Aclasta Injection
Zoledronic Acid 5mg
1mg/20ml
Novartis Pharma AG
| Pack size | 100ml Plastic Vial |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 2331.50 AED |
Indications
Aclasta Injection is used for:
Paget's disease of bone, Postmenopausal osteoporosis, Corticosteroid-induced osteoporosis
Adult Dose
Paget's disease of bone
Adult: 5 mg as a single infusion over 15 min. Patients should receive elemental Ca 1,500 mg and vit D 800 IU daily particularly w/in 2 wk after admin. Patients who have relapsed: May be given an additional infusion of 5 mg after an interval of at least 1 yr from the initial dose.
Osteoporosis in postmenopausal women; Increase bone mass in men with osteoporosis; Corticosteroid-induced osteoporosis
Adult: 5 mg as a single infusion over at least 15 min, once yrly, w/ adequate Ca and vit D intake. Patients w/ low-trauma hip fracture: Start 2 or more wk after hip fracture repair w/ a loading dose of vit D 50,000-125,000 IU given orally or by IM route prior to 1st infusion.
Prophylaxis of postmenopausal osteoporosis
Adult: 5 mg as a single infusion once every 2 yr.
Hepatic impairment
Safety and efficacy not established
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
CrCl >35 mL/min: No adjustment needed
CrCl <35 mL/min: Contraindicated
Administration
Reconstitute powder with 5 mL SWI; once powder is fully dissolved, dilute further in 100 mL NS or D5W before administering
Contra Indications
The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.
Precautions
Patient w/ aspirin-sensitive asthma. Mild to moderate renal impairment. Pregnancy. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Adequately hydrate patients prior to admin. Ensure adequate Ca and vit D intake. Monitoring Parameters Monitor serum Ca, Mg, phosphate and electrolytes; haematocrit/Hb (oncology use); biochemical markers of bone turnover (non-oncology use). Prior to therapy, perform dental exam and preventive dentistry in patients at risk of osteonecrosis.
Lactation: Unknown whether drug crosses into breast milk; avoid using
Pregnancy-Lactation
Pregnancy
There are no available data in pregnant women to inform the drug-associated risk
Bisphosphonates are incorporated into bone matrix and are gradually released over periods of weeks to years; there may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy; advise pregnant women and females of reproductive potential of the potential risk to a fetus
Verify pregnancy status of females of reproductive potential prior to initiation of therapy
Therapy can cause fetal harm when administered to a pregnant woman; drug binds to bone long term and may be released over weeks to years; advise females of reproductive potential to use effective contraception during and after therapy
Based on animal studies, therapy may impair fertility in females of reproductive potential
Animal data
Based on findings from animal studies and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; in animal reproduction studies, administration of drug to pregnant rats during organogenesis resulted in fetal malformations and embryo-fetal lethality at maternal exposures that were greater than or equal to 2.4 times the human clinical exposure based on AUC
Lactation
Not known whether drug is present in human milk, or whether it affects milk production, or breastfed child; drug binds to bone long term and may be released over weeks to years; because of potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during and after treatment
Interactions
Increased risk of hypocalcaemia with aminoglycosides and loop diuretics. Increased risk renal dysfunction with nephrotoxic agents.
Adverse Effects
Side effects of Zoledronic Acid 5mg :
Arthralgia, fever, flu-like symptoms, myalgia, headache, pain in extremity, nausea, vomiting, diarrhoea, eye inflammation; alopecia, hyperhidrosis, bone/joint/muscle pain, osteonecrosis of the jaw, femoral fracture, hypersensitivity reactions (e.g. urticaria, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis, hypotension.
Potentially Fatal: Severe hypocalcaemia, severe kidney problems.
Mechanism of Action
Zoledronic acid, an aminobiphosphonate, is a potent inhibitor of bone resorption. It inhibits osteoclastic activity and skeletal calcium release caused by tumours.
Note
Aclasta 1mg/20ml Injection manufactured by Novartis Pharma AG. Its generic name is Zoledronic Acid 5mg. Aclasta is availble in United Arab Emirates.
Farmaco UAE drug index information on Aclasta Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.