Introduction
Sogroya (somapacitan-beco) is a long-acting recombinant human growth hormone (GH) analog approved by the FDA in 2020. It represents a significant advancement in growth hormone therapy, offering once-weekly subcutaneous administration compared to traditional daily growth hormone injections. Sogroya is manufactured by Novo Nordisk and is designed to improve treatment adherence and quality of life for patients requiring growth hormone replacement therapy.
Mechanism of Action
Sogroya works through the same mechanism as endogenous human growth hormone. It binds to growth hormone receptors, stimulating the production of insulin-like growth factor 1 (IGF-1) in the liver and other tissues. The unique molecular structure of somapacitan-beco includes albumin-binding properties that prolong its circulation time, allowing for reduced dosing frequency. The drug promotes linear growth in children and has metabolic effects in adults, including protein synthesis, lipolysis, and carbohydrate metabolism.
Indications
Sogroya is FDA-approved for:
- Growth hormone deficiency in adults
- Pediatric growth hormone deficiency
Dosage and Administration
Adults: Starting dose 2 mg subcutaneously once weekly; titrate based on clinical response and IGF-1 levels (maximum 8 mg weekly) Pediatrics: Starting dose 0.16 mg/kg subcutaneously once weekly; adjust based on growth response Administration:- Administer subcutaneously in the abdomen, thigh, or upper arm
- Rotate injection sites to prevent lipoatrophy
- May be administered at any time of day
- Missed dose: Administer as soon as possible, then resume regular weekly schedule
- Renal impairment: No dosage adjustment necessary
- Hepatic impairment: Use with caution; monitor IGF-1 levels closely
- Elderly: No specific dosage recommendations
Pharmacokinetics
Absorption: Bioavailability approximately 76% following subcutaneous administration Distribution: Binds to albumin in circulation; volume of distribution ~10.3 L Metabolism: Hepatic metabolism via proteolytic pathways Elimination: Half-life approximately 34-38 hours; primarily renal elimination Time to peak concentration: 6-8 hours post-doseContraindications
- Active malignancy
- Hypersensitivity to somapacitan-beco or any component
- Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure
- Pediatric patients with closed epiphyses
- Diabetic retinopathy
Warnings and Precautions
Boxed Warning: Increased mortality in patients with acute critical illness- Neoplasms: Monitor patients with history of malignancy
- Glucose intolerance: May cause insulin resistance; monitor blood glucose
- Intracranial hypertension: Monitor for visual changes, headache, and nausea
- Fluid retention: May occur, particularly during initiation
- Hypothyroidism: May exacerbate or unmask hypothyroidism
- Pancreatitis: Use with caution in patients at risk
- Lipoatrophy: Rotate injection sites to prevent
Drug Interactions
- Glucocorticoids: May inhibit growth promotion
- Cytochrome P450 substrates: Theoretical potential for interactions
- Oral estrogen: May reduce IGF-1 response
- Insulin and oral hypoglycemics: May require dosage adjustment
Adverse Effects
Common (≥5%):- Injection site reactions
- Headache
- Arthralgia
- Edema
- Nausea
- Fatigue
- Intracranial hypertension
- Hypersensitivity reactions
- Glucose intolerance
- Pancreatitis
- Slipped capital femoral epiphysis
Monitoring Parameters
- Height and growth velocity (pediatrics)
- IGF-1 levels (target mid-normal range for age)
- Blood glucose and HbA1c
- Thyroid function tests
- Fundoscopic examinations
- Adverse effects assessment
- Injection site evaluation
Patient Education
- Proper injection technique and site rotation
- Importance of adherence to weekly schedule
- Recognition and reporting of adverse effects
- Storage requirements (refrigerate at 2-8°C; may be kept at room temperature for up to 6 days)
- Never share injection devices
- Regular follow-up with healthcare provider
- Importance of maintaining healthy lifestyle
References
1. FDA Prescribing Information: Sogroya (somapacitan-beco) injection. 2020 2. Johannsson G, et al. Once-weekly somapacitan vs daily GH in children with GH deficiency: results from a randomized phase 2 trial. J Clin Endocrinol Metab. 2020 3. Hare KJ, et al. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in adults with GH deficiency: a randomized dose-finding study. J Clin Endocrinol Metab. 2021 4. American Association of Clinical Endocrinologists Growth Hormone Task Force. Medical guidelines for clinical practice for growth hormone use in adults and children. Endocr Pract. 2020 5. Novo Nordisk. Sogroya clinical trial data. 2022