in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in SHOX deficiency, and short stature in children born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone Safety and effectiveness of ZOMACTON have been established in pediatric patients with growth failure due to growth hormone deficiency based on data from a multi-center, open-label study in 164 pediatric patients conducted for a two-year period [see Clinical Studies (14.1) ].
Short Stature associated with Turner Syndrome Safety and effectiveness of ZOMACTON have been established in pediatric patients with short stature associated with Turner syndrome based on data from one long-term, randomized, open-label, Canadian multicenter, concurrently controlled study; two long-term, open-label multicenter, historically controlled US studies; and one long-term, randomized, US dose-response study with another somatropin product in 181 pediatric patients [see Clinical Stud…
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of ZOMACTON in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in SHOX deficiency, and short stature in children born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone Safety and effectiveness of ZOMACTON have been established in pediatric patients with growth failure due to growth hormone deficiency based on data from a multi-center, open-label study in 164 pediatric patients conducted for a two-year period [see Clinical Studies (14.1) ].
Short Stature associated with Turner Syndrome Safety and effectiveness of ZOMACTON have been established in pediatric patients with short stature associated with Turner syndrome based on data from one long-term, randomized, open-label, Canadian multicenter, concurrently controlled study; two long-term, open-label multicenter, historically controlled US studies; and one long-term, randomized, US dose-response study with another somatropin product in 181 pediatric patients [see Clinical Studies (14.2) ]. Idiopathic Short Stature (ISS) Safety and effectiveness of ZOMACTON have been established in pediatric patients with ISS based on data from two randomized, multicenter studies, one placebo-controlled study and one dose-response study with another somatropin product in 310 pediatric patients [see Clinical Studies (14.3) ].
Short Stature or Growth Failure in SHOX Deficiency Safety and effectiveness of ZOMACTON have been established in pediatric patients with short stature or growth failure in SHOX deficiency based on data from a randomized, controlled, two-year, three-arm, open-label study with another somatropin product in 52 pediatric patients [see Clinical Studies (14.4) ]. Short Stature in Children Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 Years to 4 Years of Age Safety and effectiveness of ZOMACTON have been established in pediatric patients with short stature born SGA with no catch-up growth based on data from two clinical studies with another somatropin product in 228 pediatric patients [see Clinical Studies (14.5) ].
Toxicity (Gasping Syndrome) with Benzyl Alcohol-Preserved Solution Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/L to 1.378 mmol/L). The maximal daily uptake of benzyl alcohol is 39 mg at ZOMACTON doses of 0.067 mg/kg/day.
Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. When administering ZOMACTON 5 mg to infants, reconstitute with 0.9% sodium chloride injection, not with the diluent provided.
Use only one dose per vial and discard the unused portion [see Warnings and Precautions (5.13) ].
🧓 Geriatric Use ▾
8.5Geriatric Use The safety and effectiveness of somatropin in patients aged 65 years and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to development of adverse reactions. A lower starting dose and smaller dose increments should be considered for geriatric patients [see Dosage and Administration (2.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage may result in signs and symptoms of gigantism or acromegaly consistent with the known effects of excess growth hormone.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or effects mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation of hepatic glucose output, protein synthesis, and lipolysis.
Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.
12.2Pharmacodynamics Subcutaneous administration of a single dose of 4 mg ZOMACTON in healthy subjects (n=54) with suppressed endogenous growth hormone results in an increased mean (SD) IGF-1 level from 233 (95) ng/mL predose to maximal level of 414 (120) ng/mL after approx. 24 hours. After 96 hours, the subjects displayed a mean (SD) IGF-1 concentration of 228 (74) ng/mL, comparable to the predose value.
12.3Pharmacokinetics Absorption — Somatropin has been studied following subcutaneous, and intravenous administration in adult healthy subjects. A single subcutaneous dose of 4 mg ZOMACTON in healthy subjects (n=54) with suppressed endogenous growth hormone resulted in a mean (SD) Cmax of 38.1 (19.3) ng/mL after approximately 4.5 hours. The absolute bioavailability of somatropin is approximately 70% after subcutaneous administration.
Distribution — The mean (SD) apparent volume of distribution of somatropin after single dose subcutaneous administration of 4 mg ZOMACTON in healthy subjects is 53.3 (24.6) L. Elimination Metabolism — Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys.
Excretion - In healthy subjects, mean somatropin clearance is 0.133 L/min following intravenous administration. The mean elimination half-life of intravenous somatropin is 0.42 hours, whereas subcutaneously administered somatropin has a mean half-life of 2.3 hours. The longer half-life observed after subcutaneous administration is due to slow absorption from the injection site.
Urinary excretion of intact somatropin has not been measured. Specific Populations Geriatric patients — The pharmacokinetics of somatropin have not been studied in patients greater than 65 years of age. Pediatric patients — The pharmacokinetics of somatropin in pediatric patients are similar to those of adults.
