Livial (Tibolone)

Prescription Required
Brand
Dose Size & Price Qty
2.5mg
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Fact Table

Fact Table
Formula C21H28O2
License Approved in many countries for menopausal symptom treatment; not FDA-approved in the U.S.
Bioavailability Rapid absorption; active metabolites reach peak concentration within ~1–2 hours
Legal status Prescription only (Rx)
Chemical Name (7a,17a)-17-hydroxy-7-methyl-19-nor-pregn-5(10)-en-20-yn-3-one
Elimination half-life ~7 hours (varies by metabolite)
Dosage (Strength) 2.5 mg oral tablet once daily
Pregnancy Contraindicated – not for use in pregnancy or breastfeeding
Brands Livial®, Tibolone (generic), Ledibon®
Protein binding ~96%
PubChem CID 6431969
MedlinePlus Not assigned
ChEBI 31623
ATC code G03CX01
DrugBank DB09033
KEGG D02172
Routes of administration Oral (tablet)

Livial (tibolone) is a synthetic hormone replacement therapy (HRT) medication used to treat symptoms of menopause in postmenopausal women. The medication contains tibolone, which the body breaks down into substances that mimic the effects of three hormones: estrogen, progesterone, and testosterone. This combination helps relieve common menopause symptoms like hot flushes, night sweats, mood changes, and vaginal dryness. Tibolone can also help prevent osteoporosis, a condition where bones become weak and brittle after menopause.

Directions

Take Livial as a single tablet once daily, swallowing it whole with water at around the same time each day. Patients should wait at least 12 months after their last natural period before starting treatment, as beginning too early may increase the risk of irregular bleeding.

If a dose is missed and it's been less than 12 hours, take the tablet right away; if more than 12 hours have passed, skip the missed dose and continue with the regular schedule the next day. Don't take a double dose to make up for a forgotten tablet.

Ingredients

The active ingredient in this drug is tibolone.

Cautions

  • Before using this medication, you may want to consult a healthcare provider about the following:
    • Any existing health conditions
    • Any allergies
    • A list of all medications currently being taken
  • Tibolone is a hormone therapy used for menopausal symptoms, but it can increase certain health risks. Before starting it, your doctor may want to monitor you more closely if you've had fibroids, endometriosis, liver problems, blood clots, high blood pressure, migraines, diabetes, asthma, or a family history of breast cancer
  • Stop taking tibolone and contact your doctor right away if you notice jaundice (yellowing of the skin or eyes), a sudden rise in blood pressure, new migraine-like headaches, or symptoms of a blood clot like leg swelling, chest pain, or trouble breathing.
  • Tibolone can increase the risk of certain cancers, especially cancer of the womb lining and breast cancer. You may also notice light bleeding or spotting in the first few months, but bleeding that continues beyond six months should be checked.
  • Like other hormone therapies, tibolone slightly increases the risk of ovarian cancer, although this cancer is rare overall. The risk increases the longer you use hormone therapy, but the overall increase is small for most women.
  • Tibolone may increase the risk of blood clots, especially in the first year of treatment or if you have other risk factors like obesity, long periods of immobility, recent surgery, or a family history of clots.
  • Hormone therapy will not prevent memory loss and may even increase the risk of memory problems if started after age 65. It can also cause fluid retention and affect cholesterol and triglyceride levels, so people with heart or kidney problems may need closer monitoring.
  • Some medications, such as blood thinners, seizure medicines, certain antibiotics for tuberculosis, and St. John's Wort, can interfere with tibolone and lead to irregular bleeding.
  • If you need surgery, your doctor may ask you to stop taking tibolone about 4–6 weeks beforehand to reduce the risk of blood clots. Tibolone is meant only for postmenopausal women, so stop taking it if you become pregnant.

