ACLASTA 5mg/100ml Injection/Solution for

What is ACLASTA 5mg/100ml

Aclasta is an intravenous infusion containing 5 mg of Zoledronic Acid per 100 ml solution. Zoledronic Acid is a potent bisphosphonate that inhibits bone resorption by osteoclasts. Aclasta is primarily used to treat and prevent bone-related conditions, including:

• Postmenopausal osteoporosis: Reduces the risk of fractures in women after menopause.
• Osteoporosis in men: Increases bone mass and reduces fracture risk.
• Glucocorticoid-induced osteoporosis: Prevents bone loss in patients on long-term steroid therapy.
• Paget's disease of bone: Regulates abnormal bone turnover.

This medication is administered as a once-yearly intravenous infusion, offering a convenient dosing schedule for patients.

How to use ACLASTA 5mg/100ml

Administration Instructions:

• Administer Aclasta as a single intravenous infusion over at least 15 minutes.
• Ensure the patient is adequately hydrated prior to infusion to minimize the risk of renal complications.
• Use a separate, vented infusion line; do not mix with calcium-containing solutions.
• After infusion, flush the line with 10 ml of normal saline.
• If the solution has been refrigerated, allow it to reach room temperature before administration.

Preparation:

• Inspect the solution for particulate matter and discoloration before use.
• Do not use if the solution is cloudy or contains particles.
• Use aseptic techniques during preparation and administration.

Post-Administration:

• Monitor the patient for any adverse reactions, especially within the first 3 days post-infusion.
• Advise patients to maintain adequate calcium and vitamin D intake.

Mode of Action ACLASTA 5mg/100ml

Zoledronic Acid, the active ingredient in Aclasta, is a bisphosphonate that:

• Has a high affinity for bone mineral, particularly at sites of active bone turnover.
• Inhibits the enzyme farnesyl pyrophosphate synthase in osteoclasts, leading to reduced bone resorption.
• Results in decreased bone turnover, increased bone mineral density, and reduced fracture risk.

This targeted action makes Aclasta effective in treating conditions characterized by excessive bone resorption.

ACLASTA 5mg/100ml Interactions ACLASTA 5mg/100ml

Potential Drug Interactions:

• Aminoglycosides: Concurrent use may lead to prolonged hypocalcemia.
• Loop diuretics: May increase the risk of hypocalcemia.
• Nephrotoxic drugs: Combined use may enhance the risk of renal impairment.
• Other bisphosphonates: Avoid concurrent use due to potential additive effects.

Monitoring:

• Assess renal function before each dose.
• Monitor serum calcium, phosphate, magnesium, and potassium levels.

Always inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

Dosage of ACLASTA 5mg/100ml

Recommended Dosage:

• Osteoporosis (postmenopausal women and men): 5 mg intravenous infusion once yearly.
• Glucocorticoid-induced osteoporosis: 5 mg intravenous infusion once yearly.
• Paget's disease of bone: A single 5 mg intravenous infusion; re-treatment may be considered after one year if relapse occurs.

Special Populations:

• Renal impairment: Not recommended for patients with creatinine clearance <35 mL/min.
• Hepatic impairment: No dosage adjustment required.
• Elderly patients: No dosage adjustment required, but monitor renal function closely.

Ensure adequate calcium and vitamin D intake during treatment.

Possible side effects of ACLASTA 5mg/100ml

Common Side Effects (≥1%):

• Fever
• Muscle pain (myalgia)
• Headache
• Joint pain (arthralgia)
• Flu-like symptoms

Less Common Side Effects:

• Nausea
• Vomiting
• Diarrhea
• Eye inflammation
• Hypocalcemia

Rare but Serious Side Effects:

• Osteonecrosis of the jaw
• Severe renal impairment
• Severe bone, joint, or muscle pain

Most side effects occur within the first 3 days post-infusion and are transient. Pre-treatment with acetaminophen or ibuprofen may reduce the incidence of acute-phase reactions.

ACLASTA 5mg/100ml Contraindications ACLASTA 5mg/100ml

Do not use Aclasta in patients with:

• Hypocalcemia
• Severe renal impairment (creatinine clearance <35 mL/min)
• Known hypersensitivity to Zoledronic Acid or any component of the formulation
• Pregnancy or breastfeeding
• Children and adolescents under 18 years of age

Before initiating therapy, correct any disturbances in calcium and mineral metabolism.

Storage of ACLASTA 5mg/100ml

Unopened Vial:

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

After Opening:

• Use immediately to avoid microbial contamination.
• If not used immediately, store at 2°C–8°C for up to 24 hours.
• Allow the refrigerated solution to reach room temperature before administration.

Do not use the solution if it is cloudy or contains particles. Discard any unused portion appropriately.