Gynaecology - Ryeqo for the treatment of symptomatic fibroids and endometriosis

Ryeqo for the treatment of symptomatic fibroids and endometriosis.

As part of the NCA’s ongoing commitment to providing care, we would like to take this opportunity to inform you about a new treatment option for pelvic pain associated with endometriosis and symptomatic fibroids.

Relugolix/estradiol/norethisterone acetate: efficacy as per the spirit trials

• 85% improvement in dysmenorrhea 74% improvement in non- menstrual pelvic pain (after 1 year of treatment)
• Median time to becoming analgesia free - 16 weeks
• At 52 weeks 80% of patients were bleeding free(amenorrhoeic)
• 60% of patients who did not respond to initial therapies improved with Ryeqo
• <1% bone loss over 2 years of treatments
• Benefits sustained over the longer term

What is Ryeqo?

Ryeqo is a combined oral therapy that includes three active ingredients: Relugolix 40mg, Estradiol hemihydrate 1mg and Norethisterone acetate 0.5 mg. It works by inhibiting the release of hormones that stimulate the ovaries to produce oestrogen and progesterone by significantly lowering oestrogen levels, Ryeqo helps manage the pain associated with inflammation and abnormal tissue growth in endometriosis. Additionally, it has demonstrated efficacy in reducing the size of fibroid and heavy menstrual bleeding.

The added hormone replacement therapy component in the form of estradiol and norethisterone acetate are intended to lessen the possible side effects such as hot flushes and prevent bone thinning. The doses of these additional hormones are not sufficient to diminish the effectiveness of relugolix or trigger endometriosis flare-ups.

Why shall I consider Ryeqo?

• Effective non-surgical treatment that is well tolerated
• Taken orally as a once-daily pill
• Minimises the need for hospital visits
• When used for more than a month, also offers sufficient contraception

Potential Side Effects and Considerations

As with any treatment, it’s important to inform us about any side-effects you may experience or any challenges you face while adapting to the new medication. This can be done by contacting our Endometriosis specialist nurse or emailing Endometriosis@nca.nhs.uk.

The most common reported side-effects include:

• Hot flushes
• Headaches
• Changes in menstrual bleeding
• Mood changes and irritability
• Hair loss
• Decreased libido

Contraindications:

• Thromboembolic or thrombophilic disorder
• Migraine with aura
• Osteoporosis
• Hormone-sensitive malignancies
• Severe liver disease or impairment
• Undiagnosed abnormal uterine bleeding
• Concomitant use of contraceptives
• Pregnancy
• Breastfeeding

Special warnings and precautions for use

Any medications containing oestrogen and progesterone can increase the risk of blood clots. Since Ryeqo's hormone dosages are smaller than those of combined oral contraceptives, this risk has not been fully established. We will discuss this with you before starting the medication, however, be advised that any of the following could further increase your risk of developing blood clots:

• Obesity (BMI>30)
• Smoking
• Age >35
• Hypertension
• Family history of blood clots in a first-degree relative
• Other medical conditions associated with VTE (Cancer, systemic lupus erythematosus, chronic inflammatory bowel disease and sickle cell disease

Additional monitoring

Ryeqo carries a small risk of bone thinning. If you decide to stay on this medication for more than 1 year, a bone mineral density scan will be arranged. If this is normal, you can safely continue Ryeqo without the need for additional tests.

Ryeqo and Contraceptive considerations

Ryeqo stops ovulation, so you are unlikely to get pregnant whilst following the usual once daily recommended dose.

When starting Ryeqo it may take time to achieve full inhibition of ovulation. Therefore, a non-hormonal contraceptive method is recommended for a month after initiation of treatment and for 7 days following two or more consecutive missed doses.

How long can I be on Ryeqo for?

Data beyond two years of treatment remains limited, but current evidence supports it can be used for an extended period if well tolerated and no bone density loss is noted after 1 year of treatment.

Next Steps

The initial prescription for this medication needs to be prescribed by us and be collected from the Royal Oldham Hospital pharmacy. Your GP will then be notified of the change in your treatment, and a repeat prescription can be issued for you.

For more information, please get in touch with our endometriosis nurses or email Endometriosis@nca.nhs.uk