Drugs List

Therapeutic Indications

Uses

Atrophic vaginitis - post-menopausal

Treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.

Contraindications

Children under 18 years
Breast cancer
Breastfeeding
Deep vein thrombosis
Endometrial hyperplasia
Galactosaemia
History of venous thromboembolism
Hormone dependent neoplasm
Pregnancy
Pulmonary embolism
Retinal vein thrombosis
Severe hepatic impairment
Undiagnosed gynaecological haemorrhage
Venous thromboembolism

Precautions and Warnings

Body mass index above 30kg per square metre
Family history of venous thromboembolism
Predisposition to venous thromboembolism
Prolonged immobilisation
Recent surgery
Risk of cerebrovascular accident
Severe trauma
Cerebrovascular disorder
CYP2C9 poor metaboliser genotype
Glucose-galactose malabsorption syndrome
History of cerebrovascular accident
Lactose intolerance
Systemic lupus erythematosus

Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Contains lactose
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
Advise patients of risks/benefits & review need for treatment regularly
Breakthrough bleeding should be investigated
Advise patient to contact a doctor if symptoms of thromboembolism develop
Discontinue if venous thromboembolism develops
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently

A careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks. Ospemifene should only be continued as long as the benefit outweighs the risk.

If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.

Due to a risk of venous thromboembolic events, ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation. Treatment should be resumed only after the patient is mobilised.

Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2 to 3 clinical programme due to hot flushes.

Co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.

Pregnancy and Lactation

Pregnancy

Ospemifene is contraindicated during pregnancy.
Use of ospemifene is contraindicated by the manufacturer. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately. Animals studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Ospemifene is contraindicated during breastfeeding.

Use of ospemifene when breastfeeding is contraindicated by the manufacturer. Effects on exposed infants are unknown.

Side Effects

Endometrial hypertrophy
Headache
Hot flushes
Hypersensitivity reactions
Muscle spasm
Pharyngeal oedema
Pruritus
Rash
Subcutaneous tissue disorders
Throat tightness
Tongue swelling
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vulvovaginal infections

Drugs List

Therapeutic Indications

Uses

Atrophic vaginitis - post-menopausal

Treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breast cancer
Breastfeeding
Deep vein thrombosis
Endometrial hyperplasia
Galactosaemia
History of venous thromboembolism
Hormone dependent neoplasm
Pregnancy
Pulmonary embolism
Retinal vein thrombosis
Severe hepatic impairment
Undiagnosed gynaecological haemorrhage
Venous thromboembolism

Precautions and Warnings

Body mass index above 30kg per square metre
Family history of venous thromboembolism
Predisposition to venous thromboembolism
Prolonged immobilisation
Recent surgery
Risk of cerebrovascular accident
Severe trauma
Cerebrovascular disorder
CYP2C9 poor metaboliser genotype
Glucose-galactose malabsorption syndrome
History of cerebrovascular accident
Lactose intolerance
Systemic lupus erythematosus

Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Contains lactose
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
Advise patients of risks/benefits & review need for treatment regularly
Breakthrough bleeding should be investigated
Advise patient to contact a doctor if symptoms of thromboembolism develop
Discontinue if venous thromboembolism develops
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently

A careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks. Ospemifene should only be continued as long as the benefit outweighs the risk.

If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.

Due to a risk of venous thromboembolic events, ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation. Treatment should be resumed only after the patient is mobilised.

Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2 to 3 clinical programme due to hot flushes.

Co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.

Pregnancy and Lactation

Pregnancy

Ospemifene is contraindicated during pregnancy.
Use of ospemifene is contraindicated by the manufacturer. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately. Animals studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Ospemifene is contraindicated during breastfeeding.

Use of ospemifene when breastfeeding is contraindicated by the manufacturer. Effects on exposed infants are unknown.

Side Effects

Endometrial hypertrophy
Headache
Hot flushes
Hypersensitivity reactions
Muscle spasm
Pharyngeal oedema
Pruritus
Rash
Subcutaneous tissue disorders
Throat tightness
Tongue swelling
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vulvovaginal infections

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2020

Reference Sources

Summary of Product Characteristics: Senshio 60mg film coated tablets. Shionogi. Revised November 2019.