Indivina

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Indivina on Prescriptsy

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Indivina is a prescription-only continuous combined hormone replacement therapy (HRT) tablet used to relieve the symptoms of menopause in women who are at least 12 months past their last natural period.

Each tablet contains estradiol valerate (an oestrogen) and medroxyprogesterone acetate (a progestogen).

Indivina is manufactured by Orion Pharma and is available in three strengths: 1 mg/2.5 mg, 1 mg/5 mg, and 2 mg/5 mg.

As a continuous combined preparation, it is taken every day without a break and is designed to provide symptom relief without monthly withdrawal bleeds.

The menopause is a natural biological transition that occurs when the ovaries stop producing eggs and levels of the hormones oestrogen and progesterone decline.

In the UK, the average age of menopause is 51, though it can occur at any age from the early 40s to the late 50s.

Premature menopause (before age 40) and early menopause (between 40 and 45) affect approximately 1 in 100 and 5 in 100 women respectively.

Common menopausal symptoms include hot flushes, night sweats, vaginal dryness, reduced libido, mood changes, sleep disturbance, joint aches, and difficulty concentrating.

These symptoms result from oestrogen deficiency and can significantly affect quality of life. HRT replaces the declining hormones and remains the most effective treatment for menopausal symptoms.

This page provides a comprehensive clinical overview of Indivina, covering how it works, who it is suitable for, dosage guidance, potential side effects, important safety information, and how to obtain a prescription in the United Kingdom.

Important safety information about Indivina

Before reading further, note these essential safety points about Indivina and combined HRT.

• Indivina is a prescription-only medicine (POM) and requires a clinical assessment before use.
• Continuous combined HRT is suitable only for women who are at least 12 months past their last natural period.
• Combined HRT carries a small increased risk of breast cancer, venous thromboembolism, and stroke.
• Women with a uterus must use combined HRT (not oestrogen-only) to protect the womb lining.
• Use the lowest effective dose for the shortest duration needed. Review with your prescriber at least annually.
• Report any unexpected vaginal bleeding that persists beyond 6 months to your GP.

Understanding the menopause and HRT

The menopause marks the permanent cessation of menstruation, confirmed retrospectively after 12 consecutive months without a period.

The perimenopause is the transitional phase leading up to the menopause, during which hormone levels fluctuate and symptoms often begin. The postmenopause is the period following the menopause.

Together, these stages are often referred to as the "menopausal transition."

Oestrogen has protective effects on many body systems, including the cardiovascular system, bones, brain, urogenital tract, and skin.

As oestrogen levels fall during the menopause, women may experience vasomotor symptoms (hot flushes and night sweats), urogenital atrophy (vaginal dryness, urinary frequency, recurrent urinary tract infections), musculoskeletal symptoms (joint stiffness and pain), psychological symptoms (low mood, anxiety, poor concentration, memory difficulties), and accelerated bone loss leading to osteoporosis.

HRT addresses these symptoms by restoring circulating oestrogen levels to a therapeutic range.

NICE guideline NG23 on menopause provides comprehensive recommendations for the assessment and management of menopausal symptoms.

It states that HRT is the most effective treatment for vasomotor symptoms and should be offered after a discussion of the benefits and risks tailored to the individual woman.

The British Menopause Society (BMS) provides additional clinical guidance and patient resources.

How Indivina works: mechanism of action

Indivina contains two active hormones. Estradiol valerate is a prodrug that is converted in the body to 17-beta estradiol, the principal oestrogen produced by the ovaries.

After absorption, estradiol binds to oestrogen receptors in target tissues, restoring the hormonal signals that decline during menopause.

This relieves vasomotor symptoms, improves urogenital tissue health, helps maintain bone mineral density, and may improve mood and sleep.

Medroxyprogesterone acetate (MPA) is a synthetic progestogen.

In women who still have a uterus, taking oestrogen alone (unopposed oestrogen) stimulates the endometrial lining and significantly increases the risk of endometrial hyperplasia and endometrial cancer.

MPA counteracts this effect by inducing secretory transformation and eventual atrophy of the endometrium, providing essential protection.

In Indivina, MPA is taken continuously rather than cyclically, which is why the endometrium thins over time and withdrawal bleeds do not occur once the initial adjustment period has passed.

The continuous combined approach is specifically designed for postmenopausal women.

In perimenopausal women who still have some endogenous hormone production, continuous combined HRT may cause unpredictable irregular bleeding, which is why sequential HRT is recommended until at least 12 months after the last natural period.

Clinical evidence and UK prescribing guidance

HRT has been extensively studied over several decades. The Women's Health Initiative (WHI), published in 2002, initially raised concerns about the cardiovascular and cancer risks of combined HRT.

Subsequent re-analyses and the WHI's own extended follow-up have clarified that the risks and benefits of HRT depend critically on the age at which it is started and the time since menopause.

For women who start HRT within 10 years of menopause or before the age of 60, the benefit-risk balance is generally favourable, with symptom relief, bone protection, and possible cardiovascular benefit outweighing the small increases in breast cancer and VTE risk.

NICE NG23 recommends HRT as first-line treatment for moderate to severe vasomotor symptoms.

It advises that the absolute risks of HRT are small and should be discussed in the context of baseline population risk.

For example, the additional breast cancer risk from 5 years of combined HRT starting at age 50 is approximately 4 extra cases per 1,000 women, which is similar to the risk associated with obesity, alcohol consumption of 2 to 3 units per day, or physical inactivity.

The BMS endorses an individualised approach to HRT prescribing and notes that there is no arbitrary duration limit for HRT.

The decision to continue should be reviewed annually, weighing ongoing symptom relief and bone protection against the small cumulative increase in breast cancer risk.

