Drugs List

Therapeutic Indications

Uses

Hypercalcaemia due to malignant disease
Management of osteolytic bone lesions
Pain in bone due to neoplastic disease

Management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with breast cancer or multiple myeloma.

Maintenance of clinically acceptable calcium levels in patients with hypercalcaemia due to malignant disease who have already been treated with intravenous sodium clodronate.

Administration

A single daily dose should be taken in the morning on an empty stomach with a glass of water. The patient should be advised not to eat, drink (other than water) or take other oral medication for 1 hour after taking the tablets.

If the daily dose is to be divided the first dose should be taken in the morning on an empty stomach with a glass of water. The second dose should be taken between meals, this should be more than 2 hours after and 1 hour before eating, drinking (other than water) or taking other oral medication.

Contraindications

Children under 18 years
Acute severe inflammatory gastrointestinal disorder
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 10ml/minute

Precautions and Warnings

Restricted sodium intake
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Renal impairment - creatinine clearance 10-50ml/minute

Reduce dose in patients with glomerular filtration rate 10-50ml/min
Some formulations contain more than 1mmol (23mg) sodium per dose
Consider a dental exam & appropriate preventive dentistry before treatment
Some formulations contain lactose
Consider dose adjustment if changing formulation;bioavailability may differ
Ensure patient has adequate fluid intake
Evaluate renal function before and during treatment
Monitor serum calcium and phosphate levels before and during treatment
Advise patient to report any ear pain, discharge or infection
Advise patient to report any new thigh, hip or groin pain
Consider osteonecrosis of external auditory canal if ear symptoms occur
Patients should seek medical attention upon signs of oesophageal irritation
Consider discontinuation if atypical femur fracture is suspected
Consider withholding treatment if osteonecrosis of the jaw occurs
Avoid giving oral dose at same time as food, antacids or mineral supplement
Advise patient of need for high oral hygiene standards
Patient to inform dentist of bisphosphonate use: avoid invasive procedures

Atypical femoral fractures have been reported in patients primarily receiving long term treatment with bisphosphonates. Fractures often occur with little trauma and some patients might experience thigh or groin pain. As fractures are often bilateral, the contralateral femur should be examined upon femoral shaft fracture. Consider discontinuation of bisphosphonate treatment in patients suspected of having an atypical femur fracture.

Invasive dental procedures should be avoided in patients taking bisphosphonates. Advise patients to inform their dentist that they are taking bisphosphonates and should not undergo invasive dental procedures. There is no data available to suggest discontinuation of bisphosphonate treatment prior to dentistry reduces the risk of osteonecrosis of the jaw. Recovery from such procedures is likely to be prolonged.

Pregnancy and Lactation

Pregnancy

Sodium clodronate is contraindicated during pregnancy.

The manufacturer does not recommend using sodium clodronate during pregnancy. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Sodium clodronate is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues sodium clodronate or discontinues breastfeeding. The presence of sodium clodronate in human breast milk is unknown. A risk to neonates cannot be excluded.

Side Effects

Acute renal failure
Atypical femoral fracture
Bone pain
Bronchospasm
Conjunctivitis
Decrease in serum phosphate
Diarrhoea
Exfoliative dermatitis
Hyperparathyroidism
Hypersensitivity reactions
Hypocalcaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum transaminases
Joint pain
Leucopenia (transient)
Muscle pain
Nausea
Osteonecrosis (primarily of the jaw)
Osteonecrosis of the external auditory canal
Proteinuria
Pruritus
Renal impairment
Respiratory symptoms
Serum creatinine increased
Urticaria
Uveitis
Vomiting

Presentation

Oral formulations of sodium clodronate.

Drugs List

Therapeutic Indications

Uses

Hypercalcaemia due to malignant disease
Management of osteolytic bone lesions
Pain in bone due to neoplastic disease

Management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with breast cancer or multiple myeloma.

Maintenance of clinically acceptable calcium levels in patients with hypercalcaemia due to malignant disease who have already been treated with intravenous sodium clodronate.

Dosage

Adults

Patients with Renal Impairment

Administration

A single daily dose should be taken in the morning on an empty stomach with a glass of water. The patient should be advised not to eat, drink (other than water) or take other oral medication for 1 hour after taking the tablets.

If the daily dose is to be divided the first dose should be taken in the morning on an empty stomach with a glass of water. The second dose should be taken between meals, this should be more than 2 hours after and 1 hour before eating, drinking (other than water) or taking other oral medication.

Contraindications

Children under 18 years
Acute severe inflammatory gastrointestinal disorder
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 10ml/minute

Precautions and Warnings

Restricted sodium intake
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Renal impairment - creatinine clearance 10-50ml/minute

Reduce dose in patients with glomerular filtration rate 10-50ml/min
Some formulations contain more than 1mmol (23mg) sodium per dose
Consider a dental exam & appropriate preventive dentistry before treatment
Some formulations contain lactose
Consider dose adjustment if changing formulation;bioavailability may differ
Ensure patient has adequate fluid intake
Evaluate renal function before and during treatment
Monitor serum calcium and phosphate levels before and during treatment
Advise patient to report any ear pain, discharge or infection
Advise patient to report any new thigh, hip or groin pain
Consider osteonecrosis of external auditory canal if ear symptoms occur
Patients should seek medical attention upon signs of oesophageal irritation
Consider discontinuation if atypical femur fracture is suspected
Consider withholding treatment if osteonecrosis of the jaw occurs
Avoid giving oral dose at same time as food, antacids or mineral supplement
Advise patient of need for high oral hygiene standards
Patient to inform dentist of bisphosphonate use: avoid invasive procedures

Atypical femoral fractures have been reported in patients primarily receiving long term treatment with bisphosphonates. Fractures often occur with little trauma and some patients might experience thigh or groin pain. As fractures are often bilateral, the contralateral femur should be examined upon femoral shaft fracture. Consider discontinuation of bisphosphonate treatment in patients suspected of having an atypical femur fracture.

Invasive dental procedures should be avoided in patients taking bisphosphonates. Advise patients to inform their dentist that they are taking bisphosphonates and should not undergo invasive dental procedures. There is no data available to suggest discontinuation of bisphosphonate treatment prior to dentistry reduces the risk of osteonecrosis of the jaw. Recovery from such procedures is likely to be prolonged.

Pregnancy and Lactation

Pregnancy

Sodium clodronate is contraindicated during pregnancy.

The manufacturer does not recommend using sodium clodronate during pregnancy. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Sodium clodronate is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues sodium clodronate or discontinues breastfeeding. The presence of sodium clodronate in human breast milk is unknown. A risk to neonates cannot be excluded.

Side Effects

Acute renal failure
Atypical femoral fracture
Bone pain
Bronchospasm
Conjunctivitis
Decrease in serum phosphate
Diarrhoea
Exfoliative dermatitis
Hyperparathyroidism
Hypersensitivity reactions
Hypocalcaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum transaminases
Joint pain
Leucopenia (transient)
Muscle pain
Nausea
Osteonecrosis (primarily of the jaw)
Osteonecrosis of the external auditory canal
Proteinuria
Pruritus
Renal impairment
Respiratory symptoms
Serum creatinine increased
Urticaria
Uveitis
Vomiting

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: October 2019

Reference Sources

Summary of Product Characteristics: Clasteon 400mg Capsules. Kent Pharmaceuticals. Revised February 2017.
Summary of Product Characteristics: Clasteon 800mg Tablets. Kent Pharmaceuticals. Revised February 2017.
Summary of Product Characteristics: Loron 520 Film-coated Tablets. Roche Products Ltd. Revised August 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 October 2019