Frequently Asked Questions

Select Safety Information

  • 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.
About Humatrope

What is Humatrope?

Humatrope is a synthetic form of human growth hormone (GH). The amino acid sequence of Humatrope is identical to that of GH produced by the human pituitary gland. Humatrope is synthesized through a process known as recombinant DNA technology.

When is the recommended time of day to inject Humatrope?

Growth hormone (GH) normally is produced at peak levels during sleep.1,2 Therefore, it is usually recommended that GH be given in the evening. However, there may be reasons to give the injection at other times of the day in certain cases.

What happens if a patient forgets to take a dose?

If a patient misses a dose of Humatrope, he or she should simply take the next dose at the regularly scheduled time. Instruct your patient to not double up on doses.

How should Humatrope be stored and handled?

Both before and after reconstitution, vials and cartridges of Humatrope and Diluent for Humatrope should be stored in a refrigerator at 36° to 46°F (2° to 8°C); they MUST NOT be frozen. The expiration dates on the label should be checked before mixing and expired Humatrope or Diluent must not be used. The reconstituted Humatrope should not be shaken; if the Humatrope solution is cloudy or contains any particles or sediment, it should not be used. Once mixed with Diluent for Humatrope, Humatrope must be used within 14 days (vials) or 28 days (cartridges).1,3

Select Safety Information

  • 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.

How should patients transport Humatrope during travel?

Humatrope should be kept cold (not frozen!) in a Lilly-supplied cooler (with provided frozen gel packs) that can be carried in a car or on board an airplane. The cooler should be carried onto an airplane, not checked as baggage. Coolers and gel packs are available by calling Lilly at 1-800-LillyRx (1-800-545-5979) 9 AM to 8 PM Eastern time.4-6

Which needles can be used with the HumatroPen® 6 mg, 12 mg, and 24 mg devices?

BDTM (Becton, Dickinson and Company) pen needles are suitable for use with the HumatroPen devices. Selection of needle size and gauge should be made with individual patient needs in mind.

BD, BD logo and all other trademarks are the property of Becton, Dickinson, and Company. © 2016 BD

What if my patient has sensitivity to the Diluent for Humatrope?

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

Select Safety Information

  • Hypersensitivity: Humatrope is contraindicated in patients with a known hypersensitivity to somatropin or the supplied diluent.

Are there specific considerations if Humatrope is used in treating a newborn infant?

  • When Humatrope is to be administered to a newborn infant it should be reconstituted with the diluent provided unless the infant is sensitive to the diluent. If the infant is sensitive to the diluent, Humatrope in a vial (but NOT a cartridge) may be reconstituted with Sterile Water for Injection, United States Pharmacopoeia (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.
  • Humatrope cartridges should not be used if the infant is allergic to metacresol or glycerin, which are components of the diluent. Humatrope cartridges should NOT be reconstituted with the diluent provided with Humatrope vials, or with any other solution.
  • It is important to note that benzyl alcohol used as a preservative in Bacteriostatic Water for Injection (Benzyl Alcohol preserved), USP, 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.

Select Safety Information

  • 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.
About Patient Support

What do I need to send to Humatrope DirectConnect for my patient so that a benefits investigation can begin?

Here’s what you'll need to send to Humatrope DirectConnect:

  • A completed Humatrope Statement of Medical Necessity form
  • Medical information to support an approved indication for Humatrope treatment
  • Any available insurance information (for example, patient identification, insurance company name and phone number, etc.)

What happens if Humatrope DirectConnect receives incomplete paperwork from my office?

Someone from Humatrope DirectConnect will contact your office to obtain the correct paperwork needed to begin the casework.

Who handles my patients' cases? One person or several people?

A Patient Service Liaison is assigned to each patient and continues to be the main point of contact with whom the patient or caregiver(s) works throughout the process, from the insurance benefits investigation through benefits renewal. However, there is a team of individuals with specific expertise who will assist at various stages of the insurance process.

When does Humatrope DirectConnect initiate reauthorization?

Humatrope DirectConnect initiates the reauthorization process approximately 60 days prior to the expiration of the patient's current authorization period.

About Device Options

When is the recommended time of day to inject Humatrope?

Growth hormone (GH) normally is produced at peak levels when people are asleep.7 Therefore, it is usually recommended that GH be given in the evening. However, there may be reasons to give the injection at other times of the day in certain cases.

What happens if a patient forgets to take a dose?

If a patient misses a dose of Humatrope, he or she should simply take the next dose at the regularly scheduled time. Instruct your patient to not double up on doses.

Which needles can be used with the HumatroPen® 6 mg, 12 mg, and 24 mg devices?

BDTM (Becton, Dickinson and Company) pen needles are suitable for use with the HumatroPen devices. Selection of needle size and gauge should be made with individual patient needs in mind.

BD, BD logo and all other trademarks are the property of Becton, Dickinson, and Company. © 2016 BD

How should Humatrope be stored and handled?

Both before and after reconstitution, vials and cartridges of Humatrope and Diluent for Humatrope should be stored in a refrigerator at 36° to 46°F (2° to 8°C); they MUST NOT be frozen. The expiration dates on the label should be checked before mixing and expired Humatrope or Diluent must not be used. The reconstituted Humatrope should not be shaken; if the Humatrope solution is cloudy or contains any particles or sediment, it should not be used (colorless specks are okay; these are small molecules of protein). Once mixed with Diluent for Humatrope, Humatrope must be used within 14 days (vials) or 28 days (cartridges).1,3

Select Safety Information

  • 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.

How should patients transport Humatrope during travel?

Humatrope should be kept cold (not frozen!) in a Lilly-supplied cooler (with provided frozen gel packs) that can be carried in a car or on board an airplane. The cooler should be carried onto an airplane, not checked as baggage. Coolers and gel packs are available by calling Lilly at 1-800-LillyRx (1-800-545-5979) 9 AM to 8 PM Eastern time.4-6

 

References

1. Humatrope [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2017.

2. Spiliotis BE, August GP, Hung W, et al. Growth hormone neurosecretory dysfunction.
A treatable cause of short stature. http://www.ncbi.nlm.nih.gov/pubmed/6708271. JAMA. 1984;251(17):2223-2230.

3. Pen User Manual. 6 mg, 12 mg, and 24 mg; "Commonly Asked Questions" section.

4. Technical Report, Justification of Travel Bag FB-l 0/2003 FD for Use with Humatrope Pens., Krause, 2008, TR2008DEC09 1504C037200A.

5. Summary of Humatrope Stability Data After Exposure to Aberrant Temperatures for Use in "Fit for Sale" and "Fit for Use" Decisions, Storms, 2004, TR210CT2004RC88123A.

6. Distribution Temperature Profile for Humatrope and Diluent for Humatrope (Revision 2), Gamboa, 2007, LD 12MAR2007C042458.

7. Takahashi Y, Kipnis DM, Daughaday WH. Growth hormone secretion during sleep. J Clin Invest. 1968;47(9):2079-2090.

Indications and Important Safety Information for Humatrope
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, with failure 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.
Important Safety Information for Humatrope
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.
See Full Pen User Manual that accompanies the HumatroPen® 6 mg, 12 mg, and 24 mg.
HG HCP ISI 13JAN2017