Drug Interactions between somapacitan-beco and troleandomycin

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.

Troleandomycin is primarily excreted by the liver and may accumulate in patients with impaired hepatic function. In addition, the use of troleandomycin has been associated with an allergic type of cholestatic hepatitis, particularly in patients receiving the drug for more than 2 weeks or given repeated courses. Therapy with troleandomycin should be administered cautiously in patients with liver and/or biliary disease. Liver function tests should be monitored during prolonged or repeated courses of therapy, and the drug discontinued if abnormalities develop.

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.

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.

Clostridioides difficile-associated diarrhea (CDAD), formerly pseudomembranous colitis, has been reported with almost all antibacterial drugs and may range from mild diarrhea to fatal colitis. The most common culprits include clindamycin and lincomycin. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C difficile, whose toxins A and B contribute to CDAD development. Morbidity and mortality are increased with hypertoxin-producing strains of C difficile; these infections can be resistant to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea after antibacterial use. Since CDAD has been reported to occur more than 2 months after antibacterial use, careful medical history is necessary. Therapy with broad-spectrum antibacterials and other agents with significant antibacterial activity should be administered cautiously in patients with history of gastrointestinal disease, particularly colitis; pseudomembranous colitis (generally characterized by severe, persistent diarrhea and severe abdominal cramps, and sometimes associated with the passage of blood and mucus), if it occurs, may be more severe in these patients and may be associated with flares in underlying disease activity. Antibacterial drugs not directed against C difficile may need to be stopped if CDAD is suspected or confirmed. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and surgical evaluation should be started as clinically indicated.

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 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 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.

Troleandomycin is primarily excreted by the liver and may accumulate in patients with impaired hepatic function. In addition, the use of troleandomycin has been associated with an allergic type of cholestatic hepatitis, particularly in patients receiving the drug for more than 2 weeks or given repeated courses. Therapy with troleandomycin should be administered cautiously in patients with liver and/or biliary disease. Liver function tests should be monitored during prolonged or repeated courses of therapy, and the drug discontinued if abnormalities develop.

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.

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.

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.

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 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.

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.