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Drug overview for NGENLA (somatrogon-ghla):
Generic name: somatrogon-ghla (soe-MA-troe-gon)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Somatrogon-ghla is a human growth hormone analog.
No enhanced Uses information available for this drug.
Generic name: somatrogon-ghla (soe-MA-troe-gon)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Somatrogon-ghla is a human growth hormone analog.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for NGENLA (somatrogon-ghla) have been approved by the FDA:
Indications:
Pituitary dwarfism
Professional Synonyms:
GH deficiency dwarfism
Growth failure due to isolated growth hormone deficiency
Growth failure due to isolated somatotropin deficiency
Hypophysial dwarfism
Lorain-Levi dwarfism
Lorain-Levi infantilism
Lorain-Levi syndrome
Pituitary infantilism
Indications:
Pituitary dwarfism
Professional Synonyms:
GH deficiency dwarfism
Growth failure due to isolated growth hormone deficiency
Growth failure due to isolated somatotropin deficiency
Hypophysial dwarfism
Lorain-Levi dwarfism
Lorain-Levi infantilism
Lorain-Levi syndrome
Pituitary infantilism
The following dosing information is available for NGENLA (somatrogon-ghla):
No enhanced Dosing information available for this drug.
Administer somatrogon-ghla by subcutaneous injection once weekly, on the same day each week, at any time of day. Administer the dose in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site each week, and use a new needle with each injection.
If more than 1 injection is required to administer a complete dose, administer each injection at a different injection site. Somatrogon-ghla treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients >=3 years of age with growth failure due to growth hormone deficiency (GHD). The day that somatrogon-ghla is administered each week can be changed as long as there are >=3 days between 2 doses.
Once a new day is chosen, continue the once weekly dosing. In patients being switched from daily growth hormone, once-weekly somatrogon-ghla may be initiated on the day after their last daily injection. If a dose is missed, administer somatrogon-ghla as soon as possible within 3 days after the missed dose.
If >3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. Somatrogon-ghla injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as a single-patient-use disposable prefilled pen containing 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2
mL (50 mg/mL). The 24 mg/1.2 mL prefilled pen delivers a dose in 0.2
mg increments, and the 60 mg/1.2 mL prefilled pen delivers a dose in 0.5 mg increments.
Inspect the solution visually for particulate matter and discoloration prior to administration. If flakes, particles, or discoloration are observed, do not use the pen. Before first use, store somatrogon-ghla at 2-8oC in the original carton to protect from light.
Once opened (after first use), store at 2-8oC between each use, for up to 28 days. Do not freeze or shake; do not use if somatrogon-ghla has been frozen. Do not expose to heat; store away from direct sunlight.
Always remove and safely discard the needle after each injection, and store the prefilled pen without an injection needle attached. Replace the cap on the prefilled pen when it is not in use. Do not use the prefilled pen more than 28 days after first use.
If more than 1 injection is required to administer a complete dose, administer each injection at a different injection site. Somatrogon-ghla treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients >=3 years of age with growth failure due to growth hormone deficiency (GHD). The day that somatrogon-ghla is administered each week can be changed as long as there are >=3 days between 2 doses.
Once a new day is chosen, continue the once weekly dosing. In patients being switched from daily growth hormone, once-weekly somatrogon-ghla may be initiated on the day after their last daily injection. If a dose is missed, administer somatrogon-ghla as soon as possible within 3 days after the missed dose.
If >3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. Somatrogon-ghla injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as a single-patient-use disposable prefilled pen containing 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2
mL (50 mg/mL). The 24 mg/1.2 mL prefilled pen delivers a dose in 0.2
mg increments, and the 60 mg/1.2 mL prefilled pen delivers a dose in 0.5 mg increments.
Inspect the solution visually for particulate matter and discoloration prior to administration. If flakes, particles, or discoloration are observed, do not use the pen. Before first use, store somatrogon-ghla at 2-8oC in the original carton to protect from light.
