Zeclast ^®

Zeclast® (Zoledronic Acid) is a bisphosphonate medication used in the treatment of bone-related disorders. It inhibits osteoclast-mediated bone resorption, thereby reducing bone breakdown, lowering serum calcium and phosphate levels, and promoting their removal from circulation and incorporation into bone.

• Osteoporosis
• Paget’s Disease of Bone

Solution for Injection containing 5 mg Zoledronic Acid in 100 mL

• Ready-to-use infusion vial (no preparation or reconstitution required)
• Once-yearly administration for the treatment of bone disorders
• Once every two years for the prevention of postmenopausal osteoporosis
• Short-duration intravenous infusion without the need for hospitalization

• Zeclast® is supplied as a ready-to-use infusion solution and does not require dilution.
• Avoid co-administration with solutions containing calcium or other divalent cations (such as Lactated Ringer’s Solution).
• Each vial is intended for single use only. Any unused portion should be discarded appropriately.
• Zeclast® should not be mixed with other medicinal products or infused simultaneously through the same line.
• If refrigerated, allow the solution to reach room temperature before administration.
• This product should be clear and colorless. Do not use if precipitation or discoloration is observed.

• Zeclast® is administered only by intravenous infusion.
• The infusion should be given over a period of at least 15 minutes.
• Patients should be adequately hydrated before administration.
• After completion of the infusion, the intravenous line should be flushed with at least 10 mL of normal saline.

• Serum creatinine and creatinine clearance before each infusion
• Dental examination before initiation of therapy
• Signs and symptoms of femoral fractures
• Musculoskeletal pain
• Signs and symptoms of ocular inflammation
• Pregnancy status
• Hydration status
• Bone biochemical markers
• Serum calcium, phosphorus, magnesium, and vitamin D levels
• Bone mineral density (BMD)
• Annual assessment of height and body weight
• Evaluation of chronic back pain
• Serum alkaline phosphatase levels and pain assessment in patients with Paget’s disease

• Hypersensitivity to Zoledronic acid, other bisphosphonates (such as alendronate), or any component of the formulation
• Acute renal impairment or creatinine clearance below 35 mL/min
• Hypocalcemia
• Pregnancy and breastfeeding

• If dietary intake of calcium and vitamin D is insufficient, calcium and vitamin D supplementation may be recommended during treatment.
• Inform your physician if severe bone, joint, or muscle pain develops during therapy.
• Whenever possible, avoid invasive dental procedures during treatment.
• Bisphosphonates may increase the risk of osteonecrosis of the jaw, particularly in patients with risk factors such as:

-Alcohol consumption

-Tobacco use

-Anemia

-Cancer

-Corticosteroid therapy

-Diabetes mellitus

-Long-term bisphosphonate therapy

-High-dose intravenous bisphosphonate use

-Autoimmune diseases

-Oral surgery or trauma

-Poor oral hygiene

-Head and neck radiotherapy

• Inform your physician if any of these conditions apply to you.
• Zeclast® should be used with caution in patients with aspirin-sensitive asthma. Inform your physician if you have this condition.
• Adequate fluid intake is recommended during treatment; however, excessive fluid intake should be avoided, particularly in patients with heart failure.
• Contact your physician if symptoms of kidney dysfunction occur, including inability to urinate, changes in urine output, blood in the urine, or excessive weight gain.

The use of Zeclast® during pregnancy and breastfeeding is not recommended.

Like all medicines, Zeclast® may cause side effects, although not everybody experiences them. Possible adverse reactions include:

• Dizziness, fatigue, and weakness
• Gastrointestinal disorders including stomach pain, nausea, loss of appetite, vomiting, constipation, or diarrhea
• Swelling of the lower extremities
• Headache
• Influenza-like symptoms
• Bone pain
• Urinary tract infections
• Cough and shortness of breath

Consult your physician or pharmacist before using Zeclast® concomitantly with any other medications or dietary supplements.

Each package contains one vial of Zeclast®.

• Store below 30°C, protected from light and moisture.
• The product may be used until the last day of the month indicated as the expiration date on the package.
• Do not use or store expired medicines.
• Keep out of the reach of children.
• Do not remove the product from its original packaging until ready for use.

1. Zoledronic Acid: Drug Information, UpToDate, 2025.
2. Electronic Medicines Compendium (Zoledronic Acid SmPC)