Contraindications

Avoid taking or using this medication if any of the following apply:

  • Known or suspected breast cancer, or a history of breast cancer
  • Known or suspected hormone-dependent cancers
  • Unexplained vaginal bleeding that hasn't been evaluated
  • Severe, untreated thickening of the womb lining
  • Previous or current blood clots in veins, such as deep vein thrombosis or pulmonary embolism
  • Active or recent arterial blood clot disorders, including heart attack or stroke
  • Liver disease or abnormal liver function
  • Porphyria (a rare blood disorder)
  • Pregnancy or breastfeeding
  • Allergy to tibolone or any ingredients in the medication

Side Effects

Common side effects of Livial include:

  • Breast pain
  • Stomach or pelvic discomfort
  • Vaginal bleeding or spotting (often in the first few months)
  • Vaginal itching, discharge, or thrush
  • Unusual hair growth
  • Weight gain

These effects are usually mild and tend to improve as your body adjusts to treatment. Some women may also notice acne, breast tenderness, or mild swelling in the hands or feet. If bleeding continues past the first few months or becomes heavy, contact your healthcare provider.

More serious reactions are possible and should be evaluated right away. Livial and other forms of HRT have been linked to a higher risk of breast cancer, ovarian cancer, and cancers of the uterine lining, as well as blood clots, stroke, and heart disease. Sudden severe headaches, jaundice, leg swelling, chest pain, or signs of a clot require immediate medical attention. Rare side effects such as vision changes, depression, skin reactions, and gallbladder problems can also occur. Report anything unusual or persistent to a doctor or healthcare provider.

Frequently Asked Questions about Livial (Tibolone)


What is Livial (Tibolone) used for?

Livial is a synthetic hormone used primarily to treat symptoms of menopause in postmenopausal women, such as hot flashes, night sweats, mood changes, and vaginal dryness. It may also help prevent osteoporosis in women who are at high risk of fractures and cannot take other medications for bone loss.


How does Livial work in the body?

Tibolone has estrogenic, progestogenic, and androgenic activity. It mimics the effects of natural female hormones by acting on estrogen and progesterone receptors in different tissues, helping balance hormone levels and relieve menopausal symptoms.


Who should take Livial?

Livial is intended for postmenopausal women whose last natural period was at least 12 months ago. It is typically prescribed for those seeking relief from moderate to severe menopausal symptoms or as an option for osteoporosis prevention when other treatments are not suitable.


Who should not take Livial?

Livial should not be used by women who are pregnant, breastfeeding, or have a history of breast cancer, endometrial cancer, blood clots, liver disease, or unexplained vaginal bleeding. It is not suitable for use in children or men.


What are the common side effects of Livial?

Common side effects include abdominal pain, breast tenderness, vaginal discharge, weight gain, and headache. Some women may also experience changes in mood or libido. If side effects persist or worsen, medical advice should be sought.


Are there any serious risks associated with Livial?

Livial has been associated with an increased risk of stroke and, in rare cases, breast or endometrial cancer. It may also increase the risk of blood clots. These risks should be carefully weighed against the benefits, especially in women with cardiovascular risk factors.


How should Livial be taken?

Livial is taken orally once daily, with or without food. It should be taken at the same time each day. Treatment usually starts at least 12 months after the last natural menstrual period to avoid irregular bleeding.


Can Livial affect periods or cause bleeding?

Although Livial is used in postmenopausal women, some may experience breakthrough bleeding or spotting during the first few months of treatment. Persistent or unexpected bleeding should be evaluated by a healthcare provider.


Can Livial be used long-term?

Livial is generally prescribed for the shortest duration necessary to control symptoms, with periodic reviews to determine if continued treatment is needed. Long-term use may increase the risk of certain health issues and should be closely monitored by a healthcare provider.


Does Livial interact with other medications?

Yes, Livial can interact with other drugs, especially those affecting liver enzymes like certain anticonvulsants and antibiotics. It may also interfere with lab tests. Always inform your doctor about any medications or supplements you are taking before starting Livial.

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