Once opened (after first use), store at 2-8oC between each use, for up to 28 days. Do not freeze or shake; do not use if somatrogon-ghla has been frozen. Do not expose to heat; store away from direct sunlight.
Always remove and safely discard the needle after each injection, and store the prefilled pen without an injection needle attached. Replace the cap on the prefilled pen when it is not in use. Do not use the prefilled pen more than 28 days after first use.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for NGENLA (somatrogon-ghla):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Selected Retinoids (Systemic)/Growth Hormone SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. 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) |
ABSORICA, ABSORICA LD, ACCUTANE, ACITRETIN, AMNESTEEM, CLARAVIS, ISOTRETINOIN, RETINOIC ACID, TRETINOIN, TRETINOIN ACID, ZENATANE |
There are 0 moderate interactions.
The following contraindication information is available for NGENLA (somatrogon-ghla):
Drug contraindication overview.
*Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure due to risk of increased mortality with somatropin. *Hypersensitivity to somatrogon-ghla or any excipient in the product. *Closed epiphyses.
*Active malignancy. *Active proliferative or severe non-proliferative diabetic retinopathy. *Prader-Willi syndrome in patients who are severely obese or have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death.
*Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure due to risk of increased mortality with somatropin. *Hypersensitivity to somatrogon-ghla or any excipient in the product. *Closed epiphyses.
*Active malignancy. *Active proliferative or severe non-proliferative diabetic retinopathy. *Prader-Willi syndrome in patients who are severely obese or have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Acute respiratory failure |
| Diabetic retinopathy |
| Invasive surgical procedure |
| Major traumatic injury |
| Morbid obesity |
| Sleep apnea |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Intracranial hypertension |
| Malignancy |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Adrenocortical insufficiency |
| Diabetes mellitus |
| Edema |
| Hypothyroidism |
| Scoliosis |
| Slipped capital epiphyses |
The following adverse reaction information is available for NGENLA (somatrogon-ghla):
Adverse reaction overview.
Adverse effects reported in >=5% of patients receiving somatrogon-ghla include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain.
Adverse effects reported in >=5% of patients receiving somatrogon-ghla include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Anaphylaxis Angioedema Intracranial hypertension Malignancy Pancreatitis |
| Rare/Very Rare |
|---|
| None. |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anemia Cough Fever Headache disorder Hypothyroidism Injection site sequelae Pain in oropharynx Skin rash Vomiting |
Adrenocortical insufficiency Body fluid retention Bronchitis Eosinophilia Slipped capital epiphyses Tonsillitis |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for NGENLA (somatrogon-ghla):
The safety and efficacy of somatrogon-ghla are established for the treatment of growth failure due to inadequate endogenous growth hormone secretion in pediatric patients >=3 years of age. The use of somatrogon-ghla for this indication is supported by evidence from a randomized, open-label, 52-week study involving 224 prepubertal pediatric patients with GHD who had not received prior treatment. The risks of growth hormone use in pediatric patients include an increased risk of second neoplasm in cancer survivors with previous radiation treatment to the brain and/or head, slipped capital femoral epiphysis, progression of preexisting scoliosis, pancreatitis, and sudden death in patients with Prader-Willi Syndrome. Somatrogon-ghla is not indicated for use in pediatric patients with growth failure secondary to Prader-Willi syndrome.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No data are available on the use of somatrogon-ghla in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity with subcutaneous administration of somatrogon-ghla during the period of organogenesis at doses up to 45 times the maximum recommended human dose based on exposure.
No data are available on the presence of somatrogon-ghla in human or animal milk. The effects of somatrogon-ghla on the breast-fed infant or on milk production are also unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for somatrogon-ghla and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Somatrogon-ghla has not been studied in geriatric patients.
The following prioritized warning is available for NGENLA (somatrogon-ghla):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NGENLA (somatrogon-ghla)'s list of indications:
| Pituitary dwarfism | |
| E23.0 | Hypopituitarism |
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