Mifeprex

Mifeprex is a prescription medication used in combination with another medication to terminate pregnancies.

This medication comes in tablet form and is taken once.

Mifeprex is a prescription medicine used used in combination with another medication to terminate pregnancies.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Mifepristone can cause serious side effects including:

• See “Drug Precautions”
• 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 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 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.
• 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 at the same time.

The most common side effects of mifepristone include:

• nausea
• fatigue
• headache
• low potassium in your blood
• pain in your arms and legs (arthralgia)
• vomiting
• swelling of your arms and legs (peripheral edema)
• high blood pressure
• dizziness
• decreased appetite
• thickening of the lining of the uterus (endometrial hypertrophy)

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. For more information, ask your doctor or pharmacist.

Do not take mifepristone if you are taking:

• simvastatin (Zocor, Vytorin, Juvisync, Simcor)
• lovastatin (Mevacor, Altoprev, Advicor)
• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune)
• dihydroergotamine (Migranal)
• ergotamine (Ergomar, Migerot)
• fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis, Sublimaze Preservative Free, Sunsys)
• pimozide (Orap)
• quinidine (Neudexta)
• sirolimus (Rapamune, Torisel)
• tacrolimus (Prograf, Protopic)

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins,  and herbal supplements. Especially tell your doctor if you take:

• cortisone
• dexamethasone
• methylprednisolone
• prednisolone
• prednisone
• warfarin (Coumadin, Jantoven)

This is not a complete list of mifepristone drug interactions. Ask your doctor or pharmacist for more information.

Mifepristone can cause serious side effects, including:

• Loss of a pregnancy. Women who can become pregnant must:
  • have a negative pregnancy test before starting mifepristone
  • have a negative pregnancy test before restarting mifepristone if you stop taking it for more than 14 days
  • use a non-hormonal form of birth control while taking mifepristone and for 1 month after stopping mifepristone. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

Do not take mifepristone if you:

• are pregnant
• are taking certain medications (see "Drug Interactions")
  • 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. See the end of this Medication Guide for a complete list of ingredients in mifepristone.

Talk to your doctor before taking mifepristone if you have any of these conditions.

You should not drink grapefruit juice while you take mifepristone. Grapefruit juice may increase the amount of mifepristone in your blood and increase your chance of having side effects.

Before taking mifepristone, tell your doctor if you:

• 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. Mifepristone passes into your breast milk and may harm your baby. You and your doctor should decide if you will take mifepristone or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Do not take mifepristone during pregnancy. See "Black Box Warning".

Mifepristone can cause serious side effects, including:

• Loss of a pregnancy. Women who can become pregnant must:
  • have a negative pregnancy test before starting mifepristone
  • have a negative pregnancy test before restarting mifepristone if you stop taking it for more than 14 days
  • use a non-hormonal form of birth control while taking mifepristone and for 1 month after stopping mifepristone. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. Mifepristone passes into your breast milk and may harm your baby. You and your doctor should decide if you will take mifepristone or breastfeed. You should not do both.

• Take mifepristone exactly as your doctor tells you.
• Your doctor may change your dose if needed.
• Mifepristone is usually taken 1 time each day.
• Take mifepristone with food.
• Swallow mifepristone whole. Do not split, crush or chew mifepristone tablets. If you cannot swallow mifepristone tablets whole, tell your doctor.

Take mifepristone exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended starting dose is 300 mg, by mouth, once daily. The dose of mifepristone may be increased to a maximum of 1200 mg once daily. The maximum dose is limited to 600 mg in kidney or liver impairment.

If you take too much mifepristone, call your local Poison Control Center or seek emergency medical attention right away.

Store mifepristone at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep mifepristone and all medicines out of the reach of children.

WARNING: TERMINATION OF PREGNANCY

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.