Humatrope (somatropin) for injection 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 (SDS) <-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 homeoboxcontaining gene (SHOX) deficiency,
short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.

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

Contraindications

Acute Critical Illness: Humatrope should not be used to treat 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.

Dosing Chart

Recommended pediatric dosing for Humatrope administration

Indication	Daily (mg/kg/day)	Weekly (mg/kg/week)
Indication Growth hormone deficiency¹	Daily (mg/kg/day) 0.026 to 0.043	Weekly (mg/kg/week) 0.18 to 0.30
Indication Turner syndrome¹	Daily (mg/kg/day) Up to 0.054	Weekly (mg/kg/week) Up to 0.375
Indication Idiopathic short stature (ISS)¹	Daily (mg/kg/day) Up to 0.053	Weekly (mg/kg/week) Up to 0.37
Indication SHOX deficiency¹	Daily (mg/kg/day) 0.050	Weekly (mg/kg/week) 0.35
Indication Small for gestational age (SGA)¹	Daily (mg/kg/day) Up to 0.067	Weekly (mg/kg/week) Up to 0.47

Larger doses of somatropin (e.g., 0.067 mg/kg/day) are recommended especially in children with height SDS < -3, and/or older pubertal children, and a reduction in dosage (e.g., gradually toward 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy.

For SGA children less than 4 years old and with less baseline height DSD values between -2 and -3, consider initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time.

¹ Dosage should be individualized within recommended range based on growth response; failure to increase height velocity should prompt close assessment.

Recommended adult dosing for Humatrope administration²

Indication	Non-weight-based starting dose (Dose range)³	Weight-based starting dose (Maximum dose)⁴
Indication Growth hormone deficiency	Non-weight-based starting dose (Dose range)³Approx. 0.2 mg/day (Range: 0.15 to 0.30 mg/day)	Weight-based starting dose (Maximum dose)⁴Not more than 0.006 mg/kg/day (Max: 0.0125 mg/kg/day)

Indication

Non-weight-based starting dose (Dose range)³

Weight-based starting dose (Maximum dose)⁴

Indication Growth hormone deficiency

Non-weight-based starting dose (Dose range)³Approx. 0.2 mg/day (Range: 0.15 to 0.30 mg/day)

Weight-based starting dose (Maximum dose)⁴Not more than 0.006 mg/kg/day (Max: 0.0125 mg/kg/day)

² Dose should be adjusted based on clinical response, side effects, and determination of age- and gender-adjusted serum IGF-1 concentration.

³ May be used without consideration of body weight, and can be increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.

⁴ The dose may be increased to a maximum of 0.0125 mg/kg (12.5 µg/kg) daily.

Pen Selection Chart

After calculating the appropriate dose, locate that dose in the columns below and then look to the far left to determine the number of doses that a single cartridge may provide. This can help you prescribe the appropriate number of cartridges and let you inform patients how often they will need to change the cartridge in their Pen.

Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases.

Humatrope cartridges must be refrigerated before and after reconstitution.

Humatrope cartridges should not be used if the patient is allergic to metacresol or glycerin, which are components of the Diluent for Humatrope.

Number of Doses Provided by a Single Cartridge	6 mg	12 mg	24 mg
Number of Doses Provided by a Single Cartridge 28	6 mg 0.025 - 0.20^*	12 mg 0.05 - 0.40^*†	24 mg 0.10 - 0.80^*‡
Number of Doses Provided by a Single Cartridge 26	6 mg 0.225	12 mg 0.45	24 mg 0.90
Number of Doses Provided by a Single Cartridge 24	6 mg 0.25	12 mg 0.50	24 mg 1.00
Number of Doses Provided by a Single Cartridge 21	6 mg 0.275	12 mg 0.55	24 mg 1.10
Number of Doses Provided by a Single Cartridge 20	6 mg 0.30	12 mg 0.60	24 mg 1.20
Number of Doses Provided by a Single Cartridge 18	6 mg 0.325	12 mg 0.65	24 mg 1.30
Number of Doses Provided by a Single Cartridge 17	6 mg 0.35	12 mg 0.70	24 mg 1.40
Number of Doses Provided by a Single Cartridge 16	6 mg 0.375	12 mg 0.75	24 mg 1.50
Number of Doses Provided by a Single Cartridge 15	6 mg 0.40	12 mg 0.80	24 mg 1.60
Number of Doses Provided by a Single Cartridge 14	6 mg 0.425	12 mg 0.85	24 mg 1.70
Number of Doses Provided by a Single Cartridge 13	6 mg 0.45	12 mg 0.90	24 mg 1.80
Number of Doses Provided by a Single Cartridge 12	6 mg 0.475 - 0.50	12 mg 0.95 - 1.00	24 mg 1.90 - 2.00
Number of Doses Provided by a Single Cartridge 11	6 mg 0.525	12 mg 1.05	24 mg 2.10
Number of Doses Provided by a Single Cartridge 10	6 mg 0.55 - 0.60	12 mg 1.10 - 1.20	24 mg 2.20 - 2.40
Number of Doses Provided by a Single Cartridge 9	6 mg 0.625 - 0.65	12 mg 1.25 - 1.30	24 mg 2.50 - 2.60
Number of Doses Provided by a Single Cartridge 8	6 mg 0.675 - 0.75	12 mg 1.35 - 1.50	24 mg 2.70 - 3.00
Number of Doses Provided by a Single Cartridge 7	6 mg 0.775 - 0.85	12 mg 1.55 - 1.70	24 mg 3.10 - 3.40
Number of Doses Provided by a Single Cartridge 6	6 mg 0.875 - 1.00	12 mg 1.75 - 2.00	24 mg 3.50 - 4.00
Number of Doses Provided by a Single Cartridge 5	6 mg 1.025 - 1.20	12 mg 2.05 - 2.40	24 mg 4.10 - 4.80
Number of Doses Provided by a Single Cartridge 4	6 mg 1.225 - 1.50	12 mg 2.45 - 3.00	24 mg 4.90 - 6.00

