| Mifepristone (mifʺ e pris′ tone) Tablets |
|
What is the most important information I should know about mifepristone tablets?
Mifepristone tablets can cause serious side effects, including:
-
Loss of a pregnancy. Women who can become pregnant must:
- have a negative pregnancy test before starting mifepristone tablets
- have a negative pregnancy test before restarting mifepristone tablets if you stop taking it for more than 14 days
- use a non-hormonal form of birth control while taking mifepristone tablets and for 1 month after stopping mifepristone tablets.
Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.
|
|
What are mifepristone tablets?
Mifepristone tablets are a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.
Mifepristone tablets are not for people who have type 2 diabetes mellitus not caused by Cushing’s syndrome.
It is not known if mifepristone tablets are safe and effective in children.
|
|
Do not take mifepristone tablets if you:
-
are pregnant. See “What is the most important information I should know about mifepristone tablets?”
-
are taking:
- simvastatin (Zocor®, Vytorin®, Simcor®)
- lovastatin (Mevacor®, Altoprev®, Advicor®)
- cyclosporine (Gengraf®, Neoral®, Restasis®, Sandimmune®)
- dihydroergotamine (Migranal®)
- ergotamine (Ergomar®, Migergot®)
- fentanyl (Abstral®, Actiq®, Duragesic®, Fentora®, Lazanda®, Onsolis®, Sublimaze Preservative Free®, Subsys®)
- pimozide (Orap®)
- quinidine (Nuedexta®)
- sirolimus (Rapamune®, Torisel®)
- tacrolimus (Prograf®, Protopic®)
- must take corticosteroid medicines for other serious medical problems
- are a woman who still has her uterus (womb) and have:
- unexplained bleeding from your vagina
- changes in the cells lining your uterus (endometrial hyperplasia) or cancer of the lining of your uterus (endometrial cancer)
- are allergic to mifepristone or any of the ingredients in mifepristone tablets. See the end of this Medication Guide for a complete list of ingredients in mifepristone tablets.
Talk to your doctor before taking mifepristone tablets if you have any of these conditions.
|
|
What should I tell my doctor before taking mifepristone tablets?
Before taking mifepristone tablets, tell your doctor if you:
- are pregnant or plan to become pregnant
- have low potassium in your blood (hypokalemia)
- have or have had a bleeding problem or are taking medicines to thin your blood
- have or have had heart problems
- have had an organ transplant
- have been taking medicines called corticosteroids (cortisone, dexamethasone, methylprednisolone, prednisolone, prednisone)
- are breastfeeding or plan to breastfeed.
|
|
Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
Using mifepristone tablets with certain other medicines can affect each other. Using mifepristone tablets with other medicines can cause serious side effects.
Especially tell your doctor if you take:
- medicines to treat:
- fungal infections (such as ketoconazole)
- depression
- HIV infection
- Hepatitis C infection
- certain bacterial infections
- high blood pressure
- steroid medicines such as prednisone
- thyroid hormones
Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. |
|
How should I take mifepristone tablets?
- Take mifepristone tablets exactly as your doctor tells you.
- Your doctor may change your dose if needed.
- Mifepristone tablets are usually taken 1 time each day.
- Take mifepristone tablets with food.
- Swallow mifepristone tablets whole. Do not split, crush or chew mifepristone tablets. If you cannot swallow mifepristone tablets whole, tell your doctor.
|
|
What should I avoid while taking mifepristone tablets?
You should not drink grapefruit juice while you take mifepristone tablets. Grapefruit juice may increase the amount of mifepristone in your blood and increase your chance of having side effects.
|
|
What are the possible side effects of mifepristone tablets?
Mifepristone tablets can cause serious side effects including:
-
See “What is the most important information I should know about mifepristone tablets?”
-
loss of pregnancy
-
reduced effects of adrenal hormones (adrenal insufficiency). Mifepristone stops an adrenal hormone in your body called cortisol from working. Tell your doctor right away if you have any symptoms of adrenal insufficiency. Symptoms may include:
- unusual tiredness or weakness
- nausea
- fatigue
- low blood pressure (hypotension)
- low blood sugar (hypoglycemia)
-
low blood potassium (hypokalemia). Your doctor should check the level of potassium in your blood before you start taking mifepristone tablets and while you take it. Tell your doctor if you have any signs of low potassium. Signs may include:
- muscle weakness, aches, or cramps
- abnormal or irregular heartbeats (palpitations)
-
bleeding from the vagina. Mifepristone tablets may cause the lining of your uterus to become thick and may cause your uterus to bleed. Tell your doctor right away about any bleeding from your vagina that is not normal for you.
-
disruption of menstrual cycle
-
problems with the electrical system of your heart (QT interval prolongation).
-
worsening of symptoms of other medical problems that are treated with corticosteroids when you take corticosteroids and mifepristone tablets at the same time.
The most common side effects of mifepristone tablets include:
|
- nausea
- headache
- pain in your arms and legs (arthralgia)
- swelling of your arms and legs (peripheral edema)
- dizziness
- thickening of the lining of the uterus (endometrial hypertrophy)
|
- fatigue
- low potassium in your blood
- vomiting
- high blood pressure
- decreased appetite
|
|
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of mifepristone tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|
|
How should I store mifepristone tablets?
Store mifepristone tablets at room temperature, between 68° to 77°F (20° to 25°C).
Keep mifepristone tablets and all medicines out of the reach of children.
|
|
General information about the safe and effective use of mifepristone tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use mifepristone tablets for a condition for which they were not prescribed. Do not give mifepristone tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your pharmacist or healthcare provider for information about mifepristone tablets that is written for healthcare professionals.
|
| What are the ingredients in mifepristone tablets?
Active ingredient: mifepristone
Inactive ingredients: FD&C Blue #1 Brilliant Blue FCF Aluminum Lake, FD&C Yellow #5 (tartrazine) Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate type A, titanium dioxide, and triacetin.
Brands listed are the trademarks of their respective owners.
Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054
For more information, call Teva at 1-888-838-2872.
|