Kliovance

Kliovance (also marketed as Activelle) is a continuous combined hormone replacement therapy (HRT) tablet containing estradiol and norethisterone acetate.

It is prescribed for postmenopausal women to relieve vasomotor symptoms such as hot flushes and night sweats, and to prevent postmenopausal osteoporosis when other therapies are not suitable.

Estradiol replaces the oestrogen that the ovaries no longer produce after menopause, addressing the root cause of menopausal symptoms.

Norethisterone acetate is a progestogen added to protect the endometrium from the stimulatory effect of unopposed oestrogen, which would otherwise increase the risk of endometrial hyperplasia and cancer.

Continuous Combined Regimen

Because Kliovance delivers both hormones every day without a break, it is designed for women who are at least 12 months past their last natural period.

This regimen avoids monthly withdrawal bleeds, which is a key practical advantage over sequential HRT. Some irregular spotting may occur during the first few months but usually settles.

How to Take Kliovance

Take one tablet daily at the same time each day, with or without food. Swallow whole with water.

Starting Treatment

Kliovance is suitable only for women who have not had a period for at least 12 months. Women switching from a sequential (cyclical) HRT should start Kliovance at the end of the progestogen phase.

Missed Dose

If you miss a dose, take it as soon as you remember unless more than 12 hours have passed. In that case, skip the missed dose and take the next one at the usual time.

Missing doses may increase the chance of breakthrough bleeding.

Standard Dose

• One tablet daily containing estradiol 1 mg and norethisterone acetate 0.5 mg

Duration

• Use the lowest effective dose for the shortest time necessary to control symptoms
• Review the need for continued treatment at least annually

No Dose Titration

• This is a fixed-dose combination; if the dose is insufficient, the prescriber may switch to a higher-strength HRT preparation

Hepatic and Renal Impairment

• Contraindicated in active liver disease
• No specific dose adjustment for renal impairment, but monitor

Common (up to 1 in 10 women)

• Breast tenderness or pain
• Irregular vaginal bleeding or spotting (especially in the first 3-6 months)
• Headache
• Nausea
• Abdominal pain or bloating

Uncommon (up to 1 in 100 women)

• Weight gain
• Mood changes or depression
• Leg cramps
• Fluid retention

Rare (up to 1 in 1,000 women)

• Venous thromboembolism (deep vein thrombosis or pulmonary embolism)
• Gallbladder disease
• Elevated blood pressure

Very Rare (fewer than 1 in 10,000 women)

• Stroke
• Breast cancer (risk increases with duration of use beyond 5 years)
• Endometrial cancer (risk minimised by the progestogen component)

Breakthrough bleeding that persists beyond six months should be investigated.

Thromboembolism

HRT carries a small increased risk of venous and arterial thromboembolism.

The risk is highest in the first year of use and in women with additional risk factors (obesity, immobility, personal or family history of VTE, thrombophilia).

Stop Kliovance and seek urgent help if you develop a painful swollen leg, sudden breathlessness, or chest pain.

Breast Cancer

Combined HRT is associated with a slightly increased risk of breast cancer, which rises with duration of use.

Attend all routine breast screening appointments and report new breast lumps or changes promptly.

Endometrial Safety

The progestogen in Kliovance protects the endometrium, but unexpected vaginal bleeding after the first six months should be investigated with ultrasound or biopsy.

Annual Review

Discuss the continued need for HRT with your prescriber at least once a year.

Do not take Kliovance if you have:

• Known or suspected breast cancer or a history of breast cancer
• Known or suspected oestrogen-dependent malignancy (e.g., endometrial cancer)
• Undiagnosed vaginal bleeding
• Untreated endometrial hyperplasia
• Active or recent venous thromboembolism (DVT, PE)
• Active or recent arterial thromboembolism (stroke, MI)
• Active liver disease or a history of liver disease where function tests have not returned to normal
• Known thrombophilic disorders
• Porphyria
• Hypersensitivity to estradiol, norethisterone, or any excipient