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Drug Details

ellaOne 30 mg tablet

• Presentation
  Tablet White to off-white, round curved tablet engraved with code “?ll?” on both faces
• Description
  Each tablet contains 30 mg ulipristal acetate. Excipients: each tablet contains 237 mg lactose monohydrate.
• Indications
  

  Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

• Adult Dosage
  

  The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.

  The tablet can be taken with or without food.

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

  ellaOne can be taken at any moment during the menstrual cycle.

  Pregnancy should be excluded before ellaOne is administered.

  Renal or hepatic impairment
  In the absence of specific studies, no specific dose recommendations for ellaOne can be made.

  Severe hepatic impairment
  In the absence of specific studies, ellaOne is not recommended.

  Children and adolescents
  A limited number of women under 18 years were included in clinical trials of ellaOne.

• Contra Indications
  

  Hypersensitivity to the active substance or to any of the excipients.

  Pregnancy.

• Special Precautions
  

  Concomitant use with an emergency contraceptive containing levonorgestrel is not recommended.

  Use in women with severe asthma insufficiently controlled by oral glucocorticoid is not recommended.

  Emergency contraception with ellaOne is an occasional method. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.

  Although the use of ellaOne does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action. Therefore, after using emergency contraception, it is recommended that subsequent acts of intercourse be protected by a reliable barrier method until the next menstrual period starts.

  Repeated administration of ellaOne within the same menstrual cycle is not advisable, as safety and efficacy of ellaOne after repeated administration within the same menstrual cycle has not been investigated.

  Emergency contraception with ellaOne does not prevent pregnancy in every case. No data is available on the efficacy of ellaOne for women who have had unprotected intercourse more than 120 hours before ellaOne intake. In case of doubt, delay of more than 7 days in next menstrual period, abnormal bleeding at the expected date of menses, or symptoms of pregnancy, pregnancy should be excluded by a pregnancy test.

  If pregnancy occurs after treatment with ellaOne, as for all pregnancies, the possibility of an ectopic pregnancy should be considered. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.

  After ellaOne intake menstrual periods can sometimes occur earlier or later than expected by a few days. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.

  This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Interactions
  

  Ulipristal acetate is metabolized by CYP3A4 in vitro. No specific drug interaction studies have been performed in vivo.

  • Potential for other medicinal products to affect ulipristal acetate:

  CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, ritonavir, St John’s wort/Hypericum perforatum) may reduce plasma concentrations of ulipristal acetate and may result in decrease in efficacy. Concomitant use is therefore not recommended. Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer within the last 2-3 weeks.

  Concomitant administration of medicinal products that increase gastric pH (e.g. proton pump inhibitors, antacids and H2-receptor antagonists) may reduce plasma concentrations of ulipristal acetate and may result in decrease in efficacy. Concomitant use is therefore not recommended.
  
  Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, telithromycin, clarithromycin, nefazodone) may increase exposure to ulipristal acetate. The clinical relevance is unknown.

  • Potential for ulipristal acetate to affect other medicinal products:

  Because ulipristal acetate binds the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products:

  - Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced
  - Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.

• Adverse Drug Reactions
  

  Adverse events reported in more than 10 percent of subjects treated with ulipristal were headache, nausea and abdominal pain
  Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.

  The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. The vast majority of adverse reactions were mild or moderate and resolved spontaneously.

  Adverse reactions listed below are classified according to frequency and system organ class. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

   

  MedDRA						Adverse reactions (frequency)
  System Organ Class	Very common ≥1/10			Common ≥1/100 to <1/10			Uncommon ≥1/1,000 to <1/100			Rare ≥1/10,000 to <1/1,000
  Infections and infestations			Vaginitis Nasopharyngitis Influenza Urinary tract infection					Conjonctivitis infective Hordeolum Pelvic inflammatory disease
  Metabolism and nutrition disorders			Appetite disorders					Dehydration
  Psychiatric disorders		Mood disorders			Emotional disorder Anxiety Insomnia Hyperactivity disorder Libido changes				Disorientation
  Nervous system disorders		Headache Dizziness			Somnolence Migraine				Tremor Disturbance in attention Dysgueusia Poor quality of sleep Parosmia Syncope
  Eye disorders			Visual disturbance					Abnormal sensation in eye Ocular hyperaemia Photophobia
  Ear and labyrinth disorders						Vertigo
  Vascular disorders			Hot flush					Haemorrhage
  Respiratory, thoracic and mediastinal disorders						Upper respiratory tract congestion Cough Dry throat Epistaxis
  Gastrointestinal disorders		Nausea Abdominal pain (NOS) Abdominal pain upper Abdominal discomfort Vomiting			Abdominal pain lower Diarrhoea Dry mouth Constipation Dyspepsia Flatulence				Gastro-oesophageal reflux disease Toothache
  Skin and subcutaneous tissue disorders			Acne Skin lesion Pruritus					Urticaria Genital pruritus
  Musculoskeletal and connective tissue disorders			Myalgia Back pain					Pain in extremity Arthralgia
  Renal and urinary disorders						Urinary tract disorder Chromaturia Nephrolithiasis Renal Pain Bladder pain
  Reproductive system and breast disorders		Dysmenorrhea Pelvic pain Breast tenderness			Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Vaginal haemorrhage Hot flush Premenstrual syndrome				Genital pruritus Dysfunctional uterine bleeding Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Menstrual discomfort Hypomenorrhea
  General disorders and administration site conditions		Fatigue			Pain Irritability Chills Malaise Pyrexia				Chest discomfort Inflammation Thirst

  The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The delay was greater than 20 days in 4 % of the women.

  A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.

  In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times). There were no safety differences in these subjects in terms of incidence and severity of adverse events, change in duration or volume of menses or incidence of intermenstrual bleeding.