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What is Purified Cortrophin Gel?

Important Safety Information

Purified Cortrophin Gel 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.

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.

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.

Please see full Prescribing Information.

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.

Purified Cortrophin Gel 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.

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.

Please see full Prescribing Information.