Novartis launches ready-to-use formulation of Zometa (zoledronic acid), a bone targeted agent for skeletal complications in advanced cancers and multiple myeloma
Novartis launches ready-to-use formulation of Zometa® (zoledronic acid), a bone targeted agent for skeletal complications in advanced cancers and multiple myeloma
- New formulation usually requires no mixing or refrigeration and has longer shelf-life, saving time and resources for healthcare teams and reducing wastage
- Ready-to-use solution can be administered in the community setting, offering improved convenience for patients
Frimley, UK, 17 October, 2011 - Novartis today announces the launch of the ready-to-use formulation of their market-leading bone targeted agent, Zometa® (zoledronic acid)1. The new formulation is supplied as a 4 mg/100 mL solution ready-mixed for infusion that is easier to use than the existing product whilst promising to generate hospital efficiency-savings in time and staff resource2.
"Zoledronic acid is the gold standard treatment for skeletal complications in advanced cancers and the new ready-to-use formulation offers more convenience for staff and patients alike," commented Martin Rees-Milton, principal pharmacist at Velindre Cancer Centre, Cardiff. "Not only will the use of valuable hospital resources be minimised with this new formulation but patients will also benefit from the convenient option of treatment in the community setting."
The new ready-to-use formulation usually needs no prior mixing in contrast to the existing formulation which must be refrigerated and used within 24 hours once mixed for use. The pre-mixed solution can be stored at room temperature and has a three year shelf-life which is likely to result in significantly reduced product wastage2.
The ease of preparation and storage presented by the ready-to-use formulation makes it more convenient to offer treatment in the community setting. This means patients may not have so far to travel for treatment and that overall treatment times could potentially be reduced, further optimising patient care and efficient use of healthcare resources.
Zoledronic acid is licensed for the prevention of skeletal-related events (SREs) in adult patients with advanced malignancies involving bone and for the treatment of adult patients with tumour-induced hypercalcaemia (elevated calcium levels in the blood)2. It is used across a wide range of advanced cancers involving bone - including breast cancer, lung cancer, prostate cancer, renal cell carcinoma and multiple myeloma - and helps reduce and delay SREs that can have a negative impact on survival and quality of life3,4.
Zoledronic acid, a bone targeted agent, belongs to the bisphosphonate class of agents and works by attaching itself to the bone and slowing down the rate of bone destruction. It has also been demonstrated to possess anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease, as shown in preclinical studies2.
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Notes to Editors
About zoledronic acid
Zometa® (zoledronic acid) is indicated for the prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with multiple myeloma and advanced malignancies involving bone. An intravenous bisphosphonate, zoledronic acid is the only licensed bone targeted agent to demonstrate efficacy in preventing bone complications across a broad range of solid tumour types, such as breast, prostate, and lung cancers as well as in multiple myeloma, in patients with metastatic disease. Zoledronic acid offers patients, nurses and clinicians a 4 mg, 15-minute infusion administered every 3-4 weeks.
Zoledronic acid is the most widely used bone targeted agent for the prevention of skeletal-related events (SREs) in patients with advanced malignancies involving bone across a broad range of tumours.
Important safety information
Zoledronic acid has been associated with reports of renal insufficiency. Patients should be adequately rehydrated and have their serum creatinine assessed prior to receiving each dose of zoledronic acid. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates including zoledronic acid.
In clinical trials, the most commonly reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, and skeletal pain), fatigue, gastrointestinal reactions, anaemia, weakness, cough, dyspnoea and oedema.
Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients with cancer receiving treatment including bisphosphonates, chemotherapy, and/or corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors.
For further information please see the summary of product characteristics.
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.co.uk.
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1. Novartis Data on File ZOM009-03
2. Zometa® (zoledronic acid) Summary of Product Characteristics.
3. Saad F. et al. ‘Pathologic Fractures Correlate With Reduced Survival in Patients With Malignant Bone Disease'. Cancer. 2007; 110:1860-1867
4. Sezer O. Myeloma Bone Disease: Recent Advances in Biology, Diagnosis, and Treatment. The Oncologist. 2009; 14:276-283