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What is Relumina (relugolix)?

Relumina (relugolix) is a medicine indicated for the management of the following symptoms associated with uterine fibroids: excessive menstruation, abdominal pain, low back pain, and anaemia. It is available in tablet form, with each tablet containing 40 mg of relugolix^[1].

How does Relumina (relugolix) work?

 

Uterine fibroids are non-cancerous growths of the uterus which usually form during childbearing years.

While it is not clearly known what causes fibroids, research and clinical experiences seem to suggest that the growths are derived from the abnormal muscle cells in the uterus which grow very quickly under the influence of oestrogen.^[2,3]

Oestrogen is a hormone which induces the development of the inner layer of the uterus during each menstrual cycle in preparation for pregnancy, also causing the growth of fibroids^[2]. The active ingredient in Relumina, relugojix, is a gonadotropin-releasing hormone (GnRH) receptor antagonist which suppresses the production of ovarian-stimulating GnRH hormones (luteinising and follicle-stimulating hormone). Thereby it inhibits the release of oestrogen, stops menstruation and reduces the disease related symptoms^[1].

Where has Relumina (relugolix) been approved?

 

Relumina (relugolix) was approved for the management of the symptoms caused by uterine fibroids by:

• Pharmaceuticals and Medical Devices Agency (PMDA), Japan, February 2019^[1].

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

 

How is Relumina (relugolix) taken?

 

The standard dosage is^[1]:

 

• 40 mg taken orally once daily.

Reduction in dose may be required based on symptoms and experienced side effects.

Complete information about Relumina (relugolix) dosage and administration can be found in the official prescribing information listed in our references section.

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known side effects or adverse reactions of Relumina (relugolix)?

 

Common adverse reactions

 

The most common adverse reactions listed in the prescribing information include^[1]:

 

• hot flushes

• irregular uterine bleeding

• heavy menstrual bleeding

• headache

• hyperhidrosis (excessive sweating)

• genital bleeding.

 

Serious adverse reactions

 

The serious adverse reactions listed in the prescribing information include^[1]:

 

• depression

• liver function disorder (increase in AST, ALT levels).

 

Use in specific populations

 

Relumina (relugolix) use early in pregnancy may increase the risk of early pregnancy loss. It is advised to avoid taking Relumina (relugolix) during pregnancies and while breastfeeding^[1].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1].

References

1. Summary of Product Characteristics [PMDA]: Relumina (relugolix) [PDF]

 

Takeda Pharmaceutical Co., Ltd., February 2019

2. Mayo Clinic, Uterine fibroids, cited on 07/03/2019.

3. UCLA Health, fibroids, cited on 07/03/2019.

4. ClinicalTrials.gov, A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids, cited on 07/03/2019.

5. ClinicalTrials.gov, A Placebo-Controlled, Phase 3 Study of TAK-385 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids, cited on 07/03/2019.