Kliovance

What is Kliovance?

Kliovance is a continuous combined Hormone Replacement Therapy (HRT). It contains two synthetic hormones that mimic those naturally produced by the ovaries:

• Estradiol (1 mg): An oestrogen that replaces the declining levels in a woman's body during menopause.
• Norethisterone Acetate (0.5 mg): A progestagen (synthetic progesterone). Its primary role in this combination is to protect the lining of the womb (endometrium) from the thickening effects of oestrogen, thereby reducing the risk of endometrial hyperplasia and cancer.

Mechanism of Action

Think of your body's hormone system as a finely tuned thermostat. During menopause, the "oestrogen thermostat" dips significantly, leading to symptoms like hot flushes and contributing to bone loss. Kliovance provides a steady, low dose of both oestrogen and progestagen, effectively "resetting" the thermostat to a more comfortable level. The oestrogen component directly alleviates symptoms and helps maintain bone density. The progestagen component acts like a monthly "shedding signal" for the womb lining, but because it's given continuously alongside oestrogen, it prevents the lining from building up excessively, offering year-round protection.

What is Kliovance Used For?

Kliovance is licensed for use in postmenopausal women who have not had a natural period for at least one year and have not had their womb removed (hysterectomy). It is used as per NICE prescribing guidelines.

Approved Indications

• Relief of Estrogen-Deficiency Symptoms: Primarily moderate to severe hot flushes (sudden feelings of heat in the face, neck, and chest) and night sweats which significantly hinder daily life. It may also help with other symptoms like vaginal dryness and discomfort.
• Prevention of Postmenopausal Osteoporosis: For women at an increased risk of fractures due to osteoporosis, and for whom other osteoporosis treatments are not suitable. The decision to use HRT for bone protection should be based on an individual risk assessment.

Before Using Kliovance

Initiating HRT requires a thorough medical evaluation. Your doctor will:

Medical History & Checklist

• Take a full personal and family medical history, focusing on:
  • History of cancers (especially breast, endometrial, ovarian).
  • History of blood clots (thrombosis), stroke, or heart disease.
  • Liver disease, gallbladder disease, or porphyria.
  • Migraine, hypertension, diabetes, asthma, lupus, epilepsy.
  • Uterine fibroids or endometriosis.
• Perform a physical examination, which may include blood pressure check, breast examination, and pelvic examination if indicated.
• Discuss the expected benefits versus the potential risks for you individually.

Required Baseline Tests

While not always mandatory for all women, your doctor may recommend:

• Mammography: In line with national breast screening programme age guidelines.
• Other investigations based on personal history (e.g., liver function tests, lipid profile).

Kliovance Contraindications

Do not take Kliovance if any of the following apply to you (Absolute Contraindications):

Absolute Contraindications

Conditions Requiring Cautious Evaluation

• Endometriosis, uterine fibroids.
• History of or increased risk for oestrogen-sensitive cancers.
• History of or risk factors for blood clots.
• Severe hypertension, active gallbladder disease, migraine with aura, pancreatitis, hypertriglyceridaemia.

Special Population Considerations

Elderly Patients (>65 years)

• There is limited experience.
• The risks of stroke and possible dementia may be increased when HRT is initiated after age 65.
• HRT is not recommended for the prevention of memory loss or dementia.

Renal Impairment

• No specific studies.
• Use with caution.

Hepatic Impairment

• Contraindicated in active liver disease.
• Metabolism occurs in the liver; impairment can lead to increased hormone levels.

Paediatric/Adolescent

• Not applicable. Kliovance is for postmenopausal women only.

Kliovance and Other Medicines

Some medicines can reduce the effectiveness of Kliovance or increase side effects. Always inform your doctor of all medications you take, including over-the-counter and herbal remedies. Refer to the official patient information leaflet for detailed interactions.

High-Risk Interactions

• Enzyme Inducers: Can significantly reduce Kliovance's effect, causing breakthrough bleeding and loss of bone/symptom protection.
  • Epilepsy drugs: Phenobarbital, phenytoin, carbamazepine.
  • Antibiotics: Rifampicin, rifabutin (for TB).
  • HIV drugs: Nevirapine, efavirenz, ritonavir, nelfinavir.
  • Herbal: St. John's Wort (Hypericum perforatum).
• Medicines affected by Kliovance: HRT can increase the frequency of seizures with lamotrigine and may interact with cyclosporine.

