Aclasta IV Infusion

✔️ Uses of Aclasta IV Infusion

Aclasta is used to treat:

1. Postmenopausal Osteoporosis
2. Corticosteroid-Induced Osteoporosis
3. Paget's Disease of Bone

✔️ Mode of Action

Zoledronic acid is a potent amino bisphosphonate that inhibits bone resorption by reducing osteoclast activity and preventing skeletal calcium release caused by tumors.

✔️ Missed Dose

If you miss a scheduled dose, consult your doctor for guidance.

✔️ Words of Advice:

1. Aclasta is administered via IV infusion over at least 15 minutes.
2. Drink plenty of fluids to stay hydrated and prevent kidney damage.
3. Take calcium and vitamin D supplements as recommended by your doctor.
4. Fever, chills, and flu-like symptoms are common but temporary; use a pain reliever if needed.
5. Inform your doctor if you experience jaw pain, as it may indicate ONJ.
6. Regular monitoring of bone mineral density (BMD) is important to track progress.

✔️ Side Effects

Common:

• Headache, fever, flu-like symptoms, myalgia, joint pain, bone pain, back pain, nausea, diarrhea.

Rare but Serious:

• Severe hypocalcemia.
• Kidney problems.
• Osteonecrosis of the jaw (ONJ).
• Atypical femoral fractures.
• Hypersensitivity reactions (e.g., urticaria, angioedema).
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Hypotension.

✔️ Overdose Management

Symptoms of overdose include renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. Treat with:

• Calcium gluconate for hypocalcemia
• Potassium or sodium phosphate for hypophosphatemia
• Magnesium sulfate for hypomagnesemia

✔️ Aclasta Dosage and Administration

Preparation and Reconstitution

1. Reconstitute the powder with 5 mL sterile water for injection (SWI).
2. Once the powder is fully dissolved, further dilute the solution in 100 mL of normal saline (NS) or 5% dextrose (D5W) before administration.

Adult Dose

Paget's Disease of Bone

• Dose: 5 mg as a single infusion over 15 minutes.
• Calcium and Vitamin D: Administer 1,500 mg elemental calcium and 800 IU vitamin D daily, especially within 2 weeks after administration.
• Re-treatment: For relapsed patients, an additional 5 mg infusion may be given after at least 1 year from the initial dose.

Osteoporosis (Postmenopausal Women, Men, or Corticosteroid-Induced)

• Dose: 5 mg as a single infusion over at least 15 minutes, administered once yearly.
• Calcium and Vitamin D: Ensure adequate intake of these supplements.

Low-Trauma Hip Fracture

• Timing: Begin therapy 2 or more weeks after hip fracture repair.
• Loading Dose: Administer 50,000–125,000 IU of vitamin D orally or intramuscularly before the first infusion.

Postmenopausal Osteoporosis Prophylaxis

• Dose: 5 mg as a single infusion once every 2 years.

Hepatic Impairment

• Safety and efficacy not established.

Renal Impairment

• Creatinine Clearance (CrCl) > 35 mL/min: No dose adjustment is needed.
• CrCl < 35 mL/min: Contraindicated.

Child Dose

• Safety and efficacy not established.

✔️ Method of Administration:

• Do not mix Zoledronic Acid with calcium or divalent cation-containing solutions.
• Administer as a single intravenous solution using a separate vented infusion line.
• If refrigerated, allow the solution to reach room temperature before use. Once opened, it remains stable for 24 hours at 2°C–8°C.

✔️ Important Administration Instructions

• Infuse Zoledronic Acid over no less than 15 minutes.
• Ensure the patient is well-hydrated before administration.
• Inspect the solution for particles or discoloration before use.
• Follow the infusion with a 10 mL saline flush.
• Administer acetaminophen after the infusion to reduce acute-phase reaction symptoms.

✔️ Drug Interactions

• Aminoglycosides: May prolong low calcium levels.
• Loop Diuretics: May increase the risk of hypocalcemia.
• Nephrotoxic Drugs: Use with caution.
• Renally Excreted Drugs: Monitor patients with impaired kidney function due to increased drug exposure.

✔️ Aclasta should not be used in patients with:

• Hypocalcemia
• Creatinine clearance below 35 mL/min or evidence of acute kidney impairment
• Hypersensitivity to Zoledronic Acid or its components

✔️ Use in Pregnancy and Lactation

• Pregnancy: Aclasta may harm the fetus and should not be used by pregnant women.
• Lactation: Should not be used during breastfeeding as it is unknown if the drug passes into human milk.

✔️ Precautions and Warnings

• Hypocalcemia: Ensure adequate calcium and vitamin D supplementation to prevent worsening.
• Renal Impairment: Do not exceed 5 mg per dose. Infuse over at least 15 minutes to minimize toxicity risks. Monitor kidney function before each dose.
• Osteonecrosis of the Jaw (ONJ): Perform a dental examination before initiating therapy.
• Atypical Femur Fractures: Evaluate patients with groin or thigh pain for femur fractures.
• Severe Pain: Discontinue treatment if severe bone, joint, or muscle pain occurs.

✔️ Storage

• Store below 30°C, protected from moisture and light.
• Keep out of reach of children.