Overview: Purified Cortrophin Gel is used to relieve symptoms of multiple sclerosis (MS), certain types of arthritis and inflammatory disorders. This medicine signals your body to make hormones that help control inflammation. Common side effects include tiredness, infections, mood changes, fluid retention, and high blood pressure. Long-term use of Purified Cortrophin Gel increases your risk of serious side effects, such as problems with your stomach, bones, or hormone glands.
Uses
What is Purified Cortrophin Gel used for?
Purified Cortrophin Gel (repository corticotropin) is commonly used for the following conditions.
- Multiple sclerosis (MS), which is a condition where your immune system attacks the tissue covering your nerves
- Certain types of joint inflammation (arthritis)
- Other inflammatory disorders or allergy-related conditions
Purified Cortrophin Gel may also be used for other conditions as determined by your health care provider.
How does Purified Cortrophin Gel work (mechanism of action)?
Corticotropin acts like a natural hormone in your body called adrenocorticotropic hormone (ACTH). It works by signaling your adrenal glands to make certain hormones that help control inflammation. This can relieve flare-ups of MS and reduce symptoms of certain inflammatory conditions.
How is Purified Cortrophin Gel supplied (dosage forms)?
Brands and other names
- Purified Cortrophin Gel
Dosage forms and strengths
- 80 units/mL injection (1 mL and 5 mL multiple-dose vials)
How should I store Purified Cortrophin Gel?
Purified Cortrophin Gel should be stored in the refrigerator, at temperatures between 36 F and 46 F (2 C and 8 C). Write the date you first use the medicine on the carton labeling. Throw away the 1 ml multiple-dose vial 6 months after first use or by the expiration date, whichever comes first. Throw away the 5 ml multiple-dose vial 28 days after first use or by the expiration date, whichever comes first.
Side Effects
What are the most common side effects of Purified Cortrophin Gel?
The most common side effects of Purified Cortrophin Gel are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Infections (see below)
- Increased blood pressure (see below)
- Mood and behavior changes (see below)
- Pain, itching, swelling, or redness near where the needle went in
- Tiredness, weakness, and generally feeling unwell
- Swelling of your hands, legs, or feet due to fluid retention
- Trouble sleeping
- Headache
- High blood sugar levels
There may be other side effects of Purified Cortrophin Gel that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Purified Cortrophin Gel?
While less common, the most serious side effects of Purified Cortrophin Gel are described below, along with what to do if they happen.
Severe Allergic Reactions. Purified Cortrophin Gel may cause allergic reactions, which can be serious. Stop using Purified Cortrophin Gel and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Infections. Purified Cortrophin Gel can increase your risk of infections, including serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Purified Cortrophin Gel may increase your risk of a latent microbe becoming active again, causing an infection. Before you start treatment with Purified Cortrophin Gel, tell your health care provider if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections.
Cushing’s Syndrome. Rarely, using Purified Cortrophin Gel for a long time may cause Cushing’s syndrome. Cushing’s syndrome is a condition that happens when your body is exposed to too much cortisol (the stress hormone). Tell your health care provider if you have any of the following symptoms of Cushing’s syndrome.
- A rounded face
- Weight gain, especially in the upper body
- A fat buildup in the upper back or base of the neck
- Thinning skin that bruises easily
- Weak muscles
- Depression or anxiety
- High blood sugar
- High blood pressure
Reduced Adrenal Function. Using Purified Cortrophin Gel for a long time can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone), which is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of a fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.
- Nausea and vomiting
- Weakness, tiredness, or lack of energy
- Low blood pressure
Increased Blood Pressure. Purified Cortrophin Gel may increase your blood pressure or make it worse if you already have high blood pressure (hypertension). If you check your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea or vomiting
- Blurry vision or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heartbeats
Low Potassium Levels (Hypokalemia). Purified Cortrophin Gel can cause a low potassium level, which can be serious and may lead to death. Your health care provider may check your potassium levels, especially if you take certain other medicines. Keep all appointments to have your blood checked. Take any potassium supplement that your health care provider may recommend. Call your health care provider if you have any of the following symptoms of a low potassium level.
- Weakness
- Unusual tiredness
- Muscle cramps or twitching
- Constipation
Fluid Retention (Edema). Purified Cortrophin Gel can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Tell your health care provider right away if you have any of the following symptoms.
- Chest pain
- Irregular heartbeat
- Shortness of breath
- Stretched or shiny skin
- Swollen body parts, such as the belly or ankles
Stomach Bleeding. Purified Cortrophin Gel can increase your risk of bleeding, ulcers, and tears (perforations) in your gut. The risk is higher if you have a history of stomach ulcers or other problems with your stomach or intestines. Get emergency help if you have any of the following symptoms.
- Vomit blood
- Black or tarry poop
- Stomach pain that does not go away
- Upset stomach
Mood and Behavior Changes. Your mood or behavior may change while you use Purified Cortrophin Gel. Tell your health care provider if you have any of the following symptoms, especially if they seem severe or worse than usual.
- Crankiness
- Unusually high energy
- Irregular mood swings
- Changes in personality
- Depression
- Trouble sleeping or sleeping too much
- Psychotic-like behaviors, such as sudden aggression, confusion, or seeing, hearing, or otherwise perceiving things that others do not
Eye Problems. Using Purified Cortrophin Gel for a long time can lead to eye problems. These may include an eye infection, cataracts, and increased pressure inside the eye (glaucoma) with possible nerve damage. Tell your health care provider right away if you have any of the following symptoms.
