Individual generic drug information

zoledronic acid

Reference monograph

Part of registered formulation

ZOLEDRONIC ACID

Reference record: Zoledronic acid
Source: BNF 80 (2020–2021)
Printed source pages: 793, 794
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Zoledronic acid only.

Indications And Dose

Prevention of skeletal related events in advanced malignancies involving bone (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 4 mg every 3–4 weeks, calcium 500 mg daily and vitamin D 400 units daily should also be taken Tumour-induced hypercalcaemia (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 4 mg for 1 dose Paget’s disease of bone (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 5 mg for 1 dose, at least 500 mg elemental calcium twice daily (with vitamin D) for at least 10 days is recommended following infusion Osteoporosis (including corticosteroid-induced osteoporosis) in men and postmenopausal women ▶BY INTRAVENOUS INFUSION ▶Adult: 5 mg once yearly as a single dose, in patients Endocrine system with a recent low-trauma hip fracture, the dose should be given at least 2 weeks after hip fracture repair; before ﬁrst infusion give 50 000–125 000 units of vitamin D

Source page 793

Cautions

Atypical femoral fractures. cardiac disease (avoid ﬂuid overload). concomitant medicines that affect renal function

Source page 793

National Funding Access Decisions

NICE decisions ▶Bisphosphonates for treating osteoporosis (updated July 2019) NICE TA464 This technology appraisal guidance should be applied clinically in conjunction with: . NICE guideline on osteoporosis (CG146), which deﬁnes who is eligible for osteoporotic fracture risk assessment. . NICE quality standard on osteoporosis (QS149), which deﬁnes the clinical intervention thresholds for the 10-year fracture probability of a major osteoporotic fracture, in those patients who have undergone fracture risk assessment. Zoledronic acid is recommended as an option for treating osteoporosis in patients: . who are eligible for risk assessment as deﬁned in the full NICE guideline and quality standard on osteoporosis, and . who have been assessed as being at higher risk of osteoporotic fragility fracture using the methods recommended in the full NICE guideline and quality standard on osteoporosis, and . when bisphosphonate treatment is appropriate, taking into account their risk of fracture, their risk of adverse effects from bisphosphonates, and their clinical circumstances and preferences. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta464 Scottish Medicines Consortium (SMC) decisions SMC No. 29/02 The Scottish Medicines Consortium has advised (May 2003) that zoledronic acid (Zometa ®) is accepted for restricted use within NHS Scotland for the prevention of skeletal related events in patients with breast cancer and multiple myeloma if prescribed by an oncologist. SMC No. 317/06 The Scottish Medicines Consortium has advised (October 2006) that zoledronic acid (Aclasta ®) is accepted for use within NHS Scotland for the treatment of Paget’s disease of bone in patients for whom the use of a bisphosphonate is appropriate. SMC No. 447/08 The Scottish Medicines Consortium has advised (March 2008) that zoledronic acid (Aclasta ®) is accepted for restricted use within NHS Scotland for the treatment of osteoporosis in postmenopausal women in those for whom oral treatment options for osteoporosis are inappropriate, when initiated by a specialist.

Source page 794

Safety

Extracted information for Zoledronic acid only.

Interactions

→Appendix 1: bisphosphonates

Source page 793

Side Effects

▶Common or very common Appetite decreased. chills. ﬂushing ▶Uncommon Anaphylactic shock. anxiety. arrhythmias. chest pain. circulatory collapse. cough. drowsiness. dry mouth. dyspnoea. haematuria. hyperhidrosis. hypertension. hypotension. leucopenia. muscle spasms. proteinuria. respiratory disorders. sensation abnormal. sleep disorder. stomatitis. syncope. thrombocytopenia. tremor. vision blurred. weight increased ▶Rare or very rare Confusion. Fanconi syndrome acquired. pancytopenia ▶Frequency not known Acute phase reaction SIDE-EFFECTS, FURTHER INFORMATION Renal impairment and renal failure have been reported; ensure patient is hydrated before each dose and assess renal function.

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Conception And Contraception

Contra-indicated in women of child-bearing potential.

Source page 793

Pregnancy

Avoid—toxicity in animal studies.

Source page 793

Breast Feeding

Avoid—no information available.

Source page 793

Hepatic Impairment

Manufacturer advises caution in severe hepatic impairment (limited information available).

Source page 793

Renal Impairment

Avoid in tumour-induced hypercalcaemia if serum creatinine above 400 micromol/litre. Avoid in advanced malignancies involving bone if eGFR less than 30 mL/minute/1.73 m2 (or if serum creatinine greater than 265 micromol/litre). Avoid in Paget’s disease, treatment of postmenopausal osteoporosis and osteoporosis in men if eGFR less than 35 mL/minute/1.73 m2. Dose adjustments In advanced malignancies involving bone, if eGFR 50–60 mL/minute/1.73 m2 reduce dose to 3.5 mg every 3–4 weeks; if eGFR 40–50 mL/minute/1.73 m2 reduce dose to 3.3 mg every 3–4 weeks; if eGFR 30–40 mL/minute/1.73 m2 reduce dose to 3 mg every 3–4 weeks; if renal function deteriorates in patients with bone metastases, withhold dose until serum creatinine returns to within 10% of baseline value.

