Pronunciation:

kor-ti-koe-TROE-pin ree-POZ-i-tor-ee

Classifications:

Pharmacologic—

Corticotropin

Uses of This Medicine:

Repository corticotropin injection is used to treat infantile spasms (seizures) in babies and children younger than 2 years of age. It is also used to treat adults with relapsing forms of multiple sclerosis. This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of flare-ups (relapses) of the disease.

Repository corticotropin injection is also used to treat joint disorders (eg, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis), autoimmune diseases (eg, systemic lupus erythematosus or SLE, polymyositis), and certain conditions of the skin (eg, erythema multiforme, Stevens-Johnson syndrome), eyes (eg, keratitis, diffuse posterior uveitis and choroiditis, optic neuritis), and lungs (eg, sarcoidosis). It is also used to treat certain allergies (eg, serum sickness) and swelling (edema) of the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of repository corticotropin injection to treat infantile spasms in babies and children younger than 2 years of age.

Older adults—

No information is available on the relationship of age to the effects of repository corticotropin injection in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Bupropion
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Ofloxacin
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sparfloxacin
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice
• Saiboku-To

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems or
• Allergy to pork proteins, history of or
• Congenital (inborn) infections in children younger than 2 years of age or
• Congestive heart failure or
• Fungus infections, systemic or
• Herpes simplex of the eye (eye infection) or
• Hypertension (high blood pressure), uncontrolled or
• Osteoporosis (thinning of the bones) or
• Peptic ulcer, or history of or
• Scleroderma (autoimmune disease) or
• Surgery, recent—Should not be used in patients with these conditions.

• Cataracts or
• Cirrhosis (liver problem) or
• Cushing's syndrome (adrenal gland disorder) or
• Depression, history of or
• Diabetes or
• Edema (fluid retention or swelling) or
• Emotional problems or
• Eye infections (fungus, virus) or
• Glaucoma or
• Heart disease or
• Hypertension (high blood pressure), controlled or
• Hypokalemia (low potassium in the blood) or
• Hypothyroidism (underactive thyroid) or
• Kidney disease, severe or
• Mental illness (eg, psychosis) or
• Myasthenia gravis (severe muscle weakness) or
• Stomach problems (ulcer, bleeding, or perforation) or
• Tuberculosis, latent—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Lennox-Gastaut syndrome—May cause this condition to occur while using this medicine to treat infantile spasms.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given as a shot under your skin (usually in the upper thigh, stomach, or back of the arm) or into one of your muscles.

Repository corticotropin injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your or your child's doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

If your child is receiving repository corticotropin injection to treat infantile spasms, this medicine usually comes with a Medication Guide and patient instructions. It is very important that you read and follow the instructions carefully. Be sure to ask your child's doctor about anything you do not understand.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into red, swollen, or painful skin areas, areas with tattoos, warts, scars, birthmarks, stretch marks, or within one inch of the knee or groin area.

To use the prefilled SelfJect™ injector:

• Wash your hands with soap and water before and after using this medicine.
• Allow the prefilled SelfJect™ injector to warm to room temperature for 45 minutes and no more than 24 hours before using it. Do not warm using heat sources.
• Do not use the injector if it is damaged or the bottom cap has come off.
• Check the liquid in the injector. It should be clear light yellow or orange. Do not use this medicine if it is cloudy or if you see particles in it.
• Pull the bottom cap off. Do not touch the gray needle guard. Do not recap.
• Place the injector on clean skin at the injection site at a 90 degree angle. Do not pinch the skin. Slowly push the handle down to inject. Do not lift during the injection. You may hear a "click" sound. This means your injection has started.
• The injection is complete when the colored body disappears. You may also hear a click. If you see the green or purple colored body and yellow band, this means you did not give the full dose. Call your doctor if this happens. Do not try to inject with this injector again or use another injector.
• Remove the injector by lifting it straight up. If you see the yellow band, the needle guard is locked.

