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Important Safety Information
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H.P. Acthar® Gel
(repository corticotropin injection) is indicated for the treatment of
acute exacerbations of multiple sclerosis in adults. Controlled clinical
trials have shown H.P. Acthar Gel to be effective in speeding the
resolution of acute exacerbations of multiple sclerosis. However, there is
no evidence that it affects the ultimate outcome or natural history of the
disease.
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Patients, parents, and
caregivers should be aware of the important information about
H.P. Acthar® Gel.
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Acthar should never be given
intravenously (into a vein). Acthar should not be used in patients with a
skin condition called scleroderma, bone density loss (osteoporosis),
infection throughout the body, eye infection called ocular herpes simplex,
recent surgery, history of or a current stomach ulcer, heart problems, high
blood pressure, or allergy to pig-derived proteins. Tell your doctor about
any health problems or medicines.
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Acthar may cause side effects
similar to side effects that happen due to treatment with steroid
medicines. Not all of these side effects have occurred with Acthar but they
may occur. Acthar is a medicine that affects a patient’s immune system, and
therefore patients may be more likely to get new infections, or inactive
infections may become active. Acthar has effects on the adrenal gland. When
a patient is taking Acthar, their adrenal gland may produce too much of a
hormone called cortisol. This can cause symptoms of Cushing’s syndrome
(upper body fat, rounded face, thin skin), which is more common in patients
who take this medicine for a long time. When a patient stops taking Acthar
after a long time, the body may not produce enough cortisol on its own (adrenal
insufficiency). The doctor may prescribe a steroid medicine to protect the
body until the adrenal gland recovers. Do not stop administering Acthar
without talking to your doctor first. Your doctor may check your blood
pressure during treatment and may instruct you to make some dietary
changes. Patients should not receive certain vaccines during treatment with
Acthar. Talk to your doctor about which vaccines are safe for use. Acthar
may hide (or mask) symptoms of other conditions or diseases and it may be
more difficult for your doctor to diagnose other conditions or diseases in
you or your child during treatment. The person receiving Acthar has an
increased risk for bleeding from the stomach or having a stomach ulcer.
Inform your doctor about any pain in the stomach area, bloody vomit, or
bloody or black stools. While on Acthar changes in mood and behavior such
as irritability, depression, or trouble sleeping, may occur.
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Other side effects are possible.
Acthar may make certain other medical conditions worse, such as diabetes
(may increase blood sugar); cause eye problems, such as cataracts,
increased pressure in the eye (glaucoma), and possible damage to the optic
nerve; and cause allergic reactions to Acthar (seen as skin rash, swelling
of the face, tongue, lips, or throat, and trouble breathing). Acthar may
affect growth and physical development after long term use. Long term use
of Acthar may cause an increase in the size of the heart, but this
condition usually goes away after Acthar is stopped.
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The most common side effects of
Acthar in infants include: infections, increased blood pressure,
irritability and changes in behavior, changes in appetite and weight,
diarrhea, and vomiting. Other adverse reactions reported in adults and
children over 2 years of age included: abdominal bloating, anxiety, asthma,
chest discomfort, congestive heart failure, dizziness, shortness of breath,
redness of the face, fluid retention, flushing, headache, injection site
pain, tiredness, muscle weakness, nervousness, rapid heart rate and lack of
energy. Tell your doctor if there is any side effect that bothers you or
your child or that does not go away.
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These are not all of the
possible side effects of Acthar. For more information, ask your doctor,
nurse, or pharmacist, go to www.acthar.com, or call 1-800-465-9217. You may report
side effects to the FDA at 1-800-FDA-1088.
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For a full list of indications,
contraindications, warnings, precautions, and adverse events related to
Acthar, please refer to the full Prescribing
Information.
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This information is intended
only for residents of the United States.
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Questcor Pharmaceuticals, Inc., 26118 Research Road, Hayward, CA 94545.
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