Somapacitan-Beco: uses, dosing, side effects & brands

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 scoliosis in pediatric patients [see Warnings and Precautions ( 5.10 )] • Pancreatitis [see Warnings and Precautions ( 5.11 )] • Lipohypertrophy/Lipoatrophy [see Warnings and Precautions ( 5.12 )] • Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions ( 5.13 )] • Common adverse reactions reported in pediatric patients treated with SOGROYA include: cough, diarrhea, ear infection, headache, injection site reaction, nasopharyngitis, pain in extremity, pyrexia, respiratory tract infection, and vomiting. ( 6.1 ) • Adult patients with GHD: Adverse reactions reported in >2% of…

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 )

Table 7 includes a list of drugs with clinically important drug interactions when administered concomitantly with SOGROYA and instructions for preventing or managing them. Table 7. 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. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA [see Warnings and Precautions ( 5.7 )]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that GH treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. SOGROYA may alter the clearance of compounds known to be metabolized by CP450 liver enzymes. Intervention: Careful monitoring is advisable when SOGROYA is administered in combination with drugs metabolized by CP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to SOGROYA. Intervention: Patients receiving oral estrogen replacement may require higher SOGROYA dosages [see Dosage and Administration (2.5 )] . Insulin and/or Other Hypoglycemic Agents Clinical Impact: Treatment with SOGROYA may decrease insulin sensitivity, particularly at higher doses. Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions ( 5.4 )]. • Replacement Glucocorticoid Treatment : Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA. ( 7 ) • Cytochrome P450-Metabolized Drugs : SOGROYA may alter the clearance. Monitor carefully if used with SOGROYA. ( 7 ) • Oral Estrogen : Larger doses of SOGROYA may be required. ( 7 ) • Insulin and/or Other Antihyperglycemic Agents : Dose adjustment of insulin or antihyperglycemic agent may be required. ( 5.4 , 7 )