Aclasta Dosage/Direction for Use

General target population: The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important in the elderly and for patients receiving diuretic therapy (see PRECAUTIONS).
Treatment of Postmenopausal Osteoporosis: For the treatment of postmenopausal osteoporosis, the recommended dose is a single intravenous infusion of 5 mg infusion of Aclasta administered once a year.
Adequate supplemental calcium and vitamin D intake is important in women with osteoporosis if dietary intake is inadequate (see PRECAUTIONS).
Prevention of Clinical Fractures after a Hip Fracture: For the prevention of clinical fractures after a low-trauma hip fracture, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
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 by the intramuscular route is recommended prior to the first Aclasta infusion (see Pharmacology: Pharmacodynamics under Actions).
Supplemental calcium and vitamin D intake is recommended for patients treated to prevent clinical fractures after a low-trauma hip fracture (see PRECAUTIONS).
Treatment of osteoporosis in men: For the treatment of osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
Adequate supplemental calcium and vitamin D intake is important in men with osteoporosis if dietary intake is inadequate (see PRECAUTIONS).
Treatment and prevention of glucocorticoid-induced osteoporosis: For the treatment and prevention of glucocorticoid-induced osteoporosis, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
Adequate supplemental calcium and vitamin D intake is important in patients with osteoporosis if dietary intake is inadequate (see PRECAUTIONS).
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.
For the prevention of postmenopausal osteoporosis it is important that patients be adequately supplemented with calcium and vitamin D if dietary intake is inadequate (see PRECAUTIONS).
Treatment of Paget's disease of bone: For the treatment of Paget's disease, Aclasta should be prescribed only by physicians with experience in treatment of Paget's disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Aclasta.
Re-treatment of Paget's disease: After the initial treatment with Aclasta in Paget's disease, an extended remission period of 7.7 years as a mean was observed in responding patients. As Paget's disease of bone is a lifelong disease, re-treatment is likely to be needed. Re-treatment of Paget's disease of bone consists of an additional intravenous infusion of 5 mg Aclasta after an interval of one year or longer from initial treatment. Periodic assessment of the patient's serum alkaline phosphatase levels, e.g., every 6 to 12 months and clinical responses to treatment should guide the decision of when re-treatment should occur on an individual basis.
In the absence of worsening of clinical symptoms (e.g. bone pain or compression symptoms) and/or bone scan consistent with relapse of Paget's disease of bone, a second intravenous infusion of Aclasta should not be administered earlier than 12 months following the initial treatment (see Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions). In patients with Paget's disease, adequate vitamin D intake is recommended in association with Aclasta administration. In addition, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured in patients with Paget's disease for at least 10 days following Aclasta administration (see PRECAUTIONS).
Special populations: Patients with renal impairment: The use of Aclasta in patients with creatinine clearance <35 mL/min is contraindicated (see CONTRAINDICATIONS and PRECAUTIONS). No dose adjustment is necessary in patients with creatinine clearance ≥35 mL/min.
Patients with hepatic impairment: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Geriatric patients (65 years or above): No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Pediatric patients: Aclasta is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Duration of treatment: The optimal duration of use of Aclasta has not been determined for long term use. All patients on Aclasta should be re-evaluated periodically for an optimal response to therapy and the need for continued treatment for a longer period, based on their response to treatment, fracture risks and co-morbidities.
Patients at a low-risk for fracture should be considered for drug discontinuation after initial 3 years of treatment with Aclasta, while the high risk patients should consider continuing on regular therapy. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically every 2-3 years and restart treatment if necessary.
Method of administration: Aclasta (5 mg in 100 mL ready to infuse solution) is administered intravenously via a vented infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.
For information on the instructions for use and handling of Aclasta, see INSTRUCTIONS FOR USE AND HANDLING under Cautions for Usage.