Schedule H

Oral

Formulation Strengths Available

Film-coated Tablet 30 mg, 60 mg, 90 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Secondary Hyperparathyroidism (SHPT) in Chronic Kidney Disease Patients on Dialysis

Parameter Recommendation

Starting Dose 30 mg orally once daily with food

Titration Increase by 30 mg increments at 2–4 week intervals based on PTH response

Usual Maintenance Dose 30–180 mg once daily

Maximum Dose 180 mg once daily

Target Intact PTH: 150–300 pg/mL (per KDOQI guidelines)

Key Notes Ensure serum calcium ≥8.4 mg/dL before each dose increase; withhold therapy if symptomatic hypocalcaemia occurs

1. Hypercalcaemia in Parathyroid Carcinoma

Parameter Recommendation

Starting Dose 30 mg orally twice daily with meals

Titration Increase every 2–4 weeks based on serum calcium response

Usual Maintenance Dose 30–90 mg two to four times daily

Maximum Dose 360 mg/day (in divided doses)

Key Notes Goal is normalisation of corrected serum calcium; more aggressive dosing may be required for malignant hypercalcaemia

1. Primary Hyperparathyroidism (when parathyroidectomy is contraindicated or unsuccessful)

Parameter Recommendation

Starting Dose 30 mg orally twice daily

Titration Adjust every 2–4 weeks guided by serum calcium

Usual Maintenance Dose 30–90 mg twice to thrice daily

Maximum Dose 360 mg/day (divided doses)

Key Notes Surgical intervention remains first-line; cinacalcet is reserved for non-surgical candidates

Secondary Indications – Adults Only (Off-label):

Indication Dose Duration Notes

Tertiary Hyperparathyroidism (post-renal transplant) 30 mg once or twice daily; titrate per calcium/PTH Short to medium term; reassess need periodically OFF-LABEL — Specialist only. Evidence: Limited RCTs; used in Indian nephrology practice when parathyroidectomy is deferred

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India):

NOT APPROVED for use in children below 18 years in India.

Secondary Indications – Paediatrics (Off-label):

Indication Secondary Hyperparathyroidism in CKD (dialysis-dependent)

Age ≥5 years only

Starting Dose 0.2 mg/kg orally once daily

Titration Increase gradually based on PTH and calcium response

Usual Maintenance Dose 0.2–0.5 mg/kg once daily

Maximum Dose 2.5 mg/kg/day (not exceeding 90 mg/day)

Monitoring Weekly serum calcium during titration; PTH every 2–4 weeks

Status OFF-LABEL — Specialist (paediatric nephrologist) supervision mandatory

Evidence Limited paediatric RCT data; extrapolated from adult studies and international paediatric nephrology practice

⚠️ Not recommended in children <5 years except under highly specialised care or research protocols.

CKD Stage 5 on Dialysis No dose adjustment required; drug indicated for this population

CKD not on Dialysis Not studied; use not advised for SHPT in non-dialysis CKD

Haemodialysis No supplemental dose required post-dialysis

Peritoneal Dialysis Can be used; no specific adjustment

• Hypocalcaemia (serum calcium <7.5 mg/dL)

• Known hypersensitivity to cinacalcet or any excipient in the formulation

• History of seizure disorder (hypocalcaemia lowers seizure threshold)

• Pre-existing QT prolongation or concurrent use of QT-prolonging drugs

• Moderate to severe hepatic impairment

• Conditions predisposing to hypocalcaemia

• Avoid abrupt discontinuation (risk of rapid PTH rebound and hypercalcaemia)

• Use in non-dialysis CKD patients not established

Parameter Recommendation

Safety Category Insufficient human data; animal studies inconclusive

Recommendation Use only when potential maternal benefit clearly outweighs fetal risk (e.g., life-threatening hypercalcaemia, parathyroid carcinoma)

Preferred Alternatives Parathyroidectomy is preferred for SHPT/primary HPT in pregnant patients when feasible

Monitoring Maternal serum calcium and PTH levels; fetal growth surveillance

Parameter Recommendation

Breast Milk Excretion Unknown; likely excreted based on pharmacokinetic properties

Expected Milk Levels Low to moderate (estimated)

Compatibility Not recommended during breastfeeding; consider temporary use of infant formula

Preferred Alternatives Defer cinacalcet if possible during lactation; surgical correction if needed

Infant Monitoring If unavoidable, monitor infant for hypocalcaemia symptoms, poor feeding, irritability

Parameter Recommendation

Starting Dose Same as adults (30 mg once daily for SHPT)

