WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Do not use ERMEZA for weight problems or weight loss. Thyroid hormones, including ERMEZA either alone or in combination with other drugs, should not be used for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of ERMEZA used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.
- Do not take ERMEZA if your adrenal glands are not working well and you have not been treated for this problem; or if you are allergic to glycerin or edetate disodium,
the inactive ingredients in ERMEZA.
- Before you take ERMEZA, tell your doctor about all of your medical conditions, including if you:
- have or have had heart problems.
- have or have had thyroid nodules.
- have adrenal or pituitary gland problems.
- have any food or drug allergies.
- have low red blood cell count (anemia).
- have diabetes.
- have weak bones (osteoporosis).
- have or have had a history of blood clotting problems.
- have recently received radiation therapy with iodine (such as I-131).
- plan to have surgery.
- are pregnant or plan to become pregnant. Your doctor may need to change your ERMEZA dose while you are pregnant.
- are breastfeeding. Levothyroxine can pass into your breast milk.
Talk to your doctor about the best way to feed your baby if you take ERMEZA. Tell your doctor about all the medicines you are taking including prescription and over-the-counter medicines, vitamins and herbal supplements. ERMEZA may affect the way other medicines work, and other medicines may affect how ERMEZA works so your doctor may have to adjust the amount of medicines you take. You can ask your doctor or pharmacist for a list of medicines that interact with ERMEZA.
- Products such as iron and calcium supplements and antacids can lower your body’s ability to absorb levothyroxine, so ERMEZA should be taken 4 hours before or after
taking these products.
- Products such as bile acid sequestrates or ion exchange resins can interfere with the absorption of levothyroxine, so ERMEZA should be taken at least 4 hours before
taking these products.
- Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less ERMEZA from the gastrointestinal tract. Grapefruit juice may
cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of ERMEZA may need to be adjusted.
- Use ERMEZA within 90 days of opening the bottle.
- Your doctor should do certain blood tests while you are taking ERMEZA and may change your daily dose of ERMEZA as needed. Keep taking ERMEZA unless your
doctor tells you to stop or to change your dose.
It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well. In case of overdose, get medical help or contact a live Poison Control expert at 1-800-222-1222. Advice is also available online at www.poison.org.
- ERMEZA may cause serious side effects, including:
- Heart problems—you may experience an increased heart rate, chest pain, and irregular heartbeat.
- Worsening diabetic control—if you are diabetic, it may be harder to control your blood sugar levels causing hyperglycemia.
- Weak or brittle bones—your risk of developing weak or brittle bones may be greater if you are post-menopausal or if you are taking too much ERMEZA.
- The most common side effects of ERMEZA include fast and irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, hives or rash,
irritability, sleep problems, tremors, muscle weakness, changes in appetite, weight loss or weight gain, excessive sweating, heat intolerance, fever, and changes in
menstrual period.
- Other side effects may include partial hair loss during the first months of treatment with ERMEZA. This usually lasts for a short period of time (temporary).
Uses:
ERMEZA is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland.
ERMEZA is used in adults and children, including newborns:
- to replace or give extra levothyroxine when the thyroid does not produce enough of this hormone; or
- with surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid dependent well-differentiated thyroid cancer.
ERMEZA should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.
These are not all the possible side effects of ERMEZA. Call your doctor for medical advice about side effects. You may report side effects to Food and Drug Administration at 1-800-FDA-1088.
Read the Instructions for Use carefully for complete directions on how to properly dose and take ERMEZA. Please see the accompanying Patient Information and full Prescribing Information, including Boxed WARNING.