Pericon1 mcg

Pericon is a synthetic vitamin D analog (a selective vitamin D receptor activator) used for the prevention and treatment of secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD).

• Established, FDA-approved use (CKD Stage 3-4, not on dialysis): Prevention and treatment of secondary hyperparathyroidism in patients with CKD Stage 3 or 4, using the oral formulation.
• Established, FDA-approved use (CKD Stage 5, dialysis-dependent): Prevention and treatment of secondary hyperparathyroidism in patients with CKD Stage 5 who are on hemodialysis or peritoneal dialysis, using either the oral or intravenous (injectable) formulation.

Pericon works by activating vitamin D receptors, primarily in the parathyroid gland, to suppress excess parathyroid hormone (PTH) production, with a comparatively lower tendency to raise intestinal calcium and phosphorus absorption than older, non-selective vitamin D compounds. It does not treat the underlying kidney disease itself and is not indicated for general vitamin D deficiency or for hyperparathyroidism unrelated to chronic kidney disease.

Each Paricalcitol soft gelatin capsule commonly contains 1 mcg, 2 mcg, or 4 mcg of paricalcitol as the active ingredient, together with excipients such as fractionated triglyceride oil. An intravenous injection formulation is also available, typically as a 2 mcg/mL or 5 mcg/mL sterile solution in single-dose vials, containing paricalcitol with excipients such as propylene glycol and alcohol. Exact strengths, dosage forms, and excipients may vary by manufacturer.

Pericon is a synthetic, biologically active analog of vitamin D2 (a selective vitamin D receptor activator) used to manage secondary hyperparathyroidism in patients with chronic kidney disease. By selectively activating vitamin D receptors, mainly in the parathyroid gland, it suppresses the excess parathyroid hormone secretion that develops as kidney function declines, while having a comparatively smaller effect on intestinal calcium and phosphorus absorption than older, non-selective vitamin D compounds.

Pericon is available as oral capsules for outpatient use and as an intravenous injection administered during hemodialysis sessions, and it is used only under medical supervision with regular laboratory monitoring.

Pericon belongs to the class of vitamin D analogs (selective vitamin D receptor activators), used specifically for the management of secondary hyperparathyroidism related to chronic kidney disease.

Mechanism of Action

Paricalcitol is a selective vitamin D receptor activator. It binds to vitamin D receptors in the parathyroid glands and other target tissues, reducing the synthesis and secretion of parathyroid hormone (PTH) with a comparatively smaller increase in intestinal calcium and phosphate absorption than seen with calcitriol and other non-selective vitamin D compounds. This helps control secondary hyperparathyroidism while aiming to reduce (though not eliminate) the risk of hypercalcemia and hyperphosphatemia.

Pharmacokinetics

• Absorption: Well absorbed after oral administration; may be taken with or without food.
• Distribution: Highly protein bound (greater than 99.9%).
• Metabolism: Extensively metabolized in the liver, primarily via CYP3A4, into several metabolites.
• Elimination half-life: Approximately 15-18 hours after oral dosing, and roughly 14-20 hours after intravenous administration.
• Excretion: Predominantly via bile/feces, with a smaller fraction excreted in urine.

• Pericon oral capsules may be taken with or without food, at approximately the same time(s) each day or on the prescribed dialysis-day schedule.
• Swallow capsules whole with water; do not chew or crush them.
• The intravenous form is given only by trained healthcare personnel as a bolus injection during hemodialysis; it is not for self-administration.
• Do not increase, decrease, or stop the dose without consulting your physician, and attend all scheduled blood tests to monitor calcium, phosphorus, and PTH levels.
• Avoid taking additional vitamin D supplements or over-the-counter calcium products unless specifically directed by your physician.

Calcium-Containing Phosphate Binders and Other Vitamin D Compounds

Concurrent use of Pericon with calcium-containing phosphate binders, calcium supplements, or other vitamin D-related compounds increases the risk of hypercalcemia and hyperphosphatemia. Excessive concurrent vitamin D or calcium supplementation should be avoided, and calcium and phosphorus levels should be monitored closely.

Digoxin (Digitalis Glycosides)

Hypercalcemia, whether caused by Pericon or another source, increases the risk of digitalis toxicity (including cardiac arrhythmias) in patients taking digoxin or related digitalis glycosides. Use Pericon with caution in patients on digoxin, with closer monitoring of serum calcium.

Strong CYP3A4 Inhibitors

Drugs such as ketoconazole can reduce the metabolism of Pericon, raising its blood levels and the risk of hypercalcemia or PTH over-suppression. Concurrent use requires caution and closer laboratory monitoring; dose adjustment may be needed.

