Europe — EMA
Niklod (Clodronate Disodium Tetrahydrate)
GNH USA supplies Niklod (Clodronate), a bisphosphonate for osteoporosis, Paget's disease, hypercalcemia and bone metastases. Request a quote for supply.
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What is Clodronate Disodium Tetrahydrate?
Clodronate, the active ingredient in Niklod, is a bisphosphonate presented as an intravenous formulation for intravenous use. It treats bone resorption disorders such as osteoporosis, Paget's disease of bone, hypercalcemia of malignancy, and bone metastases in adult patients.
GNH USA supplies Niklod as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Clodronate Disodium Tetrahydrate used for?
Niklod is a bisphosphonate that acts on conditions characterized by excessive bone turnover. - Osteoporosis: reduces bone loss and lowers fracture risk. - Paget's disease of bone: normalizes abnormal bone remodeling. - Hypercalcemia of malignancy: lowers elevated serum calcium levels. - Bone metastases: helps control skeletal‑related events and pain.
What are the side effects of Clodronate Disodium Tetrahydrate?
Adverse reactions may occur with intravenous clodronate therapy.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Fever: transient elevation of body temperature. - Injection site pain: discomfort at the infusion site. - Transient hypocalcemia: temporary drop in blood calcium. - Headache: mild to moderate head pain. - Fatigue: general feeling of tiredness.
Serious or Rare Side Effects: - Osteonecrosis of the jaw: bone death in the jaw region. - Atypical femur fracture: unusual break in the thigh bone. - Severe hypocalcemia: marked low calcium requiring medical intervention. - Renal impairment: reduced kidney function. - Anaphylactic reaction: severe allergic response. - Severe acute phase reaction: high fever, chills, and muscle pain.
What precautions apply to Clodronate Disodium Tetrahydrate?
Before initiating therapy, clinicians should evaluate patient‑specific risk factors. - Renal function: assess baseline kidney status and monitor during treatment. - Calcium/Vitamin D status: correct deficiencies prior to infusion. - Concomitant bisphosphonates: avoid simultaneous use to reduce cumulative toxicity. - Pregnancy: safety unknown; avoid unless clearly needed. - Dental procedures: complete necessary oral surgery before therapy to lower jaw osteonecrosis risk. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Clodronate Disodium Tetrahydrate interact with?
Clodronate may interact with other medicines, requiring careful management.
Major Interactions (Avoid): - Nephrotoxic drugs: increase risk of renal injury. - Other bisphosphonates: additive bone toxicity. - Calcium supplements given concurrently: may reduce drug efficacy. - Aluminum‑containing antacids: affect renal clearance.
Moderate Interactions (Monitor Closely): - NSAIDs: may exacerbate renal effects. - Corticosteroids: increase risk of bone complications. - Warfarin: potential alteration of anticoagulation parameters.



