Dosing Chart

Recommended pediatric dosing for Humatrope administration

Recommended pediatrics Humatrope Dosing Chart

1 Larger doses of somatropin (eg, 0.067 mg/kg/day) are recommended especially in children with height SDS < -3, and/or older pubertal children, and a reduction in dosage (eg, 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 (eg, 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 administration

Recommended Adult Dosing for Humatrope Administration

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

Humatrope 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.

*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.

ⵐThe 12 mg cartridge may be more appropriate in this dose range.

About the vial and syringe option

  • Humatrope is available in a 5 mg vial.
  • Each vial is supplied in a combination package with an accompanying 5 mL vial of diluent.
  • If sensitivity to the Diluent for Humatrope should occur, the vials may be reconstituted with Bacteriostatic Water for Injection (Benzyl Alcohol preserved), United States Pharmacopoeia (USP) or Sterile Water for Injection, USP.
  • When Humatrope is reconstituted with Bacteriostatic Water for Injection, USP, the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 14 days.
  • It is important to note that benzyl alcohol used as a preservative in Bacteriostatic Water has been associated with toxicity in newborns. Therefore, Bacteriostatic Water for Injection must not be used to reconstitute Humatrope for use in a newborn infant. When Humatrope is to be administered to a newborn infant, it should be reconstituted with the diluent provided or, if the infant is sensitive to the diluent, Sterile Water for Injection, USP.
  • When reconstituted with Sterile Water for Injection, the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 24 hours. Use only 1 dose per Humatrope vial and discard the unused portion.

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®6mg, 12mg, and 24mg.

  • If you miss a dose of Humatrope, you should simply take the next dose at the regularly scheduled time. Do not double up on doses.

  • Pen Needles are not included with the HumatroPen® injection device. You may need a prescription to obtain the Needles from your pharmacist.
  • BD Pen Needles are suitable for use with the HumatroPen®.
  • Ask your healthcare professional what Needle gauge and length is best to use.
  • Follow your healthcare professional's instructions on safe handling of Needles.

BD and BD Logo are trademarks of Becton, Dickinson and Company.

  • Yes, a new needle must be used for each injection.
  • Remove the needle immediately after each injection and discard into a puncture-proof container. Use a new needle for each injection. This will help minimize the risk of infection, prevent leakage of Humatrope, keep out air bubbles, and reduce needle clogs.

  • Throw away used needles in a puncture-proof container. Follow your healthcare professional's instructions on how to do this safely. Keep sharps container out of reach of children and pets.

  • No. The New Cartridge Setup should be performed only once for each Cartridge, just before a new Cartridge is used for the first time.
  • The purpose of the setup is to make sure the HumatroPen® and Cartridge are ready to use.
  • If you repeat the New Cartridge Setup before each routine dose, you may run out of Humatrope early. The small amount of product used in the New Cartridge Setup will not affect the supply of Humatrope. Confirm that you have a 6 mg, 12 mg, or 24 mg Humatrope cartridge to match the corresponding HumatroPen®. This is important to ensure the prescribed dose of Humatrope is given. If it does not match, DO NOT USE and call The Lilly Answers Center at 1-800-LillyRX (1-800-545-5979) from 9 AM to 8 PM Eastern time, or call your healthcare professional.

  • DO NOT USE the HumatroPen® if the mg number (6 mg, 12 mg, or 24 mg) on the Humatrope Cartridge label does not match the number on the end of the Dose Knob and Front Housing of the HumatroPen®. This is important to ensure the correct dose of Humatrope is given.
  • Contact The Lilly Answers Center (1-800-545-5979) or your healthcare professional for assistance or to obtain a replacement HumatroPen.

  • Be sure to gently invert the Cartridge up and down 10 times. DO NOT SHAKE. Then, let the Cartridge sit for at least 3 minutes. If the solution remains cloudy or has particles, gently invert the Cartridge up and down 10 more times. Let the Cartridge sit for 5 more minutes.
  • If the solution remains cloudy or contains particles after reconstitution (mixing), DO NOT USE. Contact your healthcare professional for assistance.

