SOGROYA may inhibit 11βHSD-1 and reduce serum cortisol concentrations, potentially requiring increased glucocorticoid maintenance or stress doses.
Source: NLP:somapacitan-beco
Somapacitan-Beco Interactions
Brand names: Sogroya
Route: Subcutaneous
Contraindications
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. Systemic hypersensitivity reactions have been reported postmarketing with somatropin [see Warnings and Precautions ( 5.2 )] . • Pediatric patients with closed epiphyses. • Active malignancy [see Warnings and Precautions ( 5.3 )]. • Active proliferative or severe non-proliferative diabetic retinopathy. • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death [see Warnings and Precautions ( 5.13 )] . • Acute critical illness ( 4 ) • Active malignancy ( 4 ) • Hypersensitivity to somapacitan-beco or excipients ( 4 ) • Active proliferative or severe non-proliferative diabetic retinopathy ( 4 ) • Closed epiphyses in children used for longitudinal growth promotion ( 4 ) • Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment due to risk of sudden death ( 4 )
Pregnancy & Breastfeeding
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. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data) . The background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in rats, somapacitan-beco was administered by subcutaneous injection at doses of 2, 6, and 18 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Fetal viability and development were not affected at doses up to 6 mg/kg/day (31 times the MRHD, based on AUC). Transient, fetal skeletal variations (short/bent/thickened long bones) were observed at 18 mg/kg/day (261 times the MRHD, based on AUC). In an embryo-fetal development study in rabbits, somapacitan-beco was administered by subcutaneous injection at doses of 1, 3, and 9 mg/kg every two days during the period of organogenesis from gestation day 6 to 18. Fetal viability and development were not adversely affected at somapacitan-beco dose of 1 mg/kg/every two days (12 times the MRHD, based on AUC). Reduced fetal growth was observed at
4 interactions on record
Somapacitan-Beco + EstrogensModerate
Oral estrogens may reduce the serum IGF-1 response to SOGROYA, potentially requiring higher SOGROYA dosages.
Source: NLP:somapacitan-beco
Somapacitan-Beco + Insulin HumanModerate
SOGROYA may decrease insulin sensitivity, particularly at higher doses, requiring adjustment of insulin doses in diabetic patients.
Source: NLP:somapacitan-beco
Somapacitan-Beco + PrednisoneModerate
SOGROYA may inhibit 11βHSD-1 and reduce serum cortisol concentrations, potentially requiring increased glucocorticoid maintenance or stress doses.
Source: NLP:somapacitan-beco