282018Aug

Norlutate addback

Norlutate®
Norethindrone acetate, Progestin

Norlutate® is the only norethindrone acetate 5 mg formulation currently approved on the Canadian market.1
Indications: – Amenorrhea
– Endometriosis
– Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology,
such as submucous fibroids or uterine cancer2
Note: NORLUTATE® (Norethindrone Acetate) should be prescribed only to women with intact uteri.2

Endometriosis
According to SOGC guideline, progestins alone are considered as first line, and combined with GnRH
agonists as second line treatment for endometriosis.3
Norlutate® as monotherapy: Dose: Initial daily dose of 5 mg for 2 weeks with increments of 2.5 mg/day every
2 weeks until 15 mg/day is reached.2
Norlutate® as add-back therapy to alleviate the hypo estrogenic symptoms of GnRH agonists while
preserving therapeutic efficacy. Dose: Lupron Depot + norethindrone 5 mg daily (up to 6 months).4
Norethindrone 5mg is listed as an ‘add-back therapy’ in Lupron® monograph.4

Uterine fibroids
Norlutate® & Fibristal: 6
Fibristal® (ulipristal): ulipristal 5 mg is indicated in moderate to severe signs and symptoms of uterine fibroids
in adult women of reproductive age, who are eligible for surgery.5
Study outcomes: women treated with norethindrone after ulipristal had an earlier onset of menstrual
bleeding and a decreased amount of blood. Norethindrone may be used to better control the timing or
amount of menstrual bleeding after ulipristal before a planned invasive surgical procedure.6
Dose: norethindrone 10 mg/day for 10 days was administered in between 3 month treatments with ulipristal.6

Norlutate® & hysteroscopy: 7
In the Institute of Reproductive Medicine in NJ, USA, up to date, norethindrone 5mg has been used
successfully on hundreds of patients as a preparation for uterine fibroid surgery, including the ones with
severe abnormal uterine bleeding from large submucous fibroids. As a result of norethindrone pretreatment,
the lining at the time of surgery was atrophic and vessels smaller, making the surgery that much easier.
Daily dose: 3×5 mg norethindrone.7

1- Health Canada Drug Product Database – consulted on June 12th 2018
2-Norlutate® product monograph, ERFA Canada 2012 Inc.
3-Endometriosis: Diagnosis and Management, SOGC CLINICAL PRACTICE GUIDELINE, Journal of Obstetrics and Gynaecology Canada, Volume 32, Number 7, July 2010.
4-PRODUCT MONOGRAPH LUPRON DEPOT®, AbbVie Corporation Feb 7, 2017
5-Product monograph “Fibristal® ”, Allergan 2016
6-Donnez Jacques et al. Long-term treatment of uterine broids with ulipristal acetate, Fertility and sterility, Volume 101, Issue 6, 1565 – 1573 e 18, June 2014.
7-Dre Serena H. Chen, FACOG, NJ, USA: 51st Annual Congress of The AOGQ, Montreal