RONAK
About US/Products/Oncology & Hematology Diseases /Zolena ®

Zolena ®

Patient Details

Zolena®

Generic Name: Zoledronic Acid
Dosage Form: Concentrate for solution for infusion containing 4 mg zoledronic acid in 5 mL
Therapeutic Class: Bisphosphonate derivatives
Indication: Used to reduce osteoclastic bone resorption (bone cell breakdown)

 

Zolena®
Zolena® (zoledronic acid) is a bisphosphonate used for bone-related conditions. It inhibits bone resorption mediated by osteoclasts or their precursors, thereby reducing bone breakdown, lowering serum calcium and phosphate, and increasing their elimination from the circulation.

 

Indications for Zolena®

  • Bone metastases due to solid (non-hematologic) tumors
  • Cancer-therapy induced bone loss in breast or prostate cancer
  • Hypercalcemia of malignancy
  • Multiple myeloma

 

Dosage form of Zolena®

Concentrate for solution for infusion containing 4 mg zoledronic acid in 5 mL

 

Preparation of Zolena®

  • Do not administer undiluted Zolena®.
  • Dilute with one of the following solutions:
    • 0.9% sodium chloride
    • 5% dextrose
  • Use the diluted solution immediately after preparation.
  • Before infusion, inspect for color, clarity, and absence of particles.
  • Do not co-infuse with any solution containing calcium or other divalent cations (e.g., Ringer’s lactate).

 

Administration of Zolena®

  • Infuse intravenously over at least 15 minutes.
  • After infusion, flush the line with ≥10 mL normal saline.
  • Do not infuse through the same line as other drugs.
  • Ensure the patient is adequately hydrated before infusion.

 

Monitoring Requirements During the Use of Zolena®

  • Serum creatinine and creatinine clearance
  • Dental examinations
  • Signs suggestive of atypical femoral fracture
  • Musculoskeletal pain
  • Signs of ocular inflammation
  • Serum electrolytes: calcium, phosphate, magnesium
  • Serum vitamin D level
  • Pregnancy status
  • Hemoglobin/hematocrit ratio
  • Hepatitis B screening
  • Urinary albumin excretion

 

Contraindications for Zolena®

  • Hypersensitivity to zoledronic acid, other bisphosphonates (e.g., alendronate), or any excipient
  • Acute renal failure or creatinine clearance <35 mL/min
  • Hypocalcemia
  • Pregnancy and breastfeeding

 

Warnings and Precautions for Zolena® Use

  • As directed by your physician, consider daily calcium (500 mg) and a multivitamin containing 400 IU vitamin D during therapy.
  • If you develop severe bone, joint, or muscle pain, contact your doctor; avoid Zolena® in patients with a prior similar reaction to other bisphosphonates.
  • Avoid invasive dental procedures during therapy when possible.
  • Bisphosphonates may increase the risk of osteonecrosis of the jaw in patients with: alcohol misuse, tobacco use, anemia, cancer and anticancer therapies, corticosteroids, diabetes, prolonged therapy, high-dose IV use, autoimmune disease, oral surgery or trauma, poor oral hygiene, ill-fitting dental appliances, head/neck radiotherapy.
  • Use caution in aspirin-sensitive asthma.
  • Maintain adequate fluid intake, but avoid over-hydration, especially with heart failure.
  • Do not use multiple products containing zoledronic acid for different indications in the same patient.
  • Contact your doctor if you develop kidney problems (inability to urinate, change in urine output, blood in urine, or rapid weight gain).

 

Zolena® Use During pregnancy and breastfeeding

Use during pregnancy and breastfeeding is not recommended.

 

Side effects of Zolena®

As with all medicines, side effects may occur (not everyone is affected). Possible reactions include:

  • Dizziness, fatigue, weakness
  • Gastrointestinal problems (abdominal pain, nausea, vomiting, diarrhea)
  • Low blood pressure
  • Peripheral edema
  • Headache
  • Flu-like symptoms
  • Hair loss
  • Bone pain
  • Fever

 

Drug interactions of Zolena®

Consult your doctor or pharmacist before combining Zolena® with other medicines or supplements.

 

Packaging

Each pack contains 1 vial of Zolena®.

Storage

  • Store below 30°C, protected from light and moisture.
  • Usable until the end of the month printed on the expiry date; do not use or keep expired medicines.
  • Keep out of the sight and reach of children.

 

References

  1. Zoledronic Acid: Drug information, UpToDate 2025
  2. medicines.org.uk/emc product 13761 SmPC
Zolena®
Prescribing Information