Norditropin FlexPro Disease Interactions

Somatropin is contraindicated in the presence of any active malignancy. Any preexistent malignancy should be inactive and its treatment should be completed prior to somatropin therapy. This includes the presence of any intracranial tumor. Somatropin should be discontinued if there is any evidence of recurrence.

Treatment with somatropin is contraindicated in patients with acute critical illness due to any complications following open heart surgery, abdominal surgery, multiple trauma, or acute respiratory failure. Patients with these conditions have an increased risk of mortality.

Somatropin is contraindicated in patients with active proliferative or severe non- proliferative diabetic retinopathy.

Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients.

The use of growth hormone has been associated with resistance to insulin. Patients with diabetes mellitus or impaired glucose tolerance should be observed closely during therapy. The dose of antihyperglycemic drugs (insulin or oral/injectable agents) may require adjustment.

The use of growth hormone has been associated with the development of hypothyroidism. Patients should be monitored baseline and periodically for adequate thyroid function. Inadequate treatment of hypothyroidism may inhibit the optimal response to growth hormone.

Intracranial hypertension with papilledema, visual changes, nausea and/or vomiting has been reported in a small number of patients treated with somatropin. Fundoscopic examination should be performed before treatment initiation to exclude preexisting papilledema, and should be continued periodically during treatment. If papilledema is observed during treatment, therapy should be stopped. Treatment could be restarted at a lower dose once intracranial hypertension has been resolved. Patients with Turner Syndrome might be at increased risk of developing intracranial hypertension.

Progression of scoliosis can occur in patients who experience rapid growth. Since somatropin increases growth rate, children with a history of scoliosis should be monitored for progression of this condition. Physicians should be alert for this skeletal abnormality which can be commonly seen in patients with Turner and Prader-Willi syndromes, and can manifest during somatropin treatment.

Somatropin may increase the risk of otitis media in patients with Turner syndrome. These patients should be evaluated carefully for otitis media and other ear disorders as they have an increased risk of ear and hearing disorders.