Many women take HRT for 5 to 10 years or longer under medical supervision.

Indivina compared with other HRT options

The UK HRT market offers a wide range of formulations, including tablets, patches, gels, sprays, and vaginal preparations.

Continuous combined tablet options include Kliovance and Kliofem (both containing estradiol and norethisterone acetate), Bijuve (estradiol and progesterone), and Indivina (estradiol valerate and medroxyprogesterone acetate).

The choice of product depends on individual preference, tolerability, and clinical considerations.

Transdermal HRT (patches and gels) delivers oestrogen through the skin, bypassing first-pass liver metabolism.

This is associated with a lower risk of VTE and is recommended for women with additional VTE risk factors (BMI above 30, previous VTE, thrombophilia).

Women who are at increased VTE risk should discuss transdermal options with their prescriber.

For women who have had a hysterectomy, oestrogen-only HRT is used because endometrial protection is not required.

Oestrogen-only HRT has a more favourable risk profile than combined HRT, with no increased breast cancer risk for up to 7 years of use in the WHI follow-up data.

Women with premature or early menopause (before age 45) are strongly advised to take HRT at least until the average age of natural menopause (51) to protect bone, cardiovascular, and cognitive health.

The risks of HRT in this group are considered to be replacement of hormones that would normally be present, rather than supplementation above physiological levels.

Dosage and administration

Take one Indivina tablet at the same time each day, every day, without a break. Swallow the tablet whole with water.

You may take it with or without food. The starting dose is usually Indivina 1 mg/2.5 mg.

If this does not adequately relieve your symptoms after 2 to 3 months, your prescriber may increase the strength. Use the lowest dose that effectively controls your symptoms.

For women switching from a sequential HRT regimen, begin Indivina on the day after completing the progestogen phase of your previous cycle. For women switching from another continuous combined preparation, you may start Indivina on any convenient day.

If you forget a dose, take it as soon as you remember unless more than 12 hours have passed, in which case skip the missed dose. Missed doses may increase the chance of breakthrough bleeding.

Side effects of Indivina

Common side effects

Breast tenderness or pain is one of the most frequently reported effects and often improves within the first 2 to 3 months.

Headache, abdominal bloating, nausea, and mood changes (low mood, irritability) are also common in the initial months.

Breakthrough bleeding or spotting affects many women in the first 3 to 6 months; this is a normal adjustment response and usually resolves as the endometrium thins.

Persistent or heavy bleeding beyond 6 months requires investigation.

Uncommon and rare side effects

Uncommon effects include migraine (or worsening of existing migraine), dizziness, leg cramps, changes in libido, skin rash, vaginal candidiasis, and gallbladder disease.

Rare serious effects include venous thromboembolism, stroke, and endometrial cancer (although the progestogen component substantially reduces this risk compared with unopposed oestrogen).

Breast cancer risk

Combined HRT is associated with a small increased risk of breast cancer that rises with duration of use.

The WHI found approximately 8 additional cases of invasive breast cancer per 10,000 women per year after 5 years of combined HRT.

The risk declines after stopping and returns to baseline within approximately 5 years.

Women should be breast-aware, attend NHS breast screening appointments, and report any new breast symptoms promptly.

When to seek urgent medical advice

Contact your GP or NHS 111 if you experience persistent breast pain, unexpected vaginal bleeding after the settling-in period, severe headache, or visual disturbance.

Call 999 or attend A&E if you develop sudden painful swelling in one leg (possible DVT), sudden breathlessness or chest pain (possible PE), signs of a stroke (sudden facial drooping, arm weakness, speech difficulty), or a severe allergic reaction.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Indivina must not be used in women with known or suspected breast cancer, other oestrogen-dependent cancers, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, current or recent VTE or arterial thromboembolism, active liver disease, known thrombophilic disorders, or porphyria.

Annual review

NICE recommends reviewing HRT at least once a year.

The review should include reassessment of menopausal symptoms, evaluation of any new risk factors for breast cancer or VTE, blood pressure measurement, and a discussion about whether to continue, reduce, or stop treatment.

There is no fixed maximum duration for HRT, but the decision to continue should be actively and regularly revisited.

Breast screening and self-examination

Women on HRT should attend all scheduled NHS breast screening appointments. Combined HRT can increase mammographic breast density, which may reduce the sensitivity of mammography.

Inform the screening service that you are taking HRT. Be breast-aware and report any new lumps, skin changes, or nipple discharge to your GP without delay.

VTE risk and surgery

HRT should be temporarily discontinued 4 to 6 weeks before planned major surgery with prolonged immobilisation.

If emergency surgery is required, thromboprophylaxis (such as compression stockings and low-molecular-weight heparin) should be considered. HRT may be restarted once full mobility is restored.

Pregnancy and contraception

HRT is not a contraceptive. Women who may still be fertile should use non-hormonal contraception alongside HRT.

The FSRH advises continuing contraception for 2 years after the last natural period if under 50, or 1 year if over 50.

Indivina must not be used during pregnancy or breastfeeding.

How to get Indivina in the UK

Indivina is available on NHS prescription.

Your GP, practice nurse with prescribing qualifications, menopause specialist, or an authorised online prescriber registered with the GPhC can prescribe it after a clinical assessment.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Women who need multiple HRT items may benefit from a Prescription Prepayment Certificate (PPC), which caps NHS prescription costs in England at a fixed annual or quarterly rate.

Sources

• Indivina, Summary of Product Characteristics (EMC)
• Estradiol with medroxyprogesterone, British National Formulary (BNF)
• NICE NG23: Menopause: diagnosis and management
• Hormone replacement therapy (HRT), NHS
• British Menopause Society
• MHRA Yellow Card Scheme