Ulipristal

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

Before taking ulipristal,

• tell your doctor and pharmacist if you are allergic to ulipristal, any other medications, or any of the ingredients in ulipristal tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG), itraconazole (Sporanox), or ketoconazole (Nizoral); barbiturates such as phenobarbital or secobarbital (Seconal); bosentan (Tracleer); certain medications for seizures such as carbamazepine (Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and topiramate (Topamax); and rifampin (Rifadin, Rimactane). Ulipristal may not work as well or may be more likely to cause side effects if it is taken with these medications.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had any medical conditions and if you are overweight.
• tell your doctor if you are pregnant. Do not take ulipristal if you are already pregnant.
• tell your doctor if you are breast-feeding.
• you should know that after you take ulipristal, it is normal for your next menstrual period to begin up to one week earlier or later than expected. If your next menstrual period is delayed for longer than one week after the expected date, call your doctor. You may be pregnant and your doctor will probably tell you to have a pregnancy test.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ulipristal is usually given as soon as possible after unprotected sex or failed birth control method (such as a condom that broke during sex). Follow your doctor's dosing instructions very carefully. Ulipristal can be taken any time during your menstrual cycle, but you must use the medicine within 5 days (120 hours) after unprotected sex.

If you vomit within 3 hours after taking ulipristal, your medication may not be as effective. Call your doctor to discuss the need for taking another ulipristal tablet.

You may take ulipristal with or without food.

After taking ulipristal, you should use a barrier form of birth control (condom or diaphragm with spermicide) at least until your next menstrual period. Ulipristal can make hormonal contraception less effective. This includes birth control pills, injections, implants, skin patches, and vaginal rings.

Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal.

Store ulipristal in the original container at room temperature, away from moisture, heat, and light.

In the U.S.

• Ella

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ulipristal, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ulipristal or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ulipristal in teenage females. ulipristal may be used as an emergency contraceptive in teenage females but is not recommended before the start of menstruation.

Geriatric

Ulipristal should not be used in postmenopausal women.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ulipristal, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ulipristal with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amobarbital
• Aprobarbital
• Barbital
• Butabarbital
• Butalbital
• Carbamazepine
• Desogestrel
• Dexamethasone
• Dienogest
• Drospirenone
• Efavirenz
• Enzalutamide
• Ethynodiol Diacetate
• Etonogestrel
• Fosphenytoin
• Gestodene
• Griseofulvin
• Hexobarbital
• Levonorgestrel
• Lumacaftor
• Mephobarbital
• Methohexital
• Mitotane
• Nilotinib
• Norethindrone
• Norgestimate
• Norgestrel
• Pentobarbital
• Phenobarbital
• Phenytoin
• Prednisone
• Primidone
• Quinidine
• Rifabutin
• Rifampin
• Rifapentine
• Secobarbital
• St John's Wort
• Thiopental
• Topiramate
• Vinblastine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

It is very important that your doctor check you closely to make sure ulipristal is working properly and does not cause unwanted effects.

Although you are using ulipristal to prevent pregnancy, you should know that using ulipristal while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using ulipristal to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

ulipristal is not recommended in breastfeeding women.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking ulipristal. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

ulipristal may make your next monthly period earlier or later than expected by a few days. If your next period after taking ulipristal is more than 1 week late, check with your doctor right away for a pregnancy test.

Your regular birth control method such as birth control pills or patch may not work as well while you are using ulipristal. You should not start taking hormonal contraceptives until at least 5 days after using ulipristal and you must use a barrier method such as a condom with spermicide, diaphragm, or contraceptive foam or jelly, until the next menstrual cycle.

ulipristal may not work as well in women with a body mass index (BMI) of more than 66 pounds per square meter.

ulipristal will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

• CDB-2914
• Ulipristal Acetate
• UPA

• Ella

Exposure in South Asian patients may exceed that in white and black patients. However, no difference in efficacy and safety was observed.

Not indicated for use in postmenopausal women.

Barbiturates: May decrease the serum concentration of Ulipristal. Avoid combination

Bosentan: May decrease the serum concentration of Ulipristal. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Ulipristal. Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Ulipristal. Management: This is specific for when ulipristal is being used for signs/symptoms of uterine fibroids (Canadian indication). When ulipristal is used as an emergency contraceptive, patients receiving this combination should be monitored for ulipristal toxicity. Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ulipristal. Management: This is specific for when ulipristal is being used for signs/symptoms of uterine fibroids (Canadian indication). When ulipristal is used as an emergency contraceptive, patients receiving this combo should be monitored for ulipristal toxicity. Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Efavirenz: May decrease the serum concentration of Ulipristal. Avoid combination

Felbamate: May decrease the serum concentration of Ulipristal. Avoid combination

Griseofulvin: May decrease the serum concentration of Ulipristal. Avoid combination

OXcarbazepine: May decrease the serum concentration of Ulipristal. Avoid combination

Progestins: Ulipristal may diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Management: Ulipristal for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping ulipristal; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping ulipristal. Avoid combination

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

St John's Wort: May decrease the serum concentration of Ulipristal. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Topiramate: May decrease the serum concentration of Ulipristal. Avoid combination