Male and Female Patients — No gender-specific pharmacokinetic studies have been performed with somatropin. The available literature indicates that the pharmacokinetics of somatropin are similar in men and women. Patients with Renal or Hepatic Impairment — No studies have been performed with somatropin.
12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ZOMACTON or other somatropins. In a clinical trial with another recombinant growth hormone during the first 6 months of somatropin therapy in 314 naive patients, 1.6% developed specific antibodies to somatropin (binding capacity ≥0.02 mg/L).
None had antibody concentrations which exceeded 2 mg/L. Throughout 8 years of this same study, two patients (0.6%) had binding capacity >2 mg/L. Neither patient demonstrated a decrease in growth velocity at or near the time of increased antibody production.
It has been report…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or effects mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation of hepatic glucose output, protein synthesis, and lipolysis.
Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied ZOMACTON (somatropin) for injection is a white, lyophilized powder available as: NDC ZOMACTON Diluent Additional Items NDC 55566-1801-1 5 mg single-patient-use vial 5 mL vial of diluent, Bacteriostatic Sodium Chloride Injection, USP with 0.9% benzyl alcohol NDC 55566-1901-1 10 mg single-patient-use vial 1 mL syringe of diluent, Bacteriostatic Water for Injection, USP with 0.33% metacresol 25G reconstitution needle
16.2Storage and Handling Before Reconstitution Store ZOMACTON vials refrigerated at 36° to 46°F (2° to 8°C) in the original carton to protect from light. Avoid freezing the accompanying diluent. After Reconstitution If needed, store ZOMACTON 5 mg vials that have been reconstituted with co-packaged Bacteriostatic Sodium Chloride Injection, USP (with 0.9% benzyl alcohol) refrigerated at 36° to 46°F (2° to 8°C) for up to 14 days.
Do not freeze. If needed, store ZOMACTON 10 mg vials that have been reconstituted with co-packaged Bacteriostatic Water for Injection, USP (with 0.33% metacresol) refrigerated at 36° to 46°F (2° to 8°C) for up to 28 days. Do not freeze.
📦 Storage and Handling ▾
16.2Storage and Handling Before Reconstitution Store ZOMACTON vials refrigerated at 36° to 46°F (2° to 8°C) in the original carton to protect from light. Avoid freezing the accompanying diluent. After Reconstitution If needed, store ZOMACTON 5 mg vials that have been reconstituted with co-packaged Bacteriostatic Sodium Chloride Injection, USP (with 0.9% benzyl alcohol) refrigerated at 36° to 46°F (2° to 8°C) for up to 14 days.
Do not freeze. If needed, store ZOMACTON 10 mg vials that have been reconstituted with co-packaged Bacteriostatic Water for Injection, USP (with 0.33% metacresol) refrigerated at 36° to 46°F (2° to 8°C) for up to 28 days. Do not freeze.
📋 Description ▾
11 DESCRIPTION Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin.
ZOMACTON (somatropin) for injection is a sterile, white lyophilized powder, intended for subcutaneous injection after reconstitution with the accompanying diluent. ZOMACTON 5 mg single-patient-use vial contains 5 mg of somatropin and mannitol (30 mg). Each 5 mg vial is co-packaged with a 5 mL vial of diluent containing Bacteriostatic Sodium Chloride Injection, USP, with 0.9% benzyl alcohol as a preservative, and Water for Injection, USP.
ZOMACTON 10 mg single-patient-use vial contains 10 mg of somatropin, mannitol (10 mg), dibasic sodium phosphate (1.415 mg), and monobasic sodium phosphate (0.608 mg). Each 10 mg vial is co-packaged with a 1 mL syringe of diluent containing Bacteriostatic Water for Injection, USP with 0.33% metacresol as a preservative. Reconstituted solutions have a pH in the range of 7 to 9.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Neoplasms – Advise childhood cancer survivors/caregivers that individuals treated with brain/head radiation are at increased risk of secondary neoplasms and as a precaution need to be monitored for recurrence. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.
Fluid Retention - Advise patients that fluid retention during ZOMACTON replacement therapy in adults may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesias) and to report to their healthcare provider any of these signs or symptoms occur during treatment with ZOMACTON. Pancreatitis - Advise patients/caregivers that pancreatitis may develop and to report to their healthcare provider any new onset abdominal pain.
Hypoadrenalism - Advise patients/caregivers who have or who are at risk for pituitary hormone deficiency(s) that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss. Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to ZOMACTON. Advise patients/caregivers they may require periodic thyroid function tests.
Intracranial Hypertension - Advise patients/caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting. Hypersensitivity Reactions – Advise patients/caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs. Glucose Intolerance/ Diabetes Mellitus – Advise patients/caregivers that new onset impaired glucose intolerance/diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with ZOMACTON may be needed.
Females of Reproductive Potential – Instruct patients to inform their healthcare provider if they are pregnant or planning to become pregnant as they may potentially require the use of a different formulation of ZOMACTON. Manufactured by: FERRING PHARMACEUTICALS INC. PARSIPPANY, NJ 07054 U.S.
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