Drugs List

Therapeutic Indications

Uses

Postmenopausal osteoporosis to reduce risk of vertebral & hip fractures
Treatment of osteoporosis in men to prevent fractures

Contraindications

Children under 18 years
Prolonged immobilisation
Breastfeeding
Cerebrovascular disorder
History of venous thromboembolism
Ischaemic heart disease
Occlusive peripheral arterial disease
Phenylketonuria
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Thromboembolic disorder
Uncontrolled hypertension

Precautions and Warnings

Patients over 80 years
Predisposition to venous thromboembolism
Risk factors for cardiovascular disorder
Renal impairment

Contains aspartame - caution in phenylketonuria
Avoid calcium supplements within 2 hours of dose
Calcium supplements may be required if risk of calcium/vitamin D deficiency
Treatment to be initiated and supervised by a specialist
Advise no food (especially calcium rich) for 2 hours pre- and post dose
Never rechallenge treatment after a severe hypersensitivity reaction
Monitor cardiac function before and every 6 to 12 months during therapy
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor renal function in patients with renal impairment
Advise patient to seek immediate medical advice if rash occurs
Discontinue if any deterioration in cardiac status occurs
Interferes with colorimetric determination of blood & urinary Calcium level
Discontinue if persistent hypertension unresponsive to therapy occurs
Discontinue if thromboembolism occurs
Discontinue in the event of a prolonged period of immobilisation
Discontinue permanently if severe skin reaction occurs

Strontium ranelate treatment is associated with an increase in venous thromboembolism (VTE) including pulmonary embolism. When treating patients at risk of VTE, particular attention should be given to the possible signs and symptoms of VTE and adequate preventative measures taken. Discontinue if the patient is immobilised due to concurrent illness or surgery and do not resume until the patient is fully mobile.

Since the risk of VTE is increased in the elderly, prescribers should re-evaluate the need for continued treatment with strontium ranelate in patients over 80 years of age.

Severe (and sometimes fatal) hypersensitivity reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with the use of strontium ranelate. Time to onset is typically 3 to 6 weeks. It is recommended that strontium ranelate is permanently withdrawn at the first sign of severe hypersensitivity and corticosteroid therapy administered.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have also been reported. The highest risk of these syndromes is within the first weeks of treatment. Strontium ranelate should be discontinued immediately and permanently.

A higher incidence of hypersensitivity, although still rare, has been shown to occur in patients of Asian origin.

Pregnancy and Lactation

Pregnancy

Strontium ranelate is contraindicated in pregnancy.

The manufacturer does not recommend using strontium ranelate during pregnancy and advises that treatment should be discontinued if strontium ranelate is inadvertently used during pregnancy.

Schaefer (2015) advises that inadvertent exposure is not grounds for invasive diagnostics or interruption of pregnancy.

Animal studies have also shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy. No clinical data is available for exposed human pregnancy.

Schaefer (2015) notes that experimental data on bone marrow cells indicate the possibility of clastogenic effects. Strontium ranelate is known to have an effect on capacitation in animals and humans, and on the activation of oocytes in rodents.

Lactation

Strontium ranelate is contraindicated in breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking strontium ranelate.

It is suggested that strontium ranelate is excreted in breast milk and it should not be given to breastfeeding mothers.

Side Effects

Abdominal pain
Alopecia
Angioedema
Arthralgia
Bone marrow failure
Bone pain
Bronchial hyperreactivity
Confusion
Constipation
Creatine kinase increased
Dermatitis
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dyspepsia
Eczema
Eosinophilia
Extremity pain
Flatulence
Gastro-intestinal pain
Gastroesophageal reflux
Headache
Hepatitis
Hypercholesterolaemia
Hypersensitivity reactions
Impaired consciousness
Increase in serum transaminases
Insomnia
Lymphadenopathy
Malaise
Memory loss
Mouth ulcers
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial infarction
Nausea
Paraesthesia
Peripheral oedema
Pruritus
Pulmonary embolism
Pyrexia
Rash
Seizures
Severe cutaneous skin eruptions
Soft or liquid stools
Stevens-Johnson syndrome
Stomatitis
Toxic epidermal necrolysis
Urticaria
Venous thrombosis
Vertigo
Vomiting

Presentation

Granules for oral suspension containing strontium ranelate.

