Posology : מינונים

4.2       Posology and method of administration

Posology
Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important for the elderly (≥65 years) and for patients receiving diuretic therapy.

Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.

Osteoporosis
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Aclasta on an individual patient basis, particularly after 5 or more years of use.

In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion at least two weeks after hip fracture repair (see section 5.1). In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.


ACL API MAY21 V13                                 Page 1 of 17                   EU SmPC Mar2021, NZ DS AUG 2020 Prevention of postmenopausal osteoporosis
For the prevention of postmenopausal osteoporosis, the recommended regimen is a single intravenous infusion of 5 mg Aclasta. An annual assessment of the patient's risk of fracture and clinical response to treatment should guide the decision of when re-treatment should occur.

Paget’s disease
For the treatment of Paget’s disease, Aclasta should be prescribed only by physicians with experience in the treatment of Paget’s disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Aclasta. In patients with Paget’s disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).

Re-treatment of Paget’s disease: After initial treatment with Aclasta in Paget’s disease, an extended remission period is observed in responding patients. Re-treatment consists of an additional intravenous infusion of 5 mg Aclasta after an interval of one year or longer from initial treatment in patients who have relapsed. Limited data on re-treatment of Paget’s disease are available (see section 5.1).

Special populations
Patients with renal impairment
Aclasta is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.

Patients with hepatic impairment
No dose adjustment is required (see section 5.2).
Elderly (≥ 65 years)
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.

Paediatric population

Aclasta is not indicated for children and adolescent below 18 years old.
Method of administration
Intravenous use.
Aclasta is administered via a vented infusion line and given slowly at a constant infusion rate. The infusion time must not be less than 15 minutes. For information on the infusion of Aclasta, see section 6.6.

Patients treated with Aclasta should be given the package leaflet.