Humatrope (somatropin)
Growth Hormone Modulators Injection Cartridge (Ea); Injection Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
USES: Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).
Generic name: somatropin
Pronunciation: (so-mah-TROW-pin)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Humatrope
Indications
The following indications are listed for Humatrope:
- Adult Growth Hormone Deficiency
- Growth Failure Associated With Turner's Syndrome
- Growth Failure In Child With Short Stature Homeobox-Containing Gene (Shox) Deficiency
- Idiopathic Short Stature
- Pituitary Dwarfism
- Short Stature In Child Born Small For Gestational Age
Also known as: Adult Gh Deficiency, Child Born Small For Gestational Age Without Catch-Up Growth, Gh Deficiency Dwarfism, Growth Failure Associated With Short Stature Homeobox-Containing Gene (Shox) Deficiency, Growth Failure Due To Isolated Growth Hormone Deficiency, Growth Failure Due To Isolated Somatotropin Deficiency, Growth Failure In Child With Turner's Syndrome, Growth Failure In Pediatric Patient With Turner's Syndrome, Hypophysial Dwarfism, Idiopathic Non-Growth Hormone Deficiency Short Stature, Lorain-Levi Dwarfism, Lorain-Levi Infantilism, Lorain-Levi Syndrome, Pituitary Infantilism, Short Sga Child, Short Stature In Pediatric Patient With Turner's Syndrome.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Humatrope 5 Mg Vial | Maintenance | Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily. |
| Humatrope 6 Mg Cartridge | Maintenance | Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily. |
| Humatrope 12 Mg Cartridge | Maintenance | Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily. |
| Humatrope 24 Mg Cartridge | Maintenance | Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily. |
No dosing information is available for this tab.
Drug interactions
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Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Agents Affecting Growth Hormone/Macimorelin
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Agents affecting growth hormone may impact the accuracy of the macimorelin diagnostic test.(1)
CLINICAL EFFECTS: Concurrent use of agents affecting growth hormone may impact the accuracy of the macimorelin diagnostic test.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of macimorelin states concurrent use with agents affecting growth hormone may impact the accuracy of the macimorelin diagnostic test. Discontinue growth hormone products at least 1 week before administering the macimorelin diagnostic test. Sufficient washout time of drugs affecting growth hormone release prior to administration of macimorelin is recommended.(1) Agents affecting growth hormone include: - Drugs that directly affect the pituitary secretion of growth hormone (e.g. somatostatin, insulin, glucocorticoids, cyclooxygenase inhibitors) - Drugs that may transiently elevate growth hormone concentrations (e.g. clonidine, levodopa, insulin) - Drugs that may blunt the growth hormone response (e.g. muscarinic antagonists, anti-thyroid medications, growth hormone products)
DISCUSSION: Concurrent use of agents affecting growth hormone may impact the accuracy of the macimorelin diagnostic test.(1)
Growth Hormone/Selected Retinoids (Systemic)
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Both systemic retinoids(1-8,11) and growth hormones(9-11) have been independently associated with medication-induced intracranial hypertension.
CLINICAL EFFECTS: The concurrent use of oral retinoids(1-8) with growth hormones(9-10) may increase the risk of intracranial hypertension (pseudotumor cerebri). Early signs of intracranial hypertension include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(12)
PREDISPOSING FACTORS: Women of childbearing age with high body mass may have a higher risk of developing intracranial hypertension.(8)
PATIENT MANAGEMENT: The US manufacturer of tretinoin advises avoiding concomitant use of other products that can cause intracranial hypertension.(1) Patients who present with symptoms of intracranial hypertension should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(1-8)
DISCUSSION: Vitamin A derivatives and growth hormone have both been strongly associated with intracranial hypertension. A review of ocular side effects from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, the Food and Drug Administration, and medical journals from 1979 to 2003 found 21 patients who developed intracranial hypertension while taking tretinoin, acitretin, or etretinate at prescribed doses. Symptom onset occurred at an average of 2-3 months after starting retinoid therapy and all except 3 cases resolved within a few months after discontinuing therapy.(8) In a systematic review of 580 reported cases of medication-induced intracranial hypertension between January 1900 and June 2019 found in MEDLINE, EMBASE, and Cochrane Review Databases, there were 259 verifiable cases of intracranial hypertension. Vitamin A derivatives were implicated in 84 cases, though 25 cases occurred with excessive vitamin A supplementation. Growth hormone was implicated in 24 cases, all of which occurred in pediatric patients and involved frequent or higher doses of growth hormone.(12)
There are no severe interactions for this drug.
