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Ngenla (somatrogon-ghla)
somatrogon
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: INJ (pen): 24 mg per 1.2 mL, 60 mg per 1.2 mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = somatrogon-ghla
- [strength clarification]
- Info: 24 mg per 1.2 mL pen delivers up to 12 mg/dose in 0.2 mg increments; 60 mg per 1.2 mL pen delivers up to 30 mg/dose in 0.5 mg increments
growth hormone deficiency
- [3 yo and older]
- Dose: 0.66 mg/kg/dose SC qwk; Info: adjust dose based on clinical response; D/C when pt reaches satisfactory ht, epiphyses close, or no response
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- malignancy, active
- illness, acute critical
- respiratory failure, acute
- diabetic retinopathy
- papilledema
- epiphysis, closed
- obesity, severe (pts w/ Prader-Willi syndrome)
- respiratory impairment, severe (pts w/ Prader-Willi syndrome)
- upper airway obstruction (pts w/ Prader-Willi syndrome)
- sleep apnea (pts w/ Prader-Willi syndrome)
- respiratory infection (pts w/ Prader-Willi syndrome)
- caution: intracranial neoplasm hx
- caution: craniospinal XRT hx
- caution: malignancy risk
- caution: hypopituitarism risk
- caution: hypoadrenalism
- caution: hypothyroidism
- caution: prediabetes
- caution: diabetes mellitus
- caution: obesity
- caution: scoliosis
Drug Interactions .
Overview
somatrogon
growth hormone agonist
- 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor
- affects growth hormone diagnostic test results
- hyperglycemic effects
- pseudotumor cerebri
- caution advised w/ drugs metabolized by CYP450 liver enzymes; growth hormone may incr. CYP450 metabolic function, decr. levels of concomitant drugs, efficacy
Avoid/Use Alternative
- macimorelin
- tretinoin
Monitor/Modify Tx
- acarbose
- alogliptin
- betamethasone
- bexagliflozin
- bromocriptine
- budesonide
- canagliflozin
- colesevelam
- cortisone
- cyclosporine
- cysteamine
- dapagliflozin
- deflazacort
- demeclocycline
- dexamethasone
- doxycycline
- dulaglutide
- empagliflozin
- eravacycline
- ertugliflozin
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- exenatide
- fludrocortisone
- glimepiride
- glipizide
- glyburide
- goserelin
- insulin
- linagliptin
- liraglutide
- metformin
- methylprednisolone
- miglitol
- minocycline
- nateglinide
- omadacycline
- palovarotene
- pioglitazone
- pramlintide
- prednisolone
- prednisone
- repaglinide
- rosiglitazone
- sarecycline
- saxagliptin
- semaglutide
- sitagliptin
- tetracycline
- tigecycline
- tirzepatide
- triamcinolone
Caution Advised
- hydrocortisone
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- secondary neoplasm
- diabetes mellitus
- intracranial HTN
- hypothyroidism unmasked
- hypoadrenalism unmasked
- pancreatitis
- scoliosis progression
- slipped capital femoral epiphysis
- sudden death (Prader-Willi pts)
Common Reactions
- injection site rxn
- nasopharyngitis
- eosinophilia
- headache
- fever
- anemia
- cough
- vomiting
- hypothyroidism
- abdominal pain
- rash
- oropharyngeal pain
- arthralgia
- otitis media
- tonsillitis
- bronchitis
- fluid retention
- injection site lipoatrophy
- hyperphosphatemia
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
glucose, esp. if diabetes or diabetes risk; TFTs; fundoscopic exam at baseline, then periodically; dermatologic exams; cortisol if hypoadrenalism
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of teratogenicity based on animal data at 45x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: proteolytic degradation; CYP450: unknown
Excretion: unknown; Half-life:37.7h
Subclass: Growth Hormones/Agonists
Mechanism of Action
binds to growth hormone receptor, stimulating multiple growth, anabolic, and anti-catabolic effects (growth hormone analog)
Formulary .
No Formulary Selected
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