- Eye pain, itchiness, or redness
- Eye discharge
- Swollen eyelids
- Fever
- Blurriness or shadows
- Sensitivity to light
- Worsening vision or loss of vision
- Problems with glare or driving at night
Slowed Growth and Bone Problems. Using Purified Cortrophin Gel for a long time can slow growth and delay development in children. It may also lead to weakened bones (osteoporosis) in people of all ages. Keep all medical appointments, so that your health care provider can check your height, weight, and bone density.
Warnings & Precautions
Who should not use Purified Cortrophin Gel?
Allergies to Ingredients. People who are allergic to any of the following should not use Purified Cortrophin Gel.
- Purified Cortrophin Gel
- Repository corticotropin
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Purified Cortrophin Gel.
Intravenous (IV) Use. Purified Cortrophin Gel should not be injected into a vein. It should only be given as a shot under the skin or into a muscle.
Current and Past Health Conditions. People with the following health problems should not use Purified Cortrophin Gel.
- Scleroderma, which is a condition that causes hardening of your skin and other tissues
- Weak bones (osteoporosis)
- A fungal infection that can affect your whole body
- An eye problem called ocular herpes simplex
- Recent surgery
- Stomach ulcer
- Heart failure
- High blood pressure
- Adrenal problems, including primary adrenal insufficiency or overactive adrenal glands
- Allergy or sensitivity to porcine (pig) proteins
What should I know about Purified Cortrophin Gel before using it?
Do not use Purified Cortrophin Gel unless it has been prescribed to you by a health care provider. Use it as prescribed. Read and follow the “Instructions for Use”. If you have any questions, talk to your health care provider.
Do not share Purified Cortrophin Gel with other people, even if they have the same condition as you. It may harm them.
Keep Purified Cortrophin Gel out of the reach of children. Since this medicine is kept in a refrigerator, take special care to keep it away from children who also use the refrigerator.
It is important to keep all of your appointments, including ones for bloodwork or other tests, while using Purified Cortrophin Gel.
Purified Cortrophin Gel can make your body less able to fight infections. Take special care to protect yourself from getting infections by doing things like washing your hands and limiting contact with people who are sick. Tell your health care provider right away if you think you have an infection.
Do not stop using Purified Cortrophin Gel without talking to your health care provider. Stopping too quickly may cause serious side effects. Call your health care provider right away if you have any of the following symptoms.
- Loss of appetite
- Weakness and tiredness
- Darkening of skin color
- Weight loss
- Dizziness
- Stomach pain
Purified Cortrophin Gel can sometimes hide, or mask, the symptoms of a condition or infection that you and your health care provider did not know about. After stopping Purified Cortrophin Gel, tell your health care provider if you have any new or unusual symptoms. Examples may include seizures, fever, unexpected tiredness, fainting, feeling like your heart is racing or pounding, headaches, increased thirst, weight loss or gain, or blood in your stool (poop).
Follow any diet recommendations from your health care provider. You may be asked to follow a low sodium (salt) diet.
What should I tell my health care provider before using Purified Cortrophin Gel?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Purified Cortrophin Gel is right for you.
In particular, make sure that you discuss any of the following.
Infections. Purified Cortrophin Gel can make your immune system less able to fight infections. Before you start treatment with Purified Cortrophin Gel, tell your health care provider if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections. Also let them know if you have an infection that keeps coming back or have been recently exposed to TB.
Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Any type of infection
- Diabetes
- High blood pressure
- Problems with your heart or kidneys
- Stomach ulcer, diverticulitis, or other problems with your stomach or intestines
- Liver scarring (cirrhosis)
- Thyroid problems
- Myasthenia gravis or other conditions affecting your nerves and muscles
- Mental health problems
- Electrolyte imbalance
Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Purified Cortrophin Gel. Tell your health care provider about any vaccines you have recently received or have scheduled.
Other Medicines and Supplements. Purified Cortrophin Gel may interact with other medicines and supplements. Before using Purified Cortrophin Gel, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not use Purified Cortrophin Gel during pregnancy without talking to your health care provider. Using Purified Cortrophin Gel during pregnancy may harm an unborn baby, or your baby may have side effects after birth. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Purified Cortrophin Gel while you are pregnant or trying to get pregnant.
Breastfeeding. It is not known if Purified Cortrophin Gel passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Purified Cortrophin Gel while breastfeeding.
How can I get more information about Purified Cortrophin Gel?
For more information about Purified Cortrophin Gel, you can visit the drugmaker’s website at www.cortrophin.com.
Interactions
Does Purified Cortrophin Gel interact with foods or drinks?
There are no known interactions between Purified Cortrophin Gel and foods or drinks.
It is unknown if drinking alcohol will affect Purified Cortrophin Gel.
Does Purified Cortrophin Gel interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are taking a diuretic, also called a water pill, which is a medicine used for high blood pressure and fluid retention.
This may not be a complete list of medicines that can interact with Purified Cortrophin Gel. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Purified Cortrophin Gel?
If you or someone else has used too much Purified Cortrophin Gel, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Purified Cortrophin Gel?
Purified Cortrophin Gel is meant to be used only when needed. Use it as your health care provider recommends. Do not use double or extra doses.
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