Product Information:

VOXVER 10mg Tablets contain Cinacalcet Hydrochloride 10mg, a calcimimetic agent that increases the sensitivity of calcium-sensing receptors (CaSR) on the parathyroid glands to extracellular calcium. This action reduces the secretion of parathyroid hormone (PTH), thereby lowering serum calcium and phosphorus levels.

This low-strength formulation is primarily used for dose titration in patients with secondary hyperparathyroidism or parathyroid carcinoma.

Uses of (VOXVER 10MG TABLETS):

1. Treatment of secondary hyperparathyroidism (SHPT) in adults with end-stage renal disease (ESRD) on dialysis
2. Management of hypercalcemia in patients with parathyroid carcinoma
3. Treatment of primary hyperparathyroidism in patients who are not candidates for surgery

Key Benefits of (VOXVER 10MG TABLETS):

1. Reduces PTH, calcium, and phosphorus levels without increasing vitamin D or calcium load
2. Helps prevent renal osteodystrophy and vascular calcification in dialysis patients
3. Oral therapy alternative to parathyroidectomy in inoperable cases
4. Low starting dose (10mg) allows safe titration based on lab values

How To Use (VOXVER 10MG TABLETS):

1. Take once daily with food or shortly after a meal (food enhances absorption).
2. Swallow whole with water—do not crush or chew.
3. Starting dose: Typically 30mg once daily, but 10mg tablets allow flexible titration (e.g., 10mg → 20mg → 30mg).
4. Dose adjustments should be based on serum calcium and PTH levels, monitored every 1–4 weeks during titration.
5. Maintenance doses usually range from 30–180mg once daily.

When Not to Use (VOXVER 10MG TABLETS):

Do not use if you have:

1. Hypocalcemia (low blood calcium)
2. Hypersensitivity to cinacalcet or any excipients
3. Severe hepatic impairment (use with caution)

⚠️ Important: VOXVER is not for acute hypocalcemia management and should not be initiated if serum calcium is already low.

Side Effects of (VOXVER 10MG TABLETS):

Common:

1. Nausea, vomiting
2. Diarrhea, abdominal pain
3. Dizziness, headache
4. Muscle cramps (due to falling calcium levels)

Less common:

1. Hypocalcemia (symptoms: tingling, numbness, muscle spasms, seizures)
2. Fatigue, weakness

Serious (rare):

1. Severe hypocalcemia—can cause tetany, arrhythmias, or seizures
2. Gastrointestinal bleeding (reported post-marketing)
3. Discontinue and seek help if perioral numbness, carpopedal spasm, or irregular heartbeat occurs.

Dosage: (VOXVER 10MG TABLETS):

1. Secondary HPT (dialysis patients): Start at 30mg/day; titrate using 10mg increments every 2–4 weeks based on PTH and calcium
2. Parathyroid carcinoma: Start at 30mg twice daily; may increase up to 90mg three times daily
3. Maximum dose: 180mg once daily or 90mg three times daily
4. 10mg strength is primarily for dose adjustment, not maintenance monotherapy

Who It’s For (VOXVER 10MG TABLETS):

1. Dialysis patients with uncontrolled secondary hyperparathyroidism
2. Patients with parathyroid carcinoma or inoperable primary hyperparathyroidism
3. Those requiring fine-tuned dosing due to sensitivity or comorbidities

Warnings & Precautions:

1. Monitor serum calcium, phosphorus, and PTH regularly
2. Correct vitamin D deficiency before starting therapy
3. Avoid in patients with seizure disorders (hypocalcemia may lower seizure threshold)
4. Use caution with QT-prolonging drugs (hypocalcemia can exacerbate arrhythmia risk)

Drug Interactions:

1. CYP2D6 substrates (e.g., thioridazine, flecainide): Cinacalcet inhibits CYP2D6—monitor for toxicity
2. QT-prolonging drugs (e.g., amiodarone, moxifloxacin): ↑ Risk of arrhythmias if hypocalcemia occurs
3. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription only in Pakistan.