Clasteon 800mg film-coated tablets Prescribing Information

Refer to the full Summary of Product Characteristics (SmPC) before prescribing. 

Name and active ingredient: CLASTEON 800mg film-coated tablets.

Each tablet contains 1000mg of disodium clodronate tetrahydrate, equivalent to 800mg of anhydrous sodium clodronate. Pharmaceutical form: Film coated tablets.

White, oval, convex tablet with breakline.

Indications: Sodium clodronate is indicated for the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma.

Sodium clodronate tablets are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous bisphosphonate.

Posology: For adults and the elderly, the recommended dose is 2 tablets (1600mg sodium clodronate) taken as a single dose.

If necessary, the dosage may be increased but should not exceed a maximum 3200mg daily.

Refer to SmPC section 4.2 for full details and information regarding paediatric and renally impaired patients.

Method of administration: Adequate fluid intake should be maintained during treatment.

A Clasteon 800mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration.

Clasteon tablets should not be crushed or dissolved before intake.

The oral bioavailability of bisphosphonates is poor.

Bioequivalence studies have shown appreciable differences in bioavailability between different oral formulations of sodium clodronate, as well as marked inter and intra patient variability.

Dose adjustment may be required if the formulation is changed.

Contraindications: Sodium clodronate tablets are contraindicated in patients with severe renal failure where creatinine clearance less than 10 ml/min, hypersensitivity to the active substance or to any of the excipients (listed in section 6.1 of the SmPC) and in patients receiving concomitant treatment with other bisphosphonates.

Special warnings and precautions for use: No information is available on the potential carcinogenicity of sodium clodronate, but patients have been treated in clinical trials for up to 2 years.

The duration of the treatment is therefore at the discretion of the physician, according to the status of the underlying malignancy.

Adequate fluid intake should be maintained during treatment.

Renal impairment: Renal function with serum creatinine, serum calcium and phosphate levels should be monitored before and during treatment.

Dental conditions and osteonecrosis of the jaw: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygenie).

While on treatment, these patients should avoid invasive dental procedures if possible.

For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.

Osteonecrosis of the external auditory canal: Mainly in association with long-term therapy.

Possible risk factors include steroid use and chemotherapy and/or local risk factors such as infection or trauma.

Irritation of the upper gastrointestinal mucosa: Caution should be used when clodronate disodium is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).

Physicians should be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue clodronate disodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

Atypical fractures of the femur: Primarily in patients receiving long-term treatment for osteoporosis.

Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.

During treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.

Refer to SmPC section 4.4 for full details.

Interaction with other medicinal products and other forms of interaction: Concomitant use of other bisphosphonates is contraindicated.

Aminoglycosides can cause severe hypocalcaemia and Hypomagnesaemia may also occur simultaneously.

Patients receiving NSAID's in addition to sodium clodronate have developed renal dysfunction.

Concomitant use of estramustine phosphate with clodronate has been reported to increase the serum concentration of estramustine phosphate by 80% at the maximum.

Calcium rich foods, mineral supplements and antacids may impair absorption as sodium clodronate forms complexes with divalent metal ions.

SmPC section 4.5 for full details.

Fertility, pregnancy and breast feeding: Fertility: Fertility in animal studies, clodronate did not cause foetal damage, but large doses decreased male fertility No clinical data on the effect of clodronate on fertility in humans are available.

Pregnancy: Sodium clodronate is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

Although in animals clodronate passes through the placental barrier, it is not known if it passes into the foetus in humans.

It is not known if clodronate can cause foetal damage or affect reproduction in humans.

Studies in animals have shown reproductive toxicity (SmPC section 5.3) Breast-feeding: It is unknown whether clodronate is excreted in human milk.

A risk to the suckling child cannot be excluded.

Breast-feeding should be discontinued during treatment with sodium clodronate.

Undesirable effects:Common ≥ 1/100 to <1/10: Asymptomatic hypocalcaemia, diarrhoea, nausea, vomiting, levels of transaminases increased (usually within normal range).

Rare ≥ 1/10,000 to <1/1,000: Allergic reaction, symptomatic hypocalcaemia, increased levels of serum parathyroid hormone associated with decreased serum calcium levels, increased levels of serum alkaline phosphatase, levels of transaminases increased to more than twice the normal range without associated abnormal hepatic function, hypersensitivity reaction manifesting as skin reaction, bronchospasm in patients with and without a previous history of asthma, impairment of renal function, atypical subtrochanteric and diaphyseal femoral fractures. (see section 4.4).

Refer to SmPC section 4.8 for full details.

Legal classification: POM.

Presentations: Packs of 60 tablets.

NHS Cost: 60 tablets (£146.43).

Marketing Authorisation Number: PL 51463/0090.

MA Holder: Kent Pharma UK Ltd.

Date of preparation: September 2024.

Ref: UK24/013/SmPC August 2024.

Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Kent Pharma UK Ltd on 01233 506574 or medical@kent-athlone.com For a copy of the SmPC or further medical information, please contact: medical@kent-athlone.com Additional information available on request.