Zoledro-Denk Infusion
Zoledronic Acid 4mg
4mg/5ml
DENK PHARMA GmbH & Co. KG
| Pack size | 5ml Plastic Vial |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | AL ITTIHAD DRUG STORE |
| Retail Price | 780.00 AED |
Indications
Zoledro-Denk Infusion is used for:
Hypercalcaemia of malignancy, Bone metastases associated with solid tumours, Multiple myeloma
Adult Dose
Intravenous
Hypercalcaemia of malignancy
Adult: 4 mg as a single dose by infusion over at least 15 minutes. Retreatment in patients who relapse or who are refractory to initial treatment: 4 mg as an infusion over at least 15 minutes, after at least 1 wk from initial dose.
Bone metastases associated with solid tumours, Multiple Myeloma;
Adult: 4 mg infusion over at least 15 minutes every 3-4 wk, in conjunction with 500 mg calcium and 400 IU vitamin D oral supplement.
Patients with hepatic impairment
Safety and efficacy not established
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
CrCl >60 mL/min: 4 mg
CrCl 50-60 mL/min: 3.5 mg
CrCl 40-49 mL/min: 3.3 mg
CrCl 30-39 mL/min: 3 mg
CrCl <30 mL/min: Not recommended
Administration
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 4mg :
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
Zoledro-Denk 4mg/5ml Infusion manufactured by DENK PHARMA GmbH & Co. KG. Its generic name is Zoledronic Acid 4mg. Zoledro-Denk is availble in United Arab Emirates.
Farmaco UAE drug index information on Zoledro-Denk Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.