Source page 793

Monitoring Requirements

▶Correct disturbances of calcium metabolism (e.g. vitamin D deﬁciency, hypocalcaemia) before starting. Monitor serum electrolytes, calcium, phosphate and magnesium. ▶Monitor renal function in patients at risk, such as those with pre-existing renal impairment, those of advanced age, those taking concomitant nephrotoxic drugs or diuretics, or those who are dehydrated.

Source page 793

Dose and formulations

Extracted information for Zoledronic acid only.

Directions For Administration

▶When used for Prevention of skeletal related events in advanced malignancies involving bone or Tumour-induced hypercalcaemia For intravenous infusion, infuse over at least 15 minutes; administer as a single intravenous solution in a separate infusion line. If using 4 mg/5 mL concentrate for solution for infusion or preparing a reduced dose of 4 mg/100 mL solution for infusion for patients with renal impairment, dilute requisite dose according to product literature. ▶When used for Paget’s disease of bone or Osteoporosis (including corticosteroid-induced osteoporosis) in men and postmenopausal women For intravenous infusion, give via a vented infusion line over at least 15 minutes.

Source pages 793, 794

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Infusion ▶Zoledronic acid (Non-proprietary) Zoledronic acid (as Zoledronic acid monohydrate) 40 microgram per 1 ml Zoledronic acid 4mg/100ml infusion bags | 1 bag P £174.14 (Hospital only) | 1 bag P £150.00 Zoledronic acid (as Zoledronic acid monohydrate) 50 microgram per 1 ml Zoledronic acid 5mg/100ml infusion bags | 1 bag P £217.68 (Hospital only) ▶Aclasta (Novartis Pharmaceuticals UK Ltd) Zoledronic acid (as Zoledronic acid monohydrate) 50 microgram per 1 ml Aclasta 5mg/100ml infusion bottles | 1 bottle P £253.38 ▶Zerlinda (Actavis UK Ltd) Zoledronic acid (as Zoledronic acid monohydrate) 40 microgram per 1 ml Zerlinda 4mg/100ml infusion bags | 1 bag P £150.00 (Hospital only) ▶Zometa (Novartis Pharmaceuticals UK Ltd) Zoledronic acid (as Zoledronic acid monohydrate) 40 microgram per 1 ml Zometa 4mg/100ml infusion bottles | 1 bottle P £174.14 Solution for infusion ▶Zoledronic acid (Non-proprietary) Zoledronic acid (as Zoledronic acid monohydrate) 40 microgram per 1 ml Zoledronic acid 4mg/100ml solution for infusion vials | 1 vial P £135.00 (Hospital only) | 1 vial P £174.14 Zoledronic acid (as Zoledronic acid monohydrate) 50 microgram per 1 ml Zoledronic acid 5mg/100ml solution for infusion vials | 1 vial P £135.00 (Hospital only) | 1 vial P £253.58–£266.72 Zoledronic acid (as Zoledronic acid monohydrate) 800 microgram per 1 ml Zoledronic acid 4mg/5ml concentrate for solution for infusion vials | 1 vial P £165.43–£174.14 (Hospital only) | 1 vial P £148.04–£233.40 | 5 vial P £25.00 (Hospital only) Zoledronic acid 4mg/5ml solution for infusion vials | 1 vial P £91.95 ▶Zometa (Novartis Pharmaceuticals UK Ltd) Zoledronic acid (as Zoledronic acid monohydrate) 800 microgram per 1 ml Zometa 4mg/5ml solution for infusion vials | 1 vial P £174.14 CALCIUM REGULATING DRUGS › BONE RESORPTION INHIBITORS

Source page 794

Clinical care

Extracted information for Zoledronic acid only.

Patient And Carer Advice

A patient reminder card should be provided (risk of osteonecrosis of the jaw). Endocrine system

Source page 794

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

4 mg every 3–4 weeks, calcium 500 mg daily and

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

4 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

5 mg for 1 dose, at least 500 mg elemental

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

5 mg once yearly as a single dose, in patients

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

zoledronic acid

Reference monograph

Part of registered formulation

ZOLEDRONIC ACID

Reference record: Zoledronic acid
Source: BNF 80 (2020–2021)
Printed source pages: 793, 794
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Zoledronic acid only.

Indications And Dose

Source page 793

Cautions

Atypical femoral fractures. cardiac disease (avoid ﬂuid overload). concomitant medicines that affect renal function

Source page 793

National Funding Access Decisions

Source page 794

Safety

Extracted information for Zoledronic acid only.

Interactions

→Appendix 1: bisphosphonates

Source page 793

Side Effects

Source page 793

Conception And Contraception

Contra-indicated in women of child-bearing potential.

Source page 793

Pregnancy

Avoid—toxicity in animal studies.

Source page 793

Breast Feeding

Avoid—no information available.

Source page 793

Hepatic Impairment

Manufacturer advises caution in severe hepatic impairment (limited information available).

Source page 793

Renal Impairment

Source page 793

Monitoring Requirements

Source page 793

Dose and formulations

Extracted information for Zoledronic acid only.

Directions For Administration

Source pages 793, 794

Medicinal Forms

Source page 794

Clinical care

Extracted information for Zoledronic acid only.

Patient And Carer Advice

A patient reminder card should be provided (risk of osteonecrosis of the jaw). Endocrine system

Source page 794

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

4 mg every 3–4 weeks, calcium 500 mg daily and

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

4 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

5 mg for 1 dose, at least 500 mg elemental

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Adults

First line only; read the complete Indications and dose section above.

5 mg once yearly as a single dose, in patients

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 793

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.