Ulipristal. acetate [elle one ]

Question 1

Question

Answer 1

Answer

Question 2

Drug action

Answer 2

For ulipristal acetate: Ulipristal acetate is a synthetic, selective progesterone receptor modulator with a partial progesterone antagonist effect.

Question 3

Indications and dose (Emergency Contraception)

Answer 3

1. By mouth
2. Females of childbearing potential
3. 30 mg for 1 dose, to be taken as soon as possible after coitus,
4. No later than after 120 hours.

Question 4

Indications and dose (Uterine fibroids)

Answer 4

1. By mouthAdult
2. 5 mg daily for up to 3 months, starting during the first week of menstruation,
3. treatment course may be repeated if necessary;
4. re-treatment should start no sooner than during the first week of the second menstruation following completion of the previous course;
5. maximum 4 courses.

Question 5

Important safety information

Answer 5

1. Rare but serious cases of liver injury and hepatic failure requiring liver transplantation have been reported worldwide in women treated with Esmya®

Liver function should be monitored before, during, and after treatment courses (see Monitoring requirements);

Esmya® should not be used in those with an underlying liver disorder.

Patients should be advised to stop therapy and seek immediate medical advice if any signs of liver damage develop

There are currently no concerns with the use of the emergency contraceptive ellaOne®—see Indications and dose.

Question 6

Contra-indications (General)

Answer 6

1. Breast cancer;
2. cervical cancer;
3. ovarian cancer;
4. severe asthma controlled by oral glucocorticoids;
5. undiagnosed vaginal bleeding;
6. uterine cancer

Question 7

Contra-indications (Specific for Uterine fibroids)

Answer 7

When used for Uterine fibroids
Vaginal bleeding not caused by uterine fibroids

Question 8

Interactions

Answer 8

Link to view interactions for ulipristal

Question 9

Side-effects

Answer 9

1. Asthenia;
2. breast abnormalities;
3. dizziness;
4. endometrial thickening; gastrointestinal discomfort; headaches;
5. hot flush;
6. menstrual cycle irregularities;
7. mood altered; myalgia;
8. ovarian and fallopian tube disorders; pain; pelvic pain; skin reactions; vertigo; vomiting; weight increased

Question 10

Conception and contraception

Answer 10

When used for Uterine fibroids:
1. Non-hormonal contraceptive methods should be used during treatment
2. And 12 days after stopping, if required.

Question 11

Pregnancy (Emergency Contraception)

Answer 11

Limited information available

if pregnancy occurs, report to the
ellaOne® pregnancy registry.

Question 12

Pregnancy (Uterine fibroids)

Answer 12

Avoid
limited information available.

Question 13

Breast feeding (Emergency Contraception)

Answer 13

Avoid for 1 week after administration
present in milk.

Question 14

Breast feeding (Uterine fibroids)

Answer 14

Avoid
present in milk
but no further information available.

Question 15

Hepatic impairment (Emergency Contraception)

Answer 15

Avoid in severe impairment
no information available.

Question 16

Hepatic impairment (Uterine fibroids)

Answer 16

Avoid
risk of increased exposure.

Question 17

Renal impairment (Uterine fibroids)

Answer 17

Avoid in severe impairment unless patient is closely monitored

no information available.

Question 18

Monitoring requirements

Answer 18

Monitoring of patient parameters…
(Detailed monitoring requirements provided)

Question 19

Patient and carer advice (Emergency Contraception)

Answer 19

When prescribing or supplying hormonal emergency contraception,
women should be told:… (Detailed advice provided)

Question 20

Patient and carer advice (Uterine fibroids)

Answer 20

1. Prescribers should explain to patients the requirement for treatment-free intervals
2. see also Important safety information
3. A patient card should be provided.
4. If a dose is more than 12 hours late,
5. the missed dose should not be taken
6. and the next dose should be taken at the normal time.
5. Patients and carers should be counselled on the effects on driving and performance of skilled tasks
6.increased risk of dizziness.