Kliovance

What is Kliovance?

Kliovance is a form of hormone replacement therapy (HRT) used for the short-term relief of the symptoms of menopause. It contains estradiol and norethisterone acetate which supplement the body’s natural levels of oestrogen and progesterone and is suitable for use in women who have not had a hysterectomy, and who have finished having regular periods. Kliovance is also used to prevent osteoporosis in women who have been unsuccessful with other prevention strategies.

How does Kliovance work?

Kliovance contains estradiol, a form of oestrogen naturally occurring in women, and norethisterone acetate, a synthetic form of progesterone. During menopause, the level of oestrogen produced by the ovaries declines, resulting in symptoms such as mood swings, hot flushes and night sweats, vaginal dryness and a weakening of the bones known as osteoporosis. The estradiol in Kliovance relieves these symptoms by supplementing the body’s natural oestrogen levels. The norethisterone counteracts excessive growth of the womb lining (endometrial hyperplasia) caused by an increase of oestrogen, reducing the risk of developing endometrial cancer or endometriosis (growth of the uterus lining outside of the womb).

Active ingredients

The active ingredients in Kliovance are 1mg of estradiol and 0.5mg of norethisterone acetate.

Inactive ingredients

The inactive ingredients in Kliovance are lactose monohydrate, maize starch, copovidone, talc, magnesium stearate, hypromellose and triacetin.

How to take Kliovance?

Always take Kliovance as instructed by a doctor or pharmacist. Take one tablet a day, at around the same time each day. To help you remember, try and make this a part of your daily routine. For example, take your tablet with breakfast every day. Kliovance comes in calendar packs of 28 tablets, labelled with the days of the week to help you keep track. When you finish a pack, start a new one the next day without leaving a break.

If you forget to take your tablet, try and take it within the next 12 hours. If 12 hours have already passed, just skip the dose and take your next tablet at the normal time. You may experience some light bleeding or spotting during this time, but this is nothing to worry about. Never take a double dose to make up for a missed one.

When to take Kliovance?

Kliovance is suitable for use in women with an intact uterus who have not experienced a natural period in the last 12 months. If you are new to HRT or are switching from another type of continuous combined HRT, you can start Kliovance at any time. If you are transitioning from a cyclical or sequential form of HRT in which you experience a bleed, you should start Kliovance right after your bleed has ended. 

Kliovance dosage

The recommended dosage for Kliovance is 1 tablet (containing 1mg estradiol and 0.5mg norethisterone) taken once daily. If, after 3 months, you feel your symptoms are still not controlled, speak to your doctor about taking an HRT which contains a higher dose of oestrogen.

Kliovance side effects

Like all medications, Kliovance can cause side effects in some patients. You should stop taking Kliovance and seek medical attention immediately if you experience any symptoms of hypersensitivity (allergy), such as hives, itching, swelling, difficulty breathing, low blood pressure, feeling dizzy, and sweating.

The most common side effects of Kliovance, occurring in more than 1 in 10 women, are breast tenderness or pain, and changes in vaginal bleeding pattern. Other side effects are listed below.

Common side effects, which can affect up to 1 in 10 patients, include:

• Headaches or migraines
• Fluid retention
• Vaginal inflammation
• Fungal infection of the vagina (thrush)
• Depression
• Nausea
• Breast swelling or enlargement
• Back pain
• Uterine fibroids
• Swelling of arms of legs
• Weight gain

Uncommon side effects (affecting up to 1 in 100 people) include:

• Abdominal pain
• Abdominal bloating, swelling or flatulence
• Acne
• Alopecia (hair loss)
• Male pattern hair growth
• Itching or hives
• Superficial thrombophlebitis (inflammation of a vein)
• Leg cramps
• Drug ineffective
• Allergic reaction
• Nervousness

Very rare side effects can affect up to 1 in 10,000 patients and include:

• Endometrial cancer (cancer of the womb)
• Endometrial hyperplasia (excessive thickening of the lining of the womb)
• Increase in blood pressure
• Gallbladder disease or gallstones
• Excessive secretion of sebum or skin eruption
• Angioneurotic oedema
• Insomnia, dizziness, anxiety
• Change in sexual desire
• Visual disturbance
• Weight loss
• Vomiting
• Heartburn
• Vaginal itching
• Heart attack and stroke

Combined HRT harbours an increased risk of:

• Breast cancer
• Ovarian cancer
• Endometrial cancer
• Venous thromboembolism (blood clot in a vein)
• Coronary artery disease (heart disease)
• Stroke

Speak with your doctor if you experience side effects or are worried about the increased risks associated with taking HRT.

