Ulipristal acetate is a hormonal drug that inhibits ovulation, follicular rupture, and induces apoptosis of uterine fibroids.

Ulipristal acetate Uses:

• Emergency contraception (Ella):

  • It is used as an emergency contraceptive drug for the prevention of pregnancy following unprotected sexual intercourse or following contraceptive failure.

• Uterine fibroids (Fibristal):

  • It is used for the treatment of uterine fibroids in women of reproductive age with moderate to severe symptoms.

Ulipristal acetate Dose in Adults

Ulipristal acetate Dose in Emergency contraception (Ella):

• Ella 30 mg orally soon after unprotected sexual intercourse or following the failure of a contraceptive device.
• It may be taken as late as within five days (120 hours) of unprotected sexual intercourse.

Ulipristal acetate Dose in the treatment of Uterine fibroids (Fibristal):

• Premenopausal Females:

  • Fibristal 5 mg orally once a day for three consecutive months
  • The treatment should be initiated within the first seven days of the menstrual cycle.
  • The subsequent treatment courses should be initiated within the first week of the second menstruation following completion of the prior treatment course.
  • The recommended treatment-free interval between treatment courses is two menstrual cycles.
  • Up to four intermittent treatment courses may be repeated.

Ulipristal acetate Dose in Childrens

Ulipristal acetate Dose in Emergency contraception (Ella):

• Children and Adolescents (prepubertal):

  • It is not indicated in prepubertal children (prior to menarche).

• Postpubertal Adolescents:

  • Refer to adult dosing.

Ulipristal acetate Pregnancy Risk Category: X

• If you are pregnant or have a suspicion of becoming pregnant, it is not recommended.
• It is not recommended for termination of a pregnancy. A pregnancy test should be done prior to intake.
• It should only be used as an emergency contraceptive. Routine contraceptive measures should then be taken as the return to fertility is quick.
• It is possible for hormonal contraception to lose effectiveness after it has been taken.
• Therefore, barrier methods of contraception should be used immediately following emergency contraception.
• Manufacturers recommend a wait of at least 5 days between taking ulipristal and when you start to take oral hormonal contraceptives.
• The CDC recommends that you use any type of contraception and barrier contraception during the first 14 days of emergency contraception.
• Ulipristal may not be as effective in obese females with a BSA > 30kg/m2.

Ulipristal acetate use during breastfeeding:

• Breastmilk contains Ulipristal and its activemetabolite.
• Manufacturers recommend that you weigh the risks to your infant and the benefits for the mother.
• The CDC recommends that breastmilk be used by breastfeeding mothers as an emergency contraceptive.
• However, it should not be consumed for more than 24 hours after intake of ulipristal.

Dose in kidney disease:

• Ella:

  • It has not been studied in patients with kidney disease.
  • The manufacturer has not recommended any adjustments in the dose.
  • However, since it is minimally excreted via the kidneys, dose adjustment may not be necessary.

• Fibristal:

  • Since it is minimally excreted via the kidneys, dose adjustment may not be necessary.
  • The manufacturer does not recommend its use in patients with moderate or severe renal impairment unless the patient is closely supervised.

Ulipristal acetate dose in Liver disease:

• Ella:

  • It has not been studied in patients with liver disease.
  • The manufacturer has not recommended any adjustments in the dose.

• Fibristal:

  • In mild to moderate liver disease, an adjustment in the dose is not necessary.
  • In severe liver disease, the manufacturer recommends avoiding its use.

Emergency contraception (ella):

Common Side Effects of Ella (Ulipristal acetate) Include:

• Central Nervous System:

  • Headache

• Endocrine & Metabolic:

  • Suppressed Menstruation

• Gastrointestinal:

  • Abdominal Pain
  • Nausea

• Genitourinary:

  • Dysmenorrhea

Less Common Side Effects of Ella (Ulipristal acetate) Include:

• Central Nervous System:

  • Fatigue
  • Dizziness

• Endocrine & Metabolic:

  • Intermenstrual Bleeding

• Genitourinary:

  • Early Menses

Common Side Effects of Fibristal (Ulipristal acetate) Include:

• Central nervous system:

  • Headache

• Endocrine & metabolic:

  • Hot flash

Less Common Side Effects of Fibristal (Ulipristal acetate) Include:

• Cardiovascular:

  • Edema
  • Hypotension
  • Sinus Bradycardia

• Central Nervous System:

  • Fatigue
  • Vertigo
  • Insomnia
  • Dizziness
  • Aggressive Behavior
  • Drowsiness
  • Emotional Lability
  • Migraine
  • Sleep Disorder

• Dermatologic:

  • Night Sweats
  • Acne Vulgaris
  • Alopecia
  • Seborrhea
  • Xeroderma

• Endocrine & Metabolic:

