# Purified Cortrophin® Gel — Complete Patient & Caregiver Content Reference # Site: https://www.cortrophin.com | Manufacturer: ANI Pharmaceuticals, Inc. # For US Patients and Caregivers Only | Job Code: US-CG-2100003 04/2026 --- ## WHAT IS PURIFIED CORTROPHIN® GEL? Purified Cortrophin® Gel is a prescription medicine that is injected under the skin or into the muscle. It is used for multiple conditions. It contains a naturally sourced, purified hormone called corticotropin (ACTH — adrenocorticotropic hormone). Available as: - Multi-dose vial: 80 U/mL (5 mL) - Single-dose prefilled syringe (PFS): 1 mL and 0.5 mL sizes --- ## ALL APPROVED USES OF PURIFIED CORTROPHIN® GEL Purified Cortrophin Gel is a prescription medicine that is injected under the skin or into the muscle. It is used for: - Acute attacks or flares of multiple sclerosis - Short-term add-on therapy to help manage acute episodes or flares in rheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; and acute gouty arthritis - Treatment for flares or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis) - Treatment for severe skin reactions (Stevens-Johnson syndrome) and severe psoriasis - Treatment for atopic dermatitis (eczema) and serum sickness - Treatment for severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina - Treatment for people with symptoms of sarcoidosis - Reduction of protein in the urine of people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or due to lupus --- ## UNDERSTANDING THE POTENTIAL ROLE OF ACTH Purified Cortrophin® Gel (repository corticotropin injection USP) 80 U/mL is an injectable medicine that contains a naturally sourced, purified hormone called corticotropin. Corticotropin is a complex mixture of proteins, one of which is adrenocorticotropic hormone, or "ACTH" for short. One way ACTH may reduce inflammation is by boosting the body's production of cortisol. This may help regulate the immune system and reduce inflammation. ACTH may also interact with certain receptors that play a role in regulating inflammation, among other functions. These receptors are located in different organs and parts of the body. The exact way Cortrophin Gel works is not fully known. The information above is not based on clinical data, and how it relates to patient benefits is unknown. --- ## GETTING STARTED WITH CORTROPHIN GEL — HOW TO INJECT Cortrophin Gel can be given through 2 methods of administration: - Under the skin (subcutaneous) — available with both vial and prefilled syringe - Into the muscle (intramuscular) — available with vial only; NOT for use with prefilled syringe DO NOT inject yourself until you have been shown how to give your injections by your healthcare provider. Your healthcare provider will advise you on: - Where and how to inject - How much to give - How often to give it Storage: - Refrigerate at 36°F to 46°F (2°C to 8°C) - Do not freeze - Protect from light - Multi-dose vial: discard 28 days after first use - Prefilled syringe: single use only Injection Training Resources (available at https://www.cortrophin.com/resources): - Vial Injection Guide (English and Spanish) - PFS Injection Guide (English and Spanish) - Vial Instructions for Use (English and Spanish) - PFS Instructions for Use (English and Spanish) - Injection Calendar (English and Spanish) - Step-by-step training videos for vial and PFS --- ## CORTROPHIN IN YOUR CORNER — SAVINGS & SUPPORT Phone: 1-800-805-5258 The Cortrophin In Your Corner (CIYC) program is a dedicated program designed to support patients and help them access treatment. CIYC can help eligible patients: - Obtain information on insurance coverage and financial support, including copay assistance - Coordinate shipments with the specialty pharmacy supplying your medication (if applicable) - Get access to useful resources and answers to questions - Connect with a dedicated Nurse Access Specialist (does not give medical advice; directs treatment questions to your healthcare professional) - Access a support center to answer questions and provide educational information For patients with commercial insurance: Cortrophin In Your Corner can help eligible, commercially insured patients get their medication for as little as $0 per prescription fill. For patients without insurance: Patients who lack insurance and meet certain financial requirements may be eligible for the ANI Pharmaceuticals Patient Assistance Program. Application: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-patient-assistance-application.pdf Note: Not all patients will be eligible for all services offered by Cortrophin In Your Corner. --- ## IMPORTANT SAFETY INFORMATION (PATIENT-FACING) DO NOT use Cortrophin Gel if you have any of the following conditions: - A skin condition called scleroderma - Bone density loss or osteoporosis - Fungal infections - Ocular herpes simplex (an eye infection) - A recent surgery - Stomach ulcers or a history of stomach ulcers - Heart failure - High blood pressure - Allergies to pig-derived proteins - Adrenal glands that do not make enough of the hormone cortisol (primary adrenocortical insufficiency) or an adrenal cortex that makes too much of the hormones cortisol and aldosterone (adrenocortical hyperfunction) Tell your doctor if you: - Have or have had