Corticotropin( Adrenocorticotropic hormone; ACTH )
HP Acthar Gel
- Injection, gel 80 units/mL
Stimulates adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances.
Rapidly disappears from the circulation following IV administration.
Plasma half-life is approximately 15 min.
Indications and Usage
As monotherapy for the treatment of infantile spasms in infants and children younger than 2 y; for the treatment of acute exacerbations of multiple sclerosis in adults; as adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), and/or ankylosing spondylitis; during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and/or systemic dermatomyositis (polymyositis); for the treatment of severe erythema multiforme and/or Stevens-Johnson syndrome; for the treatment of serum sickness; for the treatment of severe acute and chronic allergic inflammatory processes involving the eye and its adnexa, such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and/or anterior segment inflammation; for the treatment of symptomatic sarcoidosis; to induce a diuresis or remission of proteinuria in the nephritic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
Administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of repository corticotropin; adrenocortical insufficiency or adrenocortical hyperfunction; CHF; history or presence of peptic ulcer; infants in whom congenital infections are suspected; IV administration; ocular herpes simplex; osteoporosis; recent surgery; scleroderma; sensitivity to porcine proteins; systemic fungal infections; uncontrolled hypertension.
Dosage and AdministrationAll Approved Uses Except Multiple Sclerosis
Adults and children older than 2 y
IM/Subcutaneous 40 to 80 units every 24 to 72 h.Infantile Spasms
Infants and children younger than 2 y
IM 75 units/m 2 twice daily for 2 wk. Dosing should be gradually tapered over a 2-wk period to avoid adrenal insufficiency (eg, 30 units/m 2 in the morning for 3 days; 15 units/m 2 in the morning for 3 days; 10 units/m 2 in the morning for 3 days; 10 units/m 2 every other morning for 6 days).Multiple Sclerosis
IM/Subcutaneous 80 to 120 units/day for 2 to 3 wk.
- For IM or subcutaneous use only. IV use is contraindicated. For the treatment of infantile spasms, administer IM only.
- Dosage should be individualized. Frequency and dose should be determined by considering the severity of the disease and the initial response of the patient.
- Warm the gel to room temperature before using. Take caution not to overpressurize the vial prior to withdrawing the product.
- Sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms, which makes it difficult to stop therapy. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.
Store between 36° and 46°F.
Effects of these agents may be antagonized in myasthenia gravis. Monitor the clinical response and provide mechanical respiratory support if needed.Anticoagulants
The hypoprothrombinemic effect of anticoagulants may be altered unpredictably. Close clinical monitoring for signs of excessive hypoprothrombinemia or anticoagulant failure is warranted. If an interaction is suspected, adjust the anticoagulant dose as needed.Diuretic therapy (eg, thiazides [eg, hydrochlorothiazide])
Electrolyte loss associated with diuretic therapy may be accentuated. Monitor electrolytes and supplement if needed.Interleukin-2
The pharmacologic effects of interleukin-2 may be decreased. Avoid coadministration.Itraconazole
Corticotropin plasma concentrations and pharmacologic effects may be increased. The adrenal-suppressant effect of corticotropin may be enhanced. Close clinical monitoring is warranted.Mifepristone
Coadministration is contraindicated.Ritodrine
The risk of maternal pulmonary edema may be increased. If maternal pulmonary edema develops, ritodrine should be stopped.Vaccines
Coadministration of live or live attenuated vaccines is contraindicated. Killed or inactivated vaccines may be given; however, the response to such vaccines cannot be predicted because of possible neurologic complications or lack of response.
Hypertension (19%); cardiac hypertrophy (3%); CHF, necrotizing angiitis (postmarketing).
Irritability (19%); convulsions (12%); behavioral and mood changes; headache, intracranial hemorrhage, reversible brain shrinkage usually secondary to hypertension, subdural hematoma, vertigo (postmarketing).
Acne (14%); rash (8%); facial erythema, increased sweating, skin thinning (postmarketing).
Diarrhea (14%); constipation, increased appetite, vomiting (5%); decreased appetite (3%); abdominal distension, pancreatitis, ulcerative esophagitis (postmarketing).
Dizziness, nausea, shock (postmarketing).
Weight gain (3%); fluid and electrolyte disturbances; decreased carbohydrate tolerance, hypokalemic alkalosis (postmarketing).
Muscle weakness, vertebral compression fractures (postmarketing).
Infection (46%); cushingoid (22%); pyrexia (8%); nasal congestion (5%); glucose intolerance; hirsutism (postmarketing).