To use the vial:

• Take the vial from the refrigerator and let it warm to room temperature before using it. Do not over-pressurize the vial before withdrawing the medicine.
• Wash your hands before and after using this medicine.
• Wipe the injection site with a new sterile alcohol wipe and let it dry before giving an injection.
• Clean the top of the rubber stopper vial with a new sterile alcohol wipe.
• Use a new needle or syringe to get the prescribed amount of medicine to be injected.
• Give the medicine the way your doctor has instructed you.
• Return the vial to the refrigerator after using it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (gel):
  • For infantile spasms:
    • Children 2 years of age and older—Use and dose must be determined by your doctor.
    • Infants and children younger than 2 years of age—Dose is based on body size and must be determined by your child's doctor. The dose is usually 150 units per square meter (U/m2) of body size divided into two equal doses injected into a muscle per day for 2 weeks. Your child's doctor will adjust the dose as needed.
  • For multiple sclerosis:
    • Adults—The dose is usually 80 to 120 units injected under your skin or into a muscle per day for 2 to 3 weeks. Your doctor will adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For other indications (joint disorders, autoimmune diseases, allergies, swelling, and certain conditions of the skin, eyes, and lungs):
    • Adults—The dose is usually 40 to 80 units injected under your skin or into a muscle every 24 to 72 hours. Your doctor will adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

You may store the prefilled SelfJect™ injector at room temperature for up to 24 hours.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not receive live vaccines while you or your child are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems (eg, Cushing's syndrome). The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, fractures, increased thirst or urination, irritability, round or "moon" face, neck, or trunk, stomach pain, thin skin or easy bruising, weight gain or loss, or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially salt intake).

This medicine may mask or hide symptoms of other diseases while you are using it. Check with your doctor if you or your child have symptoms of infection, black, tarry stools, changes in body weight, difficulty with breathing, fast heart rate, increased thirst, stomach pain, unusual tiredness, or vomiting.

Check with your doctor right away if you start having severe stomach burning, cramps, or pains, bloody or black, tarry stools, constipation or diarrhea, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

This medicine may cause changes in mood and behavior. Check with your doctor if you or your child has trouble sleeping, feeling depressed or irritable, mood swings, or other changes in behavior.

Check with your doctor right away if you or your child has any changes to your eyes, including redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want your eyes to be checked by an eye doctor (ophthalmologist).

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause slow growth and may lead to osteoporosis at any age. If you have any questions about this ask your doctor.

Do not stop using this medicine suddenly without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Backache

blurred vision

body aches or pain

chest pain or tightness

chills

cough

difficulty with breathing

dizziness

ear congestion

earache

facial hair growth in females

fever

fractures

full or round face, neck, or trunk

headache

increased thirst or urination

irritability

loss of sexual desire or ability

loss of voice

menstrual irregularities

muscle wasting

nervousness

pounding in the ears

redness or swelling in the ear

runny or stuffy nose

seizures

slow or fast heartbeat

sneezing

sore throat

unusual tiredness or weakness

white patches in the mouth or throat or on the tongue

white patches with diaper rash

Incidence not known

Accumulation of pus

bruising

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

decreased range of motion

decreased urine output

dilated neck veins

extreme tiredness or weakness

eyeballs bulge out of the eye sockets

fast, weak pulse

full or bloated feeling

heartburn

irregular breathing

irregular heartbeat

joint pain

large, flat, blue, or purplish patches in the skin

lightheadedness

limp

loss of appetite

nausea

noisy, rattling breathing

pressure in the stomach

severe headache

slow healing

small red or purple spots on the skin

swelling of the stomach area

swelling of the face, fingers, feet, or lower legs

swollen, red, or tender area of infection

trouble sleeping

vomiting

weight gain

Incidence not known-For adults only

Bloating

cold clammy skin

confusion

constipation

coughing up blood

dark urine

feeling of constant movement of self or surroundings

headache, sudden and severe

increased sweating

indigestion

loss of appetite

pain in the muscles

pains in the stomach, side, or abdomen, possibly radiating to the back

redness of the face

sensation of spinning

skin rash

sweating

thinning of the skin

unusual weight loss

weakness

yellow eyes or skin

Incidence not known-For infants only

Diarrhea

dry mouth

excess air or gas in the stomach or bowels

mood changes

muscle pain or cramps

numbness or tingling in the hands, feet, or lips

passing gas

problems with speech or speaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blemishes on the skin

diarrhea

pimples

Less common

Changes in appetite

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

general feeling of discomfort or illness

increased hair growth, especially on the face

muscle weakness

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.