Last update Aug. 7, 2018

Ulipristal Acetate (treatment of Myomas, Fibroids)

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Selective modulator of progesterone receptors with slightly antagonistic effect on it.
It is used on the treatment of uterine fibroids (Donnez 2012, Vázquez 2013) and as an emergency contraceptive.

This comment informs about its use for TREATMENT OF FIBROIDS

A high plasma protein-binding capacity explains its small passage (0.02 mg / L) into breastmilk observed at the first day (HRA Pharma 2015: 8.3).

As an emergency contraceptive it is a medication of limited and occasional use. World Health Organization considers it compatible with breastfeeding on such cases. (WHO 2015). See specific info on "Ulipristal acetate (contraceptive)".

On the treatment of fibroids, the issue of a possible increased risk is posed on long lasting treatments (one daily intake on cycles of 3 months each at a maximum of 4 cycles with a two-months resting period between cycles). Theoretically, the relative daily dose ingested by the infant would reach 1%, that is, on an each complete cycle (90 days) the infant would not even have been able to ingest the dose (weight-based) corresponding to one-day treatment.
There are no published data on this medication related to breastfeeding, hence, a known safer alternative should be evaluated by following the best health caregiver knowledge.

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For Ulipristal as an EMERGENCY CONTRACEPTIVE, see specific info on "Ulipristal acetate (contraceptive)”.


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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Other names

Ulipristal Acetate (treatment of Myomas, Fibroids) in other languages or writings:

Group

Ulipristal Acetate (treatment of Myomas, Fibroids) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Ulipristal Acetate (treatment of Myomas, Fibroids) in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 476 daltons
Protein Binding 98 - 99.5 %
Tmax 0.5 - 2 hours
T½ 38 hours
M/P ratio 0.5 - 0.7 -
Theoretical Dose 0.0034 mg/Kg/d
Relative Dose 0.8 - 1 %

References

  1. EMA. Esmya (Ulipristal). Ficha técnica. 2016 Full text (in our servers)
  2. EMA. Esmya (Ulipristal). Drug Summary. 2016 Full text (in our servers)
  3. Vázquez F, Baró F, Palacios S, Parrilla JJ, Carmona F et al. Acetato de ulipristal 5 mg en el manejo de los miomas uterinos. Prog Obstet Ginecol. 2013;56(Supl. 1):2-19. 2013 Full text (in our servers)
  4. Donnez J, Tomaszewski J, Vázquez F, Bouchard P, Lemieszczuk B, Baró F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group.. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Abstract

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