Moderate Interaction: Assess the risk to the patient and take action as needed.
Growth Hormone/Oral Estrogens
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Growth hormone (somatropin or lonapegsomatropin-tcgd) binds to growth hormone receptors and stimulates Janus activating tyrosine kinases (JAK 1 and 2) and signal transducer activators of transcription (STAT1, STAT3, STAT5) to increase gene transcription and metabolism to produce and secrete insulin like growth factor-1 (IGF-1). IGF-1 promotes cell growth, proliferation, and survival. Estrogens block STAT phosphorylation and inhibit IGF-1 secretion and production.(1,2) Higher quantities of growth hormone are required to raise serum IGF-1 concentrations to the normal range.
CLINICAL EFFECTS: Oral estrogens may reduce the IGF-1 response to growth hormone (somatropin and lonapegsomatropin-tcgd).(1-9)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of somatropin states a larger dose of somatropin may be required to achieve the treatment goal.(3-9) The manufacturer of lonapegsomatropin-tcgd states adults of any age concurrently taking oral estrogen should increase the dose of lonapegsomatropin-tcgd to 2.1 mg once weekly.(3) The American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for growth hormone deficiency states that higher recombinant human growth hormone (rhGH) doses are advised in women on oral estrogen therapy and that switching women to transdermal estrogen patches may allow lower rhGH doses to be used for equivalent IGF-1 responses.(10)
DISCUSSION: A prospective study compared growth hormone replacement requirements in women with elevated estrogen (on oral estrogen), women without elevated estrogen (no estrogen therapy or on transdermal estrogen), and growth hormone treated adult hypopituitary males. Women on oral estrogen required 10.6 +/-0.7 mcg/kg/day or 867 +/- 45 mcg/day growth hormone, women not taking oral estrogen required 5.0 +/- 0.7 mcg/kg/day or 424 +/-57 mcg/day, and men required 4.1 +/- 0.6 mcg/kg/day or 376 +/-49 mcg/day.(1) A randomized cross-over study compared one month of treatment with ethinyl estradiol (20 mcg), conjugated equine estrogen (1.25 mg Premarin), and estradiol valerate (2 mg). All three formulations resulted in a significant reduction in IGF-1 levels compared to baseline.(11) A study compared IGF-1 concentrations in premenopausal women and postmenopausal women before and after 2 months of cyclical replacement therapy with either oral ethinyl estradiol (20 mcg daily) or transdermal 17 beta-estradiol (100 mcg patch applied twice weekly). Oral ethinyl estradiol significantly reduced circulating IGF-1 (0.70 +/- 0.09 to 0.47 +/- 0.04 units/mL, P < 0.02) levels. Transdermal 17-beta estradiol increased IGF-1 levels (0.86 +/- 0.15 to 1.10 +/- 0.14 units/mL, P < 0.005).(12) In a clinical trial, somapacitan administered once weekly was compared to somatropin once daily injections in patients with and without oral estrogen replacement therapy. Patients with oral estrogen therapy were administered 2 mg/wk compared to 1 mg/wk for patients without estrogen replacement therapy. Observed doses after titration for somapacitan and somatropin were highest for females on oral estrogen.(13) An open-label, randomized crossover study in growth hormone deficient women compared oral estrogen with transdermal estrogen treatment while on growth hormone. Women received incremental doses of growth hormone (0.5, 1.0, 2.0 units/day for 1 week; increased to next dose each week) for 8 weeks and estradiol valerate (2 mg/day) or transdermal estrogen patches (Estraderm-TTS 100 mcg). IGF-1 levels were significantly reduced during oral estrogen treatment and rose dose-dependently during growth hormone administration by a lower magnitude compared with transdermal treatment (change in IGF-1: 109 +/-43% vs. 135 +/-41%).(14)
