Precautions

  1. General

    Corticotropin injection should be used in the lowest dose for the shortest period of time to accomplish the therapeutic goal. Corticotropin should be used for treatment only when the disease is intractable to non-steroid treatment.

    There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise.

    When an infection is present, appropriate antibiotic therapy should be given. Patients with latent tuberculosis should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted.

    Psychic symptoms may appear with use of corticotropin or preexisting symptoms may be enhanced. These may range from mood alteration to a psychotic state.

    Patients with a secondary disease may have that disease worsened. Caution should be used when prescribing corticotropin in patients with diabetes, renal insufficiency, diverticulitis, and myasthenia gravis.

    Corticotropin often acts by suppressing symptoms without altering the course of the underlying disease. Since complications with corticotropin use are dependent on the dose and duration of treatment, a risk/benefit decision must be made in each case.

    Suppression of the pituitary adrenal axis occurs following prolonged therapy which may be slow in returning to normal. Patients should be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress.

    Since maximal corticotropin stimulation of the adrenals may be limited during the first few days of treatment, other drugs should be administered when an immediate therapeutic effect is desirable.

    Although controlled clinical trials have shown ACTH to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that it affects the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of ACTH are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION section).

    Treatment of acute gouty arthritis should be limited to a few days. Since rebound attacks may occur when corticotropin is discontinued, conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.

    Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.

  2. Drug Interactions

    Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.

  3. Carcinogenesis, Mutagenesis, Impairment of Fertility

    Adequate and well-controlled studies have not been done in animals. Human use has not been associated with an increase in malignant disease. See Pregnancy warning below.

  4. Pregnancy

    Pregnancy Class C: Corticotropin has been shown to have an embryocidal effect. There are no adequate and well-controlled studies in pregnant women. Corticotropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  5. Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from corticotropin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

  6. Pediatric Use

    Prolonged use of corticotropin in children will inhibit skeletal growth. If use is necessary, it should be given intermittently and the child carefully observed.