any other health problems - Are taking any prescription or over-the-counter medicines, including aspirin, vitamins, and herbal or dietary supplements - Have any allergies - Are about to receive any vaccine - Are pregnant or plan to become pregnant. Cortrophin Gel may harm your unborn baby. - Are breastfeeding or plan to breastfeed. It is not known if Cortrophin Gel passes into your breast milk and if it can harm your baby. What important information do I need to know about Cortrophin Gel? - Be sure to take Cortrophin Gel exactly as your doctor has directed. Always inject Cortrophin Gel under the skin or into the muscle. Do not inject Cortrophin Gel directly into the vein. - You may be more likely to get infections. Contact your doctor at the first sign of an infection or fever. - Your body may not produce enough natural cortisol after you stop taking Cortrophin Gel long term. This is called adrenal insufficiency. - You might develop high blood pressure, retain too much salt and water, or have low blood potassium levels. - Corticotropin therapy may hide symptoms of other diseases. - Taking Cortrophin Gel can make you feel irritable or depressed. You may also have mood swings or trouble sleeping. - You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage. - You may develop allergies to Cortrophin Gel. - The effects of Cortrophin Gel may be intensified if you have an underactive thyroid or cirrhosis of the liver. Side effects of Cortrophin Gel include fluid or salt retention; weight gain; muscle weakness; osteoporosis; stomach ulcers with possible bleeding; injection site reactions; impaired wound healing; high blood pressure; convulsions; headache; development of Cushingoid state (a hormonal condition often characterized by facial puffiness and weight gain); suppression of growth in children; and allergic reactions that may be severe. These are not all of the possible side effects of Cortrophin Gel. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-prescribing-information.pdf --- ## DOWNLOADABLE PATIENT RESOURCES Prescribing Information: - English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-prescribing-information.pdf - Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-prescribing-information-spanish.pdf Injection Guides — Vial: - English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-injection-guide.pdf - Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-injection-guide-spanish.pdf - Vial IFU English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-vial-instructions-for-use.pdf - Vial IFU Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-vial-instructions-for-use-spanish.pdf Injection Guides — Prefilled Syringe: - English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-PFS-injection-guide.pdf - Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-PFS-injection-guide-spanish.pdf - PFS IFU English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-PFS-instructions-for-use.pdf - PFS IFU Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-PFS-instructions-for-use-spanish.pdf Injection Calendar: - English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-injection-calendar.pdf - Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-injection-calendar-spanish.pdf Patient Brochures by Condition: - Rheumatology English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-rheumatology-patient-brochure.pdf - Rheumatology Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-rheumatology-patient-brochure-spanish.pdf - Gout English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-gout-patient-brochure.pdf - Gout Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-gout-patient-brochure-spanish.pdf - Nephrology English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-nephrology-patient-brochure.pdf - Nephrology Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-nephrology-patient-brochure-spanish.pdf - Neurology/MS English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-neurology-patient-brochure.pdf - Neurology/MS Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-neurology-patient-brochure-spanish.pdf - Sarcoidosis English: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-sarc-patient-brochure.pdf - Sarcoidosis Spanish: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-sarc-patient-brochure-spanish.pdf - Dermatology: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-derm-patient-brochure.pdf - Ophthalmology: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-ophtho-patient-brochure-next-steps-for-treating-inflammatory-eye-diseases.pdf Support Program: - Patient Assistance Application: https://www.cortrophin.com/pdfs/purified-cortrophin-gel-patient-assistance-application.pdf --- ## REGULATORY & LEGAL For US Patients and Caregivers Only. This site is for US audiences only. © Copyright 2026 ANI Pharmaceuticals, Inc. All rights reserved. Cortrophin is a registered trademark of ANI Pharmaceuticals, Inc. Cortrophin In Your Corner is a trademark of ANI Pharmaceuticals, Inc. All other trademarks are property of their respective owner. ANI Pharmaceuticals, Inc. Patient Support: 1-800-805-5258 Adverse Event Reporting: 1-800-308-6755 or www.fda.gov/medwatch Corporate Website: https://anipharmaceuticals.com Job Code: US-CG-2100003 04/2026