Titration Slower titration recommended due to reduced calcium reserve and renal function

Special Risks Increased risk of symptomatic hypocalcaemia, falls, fractures, cardiac arrhythmias

Monitoring More frequent serum calcium monitoring; watch for polypharmacy interactions

Interacting Drug/Class Mechanism Clinical Advice

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) Increased cinacalcet plasma levels Start at lower dose; monitor for hypocalcaemia

Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) Reduced cinacalcet efficacy Avoid combination or adjust dose upward with close PTH monitoring

QT-prolonging drugs (amiodarone, domperidone, ondansetron, haloperidol) Additive QT prolongation risk Avoid if possible; obtain baseline ECG

Bisphosphonates (zoledronic acid, alendronate) Additive hypocalcaemia risk Monitor calcium closely; ensure adequate calcium/vitamin D supplementation

Interacting Drug/Class Mechanism Clinical Advice

Calcium supplements / Vitamin D analogues May blunt PTH-lowering effect May need dose adjustment of either agent; titrate based on PTH

Sevelamer / Phosphate binders Minor interaction Monitor phosphate and calcium; adjust regimen as needed

Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) Modest increase in cinacalcet levels Monitor for adverse effects; may need slower titration

Anticonvulsants (valproate, levetiracetam) Hypocalcaemia may lower seizure threshold Monitor seizure control and calcium levels

• Nausea (up to 30%)

• Vomiting

• Diarrhoea

• Anorexia / decreased appetite

• Muscle cramps

• Myalgia

• Paraesthesias (perioral, extremities)

• Dizziness

• Asthenia

Adverse Effect Clinical Notes

Severe hypocalcaemia May cause tetany, seizures, cardiac arrhythmias; may require hospitalisation and IV calcium

Seizures Secondary to hypocalcaemia; increased risk in those with prior seizure history

QT prolongation / Ventricular arrhythmias ECG monitoring recommended in at-risk patients

Upper GI bleeding Rare; reported more in dialysis patients

Worsening heart failure / Hypotension Monitor in patients with cardiac comorbidities

Adynamic bone disease With excessive PTH suppression; avoid over-suppression

Phase Parameter Frequency

Baseline Serum calcium (corrected), phosphorus, intact PTH, albumin Before initiation

ECG If QT risk factors present

During Titration Serum calcium Weekly for first 4 weeks, then after each dose change

Intact PTH Every 2–4 weeks

Maintenance Serum calcium, phosphorus Monthly

Intact PTH Every 1–3 months

ECG Periodically if on QT-prolonging medications

Clinical Symptoms of hypocalcaemia At each visit

• Sensipar

• Mimpara

• Bonacalcin

• Acelcal

• Cinarest

• Cinacal

• Calcimim

(Brand availability may vary by region; verify tablet scoring before splitting)

Strength Approximate Price per Tablet

• Not included in NLEM; significant price variation across brands

• Available under some state government dialysis support programmes and CGHS

• Cost may be a barrier to long-term therapy; counsel patients accordingly

1. Correct hypocalcaemia first — Never initiate cinacalcet if serum calcium is below normal range.

1. PTH is the primary target — Do not chase calcium alone; titrate based on intact PTH while keeping calcium within safe limits.

1. Hypocalcaemia is dose-limiting — Slow titration and adequate calcium/vitamin D supplementation minimise this risk.

1. Educate patients — Warn about symptoms of hypocalcaemia: perioral tingling, muscle cramps, numbness in fingers.

1. Combine rationally — Use alongside phosphate binders and active vitamin D analogues; tailor the regimen to individual patient biochemistry.

1. In parathyroid carcinoma — Higher and more frequent dosing may be required; calcium control is often clinically urgent.

cinacalcet; secondary hyperparathyroidism; dialysis; parathyroid carcinoma; hypercalcaemia; calcimimetic; CKD; renal-safe; specialist-use; SHPT

RxIndia v1.0 — 09 Jan 2025

• CDSCO (Central Drugs Standard Control Organisation) product information

• Indian Pharmacopoeia / National Formulary of India

• AIIMS Nephrology Treatment Protocols

• API Textbook of Medicine

• Indian Society of Nephrology Guidelines on CKD-MBD Management

• Cinacalcet Product Inserts (Indian manufacturers)

• ICMR Guidelines on Chronic Kidney Disease Management

• KDOQI Clinical Practice Guidelines (supportive reference for PTH targets)

• Published RCTs on tertiary hyperparathyroidism (for off-label evidence only)