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What is Acthar?

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Acthar is a prescription medication containing the hormone adrenocorticotropin (“a-DRE-no-cor-ti-co-tro-pin”), also known as ACTH. Acthar is one of the first effective medications approved by the FDA for the treatment of acute relapses of multiple sclerosis (MS) in adults. Controlled clinical trials have shown that Acthar is effective in speeding the resolution of acute relapses of MS. There is no evidence, however, that it modifies the progression of the disease.

How do I prepare Acthar for use?

Acthar is ready to use. There is nothing to mix. It is important, however, that you allow the gel to become warmed to room temperature and liquefied before use. To help warm the vial, roll it between the palms of your hands for a few minutes.

How should I store Acthar?

Store Acthar in the refrigerator between 36°-46°F (2°-8°C). Acthar should be warmed to room temperature before using.

How does Acthar work?

Acthar is a hormone and has been proven to speed recovery from MS relapses. It works by helping the body produce natural steroid hormones to reduce inflammation.

Who should not use Acthar?

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. If you have one of these conditions, be sure to speak with your doctor before beginning treatment with Acthar.

What are the most common side effects of Acthar?

The most common side effects of Acthar 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 include: 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. These are not all of the possible side effects of Acthar. For more information, ask your doctor, nurse, or pharmacist or call 1-800-465-9217.

Are there special dietary recommendations for someone receiving Acthar therapy?

Acthar can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary. Caution should be used in patients with hypertension, congestive heart failure, or renal insufficiency. Please discuss dietary adjustments with your doctor.

Are there possible drug interactions associated with Acthar therapy?

Acthar may increase the loss of electrolytes in patients treated with diuretic drugs. Other drug interactions are possible. Make sure you inform your doctor if you are being treated with diuretic drugs or any other medications.

What is the right dose?

Your doctor will need to determine the right dose and provide instructions on when and how often to inject Acthar.

If symptoms improve, can I stop therapy?

It is important to complete the full course of Acthar therapy as instructed by your doctor. Sudden withdrawal after prolonged use may lead to recurrent symptoms that make it difficult to stop therapy. Discuss any discontinuation of therapy with your doctor.

Can pregnant women receive Acthar therapy?

Acthar could have a potentially harmful effect on the fetus. There are no adequate and well-controlled studies in pregnant women. Acthar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can nursing mothers receive Acthar therapy?

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Acthar, when treating a nursing mother, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother.

What are the ingredients in Acthar?

Active ingredient: adrenocorticotropic hormone (ACTH, corticotropin).

Inactive ingredients: 16% gelatin. Also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH, and water for injection, q.s.


 

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