PAMISOL

What it is

Pamisol is pamidronate disodium. It is a concentrated injection supplied as a clear, colourless, sterile solution. Pamisol is available in four strengths: 15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL, and 90 mg/10 mL injection vials.

Approved indications —

Treatment of predominantly lytic bone metastases from breast cancer and advanced multiple myeloma. — Acute management of tumour induced hypercalcaemia (hypercalcaemia of malignancy). — Treatment of symptomatic Paget's disease of bone.

Dosing overview

Pamisol is for intravenous use as infusion only. Pamisol must never be given as a bolus injection since severe local reactions and thrombophlebitis may occur as a result of high local concentrations.

Key safety warnings

Osteonecrosis of the jaw has been reported predominantly in cancer patients treated with bisphosphonates including pamidronate disodium. Many of these patients were also receiving chemotherapy and corticosteroids. Many had signs of local infection including osteomyelitis. Presentation may include jaw pain, toothache, exposed bone, altered sensation and local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures if possible. Cases of osteonecrosis of the external auditory canal have been reported predominantly in adult cancer patients treated with bisphosphonates including pamidronate disodium. Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors include steroid use and chemotherapy and/or local risk factors such as infection or trauma. Bisphosphonates including pamidronate disodium have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure. Pamidronate disodium is excreted intact primarily via the kidney and therefore, the risk of renal adverse reactions may be greater in patients with impaired renal function. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates in post-marketing experience, although such reports have been infrequent.

Contraindications

Pamisol is contraindicated in patients with known hypersensitivity to pamidronate disodium or other bisphosphonates, or to any of the other ingredients. Pamisol is contraindicated in pregnancy and lactation.

Regulatory history

Pamisol pamidronate disodium was first listed on the Australian Register of Therapeutic Goods on 1 August 2000 in all four strengths (15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL, and 90 mg/10 mL).