Novartis_ad.qxp 25/7/07 02:18 Page 25
HELP DEFEND YOUR PATIENTS’
INDEPENDENCE
WHEN BONE METASTASES STRIKE
For prostate cancer patients with bone metastases
• ZOMETA helps defend functional independence by
reducing and delaying bone complications – skeletal-
related events (SREs) – and providing pain control
1-5
• ZOMETA is the only treatment proven effective
against SREs in prostate cancer with a convenient
infusion over no less than 15 minutes
1-3,6
References: 1. Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized,
placebo-controlled trial. J Clin Oncol. 2005;23:3314-3321. 2. Rosen LS, Gordon D, Tchekmedyian NS, et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with
nonsmall cell lung carcinoma and other solid tumors: a randomized, phase III, double-blind, placebo-controlled trial. Cancer. 2004;100:2613-2621. 3. Saad F. Clinical benefit of zoledronic acid for the prevention of
skeletal complications in advanced prostate cancer. Clin Prostate Cancer. 2005;4:31-37. 4. Wardley A, Davidson N, Barrett-Lee P, et al. Zoledronic acid significantly improves pain scores and quality of life in breast
cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br J Cancer. 2005;92:1869-1876. 5. Weinfurt KP, Li Y, Castel LD, et al. The significance
of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer. Ann Oncol. 2005;16:579-584. 6. Chern B, Joseph D, Joshua D, et al. Bisphosphonate infusions: patient
preference, safety and clinic use. Support Care Cancer. 2004;12:463-466.
ZOMETA
®
4 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION. PRESENTATION: Zoledronic acid. Vials containing 4 mg of zoledronic acid supplied as a powder together with ampoules containing
5 mL of water for injections for reconstitution. 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 hypercalcaemia of malignancy (HCM). DOSAGE: For “prevention of skeletal-related events in patients with advanced malignancies involving bone,”
the recommended dose is 4 mg (reconstituted and diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v glucose solution) given as an intravenous infusion of no less than 15 minutes every 3 to 4 weeks. Dose
reduction is recommended in patients with preexisting mild to moderate renal impairment. For “treatment of HCM,” the recommended dose is 4 mg given as a single intravenous infusion for no less than 15 min-
utes. No dose adjustment in patients with mild to moderate renal impairment. Patients without hypercalcaemia should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
CONTRAINDICATIONS: Pregnancy, breast-feeding women, patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of ZOMETA.
PRECAUTIONS/WARNINGS: Patients must be assessed prior to administration of ZOMETA to assure that they are adequately hydrated. Monitoring of standard hypercalcaemia-related metabolic parameters such
as serum levels of calcium, phosphate and magnesium, and, particularly, serum creatinine. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported infrequently in patients taking
bisphosphonates. In view of the potential impact of bisphosphonates on renal function and the lack of extensive clinical safety data in patients with severe renal impairment with ZOMETA, its use in this popula-
tion is not recommended. Dose reduction in patients with preexisting mild to moderate renal impairment. In patients requiring repeated administration of ZOMETA, serum creatinine should be evaluated prior to
each dose. If renal function has deteriorated, the dose should be withheld. Limited clinical data in patients with severe hepatic insufficiency; no specific recommendations can be given for this patient population.
Overhydration should be avoided in patients at risk of cardiac failure. No experience in children. Patient should inform the dentist while under dental treatment or if dental surgery is foreseen. INTERACTIONS:
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro, but no formal clinical interaction studies have been performed. Caution is advised when bis-
phosphonates are administered with aminoglycosides since both agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required. Caution is asked when used with other
potentially nephrotoxic drugs. Attention should also be paid to the possibility of hypomagnesaemia developing during treatment. In multiple myeloma patients, the risk of renal dysfunction may be increased when
IV bisphosphonates are used in combination with thalidomide. ADVERSE REACTIONS: Usually mild and transient and similar to those reported for other bisphosphonates: most commonly reduction in renal cal-
cium excretion is accompanied by a fall in serum phosphate levels (hypophosphataemia); commonly flu-like syndrome consisting of fever, fatigue, chills, and bone, joint, and/or muscle pain; headache; elevation of
serum creatinine and blood urea; renal impairment; anaemia; conjunctivitis; gastrointestinal reactions such as nausea and vomiting, anorexia, serum calcium may fall to asymptomatic hypocalcaemic levels;
uncommonly thrombocytopenia, leucopenia; hypersensitivity reactions; hypertension, hypotension, resulting very rarely in syncope or circulatory collapse; shortness of breath, cough; dizziness, paraesthesia, taste
disturbance, hypoaesthesia, hyperaesthesia, tremor, anxiety, sleeping disturbances; blurred vision; diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth; local reactions at the infusion site such
as redness or swelling; asthenia, peripheral oedema, weight increase, chest pain; rash and pruritus, increased sweating; muscle cramps, osteonecrosis (primarily of the jaw); acute renal failure, haematuria,
proteinuria, hypomagnesaemia, hypokalaemia; rarely pancytopenia, confusion, bradycardia, angioneurotic oedema, hyperkalaemia, hypernatraemia; very rarely uveitis and episcleritis. PACKS AND PRICES: Country-
specific. NOTE: Before prescribing, please read full Prescribing Information.
© 2007 Novartis March 2007 G-ZOM-0011
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