Paricalcitol

Paricalcitol Brand Name– Zemplar

What is Paricalcitol

Paricalcitol is a synthetic, biologically active analog of calcitriol. Intravenous paricalcitol is indicated for the treatment and prevention of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stage 5 (chronic renal failure requiring dialysis).

Oral paricalcitol is indicated for the treatment and prevention of secondary hyperparathyroidism associated with CKD stage 3 and 4 and CKD stage 5 patients requiring dialysis.

Vitamin D is a fat-soluble vitamin, which is found in 2 forms, vitamin D₃ or calcitriol, and vitamin D₂. Both forms of vitamin D have effects on calcium absorption from the intestine and through bone resorption.

Paricalcitol is approximately 10-fold less active than calcitriol in promoting resorption of calcium and phosphorus from the bone and does not increase absorption from the GI tract.

Paricalcitol decreases parathyroid hormone (PTH) concentrations but has a lower incidence of hypercalcemia and hyperphosphatemia than calcitriol; the relative dosing of paricalcitol to calcitriol is 4:1.

Chronic renal failure patients with secondary hyperparathyroidism treated with intravenous paricalcitol for 12 weeks achieved more than a 50% decrease in PTH concentrations.

There was no significant change in serum calcium and phosphorus concentrations in the paricalcitol-treated patients compared to placebo.

Similarly, 91% of patients treated with oral paricalcitol for 24 weeks achieved 2 consecutive reductions in PTH concentrations of 30% or more relative to baseline; there was no significant difference in the incidence of hypercalcemia or hyperphosphatemia between paricalcitol- and placebo-treated patients.

Indications

• hyperparathyroidism
• renal osteodystrophy

For the prevention and treatment of secondary hyperparathyroidism and resultant metabolic bone disease (renal osteodystrophy†)

NOTE: Dosage adjustments should be determined based on serum calcium, serum phosphorous, and serum or plasma iPTH concentrations. Initially and following a dosage adjustment, serum calcium, serum phosphorous, and serum or plasma iPTH concentrations should be monitored at least every 2 weeks for 3 months, monthly for 3 months, and then every 3 months thereafter.

Side Effects

1. abdominal pain
2. acne vulgaris
3. agitation
4. alopecia
5. anemia
6. angioedema
7. anxiety
8. arrhythmia exacerbation
9. arthralgia
10. asthenia
11. atrial flutter
12. back pain
13. bone fractures
14. bowel ischemia
15. cardiac arrest
16. chest pain (unspecified)
17. chills
18. confusion
19. conjunctivitis
20. constipation
21. cough
22. dehydration
23. delirium
24. depression
25. diarrhea
26. dizziness
27. dysgeusia
28. dysphagia
29. dyspnea
30. edema
31. elevated hepatic enzymes
32. fatigue
33. fever
34. gastritis
35. gastroesophageal reflux
36. GI bleeding
37. headache
38. hirsutism
39. hypercalcemia
40. hypercalciuria
41. hyperemia
42. hyperkalemia
43. hyperphosphatemia
44. hypertension
45. hypervitaminosis D
46. hypocalcemia
47. hypoesthesia
48. hypoglycemia
49. hypotension
50. impotence (erectile dysfunction)
51. infection
52. influenza
53. injection site reaction
54. insomnia
55. laryngeal edema
56. lymphadenopathy
57. malaise
58. muscle cramps
59. myalgia
60. myoclonia
61. nausea
62. new primary malignancy
63. night sweats
64. ocular hypertension
65. palpitations
66. paresthesias
67. peripheral edema
68. pharyngitis
69. prolonged bleeding time
70. pruritus
71. pulmonary edema
72. rash
73. renal failure (unspecified)
74. restlessness
75. rhinitis
76. sinusitis
77. skin ulcer
78. syncope
79. urinary urgency
80. urticaria
81. vertigo
82. vomiting
83. weight loss
84. wheezing
85. xerostomia

Monitoring Parameters

• serum calcium
• serum intact parathyroid hormone concentrations (iPTH)
• serum phosphate

Contraindications

• breast-feeding
• hypercalcemia
• hypervitaminosis D
• pregnancy

Interactions

• Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
• Aliskiren; Hydrochlorothiazide, HCTZ
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