Timing Recommendation

If you must take a short course of an enzyme-inducing antibiotic (e.g., rifampicin), use additional non-hormonal contraception during and for 28 days after the course, as Kliovance's efficacy may be reduced.

Pregnancy & Breastfeeding

Pregnancy

• Contraindicated. Kliovance is for postmenopausal women only.
• If you suspect pregnancy, stop taking Kliovance immediately and consult your doctor.

Breastfeeding

• Contraindicated. Do not use Kliovance if you are breastfeeding.

Contraception

• Kliovance is NOT a contraceptive.
• If you are under 50 or within 12 months of your last period, you may still be fertile and should use a non-hormonal barrier method of contraception (e.g., condoms).

Driving & Machine Operation

• Kliovance has no known effect on the ability to drive or operate machinery.
• However, if you experience side effects such as dizziness, migraine, or visual disturbances (which are possible but not common), you should avoid these activities until you feel well.

Kliovance Ingredients

Active Substances

• Estradiol 1 mg (as estradiol hemihydrate)
• Norethisterone acetate 0.5 mg

Excipients

• Lactose monohydrate
• Maize starch
• Copovidone
• Talc
• Magnesium stearate

Film-Coating

• Hypromellose
• Triacetin
• Talc

Allergen Warning

Kliovance contains lactose. If you have been diagnosed with lactose intolerance or galactose intolerance, discuss this with your doctor before taking this medicine.

How to Use Kliovance

Take Kliovance exactly as prescribed by your doctor. The standard regimen is continuous, without a break. For guidance on how and when to take continuous combined HRT, see the NHS guidance.

Kliovance Dosage Guidelines

Standard Dosage

Dose Philosophy

"Start low, go slow." The 1mg/0.5mg strength is the standard. Your doctor should aim to use the lowest effective dose for the shortest necessary time to control your symptoms.

Administration Instructions

Step-by-step guide for taking Kliovance tablets:

Using the Calendar Pack

1. Set the Day Reminder: Turn the inner disc of the calendar pack to set the current day of the week opposite the plastic tab.
2. Take the First Tablet: Break the plastic tab and tip out the first tablet.
3. Daily Routine: Take one tablet once a day, at about the same time each day. It can be taken with or without food.
4. Move the Dial: Each day, move the transparent dial clockwise one space to reveal the next tablet. Only turn the dial after removing the tablet from the opening.
5. Continuous Use: Finish all 28 tablets. On day 29, immediately start a new pack without any break in treatment.

Missed Dose Management

General Principles

Overdose Information

Symptoms

• Taking several tablets at once is unlikely to cause life-threatening symptoms.
• Possible effects may include nausea, vomiting, and possibly withdrawal bleeding in women.

Management

There is no specific antidote. If you have taken a significant overdose, contact your doctor, pharmacist, or go to the nearest hospital accident and emergency department, taking the medicine pack with you.

Possible Side Effects

Side effects are categorised by frequency, based on the PIL.

Very Common (>1 in 10 users)

• Breast pain or tenderness
• Vaginal bleeding (especially in first 3-6 months)

Common (1 to 10 in 100 users)

• Headache, migraine
• Nausea, abdominal pain
• Weight gain, fluid retention (oedema)
• Vaginal inflammation or fungal infection
• Depression, mood changes
• Back pain

Uncommon (1 to 10 in 1,000 users)

• Acne, hair loss, abnormal hair growth
• Itching, hives, allergic reactions
• Leg cramps, nervousness

Serious Risks Associated with Combined HRT

How to Store Kliovance

Storage Conditions

• Keep out of sight and reach of children.
• Do not use after the expiry date (EXP) on the label/carton.
• Store below 25°C. Do not refrigerate.
• Keep the container in the outer carton to protect from light.

Disposal

• Do not dispose of via wastewater or household waste.
• Return unused medicine to a pharmacy for safe disposal.

Pack Information

Appearance

• White, round film-coated tablet (6mm)
• Engraved "NOVO 288" on one side and the Novo Nordisk bull logo on the other.

Pack Sizes

• Calendar packs containing 1 x 28 tablets
• Calendar packs containing 3 x 28 tablets

Marketing Authorisation

• Holder: Novo Nordisk Limited, UK.
• Manufacturer: Novo Nordisk A/S, Denmark.

Where Can I Buy Kliovance Online in the UK