o room temperature before using.
Caution should be taken not to over-pressurize the vial prior to withdrawing the product.
5 mL multi-dose vial containing 80 USP Units per mL.
H.P. Acthar Gel is contraindicated for intravenous administration.
H.P. Acthar Gel is contraindicated where congenital infections are suspected in infants.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P Acthar Gel.
H.P. Acthar Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origin.
The adverse effects of H.P. Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with H.P. Acthar Gel, but might be expected to occur. [see Adverse Reactins (6.3)].
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.
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.
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.
Administration of live or live attenuated vaccin |