  • Air bubbles may remain in the Cartridge after reconstitution (mixing).
  • If the HumatroPen® is stored with a needle attached, air bubbles may form in the Cartridge. DO NOT STORE the HumatroPen® with a needle attached.
  • If air bubbles are present, perform the New Cartridge Setup to remove air bubbles from the Cartridge.
  • A small air bubble is normal. It will not cause any harm nor affect the dose.

  • The Screw may not move out when you push the Injection Button unless there is a Cartridge in the HumatroPen®. This feature allows you to easily push the Screw into the HumatroPen® Body when replacing a Cartridge.
  • Once a Cartridge is attached, the Screw will move out when the Injection Button is pushed.

  • Check that the Cartridge is not damaged or broken.
  • Carefully line up the Cartridge with the HumatroPen® Body and screw together until secure. If the Cartridge and HumatroPen® cannot be screwed together, contact your healthcare professional.

  • The Needle may be clogged. Try attaching a new Needle.
  • Pushing the Injection Button down quickly may make the Injection Button harder to push. Pushing the Injection Button more slowly may make it easier.
  • Using a larger-diameter Needle will make it easier to push the Injection Button during injection. Ask your healthcare professional which Needle is best for you or your child.
  • The Injection Button may become harder to push if the inside of the HumatroPen® gets dirty.

  • This can happen if the Humatrope Cartridge does not have enough Humatrope left in it for the full dose. It is possible to set a dose larger than the amount of Humatrope left in the Cartridge. At the end of the injection, the number in the Dose Window should be 0.00. If it is not, the number showing in the window is the amount of Humatrope that WAS NOT delivered. Consult with your healthcare professional on how to handle a partial dose. Remove the needle and the empty cartridge. For the next daily use, attach a new Cartridge as shown in the HumatroPen® User Manual, and continue with New Cartridge Setup.

  • It is normal for a single drop to remain on the tip of the needle after the injection is complete. If you see more than one drop:
    • The full dose may not have been delivered. DO NOT INJECT another dose. Consult with your healthcare professional for assistance.
    • To prevent this, for the next dose, firmly push and hold the Injection Button in and slowly count to five.

  • The injection is complete when:
    • You have slowly counted to five while you are still holding the Injection Button in and before you remove the needle from the skin,
    • AND
    • 0.00 is in the center of the Dose Window.

Indications and Important Safety Information
INDICATION

Humatrope® (somatropin for injection) is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone (GH) deficiency.
  • Turner syndrome.
  • Idiopathic short stature, defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded.
  • SHOX deficiency.
  • Small for gestational age birth, and fail to show catch-up growth by 2 to 4 years of age.

Humatrope is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult-onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated to determine if they should continue growth hormone.

CONTRAINDICATIONS

  • Acute Critical Illness: Somatropin should not be used to treat patients with acute critical illness from complications after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure.
  • Prader-Willi Syndrome in Children: Somatropin 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. Humatrope is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
  • Active Malignancy: Somatropin is contraindicated in patients with any evidence of active malignancy.
  • Hypersensitivity: Humatrope is contraindicated in patients with a known hypersensitivity to somatropin or the supplied diluent.
  • Diabetic Retinopathy or Closed Epiphyses: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. It should not be used for growth promotion 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 somatropin.
  • Prader-Willi Syndrome in Children: There have been reports of fatalities 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.
  • Neoplasms: An increased risk of a second neoplasm has been reported for childhood 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 somatropin therapy 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 somatropin, 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 antihyperglycemic drugs 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 funduscopy during treatment with somatropin, 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 in adults 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 somatropin treatment.
  • 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 with endocrine disorders and in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
  • Progression of Scoliosis in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. Somatropin has not been shown to increase the occurrence of scoliosis.
  • Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops abdominal pain.
  • Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. This can be avoided by rotating the injection site.
ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions, hypersensitivity to the diluent, and hypothyroidism. Additional common adverse reactions in adults include edema, arthralgia, myalgia, carpal tunnel syndrome, paresthesias, and hyperglycemia.

ADDITIONAL INFORMATION

Click to access Full Prescribing Information, Patient Information-Cartridge, and Patient Information-Vial.

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

Humatrope is a registered trademark owned or licensed by Eli Lilly & Company, its subsidiaries, or affiliates.
HG HCP ISI 13JAN2017