Drugs List

Therapeutic Indications

Uses

Postmenopausal osteoporosis to reduce risk of vertebral & hip fractures
Treatment of osteoporosis in men to prevent fractures

Dosage

Adults

Contraindications

Children under 18 years
Prolonged immobilisation
Breastfeeding
Cerebrovascular disorder
History of venous thromboembolism
Ischaemic heart disease
Occlusive peripheral arterial disease
Phenylketonuria
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Thromboembolic disorder
Uncontrolled hypertension

Precautions and Warnings

Patients over 80 years
Predisposition to venous thromboembolism
Risk factors for cardiovascular disorder
Renal impairment

Contains aspartame - caution in phenylketonuria
Avoid calcium supplements within 2 hours of dose
Calcium supplements may be required if risk of calcium/vitamin D deficiency
Treatment to be initiated and supervised by a specialist
Advise no food (especially calcium rich) for 2 hours pre- and post dose
Never rechallenge treatment after a severe hypersensitivity reaction
Monitor cardiac function before and every 6 to 12 months during therapy
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor renal function in patients with renal impairment
Advise patient to seek immediate medical advice if rash occurs
Discontinue if any deterioration in cardiac status occurs
Interferes with colorimetric determination of blood & urinary Calcium level
Discontinue if persistent hypertension unresponsive to therapy occurs
Discontinue if thromboembolism occurs
Discontinue in the event of a prolonged period of immobilisation
Discontinue permanently if severe skin reaction occurs

Strontium ranelate treatment is associated with an increase in venous thromboembolism (VTE) including pulmonary embolism. When treating patients at risk of VTE, particular attention should be given to the possible signs and symptoms of VTE and adequate preventative measures taken. Discontinue if the patient is immobilised due to concurrent illness or surgery and do not resume until the patient is fully mobile.

Since the risk of VTE is increased in the elderly, prescribers should re-evaluate the need for continued treatment with strontium ranelate in patients over 80 years of age.

Severe (and sometimes fatal) hypersensitivity reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with the use of strontium ranelate. Time to onset is typically 3 to 6 weeks. It is recommended that strontium ranelate is permanently withdrawn at the first sign of severe hypersensitivity and corticosteroid therapy administered.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have also been reported. The highest risk of these syndromes is within the first weeks of treatment. Strontium ranelate should be discontinued immediately and permanently.

A higher incidence of hypersensitivity, although still rare, has been shown to occur in patients of Asian origin.

Pregnancy and Lactation

Pregnancy

Strontium ranelate is contraindicated in pregnancy.

The manufacturer does not recommend using strontium ranelate during pregnancy and advises that treatment should be discontinued if strontium ranelate is inadvertently used during pregnancy.

Schaefer (2015) advises that inadvertent exposure is not grounds for invasive diagnostics or interruption of pregnancy.

Animal studies have also shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy. No clinical data is available for exposed human pregnancy.

Schaefer (2015) notes that experimental data on bone marrow cells indicate the possibility of clastogenic effects. Strontium ranelate is known to have an effect on capacitation in animals and humans, and on the activation of oocytes in rodents.

Lactation

Strontium ranelate is contraindicated in breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking strontium ranelate.

It is suggested that strontium ranelate is excreted in breast milk and it should not be given to breastfeeding mothers.

Counselling

Ideally take at bedtime at least 2 hours after eating food. The absorption of strontium ranelate is reduced by food, milk, milk derivatives and calcium containing products.

Advise patient to avoid calcium supplementation within 2 hours of dose.

Advise patient that it is preferable to take antacids, if needed, at least 2 hours after dose.

The granules in the sachet must first be dispersed in a minimum of 30ml of water (approximately one third of a standard glass) and the suspension drunk immediately.

Patients should be advised to stop strontium ranelate therapy immediately and permanently if a rash occurs and to seek medical advice.

Patients should be advised to discontinue treatment in the event of a prolonged period of immobilisation.

Side Effects

Abdominal pain
Alopecia
Angioedema
Arthralgia
Bone marrow failure
Bone pain
Bronchial hyperreactivity
Confusion
Constipation
Creatine kinase increased
Dermatitis
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dyspepsia
Eczema
Eosinophilia
Extremity pain
Flatulence
Gastro-intestinal pain
Gastroesophageal reflux
Headache
Hepatitis
Hypercholesterolaemia
Hypersensitivity reactions
Impaired consciousness
Increase in serum transaminases
Insomnia
Lymphadenopathy
Malaise
Memory loss
Mouth ulcers
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial infarction
Nausea
Paraesthesia
Peripheral oedema
Pruritus
Pulmonary embolism
Pyrexia
Rash
Seizures
Severe cutaneous skin eruptions
Soft or liquid stools
Stevens-Johnson syndrome
Stomatitis
Toxic epidermal necrolysis
Urticaria
Venous thrombosis
Vertigo
Vomiting

Effects on Laboratory Tests

Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations. Therefore to assess blood and urinary calcium levels accurately either inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry should be used.

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 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Strontium ranelate Aristo 2g granules for oral suspension. January 2018.