Monitor patients for hypothalamic-pituitary-axis (HPA) suppression (eg, weakness, hyperpigmentation, weight loss, abdominal pain) and Cushing syndrome (eg, deposition of adipose tissue in characteristic sites, cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, hypertension), especially with long-term use. Monitor bone density in patients on long-term therapy. Monitor patients 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. In patients with diabetes, monitor blood glucose frequently. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored. Observe patients with latent tuberculosis or tuberculin reactivity closely.
Category C . Corticotropin has been shown to have an embryocidal effect.
Undetermined. Per Briggs' Drugs in Pregnancy and Lactation , use during breast-feeding is probably compatible.
Effects on growth are of particular concern, especially on prolonged therapy.
May occur with prolonged administration.
Use with caution.
There is an enhanced effect in patients with cirrhosis of the liver.
Special Risk Patients
May mask symptoms of other disease/disorders without altering the course of the other diseases/disorders. Patients with a comorbid disease may have that disease worsened. Use with caution in patients with diabetes and/or myasthenia gravis. There is an enhanced effect in patients with hypothyroidism.
Decrease in bone formation and an increase in bone resorption may occur. These, together with a decrease in the protein matrix of the bone 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.
CNS effects, ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, to frank psychotic manifestations, may occur. Existing emotional instability or psychotic tendencies may be aggravated.
HPA suppression, adrenal insufficiency, and/or Cushing syndrome may occur.
May cause GI bleeding, gastric ulcer, and GI perforation. GI perforation 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.
Hypertension/Fluid and electrolyte balance
Elevated BP, salt and water retention, and increased potassium and calcium excretion may occur. Use with caution in patients with hypertension, CHF, or renal insufficiency.
Patients may develop antibodies to repository corticotropin after long-term administration and loss of endogenous ACTH and repository corticotropin activity.
May increase the risks related to infections with any pathogen.
Prolonged use may produce posterior subcapsular cataracts or glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.
None well documented.
- Inform caretakers of patients with infantile spasms of the availability of a Medication Guide and instruct them to read the Medication Guide prior to administration.
- Instruct patients to take repository corticotropin only as prescribed and not to stop treatment suddenly unless instructed by their health care provider to do so.
- Advise patients, their caregivers, and families of the importance of careful monitoring while taking repository corticotropin and during titration.
- Advise patients, their caregivers, and families that if the patient develops an infection or fever to contact their health care provider. They should be educated that a fever may not necessarily be present during an infection. Advise patients to try and limit contact with other people with infections to minimize the risk of infection.
- Advise patients, their caregivers, and families that if the patient experiences an increase in BP to contact their health care provider.
- Advise patients, their caregivers, and families that if the patient or caregiver notices blood or a change in the color of the patient's stool to contact their health care provider.
- Inform caregivers and families of infants and children that the patient may show signs of irritability and sleep disturbances. These effects are reversible once therapy is stopped.
- Advise patients, their caregivers, and families that changes in appetite, most often leading to weight gain, are seen with therapy, and become more frequent as the dose or treatment period increases. These effects are reversible once therapy is stopped.
- Advise patients, their caregivers, and families that the patient may be monitored for signs of adrenal insufficiency, such as weakness, fatigue, lethargy, anorexia, weight loss, hypotension, abdominal pain, or hyperpigmentation, after treatment is stopped. Because the recovery of the adrenal gland varies from days to months, patients may need to be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress.
- Advise patients not to be vaccinated with live or live attenuated vaccines during treatment. Additionally, other immunization procedures in patients of family members who will be in contact with the patients should be undertaken with caution.
- Advise patients, their caregivers, and families that prolonged use may result in Cushing syndrome and associated adverse reactions, may inhibit skeletal growth, and may cause osteoporosis and decreased bone density.
- Inform patients, their caregivers, and families that repository corticotropin may mask symptoms of other disease/disorders without alerting the course of the other disease/disorder. The patient will need to 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.
- In the treatment of infantile spasms, other types of seizures may occur because some patients with infantile spasms progress to other forms of seizures. Parents and caregivers should inform their health care provider of any new onset of seizures.
- Inform pregnant women and women of childbearing potential that corticotropin has been shown to have an embryocidal effect. Apprise women of the potential harm to the fetus.
- Instruct patients with diabetes to monitor blood glucose regularly throughout therapy because the dosage of insulin or oral hypoglycemic agent may need to be increased.
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