H.P. ACTHAR(repository corticotropin)injection(六)
t and fecal blood loss.
5.6 Gastrointestinal Perforation and Bleeding
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.
5.7 Behavioral and Mood Disturbances
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.
5.8 Comorbid Diseases
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.
5.9 Ophthalmic Effects
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.
5.10 Immunogenicity Potential
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.
5.11 Use in Patients with Hypothyroidism or Liver Cirrhosis
There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.
5.12 Negative Effects on Growth and Physical Development
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.
5.13 Decrease in Bone Density
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 osteoporosis (i.e., postmenopausal women) before initiating therapy, and bone density should be monitored in patients on long term therapy.
5.14 Use in Pregnancy
H.P. Acthar Gel has been shown to have an embryocidal effect. Apprise women of potential harm to the fetus. [see Use in Specific Populations (8.1)]
6 ADVERSE REACTIONS
Please refer to Adverse Reactions in Infants and Children Under 2 Years of Age (Section 6.1.1) for consideration when treat |
