ACLASTA

ACLASTA 5 mg/100 mL solution for infusion contains zoledronic acid, a medicine from the bisphosphonate group. It is used to treat selected forms of osteoporosis in adults at increased risk of fracture and to treat Paget’s disease of bone.

Each 100 mL bottle contains 5 mg of zoledronic acid, corresponding to 0.05 mg/mL. The medicine is administered as an intravenous infusion by a healthcare professional.

ACLASTA – indications, administration and important precautions

What is ACLASTA used for?

Zoledronic acid 5 mg may be used in adults for:

• osteoporosis in postmenopausal women at increased risk of fracture;
• osteoporosis in adult men at increased risk of fracture;
• osteoporosis following a recent low-trauma hip fracture;
• osteoporosis associated with long-term systemic corticosteroid treatment;
• Paget’s disease of bone.

Zoledronic acid binds to bone and reduces excessive bone breakdown. In appropriately selected patients, this may increase bone mineral density and reduce the risk of further fractures.

How is it administered?

• The infusion is given into a vein by a doctor or nurse.
• The full 5 mg dose is administered over at least 15 minutes.
• The patient must be adequately hydrated before treatment.
• Special care is needed in older people and patients taking diuretics.
• Kidney function is checked and calcium or other mineral disorders are corrected before administration.

Osteoporosis dosage

The usual dose is one 5 mg intravenous infusion once a year. The doctor periodically reassesses the need for continuing long-term treatment according to fracture risk, bone density, previous treatment duration and possible adverse effects.

Following a recent low-trauma hip fracture, the infusion is generally administered at least two weeks after surgical repair. Vitamin D supplementation or a loading dose may be prescribed before the first infusion.

Paget’s disease dosage

A single 5 mg infusion is normally administered. The effect may last for more than one year. Retreatment is considered only when the disease has become active again and after medical assessment.

Patients with Paget’s disease are usually advised to receive at least 500 mg of elemental calcium twice daily for at least ten days after treatment, together with vitamin D as directed by the doctor.

Calcium and vitamin D

Low blood calcium must be corrected before treatment. Adequate calcium and vitamin D intake is required, but the appropriate dose must be determined by a doctor, especially in patients with kidney disease, kidney stones, parathyroid disorders or high blood calcium.

Children and adolescents

ACLASTA is not intended for people under 18 years of age because safety and efficacy have not been sufficiently established.

When must ACLASTA not be used?

• allergy to zoledronic acid, another bisphosphonate or an ingredient;
• hypocalcaemia;
• severe kidney impairment with creatinine clearance below 35 mL/min;
• pregnancy;
• breastfeeding.

Kidney function and hydration

Zoledronic acid may cause deterioration of kidney function, particularly in patients with existing kidney disease, older people, dehydrated patients and those receiving diuretics or other potentially kidney-damaging medicines.

• Creatinine clearance is assessed before every dose.
• Adequate fluid intake is required before and after infusion unless medically restricted.
• The medicine is not administered when creatinine clearance is below 35 mL/min.
• Markedly reduced urination, swelling or sudden deterioration requires urgent assessment.

Jaw problems and dental treatment

Osteonecrosis of the jaw has been reported rarely, particularly in patients with poor dental health, oral infection, corticosteroid treatment, smoking, cancer or previous bisphosphonate exposure.

A dental examination may be recommended before treatment. Maintain good oral hygiene and report oral pain, swelling, numbness, loose teeth or a sore that does not heal.

Invasive dental procedures should be planned with the treating doctor and dentist. Treatment must not be stopped independently.

Thigh, hip or groin pain

Long-term bisphosphonate use has rarely been associated with atypical fractures of the thigh bone. New or unusual pain in the thigh, hip or groin should be reported even when there has been no fall or injury.

Ear symptoms

Osteonecrosis of the external ear canal has been reported very rarely. Persistent ear pain, discharge or chronic ear infection requires assessment.

Interactions

Particular caution is needed with:

• aminoglycoside antibiotics;
• diuretics that may cause dehydration;
• other potentially nephrotoxic medicines;
• other bisphosphonates;
• other medicines containing zoledronic acid.

All prescription medicines, over-the-counter medicines, vitamins and supplements must be reported before infusion.

Pregnancy, breastfeeding and fertility

ACLASTA is contraindicated during pregnancy and breastfeeding. It is not recommended in women who may become pregnant.

Driving and using machines

The medicine generally has no significant direct effect on driving. Do not drive if dizziness, weakness or flu-like symptoms occur after infusion.

Possible side effects

A temporary acute-phase reaction commonly occurs within the first three days after the first infusion. It may include:

• fever and chills;
• flu-like symptoms;
• headache and dizziness;
• muscle, bone, joint, back or limb pain;
• fatigue, weakness and malaise;
• nausea, vomiting, diarrhoea or abdominal discomfort;
• pain, redness or swelling at the infusion site.

These reactions are usually less frequent after later annual doses and normally resolve within a few days.

Serious adverse effects may include:

• acute kidney injury or worsening kidney function;
• clinically significant hypocalcaemia;
• severe allergic reaction;
• osteonecrosis of the jaw;
• atypical femoral fracture;
• eye inflammation with pain, redness or visual disturbance;
• cardiac rhythm disorders, including reported atrial fibrillation.

Overdose

Overdose is unlikely because the medicine is administered by healthcare professionals. Excessive exposure may impair kidney function and cause low calcium, phosphate or magnesium. Hospital monitoring and correction of electrolyte disturbances may be required.

Missed infusion

Contact the doctor or healthcare facility to arrange another appointment. No additional or double dose is given to compensate.

Composition

In addition to zoledronic acid, the solution contains mannitol, sodium citrate and water for injections. It is a clear, colourless solution.

Storage and handling

• The unopened bottle does not require special storage conditions.
• After opening, the solution should be used immediately.
• When not used immediately, it may be stored for up to 24 hours at 2–8 °C under appropriate aseptic conditions.
• A refrigerated solution should reach room temperature before administration.
• Only clear solution without visible particles may be used.
• The bottle is for single use.

Frequently asked questions