Contraindications

Do NOT take Kliovance if you:

• Are allergic to any of the ingredients in this medication
• Have, have ever had, or are suspected of having breast cancer
• Have a form of oestrogen-sensitive cancer
• Have unexplained vaginal bleeding
• Have endometrial hyperplasia (excessive thickening of the womb lining)
• Have or have ever had thrombosis (blood clot in a vein)
• Have a blood clotting disorder
• Have or have recently had a heart attack, angina, or any other disease caused by a blood clot in an artery
• Have or have ever had a liver disease
• Have porphyria 
• May be pregnant
• Are breastfeeding

You should tell your doctor before taking Kliovance if you have ever experienced any of the following:

• Fibroids inside the womb
• Endometriosis (growth of the womb lining outside of the womb) or endometrial hyperplasia (excessive growth of the womb lining)
• Increased risk of developing blood clots
• Increased risk of developing an oestrogen-sensitive cancer
• High blood pressure
• A liver disorder
• Diabetes
• Gallstones
• Migraines or severe headaches
• Systemic lupus erythematosus (a disease of the immune system affecting many organs of the body
• Epilepsy
• Asthma
• Otosclerosis (a disease affecting the eardrum and hearing)
• Triglycerides (high level of fat in the blood)
• Fluid retention due to kidney problems
• Lactose intolerance

Drug interactions

Before taking Kliovance, tell your doctor or pharmacist if you are taking any other medications, including those purchased over the counter without a prescription. The following medications may interfere with Kliovance:

• Medicines for epilepsy, such as phenobarbital, phenytoin and carbamazepine
• Medicines for tuberculosis, such as rifampicin
• Herbal remedies containing St John’s wort (hypericum perforatum)
• Medicine for hepatitis C infection, such as telaprevir
• Medicines containing ketoconazole

How to cope with Kliovance side effects?

Like all medications, Kliovance can cause side effects in some patients. These side effects are usually mild, and it is up to you to discuss with your doctor and decide whether the benefits outweigh the risks. In many cases, the side effects of HRT are easier to manage than the symptoms of menopause. Breast tenderness and pain can be managed by using simple painkillers, wearing a supportive bra, and applying a hot or cold compress to the breasts. Irregular vaginal bleeding often settles down within the first few months of use.

There are many different types of HRT available, and your doctor can help you work out which is best for you. This can take some time, as it may take up to 3 months for your body to adjust to HRT, in which time any side effects may have settled down. An alternative to oral HRT is transdermal patches, which transfer hormone supplements directly into the bloodstream, bypassing the digestive system and often resulting in fewer side effects. An example of this would be Evorel Conti. You should always consult your doctor before switching to a different type of HRT.

Kliovance and pregnancy

Kliovance is not suitable for use in pregnant women. If you become pregnant while taking this medication, stop taking it immediately and consult a doctor. 

Kliovance is not a contraceptive. If it is less than 12 months since your last period, or if you are under the age of 50, you may still need to use an alternative form of contraception to prevent pregnancy. Talk to your doctor for advice.

Can Kliovance cause weight gain?

Weight gain is a side effect of Kliovance that can affect up to 1 in 10 users. If you are worried about gaining weight, discuss with your doctor whether the benefits of Kliovance outweigh this side effect. Your doctor will also be able to advise you on other forms of HRT which may be better suited to you.

Kliovance and alcohol

It is safe to drink alcohol while taking this medication.

Alternatives to Kliovance

There are many different types of HRT available for the treatment of menopause, and the choice can be overwhelming. A doctor will be able to help you decide which is best for you. Like Kliovance, Elleste Duet Conti is a tablet form of a continuous combined HRT which contains both an oestrogen and a progestogen supplement and is, therefore, suitable for use in women who have not had a hysterectomy, or who do not have a Mirena intrauterine system (IUS) fitted. If you prefer a patch form of HRT, Evorel Conti provides the same hormones in patch form. 

If you still experience menstrual periods, a cyclical preparation may be more suitable as this allows for a regular, predictable menstrual bleed. Examples of cyclical HRT are Elleste Duet, Trisequens and Evorel Sequi. 
Women who have had a hysterectomy, or who have an IUS fitted, are able to take oestrogen-only HRT. These can be taken orally (Elleste Solo, Premarin) or applied to the skin as transdermal patches (Elleste Solo MX80, Elleste Solo MX40, Evorel).

Tibolone (brand name Livial) is a synthetic steroid that mimics the actions of oestrogen and progesterone in the body and is suitable for women who have not had a natural period in the past 12 months.

Kliovance vs. HRT patches

Kliovance is taken orally in tablet form. HRT is also available in the form of transdermal patches (such as Evorel Conti) which, when applied to the skin, transfer hormone supplements directly into the bloodstream. While oral HRT is taken once daily, patches are only changed twice per week. HRT patches tend to have fewer side effects than tablets because they bypass the digestive system, but can irritate the skin in some cases. Your doctor will be able to advise you on which form of HRT is right for you.

Is Kliovance safe for long term use?

Kliovance is intended for temporary relief of the symptoms of menopause and your doctor will usually prescribe the lowest dose possible for the shortest amount of time. HRT carries a slightly increased risk of developing oestrogen-sensitive cancers, such as breast cancer and endometrial cancers. While the increase is small, it becomes greater according to the age of the patient and the duration of HRT. Furthermore, HRT prevents the onset of osteoporosis but will not prevent it from occurring altogether. It is up to you to decide when to come off of HRT, and you should always speak to your doctor before doing so.

While being treated with HRT, it is important that you go for regular health checkups such as breast screenings and cervical smear tests. Regularly check your breasts for any lumps you can see or feel, any changes to the nipple or dimpling of the sin. If you notice anything unusual, speak to your doctor immediately.

Can Kliovance be used for gender transition?

While this medication contains hormone supplements which are also used in HRT for gender transition, Kliovance itself is not prescribed or licenced for this use.