Somapacitan-beco
Generic Name: somapacitan-beco
Brand Names:
Sogroya
11 DESCRIPTION Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.
Overview
11 DESCRIPTION Somapacitan-beco is a human growth hormone (hGH) analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. The albumin-binding moiety (side-chain) consists of an albumin binder and a hydrophilic spacer attached to position 101 of the protein. The protein part consists of 191 amino acids. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.
Uses
1 INDICATIONS AND USAGE SOGROYA is indicated for the: • Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH). • Replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION • SOGROYA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency ( 2.1 ). • SOGROYA should be administered by subcutaneous injection once weekly, any time of the day, in the upper arms, thigh, abdomen or buttocks with regular rotation of injection site to avoid lipohypertrophy/lipoatrophy ( 2.1 ). • See Full Prescribing Information for complete dosage, titration, and monitoring recommendations for pediatric and adult patients, including those aged 65 years and older, patients with hepatic impairment, and women receiving oral estrogen ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ).
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] • Severe hypersensitivity [see Warnings and Precautions ( 5.2 )] • Increased risk of neoplasms [see Warnings and Precautions ( 5.3 )] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions ( 5.5 )] • Fluid retention [see Warnings and Precautions ( 5.6 )] • Hypoadrenalism [see Warnings and Precautions ( 5.7 )] • Hypothyroidism [see Warnings and Precautions ( 5.8 )] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.9 )] • Progression of preexisting...
Interactions
7 DRUG INTERACTIONS Table 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them. Table 4. Clinically Important Drug Interactions with SOGROYA Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of SOGROYA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Warnings
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity: Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus: SOGROYA may decrease insulin sensitivity, particularly at higher doses. 4 CONTRAINDICATIONS SOGROYA is contraindicated in patients with: • Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity to SOGROYA or any of its excipients.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOGROYA (somapacitan-beco) injection is a clear to slightly opalescent and colorless to slightly yellow solution available as one 1.5 mL single-patient-use prefilled pen per carton: • SOGROYA 5 mg/1.5 mL (3.3 mg/mL) pen (teal) NDC 0169-2035-11 • SOGROYA 10 mg/1.5 mL (6.7 mg/mL) pen (yellow) NDC 0169-2030-11 • SOGROYA 15 mg/1.5 mL (10 mg/mL) pen (re...
Frequently Asked Questions
What is Somapacitan-beco used for?▼
1 INDICATIONS AND USAGE SOGROYA is indicated for the: • Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH). • Replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency ( 1 ).
What are the side effects of Somapacitan-beco?▼
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] • Severe hypersensitivity [see Warnings and Precautions ( 5.2 )] • Increased risk of neoplasms [see Warnings and Precautions ( 5.3 )] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions ( 5.5 )] • Fluid retention [see Warnings and Precautions ( 5.6 )] • Hypoadrenalism [see Warnings and Precautions ( 5.7 )] • Hypothyroidism [see Warnings and Precautions ( 5.8 )] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.9 )] • Progression of preexisting...
Can I take Somapacitan-beco during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week.
What are the important warnings for Somapacitan-beco?▼
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity: Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus: SOGROYA may decrease insulin sensitivity, particularly at higher doses. 4 CONTRAINDICATIONS SOGROYA is contraindicated in patients with: • Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity to SOGROYA or any of its excipients.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.