H.P. ACTHAR(repository corticotropin)injection(五)
t with H.P. Acthar Gel, but might be expected to occur. [see Adverse Reactions (6.3)].
5.1 Infections
H.P. Acthar Gel may increase the risks related to infections with any pathogen, including viral, bacterial fungal, protozoan or helminthic infections. Patients with latent tuberculosis or tuberculin reactivity should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted.
5.2 Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal
Treatment with H.P. Acthar Gel can cause hypothalamic-pituitary-axis (HPA) suppression and Cushing's syndrome. These conditions should be monitored especially with chronic use.
Suppression of the HPA may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Patients should be monitored for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing H.P. Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms [see Information for Patients (17)]
The recovery of the adrenal gland may take from days to months so patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids during the period of stress.
The adrenal insufficiency may be minimized in adults and infants by tapering of the dose when discontinuing treatment.
Signs or symptoms of Cushing's syndrome may occur during therapy but generally resolve after therapy is stopped. Patients should be monitored for these signs and symptoms such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.
5.3 Elevated Blood Pressure, Salt and Water Retention and Hypokalemia
H.P. Acthar Gel can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary. Caution should be used in the treatment of patients with hypertension, congestive heart failure, or renal insufficiency.
5.4 Vaccination
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P. Acthar Gel. Killed or inactivated vaccines may be administered; however, the response to such vaccines can not be predicted. Other immunization procedures should be undertaken with caution in patients who are receiving H.P. Acthar Gel, especially when high doses are administered, because of the possible hazards of neurological complications and lack of antibody response.
5.5 Masking Symptoms of Other Diseases
H.P. Acthar Gel often acts by masking symptoms of other diseases/disorders without altering the course of the other disease/disorder. Patients should be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weigh |
