Is HGH ever medically indicated?

1.

Food and Drug Administration (DailyMed).

Publish date: May 4, 2024.

Indications And Usage 1 INDICATIONS AND USAGE ZOMACTON (somatropin) 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 ) 1.1 Pediatric Patients ZOMACTON (somatropin) 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. 1.2 Adult Patients ZOMACTON (somatropin) is indicated for the replacement of endogenous GH in adults with GH deficiency.

2.

Food and Drug Administration (DailyMed).

Publish date: December 5, 2023.

Indications And Usage 1 INDICATIONS AND USAGE HUMATROPE (somatropin) is a recombinant human growth hormone indicated for: Pediatric Patients: 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. ( 1.1 ) Adult Patients: replacement of endogenous GH in adults with GH deficiency. ( 1.2 ) 1.1 Pediatric Patients HUMATROPE (somatropin) 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. 1.2 Adult Patients HUMATROPE (somatropin) is indicated for the replacement of endogenous GH in adults with GH deficiency.

3.

Food and Drug Administration (DailyMed).

Publish date: March 1, 2020.

Indications And Usage 1 INDICATIONS AND USAGE Norditropin (somatropin) 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 Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients Norditropin (somatropin) is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • 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, • growth failure due to Prader-Willi syndrome (PWS). 1.2 Adult Patients Norditropin (somatropin) is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)

4.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 4, 2024.

Indications And Dosage 1. AIDS-associated wasting syndrome 2. cachexia 3. growth failure 4. growth hormone deficiency 5. HIV-associated lipodystrophy 6. Noonan syndrome 7. Prader-Willi syndrome 8. SHOX (short stature homeobox-containing gene) deficiency 9. Turner syndrome

Description Genotropin is a purified recombinant growth hormone prepared by using either Escherichia coli or mammalian-cells. Endogenous human growth hormone (hGH) is produced in the pituitary gland. Somatropin is approved for treating growth hormone deficiency (GHD), growth failure, or short stature. Several somatropin products are available for growth-related indications, all with varying dosage regimens. Care should be taken in product selection as products may not be considered interchangeable. One product (Serostim) is solely approved for treating cachexia and AIDS wasting in adults. Somatropin (Serostim) has been studied in the treatment of HIV-associated lipodystrophy; limited data indicate use may decrease visceral adipose tissue, but this is still not an FDA-approved use. One product (Zorbtive) was approved to treat adults with short bowel syndrome, but is no longer marketed. Somatropin was originally approved by the FDA in 1987.

Indications And Dosage * The response to somatropin therapy in pediatric patients tends to decline with time. However, the failure to increase growth rate, especially during the first year of therapy, necessitates close assessment of compliance and evaluation for underlying causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone. * In general, the diagnosis of both adult or childhood onset growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test. Stimulation testing may not be necessary in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease. * Clinical response, side effects, and age- and gender-adjusted serum IGF-I levels may be used to guide dose titration. This approach will tend to result in larger doses for women compared to men, smaller doses for adult-onset GHD patients compared with childhood-onset GHD patients, and smaller doses for elderly and obese patients. * Patients with childhood onset growth hormone deficiency whose epiphyses are closed should be reevaluated before continuation of somatropin therapy.

5.

Patterson, Briana C., Felner, Eric I. (2025). In Nelson Textbook of Pediatrics (pp. 3364). DOI: 10.1016/B978-0-323-88305-4.00595-2

Although well-established treatments are available to replace the classical anterior pituitary hormone deficiencies, treatment must take into account patient age, pubertal maturation, and patient goals. Lifelong attention to correct administration of hormone replacement and monitoring for comorbidities are needed to optimize patient outcomes. Recombinant human GH (rhGH) has been available by prescription since the 1980s. Multiple brands are marketed in the United States, which are therapeutically equivalent, with the major differences consisting of proprietary devices for subcutaneous injection and availability of solubilized liquid forms versus powders needing reconstitution before injection. Long-acting forms are under development and will need to demonstrate comparable efficacy, safety, and tolerability to the daily injections currently available. The U.S. Food and Drug Administration (FDA) has approved eight pediatric indications for rhGH treatment to promote linear growth. They are GHD, Turner syndrome, chronic renalfailure before transplantation, idiopathic short stature, small-for-gestational-age short stature, Prader-Willi syndrome,SHOXgene abnormality, and Noonan syndrome. In the United States, FDA approval for a given indication does not ensure that a patient’s insurance carrier will approve payment for the drug. Treatment should be started as soon as possible to narrow the gap in height between patients and their classmates during childhood and to have the greatest effect on mature height. For some infants with MPHD, initiation of rhGH treatment may be urgent to reduce the frequency and severity of episodes of hypoglycemia. The recommended initial dose of rhGH for treatment of GHD is 0.16-0.24 mg/kg/wk (22-35 μg/kg/day). Higher doses have been used during puberty and for non-GHD indications. Most currently available forms of rhGH are administered subcutaneously once daily, but a weekly preparation has been recently FDA approved for use in the United States. Maximal response to rhGH occurs in the first year of treatment. Growth velocity during this first year is typically above the 95th percentile for age. With each successive year of treatment, the growth rate tends to decrease until it approximates a typical height velocity for skeletal age.

6.

Elsevier ClinicalKey Clinical Overview

Treatment Somatropin Indicated in patients with growth failure Short stature and various skeletal anomalies associated with Turner syndrome are in part caused by haploinsufficiency of SHOX gene located on the X chromosome at locus Xp22.33 ( OMIM #312865 Rarely, patients will have concomitant hGH deficiency, as evidenced by lack of hGH secretion following provocative testing; however, in patients with Turner syndrome, the hGH–insulinlike growth factor binding protein axis is disturbed Leads to greater final adult stature, decrease in central obesity, improved glucose tolerance, and increase in lean body mass Optimal timing not established Treatment is initiated and managed by endocrinologist as soon as growth failure is detected (apparent with decreasing height percentiles on reference growth curve) Continue treatment with somatropin until growth plates have fused and little growth potential remains, usually at bone age of 14 years or older, or growth velocity less than 2 cm/year FDA-approved dose Dose is adjusted based on growth response and insulinlike growth factor 1 levels Note: Several formulations are available with varying doses Subcutaneous dosage (Genotropin or Omnitrope) Somatropin (Recombinant rhGH) Solution for injection; Children: 0.33 mg/kg subcutaneously per week divided into equal doses given 6 or 7 times/week. Oxandrolone A synthetic anabolic steroid can be added as an adjunct to somatropin treatment in patients aged 8 years and older; result is an additional modest increase in final height. Indicated for patients who are severely short for age, in whom very short adult stature is anticipated, or in whom the growth rate is modest despite good compliance with somatropin treatment. Dose is managed and adjusted by an endocrinologist; optimal timing and duration of therapy is unavailable. Typical dosing