Novartis Customer Helpline 0861 929 929
- Novartis South Africa Pty Ltd.
Company Reg. No. 1946/020671/07.
PO Box 92, Isando 1600, 72 Steel Road,
Spartan, Kempton Park, 1619.
Tel: +27 11 929 9111. Fax: +27 11 929 2232
can now be prescribed for …
•
Treatment of post menopausal osteoporosis
•
Treatment of osteoporosis in men
*
•
Treatment of glucocorticoid-induced
osteoporosis
*
•
Post low trauma hip fracture, to reduce
incidence of new fractures
*
•
Treatment of Paget’s disease of bone
*
NEW INDICATIONS
S4 ACLASTA. Reg. No. A39/34/0575. Pharmacological classification
:
A 34 Other
Composition
: One bottle with 100 ml solution contains 5 mg zoledronic acid (anhydrous), corresponding to 5.330 mg zoledronic
acid monohydrate. List of excipients: Mannitol, sodium citrate, water for injections Indications:Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures
and to increase bone mineral density. In patients with a recent low trauma hipfracture,ACLASTA
®
reduces the incidence of new clinical fractures. Treatment of osteoporosis in men.Treatment of glucocorticoid-induced
osteoporosis.Treatment of Paget’s disease of bone Dosage: For the treatment of osteoporosis the recommended dose is a single intravenous infusion of 5 mg infusion of ACLASTA
®
administered once a year.Adequate
calcium and vitamin D intake is important in women with osteoporosis if dietary intake is inadequate. For Paget’s: One intravenous infusion of 5 mg zoledronic acid (anhydrous) in 100 ml aqueous solution.The infusion
time has to be at least 15 minutes.
Contraindication
: Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates. Hypocalcaemia. Pregnancy and lactation. Severe impairment of
renal function (creatinine clearance of < 35 ml/min).
Precautions/Warnings:
Renal dysfunction has been observed following the administration of Aclasta
®
, especially in patients with pre-existing renal compromise
or additional risk factors (e.g. oncology patients with chemotherapy, concomitant nephrotoxic medications and severe dehydration). Aclasta
®
is not recommended in patients with severe renal impairment (creatine
clearance < 35 ml/min) or in children and adolescents. Patients should have serum creatinine measured before receiving Aclasta
®
. Patients must be appropriately hydrated prior to and following the administration of
Aclasta
®
, this is especially important for patients receiving diuretic therapy. Caution is indicated when Aclasta
®
is administered in conjunction with medicinal products that can significantly impact renal function (e.g.
aminoglycosides or diuretics that may cause dehydration). Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta
®
. Other disturbances of mineral
metabolism must also be effectively treated (e.g., diminished parathyroid reserve; intestinal calcium malabsorption). Physicians should consider clinical monitoring for these patients. It is strongly advised that patients
with Paget’s disease receive supplemental calcium and vitamin D, this should be ensured during the initial 10 days following Aclasta
®
administration. Patients should be informed about symptoms of hypocalcaemia
and receive adequate clinical monitoring during the period of risk. Before receiving Aclasta
®
, ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration. Severe
and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Aclasta. Aclasta
®
contains the same active ingredient found in Zometa
®
(zoledronic acid) used for oncology indications, and a patient already being treated with Zometa
®
should not be treated with Aclasta
®
. Osteonecrosis of the jaw has been reported predominantly in patients with cancer
receiving bisphosphonates, including Aclasta
®
. The majority of these cases have been associated with dental procedures. Therefore, patient should inform the dentist while under dental treatment or if dental surgery
is foreseen.
Interactions
: Caution is recommended when Aclasta
®
is used concomitantly with drugs that can significantly impact renal function, such as aminoglycosides and diuretics that can cause dehydration.
Adverse events
: The adverse reactions are usually mild and transient and are similar to those reported for other intravenously administered bisphosphonates. Very common: fever. Common: headache, dizziness,
nausea, vomiting, diarrhoea, myalgia, arthralgia, bone pain, back pain, pain in extremity, flu-like symptoms (very common in Paget’s disease), chills, fatigue, asthenia, pain, malaise. Common in Paget’s disease only:
dyspnoea, hypocalcaemia and rigors. Uncommon: lethargy (common in Paget’s disease), paraesthesia, somnolence, tremor, syncope, dysgeusia, dyspepsia (common in Paget’s disease), abdominal pain, dry mouth,
oesophagitis, joint swelling, anorexia, conjunctivitis, eye pain, uveitis, vertigo, rash, transient increases in serum creatinine, peripheral oedema and thirst, insomnia, hypertension, flushing, cough, constipation, gas-
troesophageal reflux, hyperhydrosis, pruritus, erythema, neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, arthritis, muscular weakness, musculoskeletal
pain, blood creatinine increased, pollakiuria, proteinuria, acute phase reaction and non-cardiac chest pain. Rare: episcleritis, iritis, uveitis. Osteonecrosis of the jaw (ONJ) has been reported primarily in patients with
cancer receiving treatment regimens including bisphosphonates, including zoledronic acid.Atrial fibrillation has been reported in one study in osteoporosis in postmenopausal women.Additional observed side effects:
ocular hyperaemia, C-reactive protein increased, dysgeusia, toothache, gastritis, palpitations, hypocalcaemia, infusion site reactions. Post-approval use of Aclasta
®
: Rare: Hypersensitivity reactions including rare
cases of bronchoconstriction, urticaria and angioedema, renal dysfunction including renal failure requiring dialysis, especially in patients with pre-existing renal compromise or other risk factors such as concomitant
nephrotoxic medications, concomitant diuretic therapy, or dehydration in the post infusion period, Very rare: anaphylactic reaction/shock, hypotension in patients with underlying risk factors, dehydration secondary
to post-dose symptoms such as fever, vomiting and diarrhea, osteonecrosis of the jaw, scleritis and orbital inflammation.
Packs
: Aclasta
®
is supplied as packs containing one bottle.
Note
: Before prescribing consult
full prescribing information.
08/2010/ACL/024/0
