Zoledronic Acid Actavis Special Precautions

Before the patient is given Zoledronic acid Actavis, tell the doctor: If the patient has or had a kidney problem. Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each infusion of zoledronic acid. The following precautions should be taken into account to minimise the risk of renal adverse reactions: Monitoring of renal function after zoledronic acid infusion should be considered, particularly in at-risk patients such as those with pre-existing renal dysfunction, those of advanced age, those using concomitant nephrotoxic drugs or diuretic therapy, or those who are dehydrated.
Zoledronic acid should be used with caution when used concomitantly with medicines that could affect renal function.
Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated before administration of zoledronic acid.
The duration of infusion of zoledronic acid should be at least 15 minutes.
If the patient has or had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
If the patient is having dental treatment or are due to undergo dental surgery, tell the dentist that the patient is being treated with Zoledronic acid Actavis.
Zoledronic acid Actavis for cancer treatment is not recommended for use in patients with creatinine clearance <30 mL/min, and should only be considered for the treatment of hypercalcaemia in cancer patients with severe renal impairment after evaluating the risk and benefits of treatment.
In patients who show evidence of renal deterioration during the treatment period, Zoledronic acid Actavis should be withheld and only resumed when serum creatinine returns to within 10% of baseline.
Osteonecrosis of the jaw (ONJ): ONJ has been reported in the post-marketing setting in patients receiving Zoledronic Acid Actavis.
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth. A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid Actavis in patients with concomitant risk factors.
The following should be considered when evaluating a patient's risk of developing ONJ: Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with Zoledronic Acid Actavis. While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to Zoledronic Acid Actavis treatment.
The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ Temporary interruption of Zoledronic Acid Actavis should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Osteonecrosis of the external auditory canal: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Zoledronic acid Actavis contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially "sodium free".
Driving and using machines: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid. The patient should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Use in Elderly: Patients aged 65 years and over Zoledronic acid Actavis can be given to people aged 65 years and over. There is no evidence to suggest that any extra precautions are needed.
Use in Children: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.