  • Hypercholesterolemia
  • Hypertriglyceridemia
  • Hypothyroidism
  • Obesity
  • Amenorrhea
  • Increased Gamma-Glutamyl Transferase
  • Ovarian Cyst
  • Ovarian Hyperstimulation
  • Thyroid Disease

• Gastrointestinal:

  • Nausea
  • Constipation
  • Dyspepsia
  • Upper Abdominal Pain

• Genitourinary:

  • Mastalgia
  • Pelvic Pain
  • Endometrial Hyperplasia
  • Genital Bleeding
  • Breast Swelling
  • Breast Tenderness
  • Genital Discharge
  • Uterine Disease
  • Uterine Hemorrhage
  • Vaginal Dryness
  • Vulvovaginal Candidiasis

• Infection:

  • Herpes Virus Infection

• Neuromuscular & Skeletal:

  • Arthralgia
  • Muscle Spasm
  • Back Pain
  • Limb Pain

• Respiratory:

  • Dyspnea
  • Epistaxis
  • Pharyngitis

• Miscellaneous:

  • Fever

Contraindications to Ulipristal acetate Include:

• Pregnancy known or suspected
• Allergy reactions to any component of the drug or the drug itself
• Breastfeeding
• Genital bleeding other that bleeding fibroids or of unknown origin
• Liver disease, current or past history
• Ovarian, Cervical, and Breast Cancer.

Warnings and precautions

• Bleeding irregularities:

  • It is possible to notice temporary irregularities in menstrual flow (both menorrhagia or oligomenorrhea).
  • Intermenstrual bleeding may also be noticed by the patient
  • A pregnancy test should be done if the menstrual cycle is delayed for more than one week.
  • Fibristal is used to treat uterine fibroids. Usually, the symptoms of amenorrhea and oligomenorrhea are noticed within the first ten day. They usually return to normal in four weeks.

• Endometrial thickening

  • Ulipristal can increase endometrial thickness. 
  • Progesterone receptor modulator-associated endometrial changes (PAEC), which is a term that describes endometrial thickness due to progesterone, can be confused with endometrial hyperplasia.
  • This is particularly true when Fibristal is used to treat uterine fibroids.
  • The normalization of the endometrium is achieved by stopping treatment.
  • If the endometrial effects persist after stopping the drug for longer than three months, you should consult a doctor immediately.
  • Additionally, the histopathologist should know the Ulipristal-associated PAEC when performing histopathological analyses.

• Asthma

  • Fibristal, a Canadian product, is not recommended for patients suffering from severe and uncontrolled asthma.

Ulipristal: Drug Interaction

Monitor:

• A pregnancy test should be performed if the menstrual cycle is delayed by more than one week.
• Pregnancy (uterine or ectopic) should also be evaluated for if abdominal pain develops 3 - 5 weeks after its administration or persistent irregular bleeding develops.
• A pregnancy test should also be performed if bleeding does not occur within three weeks of the use of emergency contraceptive pills.

Fibristal [Canadian product]:

• Prior to initiating the treatment, a pregnancy test should be performed.
• Periodic monitoring of the endometrium should be done especially if unexpected or persistent irregular bleeding occurs.

How to administer Ulipristal acetate (Ella)?

• Ella:

  • It may be administered at any time during the menstrual cycle with or without food. The dose should be repeated if vomiting occurs within three hours of its administration.

• Fibristal:

  • It should be taken within the first seven days of the menstrual cycle at any time of the day with or without food.

Mechanism of action of Ulipristal acetate (Ella):

It blocks the binding of progestin and the progesterone receptor. This can delay or inhibit ovulation. It can also affect implantation by altering normal endometrium. It can also be used to treat uterine fibroids by inhibiting cell proliferation and inducing endometrial death.

It is growing rapidly absorbed When taken orally. The drug contains more than 98%.protein-bound(albumin), alpha-acid glycoprotein and high-density lipoprotein.

It is Metabolized It is metabolized by the liver using CYP3A4 (active and inactive metabolites). 

It is a half-life elimination approximately 32-38 hours, and the time it takes to get there peak serum concentration It takes approximately one hour. 

It takes approximately one hour. excreted The drug is mainly excreted in the feces.

International Brands of Ulipristal acetate:

• 5X
• Duella
• ella
• Ella
• ellaOne
• EllaOne
• Esmia
• Esmya
• Femelle One
• Gesprital
• Inisia
• Norpregna
• Peuli
• Post Day Plus
• Postday Plus
• Tulip
• Uliroid
• Utal
• Ella
• Fibristal

Ulipristal acetate Brand Names in Pakistan:

No Brand Available in Pakistan.