^* The number of doses provided by a cartridge within this dose range is limited to 28 because a reconstituted cartridge is stable for 28 days when refrigerated.

^† The 6 mg cartridge may be more appropriate in this dose range.

^‡ The 12 mg cartridge may be more appropriate in this dose range.

When taking Humatrope (somatropin for injection) remember

Below are some answers to questions you may have about the HumatroPen^® 6 mg, 12 mg, and 24 mg injection devices.

See Full Pen User Manual that accompanies the HumatroPen^® 6 mg, 12 mg, and 24 mg.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS -

Acute Critical Illness: Humatrope should not be used to treat 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.
Prader-Willi Syndrome in Children: Humatrope should not be used in 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. Humatrope is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Active Malignancy: Humatrope is contraindicated in patients with any evidence of active malignancy.

Hypersensitivity: Humatrope is contraindicated in patients with a known hypersensitivity to somatropin or any of the excipients in Humatrope.

Diabetic Retinopathy: Humatrope is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Closed Epiphyses: Humatrope is contraindicated in pediatric patients with closed epiphyses.

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Increased mortality in patients with acute critical illness from complications after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of Humatrope. Humatrope is not indicated for the treatment of non-GH deficient adults.
Sudden Death in Patients with Prader-Willi Syndrome: There have been reports of sudden death after starting 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. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin.
Increased risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with Humatrope. Discontinue Humatrope if there is evidence of recurrent activity. An increased risk of a second neoplasm has been reported for pediatric cancer survivors treated with somatropin for GH deficiency that developed following radiation to the brain/head. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor for progression or recurrence in all patients receiving Humatrope who have a history of GH deficiency secondary to an intracranial neoplasm.
Glucose Intolerance and Diabetes Mellitus: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. Blood glucose concentrations should be monitored periodically in all patients taking Humatrope, especially in those with risk factors for diabetes mellitus and those with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance. The dose of antidiabetic agents may require adjustment when somatropin treatment is instituted.
Intracranial Hypertension: Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients treated with somatropin. If papilledema is observed by fundoscopy during treatment with Humatrope, treatment should be stopped and the patient’s condition should be reassessed before treatment is resumed.
Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with use of somatropin products.
Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement therapy may occur frequently.
Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Humatrope treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or adjusted in cases of unmasked or worsening hypothyroidism.
Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients in patients undergoing rapid growth. Evaluate any pediatric patient with the onset of a limp or complaints of hip or knee pain.
Progression of Scoliosis in Pediatric Patients: Humatrope increases the growth rate and progression of existing scoliosis can occur in patients who experience rapid growth. Monitor patients with a history of scoliosis for progression of scoliosis. Somatropin has not been shown to increase the occurrence of scoliosis.
Pancreatitis: Cases of pancreatitis have been reported in children and adults receiving somatropin products. Pancreatitis should be considered in patients who develop abdominal pain.
Lipoatrophy: Tissue atrophy may result when somatropin products are administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Humatrope to reduce this risk.

ADVERSE REACTIONS

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.

HG HCP ISI 14SEP2022

See Full Prescribing Information, Instructions for Use - Cartridge and Instructions for Use – Vial.

INDICATIONS

Humatrope^® (somatropin) for injection 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 (SDS) <-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.

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

Dosing Chart

Pen Selection Chart

When taking Humatrope (somatropin for injection) remember

Expand accordion What happens if I forget to take a dose?

Expand accordion What kinds of Needles can be used with the HumatroPen® injection devices?

Expand accordion Must a new needle be used for each injection?

Expand accordion How do I throw away used needles?

Expand accordion Do I need to perform the New Cartridge Setup before every dose?

Expand accordion What should I do if the Cartridge Label and HumatroPen® do not match?

Expand accordion What should I do if the Humatrope is not clear?

Expand accordion Why are there air bubbles in the Cartridge?

Expand accordion Why doesn't the Screw move out when there is no Cartridge attached to the HumatroPen®?

Expand accordion What should I do if I can't attach the Cartridge to the HumatroPen® Body?

Expand accordion Why is it difficult to push the Injection Button when I try to inject the dose?

Expand accordion What should I do if the dose knob does not go to zero (0) when I inject the dose?

Expand accordion Why do I see Humatrope leaking from the needle after I have finished the injection?

Expand accordion How can I tell when the injection is complete?

Expand accordion What if I leave my HumatroPen® at room temperature?

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS -

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATIONS