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VAL-ZOLEDRONIC ACID is a brand name for Zoledronic Acid, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
). There is no clinical experience with VAL-ZOLEDRONIC ACID in lactating women and it is not known whether VAL-ZOLEDRONIC ACID passes into breast milk. A study in lactating rats has shown that another bisphosphonate AREDIA® (pamidronate) passes into the milk.
Mothers treated with VAL-ZOLEDRONIC ACID should therefore not breast feed their infants. 12 times the human systemic exposure following an intravenous dose of 4 mg (based on AUC). The effects observed included an increase in pre-implantation losses and a decrease in the number of implantations and live foetuses.
There are no data available in humans. Paediatrics (< 18 years of age) The safety and efficacy of VAL-ZOLEDRONIC ACID in paediatric patients have not been established. No toxicology studies have been conducted in juvenile animals. The most frequent finding in growing animals during repeat-dose studies consisted of increased primary spongiosa (non-proliferative hyperostosis) in the metaphysis of long bones.
VAL-ZOLEDRONIC ACID is not recommended for use in paediatric patients. Paediatric Osteogenesis Imperfecta (OI) In a one-year, active-controlled trial which compared VAL-ZOLEDRONIC ACID and pamidronate in osteogenesis imperfecta (OI), VAL-ZOLEDRONIC ACID was studied in 74 children aged 1 year to 17 years.
Of the patients with type I OI, fracture adverse events of long bones in the lower extremities were reported in approximately 26% (femur) and 11% (tibia) of patients treated with zoledronic acid vs. 0% and 3%, respectively, of patients treated with pamidronate.
Geriatrics (> 65 years of age) Controlled clinical studies of VAL-ZOLEDRONIC ACID in TIH do not provide a sufficient number of geriatric subjects to determine whether patients 65 years and older respond differently. The median age in the two controlled clinical trials in patients with tumour-induced hypercalcaemia was 61 years old (range: 21-87 years old).
Controlled clinical studies of VAL-ZOLEDRONIC ACID in the treatment of bone metastases of solid tumours and osteolytic lesions of multiple myeloma in patients over age 65 revealed similar efficacy and safety compared to younger patients.
The proportion of patients experiencing SREs is lower in the VAL-ZOLEDRONIC ACID treatment group when compared to placebo and similar to AREDIA (pamidronate) 90 mg. Older patients generally had adverse events similar to those of the overall population.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Zoledronic Acid in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
However, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients, VAL- ZOLEDRONIC ACID should be administered with caution in this patient population.
, 47% higher AUC0-24h and 39% higher Cmax than the North American population (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Race). PrVAL-ZOLEDRONIC ACID Product Monograph Page 12 of 54 Monitoring and Laboratory Tests Serum electrolytes, creatinine, phosphate, magnesium and calcium, and CBC with differential must be closely monitored in all patients treated with VAL-ZOLEDRONIC ACID.
Renal function should be assessed prior to the administration of each dose and should be monitored appropriately during therapy with of VAL-ZOLEDRONIC ACID (see WARNINGS AND PRECAUTIONS, Renal). Serum albumin-corrected calcium should be measured prior to each dose and should be monitored during therapy with VAL-ZOLEDRONIC ACID (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS, General, Hypocalcaemia).
Patients with anaemia, leukopenia or thrombocytopenia should have regular haematology assessments. In tumour-induced hypercalcaemia, either ionized calcium or total serum calcium corrected (adjusted) for albumin should be monitored during treatment with VAL-ZOLEDRONIC ACID.
Serum calcium levels in patients who have hypercalcaemia of malignancy may not reflect the severity of hypercalcaemia, since hypalbuminaemia is commonly present. 02 (mid-range albumin-measured albumin). Prior to treatment with VAL-ZOLEDRONIC ACID, an oral examination of both hard and soft tissues, with appropriate preventive dentistry is recommended.
These careful oral examinations are recommended to be continued at regularly scheduled intervals after VAL-ZOLEDRONIC ACID therapy is initiated and during treatment with VAL-ZOLEDRONIC ACID (see WARNINGS AND PRECAUTIONS, Musculoskeletal, Osteonecrosis, Osteonecrosis of the Jaw).
ADVERSE REACTIONS Adverse Drug Reaction Overview The most serious adverse drug reactions reported in patients receiving VAL-ZOLEDRONIC ACID are: anaphylactic reaction, ocular adverse events, osteonecrosis of the jaw, atypical femoral fracture, atrial fibrillation, renal function deterioration, acute phase reaction, and hypocalcaemia.
Adverse reactions to VAL-ZOLEDRONIC ACID (zoledronic acid for injection) are usually mild and transient and similar to those reported for other bisphosphonates. Intravenous administration has been most commonly associated with fever.
Within three days after VAL-ZOLEDRONIC ACID administration, an acute phase reaction has been reported commonly, with symptoms including pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, influenza-like illness, arthritis and joint swelling; these symptoms usually resolve within a few days.
Gastrointestinal reactions such as nausea and vomiting have been reported commonly following intravenous infusion of VAL-ZOLEDRONIC ACID. Local reactions at the infusion site, such as redness or swelling and/or pain, were observed infrequently.
Rash or pruritis and chest pain have been reported uncommonly following treatment with VAL- PrVAL-ZOLEDRONIC ACID Product Monograph Page 13 […]