Common

• Nausea, vomiting, diarrhea, or dyspepsia
• Headache, dizziness
• Edema
• Chills or feeling feverish (particularly with intravenous administration)
• Elevated liver enzymes

Less Common but Serious

• Hypercalcemia — can present as fatigue, weakness, drowsiness, headache, nausea/vomiting, constipation, muscle or bone pain, metallic taste, or, if severe, cardiac arrhythmia; see Precautions and Overdose
• Hyperphosphatemia, which together with elevated calcium can contribute to vascular or soft-tissue calcification
• Hypersensitivity reactions (rash, pruritus)
• Over-suppression of parathyroid hormone, which with prolonged over-treatment can contribute to adynamic bone disease

Report symptoms suggestive of hypercalcemia, persistent gastrointestinal symptoms, or any unusual heart rhythm to your physician promptly while taking Pericon.

Pregnancy

Data on the use of Pericon in pregnant women are limited. Pericon should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus, and only under close physician supervision with monitoring of maternal calcium levels; consult a physician before use in pregnancy.

Lactation

It is not known whether Pericon passes into human breast milk. Because many drugs are excreted in breast milk and effects on a nursing infant are unknown, the treating physician should decide whether to discontinue breastfeeding or discontinue Pericon, weighing the importance of the drug to the mother.

• Hypercalcemia and hyperphosphatemia: Excessive dosing of Pericon can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. An elevated calcium-phosphorus product increases the risk of soft-tissue and vascular calcification. Serum calcium, phosphorus, and intact PTH must be monitored regularly, especially during dose titration, and the dose reduced or interrupted if levels are elevated or if iPTH is over-suppressed.
• Concurrent calcium/vitamin D products: Avoid excessive concurrent use of calcium-containing phosphate binders, calcium supplements, or other vitamin D compounds, which increases the risk of hypercalcemia (see Interactions).
• Digoxin therapy: Hypercalcemia increases the risk of digitalis toxicity; use with caution and monitor closely in patients on digoxin (see Interactions).
• Adynamic bone disease: Over-suppression of PTH from excessive dosing may contribute to adynamic bone disease; dosing should aim to keep iPTH within the target range appropriate to the patient's CKD stage rather than fully suppressing it.
• Hepatic impairment: Clearance of Pericon may be altered in patients with significant hepatic impairment; use with caution and closer monitoring.
• Regular monitoring required: Pericon should be used only under medical supervision with scheduled laboratory monitoring of calcium, phosphorus, and PTH; doses should never be self-adjusted or shared with others.

Overdose or excessive dosing of Pericon can lead to hypercalcemia, hypercalciuria, and hyperphosphatemia, with symptoms such as weakness, fatigue, drowsiness, headache, nausea, vomiting, constipation, muscle or bone pain, metallic taste, and, in severe cases, cardiac arrhythmia.

If an overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Management is supportive, including discontinuation of Pericon and any calcium or vitamin D supplements, with close monitoring of serum calcium; in severe hypercalcemia, hemodialysis against a calcium-free dialysate may be used under hospital supervision.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not freeze the injectable form.

Renal Impairment

Pericon is specifically indicated for patients with chronic kidney disease (Stage 3–4 not on dialysis, and Stage 5 on dialysis); dosing is determined by CKD stage, dialysis status, and baseline iPTH as described in Dosage and Administration.

Hepatic Impairment

Clearance of Pericon may be altered in patients with significant hepatic impairment; use with caution and increased monitoring.

Elderly Patients

No overall differences in safety or effectiveness have been established between elderly and younger adult patients, though age-related declines in renal and hepatic function should be considered when dosing.

Pediatric Patients

Safety and efficacy of Pericon have not been well established in pediatric patients, particularly for the injectable formulation; any pediatric use should occur only under specialist nephrology supervision. See Pediatric Uses.

Treatment with Pericon is generally continued long-term, for as long as the patient has chronic kidney disease-related secondary hyperparathyroidism requiring control, with the dose adjusted periodically based on laboratory monitoring. Treatment should not be stopped, restarted, or changed in frequency without the treating physician's guidance, as abrupt changes can affect PTH, calcium, and phosphorus balance.

Paricalcitol is classified as a vitamin D analog / selective vitamin D receptor activator, used in the management of secondary hyperparathyroidism associated with chronic kidney disease.

Paricalcitol selectively activates vitamin D receptors, particularly in the parathyroid glands, suppressing the synthesis and secretion of parathyroid hormone (PTH) that becomes elevated in chronic kidney disease. Compared with non-selective vitamin D compounds, Paricalcitol has a reduced tendency to increase intestinal absorption of calcium and phosphorus at doses that effectively suppress PTH, which helps control secondary hyperparathyroidism while aiming to limit the risk of hypercalcemia and hyperphosphatemia.

C

The safety and efficacy of Pericon have not been well established in pediatric patients, particularly for the intravenous formulation. Where oral use is considered by a specialist for CKD-related secondary hyperparathyroidism in a pediatric patient, it should occur only under close nephrology supervision with careful monitoring of growth, calcium, phosphorus, and PTH. Pericon is not indicated for general pediatric vitamin D deficiency.