ANI Pharmaceuticals, Inc. announced FDA approval of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format.
This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network.
The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials. For full indications and important safety information, please see below.
“Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment. This approval reflects our ongoing commitment to addressing the needs of those who rely on Cortrophin Gel therapy,” stated Nikhil Lalwani, president and CEO of ANI. “We look forward to making the Cortrophin Gel prefilled syringe available in the second quarter of 2025 as we continue to advance our rare disease portfolio.”
Indications
Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:
- Short-term administration as an adjunctive therapy during an acute episode or exacerbation in:
- acute gouty arthritis
- rheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; and ankylosing spondylitis.
- Exacerbations or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
- Severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.
- Atopic dermatitis and serum sickness.
- Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.
- Symptomatic sarcoidosis.
- Inducing a diuresis or remission of proteinuria due to nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
- Acute exacerbations of multiple sclerosis.
Important Safety Information
Contraindications
- Cortrophin Gel is contraindicated for intravenous administration.
- Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources.
Warnings and Precautions
- Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.
- Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.
- Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.
- Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease.
- Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.
- Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.
- Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
- Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.
- Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.
- Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.
- Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.
- Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy.
- Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.
- Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.
- Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse Reactions
Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; injection site reactions; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; suppression of growth in children; and weight gain. These are not all the adverse reactions reported with Cortrophin Gel.
Please click here for full prescribing information for Cortrophin Gel.