"The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease "...
Myfortic Consumer (continued)
Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Because this medication weakens your immune system, you are more likely to develop infections which may be serious. Tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat/fever, night sweats, flu-like symptoms, painful urination, vision changes, a sore or wound on the skin that feels warm/tender/painful and appears reddened.
This drug increases the risk of a rare and possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, fast/irregular heartbeat, muscle weakness, easy bleeding/bruising, swelling of the feet or ankles, mental/mood changes, weakness on one side of the body, unusual change in the amount of urine.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, shortness of breath/rapid breathing.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Myfortic (mycophenolic acid) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking mycophenolate sodium, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate mofetil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: any type of cancer, liver disease (e.g., hepatitis B, hepatitis C), current/past infections (e.g., herpes, shingles), stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).
If your transplanted kidney does not work properly even though you are taking this medication, the amount of mycophenolate in your body may increase, which can result in increased side effects.
Mycophenolate may cause swelling and growth of the gums (gingival hyperplasia). Brush and floss your teeth daily, and see your dentist regularly.
Because this medication may increase your risk of developing skin cancers, it is best to avoid prolonged sun exposure, tanning booths and sunlamps while you are using this medication. Use a sunscreen and wear protective clothing when outdoors.
Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.
Avoid contact with people have the flu or any other infection.
Notify your doctor if you are scheduled for any kind of test or surgery involving your colon (e.g., colonoscopy, abdominal surgery) that requires cleaning out your colon before the procedure. Removing the bacteria in your digestive tract can decrease the amount of mycophenolate in your body.
Caution is advised when using this drug in the elderly because they are less able to remove this drug from their bodies, and therefore may be more sensitive to its effects.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of childbearing age should talk to their doctor(s) about the benefits and risks (such as miscarriage). Women of childbearing age should have a pregnancy test before starting this medication, after 8-10 days on treatment, and during routine follow-up visits. Also, use reliable forms of birth control during treatment, and continue for at least 6 weeks after mycophenolate is stopped. Consult your doctor for more details.
It is not known whether this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug and for 6 weeks after stopping mycophenolate. If you must take the drug while you are producing milk, but wish to resume breast-feeding six weeks after treatment is finished, pump your breast milk and discard. Consult your doctor for more details.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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