es 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.
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 weight and fecal blood loss.
H.P. Acthar Gel can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked by the therapy. Use caution where there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.
Use of H.P. Acthar Gel may be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated.
Patients with a comorbid disease may have that disease worsened. Caution should be used when prescribing H.P. Acthar Gel in patients with diabetes and myasthenia gravis.
Prolonged use of H.P. Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.
H.P. Acthar Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to H.P. Acthar Gel after chronic administration and loss of endogenous ACTH and H.P. Acthar Gel activity. Prolonged administration of H.P. Acthar Gel may increase the risk of hypersensitivity reactions. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise.
There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.
Long-term use of H.P. Acthar Gel may have negative effects on growth and physical development in children. Changes in appetite are seen with H.P. Acthar Gel therapy, with the effects becoming more frequent as the dose or treatment period increases. These effects are reversible once H.P. Acthar Gel therapy is stopped. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored.
Decrease in bone formation and an increase in bone resorption both through an effect on calcium regulation (i.e. decreasing absorption and increasing excretion) and inhibition of osteoblast function may occur. These, together with a decrease in the protein matrix of the bone (secondary to an increase in protein catabolism) and reduced sex hormone production, may lead to inhibition of bone growth in children and adolescents and to the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteo |
