Sogroya
(Somapacitan-Beco)Sogroya Prescribing Information
Warnings and Precautions, Slipped Capital Femoral Epiphysis in Pediatric Patients
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 clear to slightly opalescent and colorless to slightly yellow solution available as follows:
• Injection: 5 mg/1.5 mL (3.3 mg/mL) in a single-patient-use prefilled pen (teal)• Injection: 10 mg/1.5 mL (6.7 mg/mL) in a single-patient-use prefilled pen (yellow)• Injection: 15 mg/1.5 mL (10 mg/mL) in a single-patient-use prefilled pen (red)
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 Increased Mortality in Patients with Acute Critical IllnessIncreased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery and multiple accidental trauma, as well as patients with acute respiratory failure
[see Contraindications ]. The safety of continuing SOGROYA treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. SOGROYA is not indicated for the treatment of non-GH deficient adults.• Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin[see Warnings and Precautions (.)]5.2 Severe HypersensitivitySerious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs. SOGROYA is contraindicated in patients with known hypersensitivity to somatropin or any excipients in SOGROYA
[see Contraindications ].• Pediatric patients with closed epiphyses.• Active malignancy[see Warnings and Precautions ()].5.3 Increased Risk of NeoplasmsActive MalignancyThere is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy
[see Contraindications ]. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting therapy with SOGROYA. Discontinue SOGROYA if there is evidence of recurrent activity.Risk of Second Neoplasm in Pediatric PatientsIn childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency (GHD) and were treated with somatropin, an increased risk of second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor.
New Malignancy During TreatmentBecause children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting SOGROYA in these patients. If treatment with SOGROYA is initiated, carefully monitor these patients for development of neoplasms.
There is risk of malignant changes of preexisting nevi with somatropin treatment in patients. Monitor patients on SOGROYA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in the appearance of preexisting nevi
.• 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 Sudden Death in Pediatric Patients with Prader-Willi SyndromeThere have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. SOGROYA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.