Administering Cortrophin Gel

Getting started with Cortrophin Gel

Cortrophin Gel is supplied in a 5-mL multiple-dose vial containing 80 units per mL (400 units per 5-mL vial) and a 1-mL multiple-dose vial containing 80 units. Once you receive your Cortrophin Gel prescription, there are a few things to remember:

  • Store the vials of Cortrophin Gel in the refrigerator at 36°F to 46°F (2°C to 8°C)
  • 1-mL vials: Throw away (discard) any 1-mL vials 6 months after first use or by the expiration date printed on the label, whichever occurs first
  • 5-mL vials: Throw away (discard) any 5-mL vials 28 days after first use or by the expiration date printed on the label, whichever occurs first
  • Write the revised "discard by" date in the space provided on the carton
  • Do not use a vial if any signs of contamination are seen, like if the gel looks cloudy or has particles in it
Image of 5 mL vial Image of 1 mL vial

At the time of your prescription, your healthcare provider will give you specific advice and instructions based on your needs and condition. You will also be taught how to prepare and inject Cortrophin Gel the right way, including:

Where and how to inject
How much to give
How often to give it

Do not try to inject yourself until you have been shown how to give your injections by your healthcare provider.

A step-by-step process to injecting Cortrophin Gel

Cortrophin Gel can be given through 2 methods of administration. Ask your healthcare provider which injection method you should use and the best areas for your injections.

Cortrophin Gel is an adrenocorticotropic hormone (ACTH) injection treatment containing 80 U/mL. It can be administered:

Under the skin (subcutaneously)
Illustration of injecting under the skin (subcutaneously)
Into the muscle (intramuscularly)
Illustration of injecting into the muscle (intramuscularly)

do not

Do not inject Cortrophin Gel into the vein or administer by mouth.

Watch a step-by-step video on using Cortrophin Gel

Whether you are injecting yourself or someone else, this video provides guidance on how to inject Cortrophin Gel.

If you still aren't feeling comfortable with the injection process, the Cortrophin In Your Corner patient support program* can help! Cortrophin In Your Corner offers in-person injection training at no cost to you, provided by licensed nurses. If you have already been trained or have experience, a virtual injection review session may better fit your needs. If you have not received your injection training before starting treatment, you can call 1-800-805-5258 for assistance.

During this session, a home-health nurse will:

  • Verify you have all of the supplies needed for your injection
  • Walk you and/or your caregiver through the injection process for Cortrophin Gel
  • Explain important facts about storage and disposal after your injection

*Not all patients will be eligible for all services offered by Cortrophin In Your Corner.

Contact Phone

If you have questions about using Cortrophin Gel, please call Cortrophin In Your Corner before starting treatment at 1-800-805-5258.

Helpful resources for injecting Cortrophin Gel

A step-by-step guide to administering Cortrophin Gel
A calendar to help track your treatment schedule

FOR HEALTHCARE PROFESSIONALS

A guide for talking to your patients

Understanding how to dose

After selecting an injection site, you will need to make sure the right amount of medicine, as prescribed by your healthcare provider, has been drawn up in your syringe. The amount of Cortrophin Gel and how often you or your loved one administer it will be individualized by your healthcare provider according to medical condition, severity of disease, and response to treatment. This chart can help remind you how much medicine you'll need based on what your healthcare provider has prescribed.

Cortrophin Gel Dose Conversion Chart

Units Injection Amount (mL)
120 units 1.5 mL
80 units 1 mL
40 units 0.5 mL
25 units 0.3125 mL

If you have any questions about your dose or specific injection amount of Cortrophin Gel, ask your healthcare provider for guidance.

These are not all the possible doses of Cortrophin Gel. If you need to calculate additional doses, every 20-unit increment results in a 0.25 mL increase or decrease in injection amount. For example, 100 units = 1.25 mL.

FOR HEALTHCARE PROFESSIONALS

Prescribe Cortrophin Gel today!

  • Download the Enrollment Form to begin the prescription process. Complete all pages with your patient

  • Enroll your patient in the Cortrophin In Your Corner support program

  • For the 5-mL vial, fax completed form to 1-844-FAX-CIYC (1-844-329-2492) along with copies of all insurance and prescription cards. For the 1-mL vial, fax completed form to 1-833-GOUT-FLA (1-833-468-8352) along with copies of all insurance and prescription cards

Once the form is received, it will be processed and the specialty pharmacy providing the medication will reach out to both you and your patients to help coordinate their prescription, or our Cortrophin In Your Corner hub will reach out about supporting in-office use.

Download the Enrollment Form to begin the prescription process:

Download the Enrollment Form to begin the prescription process

Additional resources you may need:

See a full list of potential ICD-10 Diagnosis Codes

Download and have your patient fill out this consent form to be contacted about Cortrophin Gel

Download and have your patient fill out this HIPAA authorization form

Contact Phone

Call Cortrophin In Your Corner for questions about Cortrophin Gel at 1-800-805-5258, Monday–Friday, 8 AM–8 PM ET.

Important Safety Information & Use

Important Safety Information

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. Your doctor may try to reduce your dosage gradually or prescribe a steroid medicine to protect you until the adrenal gland recovers.
  • You might develop high blood pressure, retain too much salt and water, or have low blood potassium levels. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt or taking certain supplements.
  • Corticotropin therapy may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on.
  • 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. Signs of an allergic reaction include dizziness, nausea and vomiting, shock, and skin reactions.
  • 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); and suppression of growth in children.

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.

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:

  • 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.
  • Acute attacks or flares of multiple sclerosis.

Please see full Prescribing Information.