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. Kliovance is also used to prevent osteoporosis in women who have been unsuccessful with other HRTs.

How does Kliovance work?

Kliovance contains estradiol, a form of oestrogen naturally occuring 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 estradiol and norethisterone acetate.

Inactive ingredients

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

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 sheets of 28 tablets, labeled with the days of the week to help you keep track. When you finish a sheet, 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 has already passed, just skip the dose and take your next tablet at the normal time. You may experience some light bleeding or spotting in 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 who have not experienced a natural period in the last 12 months. If you are not already using an alternative form of HRT, you can start taking Kliovance on any convenient day. If you are transitioning from another form of HRT, finish the current pack before starting Kliovance without taking a break. If your current HRT causes a monthly bleed, start Kliovance immediately after the the bleeding has ended.

Kliovance dosage

The recommended dosage for Kliovance is 1 tablet (containing 1 mg estradiol and 0.5 mg norethisterone) taken once daily.

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.

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

• Breast pain or tenderness
• Vaginal bleeding
• Headaches
• Weight gain cause by fluid retention
• Vaginal inflammation
• Migraines
• Fungal infection of the vagina
• Depression
• Nausea
• Breast swelling or enlargement
• Back pain
• Uterine fibroid, aggravation, occurence or reoccurence
• Swelling of arms of legs
• Weight gain

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

• Abdominal pain, bloating, swelling or flatulence
• Ace
• 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

In up to 1 in 1,000, Kliovance can cause an increased risk of developing a blood clot in the blood vessels of the legs or lungs (deep vein thrombosis, lung embolism).

If you have any questions or are worried about the side effects of Kliovance, speak to a doctor or pharmacist for more information.  

Contraindications

Do NOT take Kliovance if:

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

You should tell your doctor before taking Livial 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 the effect of Livial and lead to irregular bleeding:

• 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, which may increase the effects of Kliovance

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 they symptoms of menopause. However, 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 HRTs such as Kliovance are transdermal patches, which transfer hormone supplements directly into the bloodstream, bypassing the digestive system and often resulting in less side effects. You should always consult your doctor before switching to a different type of HRT.

Kliovance and pregnancy

Kliovance in 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, of 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 a doctor will be able to help you decide which is best for you. Like Kliovance, Climesse, Elleste Duet and Elleste Duet Conti contain both an oestrogen and a progesterone supplement, and are therefore suitable for use in women who have not had a hysterectomy, or who do not have an intrauterine system (IUS), or mirena coil, fitted. Kliovance, Climesse and Elleste Duet Conti are continuous HRTs, while Elleste Duet causes a monthly bleed ad is therefore more suited to women who have experienced a natural period within the last 12 months. Tibolone (brand name Livial) is a synthetic steroid which mimics the actions of oestrogen and progesterone in the body, but is only suitable for women who have not had a natural period in the past 12 months.

Women who have had a hysterectomy, of who have an IUS fitted, are able to take oestrogen-only HRTs. These can be taken orally (Elleste Solo, Premarin) or applied to the skin as transdermal patches (Elleste Solo MX80, Elleste Solo MX40, Evorel).

Kliovance vs HRT patches

Kliovance is taken orally in tablet form. HRT is also available in the form of transdermal patches which, when applied to the skin, transfer hormone supplements directly into the bloodstream. While oral HRTs are taken once daily, patches are only changed twice per week. HRT patches tend to have less 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 prescribe the lowest dose possible for the shortest amount of time. HRTs carry a sight increase in 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 check ups 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 for this use.

Sources

• Patient information leaflet
• Virtual Medical Clinic > Kliovance