Product image of Nordeloz (Zoledronic Acid Monohydrate) supplied by GNH India

Nordeloz

Active Ingredient:
Zoledronic Acid Monohydrate
Origin:
EU

Nordeloz (Zoledronic Acid Monohydrate)

Zoledronic Acid, the active ingredient in Nordeloz, is a bisphosphonate presented as an intravenous solution for infusion use. It is employed to treat postmenopausal osteoporosis, Paget's disease of bone, bone metastases from solid tumours and hypercalcaemia of malignancy.
GNH India supplies Nordeloz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Rafarm Sa.

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Indications & Clinical Uses

Nordeloz is a bisphosphonate that reduces excessive bone turnover in several skeletal disorders.

  • Postmenopausal osteoporosis: improves bone mineral density and reduces fracture risk.
  • Paget's disease of bone: normalises abnormal bone remodeling and alleviates pain.
  • Bone metastases associated with solid tumours: limits skeletal‑related events and pain.
  • Hypercalcaemia of malignancy: rapidly lowers serum calcium levels.

How It Works

  • Zoledronic Acid binds with high affinity to hydroxyapatite crystals at sites of active bone remodeling. When osteoclasts attach to the bone surface, the drug is internalised, inhibiting farnesyl pyrophosphate synthase within the mevalonate pathway. This disruption induces osteoclast apoptosis, thereby decreasing bone resorption and stabilising skeletal architecture.

Side Effects

Zoledronic Acid may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Acute phase reaction: fever, myalgia, and flu‑like symptoms.
  • Nausea or vomiting.
  • Transient hypocalcaemia.
  • Headache.

Serious or Rare Side Effects

  • Osteonecrosis of the jaw.
  • Atypical femur fracture.
  • Severe renal impairment or acute kidney injury.
  • Anaphylactic or severe hypersensitivity reactions.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor relevant parameters.

  • Renal function: assess creatinine clearance and adjust use in impaired kidneys.
  • Calcium and vitamin D status: ensure adequate supplementation to prevent hypocalcaemia.
  • Serum calcium: monitor before and after infusion.
  • Concomitant nephrotoxic agents: avoid or use with caution.
  • Hypersensitivity: discontinue if severe allergic reaction occurs.
  • Store at ambient temperature: keep in original packaging, protect from moisture and light.

Avoid Interactions

Zoledronic Acid can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Concurrent use of other bisphosphonates or potent nephrotoxic drugs (e.g., aminoglycosides).
  • High‑dose non‑steroidal anti‑inflammatory drugs that may worsen renal function.
  • Loop diuretics when combined with inadequate calcium intake, increasing hypocalcaemia risk.

Moderate Interactions (Monitor Closely)

  • Calcium or vitamin D supplements: timing should be separated from infusion to avoid binding.
  • Antacids containing aluminium or magnesium: may reduce absorption if oral bisphosphonate is used.
  • Corticosteroids: may potentiate bone loss, requiring closer monitoring.
  • Warfarin: monitor INR as zoledronic acid may affect coagulation parameters.
  • Immunosuppressants: observe for increased infection risk.

Frequently Asked Questions

Nordeloz, containing zoledronic acid, is indicated for postmenopausal osteoporosis, Paget's disease of bone, bone metastases from solid tumours, and hypercalcaemia of malignancy. In each case the drug works by reducing excessive bone resorption, helping to strengthen bone, control calcium levels and lower the risk of skeletal complications.

Zoledronic acid binds to hydroxyapatite at active bone remodeling sites. When osteoclasts attach, the drug is taken up and blocks the enzyme farnesyl pyrophosphate synthase in the mevalonate pathway, leading to osteoclast apoptosis. This inhibition reduces bone breakdown and stabilises the skeletal matrix.

The specific dose and infusion schedule of Nordeloz are determined by the prescribing clinician based on the patient’s indication, renal function, and overall health. Healthcare providers follow approved guidelines and adjust the regimen as needed for safety and efficacy.

Safety data for zoledronic acid in pregnancy and lactation are limited. It is generally advised to avoid use unless the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare professional.

To place an order, submit an enquiry on the Nordeloz product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and necessary import documentation.

Nordeloz (zoledronic acid) is a potent, once‑yearly intravenous bisphosphonate, offering higher binding affinity and longer skeletal residence than oral agents such as alendronate. This allows less frequent dosing but requires intravenous administration and monitoring for renal function, whereas oral bisphosphonates are taken daily or weekly with strict administration instructions.

Nordeloz should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Do not freeze the product. Before use, inspect the vial for any particulate matter or discoloration and handle with aseptic technique as recommended for intravenous preparations.

Nordeloz is given as an intravenous infusion, typically over 15 minutes, by a qualified healthcare professional. The infusion is performed in a clinical setting where vital signs can be monitored, and patients are observed for any acute reactions during and after the administration.

The most serious adverse events include osteonecrosis of the jaw, atypical femur fractures, severe renal impairment, and acute severe hypocalcaemia. Patients should be educated on oral hygiene, report any jaw pain promptly, and have renal function and serum calcium checked regularly to mitigate these risks.

Nordeloz is contraindicated in patients with known hypersensitivity to zoledronic acid or any component of the formulation, in those with severe renal impairment (creatinine clearance <30 mL/min), and in individuals with untreated hypocalcaemia. Caution is also advised for patients with active dental problems or recent oral surgery.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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