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PTC Therapeutics wants to assure patients and health care providers that the supply of EMFLAZA will not be affected by the coronavirus (COVID-19) pandemic. Currently, over a year’s supply of EMFLAZA is in stock and available for delivery.
Furthermore, we are closely monitoring shipping issues in the United States and will update our patients and health care providers should challenges arise.
Our first priority is providing safe treatment. We know how important access to our therapies is, which is why we are continually looking for the best ways to serve our patients and their caregivers.
For over 20 years, PTC Therapeutics has been dedicated to improving the lives of patients with rare, difficult-to-treat, genetic diseases by providing innovative therapies. We are determined to deliver on that commitment.
If you have any questions or concerns, please call PTC Cares™ at 1-844-PTC-CARES (844-478-2227).
US-EMF-0228
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The personal information I have provided on this form is complete and accurate to the best of my knowledge.
I have voluntarily chosen to provide this personal information, including contact information. By providing this information, I am authorizing PTC Therapeutics, Inc. and its agents and contractors (“PTC Therapeutics”) to contact me about treatments, products, and services related to the treatment of Duchenne muscular distrophy (DMD), as well as to use and disclose the information for other purposes described below, using the contact information I have provided. I understand and agree that PTC Therapeutics may leave messages for me that disclose that someone has DMD or takes specific medication or that a specific medication used to treat DMD is available.
I authorize PTC Therapeutics to:
If at any time I do not wish to be contacted by PTC Therapeutics about or to receive any information related to deflazacort or any other treatment, product, or service related to the treatment of DMD or to be contacted for any of the other purposes described above, I understand that I may unsubscribe at any time.
INDICATION
EMFLAZA® is indicated for the treatment of Duchenne muscular dystrophy in patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindication: Do not use if you are allergic to deflazacort or any of the inactive ingredients in EMFLAZA.
Do not stop taking EMFLAZA, or change the amount you are taking, without first checking with your healthcare provider, as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency and steroid “withdrawal syndrome”. Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly, and can be fatal. A steroid “withdrawal syndrome” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. For patients already taking corticosteroids during times of stress, the dosage may need to be increased.
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Hyperglycemia: Corticosteroids can increase blood glucose, worsen pre-existing diabetes, predispose those on long-term treatment to diabetes mellitus, and may reduce the effect of anti-diabetic drugs. Monitor blood glucose at regular intervals. For patients with hyperglycemia, anti-diabetic treatment should be initiated or adjusted accordingly. |
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Increased Risk of Infection: Tell your healthcare provider if you have had recent or ongoing infections or if you have recently received a vaccine or are scheduled for a vaccination. Seek medical advice at once should you develop fever or other signs of infection, as some infections can potentially be severe and fatal. Avoid exposure to chickenpox or measles, but if you are exposed, medical advice should be sought without delay. |
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Alterations in Cardiovascular/Kidney Function: EMFLAZA can cause an increase in blood pressure, salt and water retention, or a decrease in your potassium and calcium levels. If this occurs, dietary salt restriction and potassium supplementation may be needed. |
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Behavioral and Mood Disturbances: There is a potential for severe behavioral and mood changes with EMFLAZA and you should seek medical attention if psychiatric symptoms develop. |
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Effects on Bones: There is a risk of osteoporosis or decrease in bone mineral density with prolonged use of EMFLAZA, which can potentially lead to vertebral and long bone fractures. |
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Effects on Growth and Development: Long-term use of corticosteroids, including EMFLAZA may slow growth and development in children. |
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Ophthalmic Effects: EMFLAZA may cause cataracts, ocular infections and glaucoma and you should be monitored if corticosteroid therapy is continued for more than 6 weeks. |
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Vaccination: The administration of live or live attenuated vaccines is not recommended in patients on EMFLAZA. Live-attenuated or live vaccines can be administered at least 4 to 6 weeks prior to starting EMFLAZA. |
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Serious Skin Rashes: Seek medical attention at the first sign of a rash. |
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Drug Interactions: Certain medications can cause an interaction with EMFLAZA. Tell your healthcare provider of all the medicines you are taking, including over-the-counter medicines (such as insulin, aspirin or other NSAIDS), dietary supplements, and herbal products. Alternate treatment, dosage adjustment, and/or special test(s) may be needed during the treatment. |
Common side effects that could occur with EMFLAZA include: Facial puffiness or Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, frequent daytime urination, unwanted hair growth, central obesity, and colds.
Please see the accompanying full Prescribing Information.
For medical information, product complaints, or to report an adverse event, please call 1‑866‑562‑4620 or email at usmedinfo@ptcbio.com.
You may also report adverse events directly to FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.