Drugs List

Therapeutic Indications

Uses

Emergency contraception (within 120 hours of intercourse)

Contraindications

Galactosaemia
Pregnancy
Severe hepatic impairment
Severe uncontrolled asthma

Precautions and Warnings

Children under 18 years
Breastfeeding
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance

Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Repeated use within one menstrual cycle is not advisable
Exclude pregnancy prior to initiation of treatment
If pregnancy occurs possibility of ectopic pregnancy should be considered
Vomiting or severe diarrhoea may impair efficacy
Advise patient not to take St John's wort concurrently
Female: Barrier contraception recommended for the rest of the monthly cycle
Advise patient early or late onset of next menstrual period is possible
Take another dose if vomiting occurs within 3 hours

Pregnancy and Lactation

Pregnancy

Ulipristal acetate is contraindicated in pregnancy.

Extremely limited data are available on the health of the foetus/newborn in case a pregnancy is exposed to ulipristal acetate. Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity.

The manufacturer has requested that healthcare providers inform them of the outcome of any pregnancies that occur despite treatment with ulipristal acetate, including undetected pregnancies at the time of treatment or pregnancies that occurred due to treatment failure. The information should be recorded at the pregnancy registry website at www.hra-pregnancy-registry.com

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ulipristal acetate with caution in breastfeeding.

Ulipristal acetate is excreted in breast milk. The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. The manufacturers recommend that breastfeeding is withheld for one week after taking ulipristal acetate, during this time breast milk should be expressed and discarded in order to stimulate lactation. However, the UK Medicines Information (UKMi) suggest that withholding breastfeeding is not necessary as the risk to the newborn/infant is low.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Abnormal sensation in eye
Acne
Anxiety
Arthralgia
Attention disturbances
Back pain
Bladder pain
Breast pain
Changes in libido
Chest discomfort
Chills
Chromaturia
Conjunctival infection
Constipation
Cough
Dehydration
Diarrhoea
Disorientation
Disturbances of appetite
Dizziness
Dry mouth
Dry throat
Dysgeusia
Dysmenorrhoea
Dyspareunia
Dyspepsia
Epistaxis
Extremity pain
Fatigue
Flatulence
Gastroesophageal reflux disease
Genital pain
Genital pruritus
Headache
Hordeolum
Hot flushes
Influenza
Insomnia
Irritability
Malaise
Menorrhagia
Menstrual disturbances
Metrorrhagia
Migraine
Mood changes
Muscle spasm
Musculoskeletal pain
Myalgia
Nasal congestion
Nasopharyngitis
Nausea
Nephrolithiasis
Ocular hyperaemia
Ovarian cysts
Pain
Parosmia
Pelvic inflammatory disease
Photophobia
Premenstrual-like syndrome
Pruritus
Pyrexia
Rash
Renal pain
Skin lesions
Sleep disturbances
Somnolence
Syncope
Thirst
Tooth ache
Tremor
Urinary tract disorders
Urinary tract infections
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vaginitis
Vertigo
Visual disturbances
Vomiting

Presentation

Tablet containing 30 mg ulipristal acetate

Drugs List

Therapeutic Indications

Uses

Emergency contraception (within 120 hours of intercourse)

Dosage

Adults

Adolescents

Contraindications

Galactosaemia
Pregnancy
Severe hepatic impairment
Severe uncontrolled asthma

Precautions and Warnings

Children under 18 years
Breastfeeding
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance

Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Repeated use within one menstrual cycle is not advisable
Exclude pregnancy prior to initiation of treatment
If pregnancy occurs possibility of ectopic pregnancy should be considered
Vomiting or severe diarrhoea may impair efficacy
Advise patient not to take St John's wort concurrently
Female: Barrier contraception recommended for the rest of the monthly cycle
Advise patient early or late onset of next menstrual period is possible
Take another dose if vomiting occurs within 3 hours

Pregnancy and Lactation

Pregnancy

Ulipristal acetate is contraindicated in pregnancy.

Extremely limited data are available on the health of the foetus/newborn in case a pregnancy is exposed to ulipristal acetate. Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity.

The manufacturer has requested that healthcare providers inform them of the outcome of any pregnancies that occur despite treatment with ulipristal acetate, including undetected pregnancies at the time of treatment or pregnancies that occurred due to treatment failure. The information should be recorded at the pregnancy registry website at www.hra-pregnancy-registry.com

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ulipristal acetate with caution in breastfeeding.

Ulipristal acetate is excreted in breast milk. The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. The manufacturers recommend that breastfeeding is withheld for one week after taking ulipristal acetate, during this time breast milk should be expressed and discarded in order to stimulate lactation. However, the UK Medicines Information (UKMi) suggest that withholding breastfeeding is not necessary as the risk to the newborn/infant is low.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patient that ulipristal should not be taken with levonorgestrel emergency contraception.

Advise patient the ulipristal has to be taken within 120 hours of unprotected intercourse and that pregnancy will not be prevented in all cases.

If vomiting occurs within 3 hours of ulipristal acetate intake, another tablet should be taken.

If patient is using hormonal contraception, advise her that additional barrier methods should be used until the next menstrual period starts.

Advise patient that pregnancy must be excluded before treatment.

Advise patient that after ulipristal acetate intake menstrual periods can sometimes occur earlier or later than expected by a few days. In some cases this has been observed up to 20 days.

Side Effects

Abdominal pain
Abnormal sensation in eye
Acne
Anxiety
Arthralgia
Attention disturbances
Back pain
Bladder pain
Breast pain
Changes in libido
Chest discomfort
Chills
Chromaturia
Conjunctival infection
Constipation
Cough
Dehydration
Diarrhoea
Disorientation
Disturbances of appetite
Dizziness
Dry mouth
Dry throat
Dysgeusia
Dysmenorrhoea
Dyspareunia
Dyspepsia
Epistaxis
Extremity pain
Fatigue
Flatulence
Gastroesophageal reflux disease
Genital pain
Genital pruritus
Headache
Hordeolum
Hot flushes
Influenza
Insomnia
Irritability
Malaise
Menorrhagia
Menstrual disturbances
Metrorrhagia
Migraine
Mood changes
Muscle spasm
Musculoskeletal pain
Myalgia
Nasal congestion
Nasopharyngitis
Nausea
Nephrolithiasis
Ocular hyperaemia
Ovarian cysts
Pain
Parosmia
Pelvic inflammatory disease
Photophobia
Premenstrual-like syndrome
Pruritus
Pyrexia
Rash
Renal pain
Skin lesions
Sleep disturbances
Somnolence
Syncope
Thirst
Tooth ache
Tremor
Urinary tract disorders
Urinary tract infections
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vaginitis
Vertigo
Visual disturbances
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2015

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 02 June 2015.

Summary of Product Characteristics: EllaOne 30 mg tablet. HRA Pharma UK Ltd. Revised January 2015.

UK Medicines Information. UKMi Medicines Q&As
https://www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Last accessed: 03 June 2015