Company: Rowex Ltd.
Legal category: Prescription. Sport permitted.
Active ingredient: Zoledronic acid 4mg/5ml.
Description: Concentrate for solution for infusion in vial.
Presentation: 5ml, €80.00.
Indications: Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone. Treatment of tumour-induced hypercalcaemia (TIH).
Pharmacology: Zoledronic acid is a bisphosphonate and a potent inhibitor of osteoclastic bone resorption. This inhibition of osteoclastic activity also alters the bone marrow microenvironment, making it less conducive to tumour cell growth. In addition, it possesses anti-angiogenic and anti-pain activity.
Dosage: Adult: 4mg/5ml reconstituted and diluted with 100ml infusion solution and given as a single 15 minute infusion. Prevention of skeletal related events: 4mg every 3 to 4 weeks. Administer oral calcium supplement 500mg and vitamin D 400IU daily also. Onset of treatment effect is 2 to 3 months. Renal impairment: See SPC. TIH: Single dose of 4mg. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.
Special precautions: Maintain patients well-hydrated prior to and following administration. Avoid over-hydration in patients at risk of cardiac failure. Monitor hypercalcaemia-related metabolic parameters and renal function. Renal dysfunction reported; assess serum creatinine levels before each dose. Not recommended: Severe renal impairment. Caution: Severe hepatic insufficiency (limited data). Osteonecrosis of the jaw reported; avoid invasive dental procedures. Atypical femoral fractures reported; advise patients to report any thigh, hip or groin pain. Driving/using machines.
Drug interactions: Not recommended: Other drugs containing zoledronic acid or other bisphosphonates. Caution: Aminoglycosides, nephrotoxic drugs, anti-angiogenic drugs (including thalidomide).
Adverse drug reactions: Anaemia, headache, conjunctivitis, nausea, vomiting, anorexia, bone pain, myalgia, arthralgia, generalised pain, renal impairment, fever, flu-like syndrome, hypophosphataemia, increased blood creatinine and blood urea, hypocalcaemia.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie