Somapacitan-beco Disease Interactions

Somapacitan 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 this drug.

Somapacitan may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving treatment, especially in patients with existing diabetes mellitus or at risk for its development. Somapacitan is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Somapacitan is contraindicated in patients with active malignancies. There is an increased risk of neoplasm when using this drug. Monitor closely patients with preexisting tumors for progression or recurrence. There is an 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. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies, so thoroughly consider the risks and benefits of starting somapacitan in these patients. If treatment is initiated, carefully monitor these patients for development of neoplasms. There is risk of malignant changes of preexisting nevi with somatropin treatment. Monitor patients on 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.

The use of somapacitan is contraindicated in 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.

Patients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of treatment with somapacitan. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases.

Undiagnosed or untreated hypothyroidism may prevent an optimal response to somapacitan treatment. In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with somatropin therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

Somapacitan is not recommended in patients with severe hepatic impairment.

Somapacitan increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Monitor patients with a history of scoliosis for disease progression.