Ulipristal Acetate (ella)

1. Health Canada Product Monograph — Ulipristal Acetate

• Ulipristal acetate (ella) is used for emergency prevention of pregnancy when taken within 120 hours (5 days) of unprotected intercourse or a known or suspected contraceptive failure.
• It is not intended for routine or repeated use as a regular method of contraception.
• Use of ella before menarche is not indicated.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Ulipristal acetate is contraindicated in women with known or suspected pregnancy.
• Ulipristal acetate does not interrupt an existing pregnancy and will not work if a woman is already pregnant.
• If pregnancy occurs despite treatment, the possibility of an ectopic pregnancy should be considered, since uterine bleeding can still occur with an ectopic pregnancy.
• Limited human data on pregnancies exposed to ulipristal acetate do not suggest a specific safety concern, but a pregnancy test should be performed if there is any doubt about pregnancy status.

• Ulipristal acetate passes into breast milk after a dose of ella.
• Breastfeeding is not recommended for one week after taking ella; milk should be expressed and discarded during this time to maintain milk supply.

• ella has not been studied in women over 65 years of age and is not intended for use in postmenopausal women.

• Safety and efficacy have been established in women of reproductive age, with limited data in those 16 to 18 years of age.
• Safety and efficacy are expected to be similar in postpubertal adolescents under 18 years and in adults, but use before menarche is not indicated.

• One 30 mg tablet is taken by mouth as a single dose, as soon as possible and no later than 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
• ella can be taken at any point in the menstrual cycle.
• If vomiting occurs within 3 hours of taking the tablet, another tablet should be taken.
• No dose adjustment is needed for renal impairment; ella is not recommended in severe hepatic impairment, since no alternate dosing has been established for this group.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Experience with overdose is limited; single doses up to 200 mg, well above the standard 30 mg dose, have been given to a small number of people without serious or severe adverse reactions.
• These high doses were generally well tolerated, though some women had an earlier-than-expected menstrual period, and in some cases the bleeding or spotting lasted longer, though not more heavily, than usual.
• There is no specific antidote; further treatment should be symptomatic.

• Headache may occur.
• Nausea may occur.
• Abdominal pain or discomfort may occur.
• Fatigue may occur.
• Dizziness may occur.
• Menstrual pain (dysmenorrhea) may occur.
• Muscle aches (myalgia) may occur.
• Back pain may occur.
• Breast tenderness may occur.
• Pelvic pain may occur.
• Mood changes may occur.
• Intermenstrual (breakthrough) bleeding may occur.
• Acne may occur.
• The next menstrual period may arrive a few days earlier or later than expected.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Hypersensitivity reactions, including swelling of the face, hives, or rash, have been reported.
• A delayed period beyond 7 days, or an unusually light or heavy period, can signal an unrecognized pregnancy and should prompt a pregnancy test.
• Ectopic pregnancy should be considered if pregnancy occurs despite treatment, particularly if abdominal pain develops.
• An isolated case of moderately elevated liver enzymes (ALT/AST) without other symptoms was observed in clinical trials.
• Seek urgent medical attention for difficulty breathing or swallowing, wheezing, a sudden drop in blood pressure, or swelling of the face, lips, tongue, or throat.

• Use with caution in women with a body mass index of 35 kg/m2 or greater, since effectiveness has not been specifically evaluated in this group.
• Use with caution in patients with severe hepatic impairment, since no alternate dosing has been established.
• Use with caution in patients who are lactose intolerant, since the tablet contains lactose.
• Driving or operating machinery should be avoided if dizziness, drowsiness, blurred vision, or reduced concentration occurs after taking ella.
• Repeated use of ella within the same menstrual cycle is not recommended, as safety and efficacy of repeat dosing in the same cycle have not been evaluated.
• Women who use emergency contraception repeatedly should discuss a regular, ongoing method of contraception with their healthcare professional.

• Contraindicated in patients with known hypersensitivity to ulipristal acetate or to any ingredient in the formulation.
• Contraindicated in women with known or suspected pregnancy.

• CYP3A4 inducers, including rifampicin, phenytoin, phenobarbital, carbamazepine, barbiturates, bosentan, felbamate, griseofulvin, oxcarbazepine, and topiramate, may reduce ulipristal acetate concentrations and its effectiveness; concomitant use is not recommended.
• Ritonavir, used for a longer period, can have an inducing effect on ulipristal acetate metabolism, reducing its plasma concentration even after ritonavir has recently been stopped.
• CYP3A4 inhibitors, including itraconazole and ketoconazole, may increase ulipristal acetate concentrations.
• Hormonal contraceptives, including combined and progestin-only products, may have reduced effectiveness for the remainder of the cycle after taking ella, so a reliable barrier method should be used until the next period.
• Emergency contraception containing levonorgestrel should not be taken together with ella, since combining them may reduce ella's effectiveness.
• Esomeprazole and other medicines that raise gastric pH can lower and delay ulipristal acetate absorption.
• Ulipristal acetate may inhibit P-glycoprotein at clinically relevant concentrations, potentially increasing levels of P-gp substrates such as dabigatran etexilate and digoxin.

• ella can be taken with or without food; a high-fat meal reduces peak concentration and delays absorption but does not reduce overall effectiveness for emergency contraception.

• Take as a single 30 mg dose, as soon as possible after unprotected intercourse or contraceptive failure, and no later than 120 hours (5 days) afterward; it can be taken at any time of day, with or without food.

• Store at 15°C to 25°C, in the original packaging, protected from light and moisture.
• Keep out of reach and sight of children.

• ella (ulipristal acetate) is a single-dose emergency contraceptive taken as soon as possible, and within 5 days, after unprotected sex or contraceptive failure.
• It does not protect against sexually transmitted infections and does not end an existing pregnancy.
• A reliable barrier method should be used for the rest of the cycle, since ella only protects against pregnancy from the act of intercourse it was taken for.
• See a healthcare professional if your period is more than 7 days late, unusually light or heavy, or if abdominal pain, breast tenderness, nausea, or vomiting develops after your expected period.
• Seek urgent care for signs of a severe allergic reaction, such as difficulty breathing or swelling of the face or throat.