ACLASTA 5MG/100ML SOLUTION FOR INFUSION [SIN13192P]

Product Info

ACLASTA 5MG/100ML SOLUTION FOR INFUSION

[SIN13192P]

4.1 Therapeutic indications

Treatment of osteoporosis

• in postmenopausal women

• in men

at increased risk of fracture, including those with a recent low-trauma hip fracture.

To prevent glucocorticoid-induced bone mineral density loss and to increase bone mineral density in postmenopausal women and men on long-term glucocorticoid use, who are at increased risk of fracture.

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis.

Treatment of Paget’s disease of the bone.

4.2 Posology and method of administration

For the treatment of postmenopausal osteoporosis, osteoporosis in men and the prevention and treatment 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.

In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. Retreatment 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. No experience of retreatment more than once is available. (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important for the elderly and for patients receiving diuretic therapy.

Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. In addition, 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 international units of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.

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 with renal impairment (see section 4.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

Use of Aclasta in patients with creatinine clearance < 35 ml/min is contraindicated.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients (65 years or above)
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.

Children and adolescents
Aclasta is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.

Duration of Treatment

The optimal duration of use of bisphosphonates for the treatment of osteoporosis has not been determined. 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 risk and comorbidities.

In the treatment of osteoporosis, 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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates.

• Patients with hypocalcemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Pregnancy and breast-feeding women (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe renal impairment with creatinine clearance <35 mL/min (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).