Contraindications
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- Acute respiratory failure
- Diabetic retinopathy
- Major traumatic injury
- Morbid obesity
- Sleep apnea
- Adrenocortical insufficiency
- Idiopathic intracranial hypertension
- Malignancy
- Pancreatitis
- Slipped capital epiphyses
- Snoring
- Untreated hypothyroidism
- Carpal tunnel syndrome
- Diabetes mellitus
- Edema
- Hypertension
- Progression of nevus
- Scoliosis
Adverse reactions
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Less Frequent
- Dyspnea
- Hypertension
- Hypothyroidism
- Increased alanine transaminase
- Increased aspartate transaminase
Rare or Very Rare
- Acute pancreatitis
- Adrenocortical insufficiency
- Anaphylaxis
- Angioedema
- Diabetic retinopathy
- Fracture
- Gastroenteritis
- Hyperglycemia
- Hyperparathyroidism
- Intracranial hypertension
- Leukemia
- Neoplasm
- Papilledema
- Pituitary insufficiency
- Retinal disorder
- Sleep apnea
- Slipped capital epiphyses
More Frequent
- Acute abdominal pain
- Arthralgia
- Carpal tunnel syndrome
- Edema
- Headache disorder
- Hematoma
- Injection site sequelae
- Lipodystrophy
- Muscle rigidity
- Myalgia
- Peripheral edema
Less Frequent
- Acne vulgaris
- Back pain
- Hypoesthesia
- Nausea
- Paresthesia
- Skin atrophy
- Upper respiratory infection
- Vomiting
Rare or Very Rare
- Abnormal glucose tolerance
- Acute bacterial otitis media
- Alopecia
- Body fluid retention
- Fatigue
- Fever
- Gynecomastia
- Hematuria
- Increased appetite
- Mood changes
- Pharyngitis
- Progression of nevus
- Skin rash
- Tonsillitis
- Type 2 diabetes mellitus
- Urinary tract infection
Precautions
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ICD codes
| Code | Type | Description |
|---|---|---|
| Adult growth hormone deficiency | ||
| E23.0 | ICD10CM | Hypopituitarism |
| E23.1 | ICD10CM | Drug-induced hypopituitarism |
| E89.3 | ICD10CM | Postprocedural hypopituitarism |
| Growth failure associated with turner's syndrome | ||
| Q96 | ICD10CM | Turner's syndrome |
| Q96.0 | ICD10CM | Karyotype 45, X |
| Q96.1 | ICD10CM | Karyotype 46, X iso (xq) |
| Q96.2 | ICD10CM | Karyotype 46, X with abnormal sex chromosome, except iso (xq) |
| Q96.3 | ICD10CM | Mosaicism, 45, x/46, XX or XY |
| Q96.4 | ICD10CM | Mosaicism, 45, x/other cell line(s) with abnormal sex chromosome |
| Q96.8 | ICD10CM | Other variants of turner's syndrome |
| Q96.9 | ICD10CM | Turner's syndrome, unspecified |
| R62.52 | ICD10CM | Short stature (child) |
| Growth failure in child with short stature homeobox-containing gene (SHOx) deficiency | ||
| Q87.1 | ICD10CM | Congenital malformation syndromes predominantly associated with short stature |
| Q87.19 | ICD10CM | Other congenital malformation syndromes predominantly associated with short stature |
| R62.52 | ICD10CM | Short stature (child) |
| Idiopathic short stature | ||
| R62.52 | ICD10CM | Short stature (child) |
| Pituitary dwarfism | ||
| E23.0 | ICD10CM | Hypopituitarism |
| Short stature in child born small for gestational age | ||
| R62.52 | ICD10CM | Short stature (child) |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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