Product image of Neodiset (Calcifediol Monohydrate) supplied by GNH India

Neodiset

Active Ingredient:
Calcifediol Monohydrate
Origin:
EU

Neodiset (Calcifediol Monohydrate)

Calcifediol, the active ingredient in Neodiset, is a vitamin D analogue presented as an oral formulation for oral administration. It is used to correct vitamin D deficiency and to manage secondary hyperparathyroidism in patients with chronic kidney disease, helping to maintain appropriate calcium and phosphate balance.

GNH India supplies Neodiset as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. Our distribution network ensures reliable access to quality‑assured products across diverse healthcare settings.

Manufacturer / TM Owner

Faes Farma, S.A.

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Indications & Clinical Uses

Neodiset is a vitamin D analogue that addresses disorders of calcium and phosphate metabolism.

  • Vitamin D deficiency: restores serum 25‑hydroxyvitamin D concentrations to normal levels.
  • Secondary hyperparathyroidism associated with chronic kidney disease: lowers parathyroid hormone levels and improves calcium/phosphate balance.
  • Renal osteodystrophy: supports bone health in patients with chronic kidney disease.

How It Works

  • Calcifediol (25‑hydroxyvitamin D3) is absorbed orally and rapidly circulates as a pre‑hormone. In the kidneys it is further hydroxylated to calcitriol (1,25‑dihydroxyvitamin D), which binds the nuclear vitamin D receptor (VDR) in target cells, up‑regulating intestinal calcium and phosphate transport proteins and modulating bone remodeling pathways.

Side Effects

Neodiset may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Hypercalcemia: elevated blood calcium levels.
  • Hyperphosphatemia: increased serum phosphate.
  • Nausea or gastrointestinal discomfort.
  • Headache or fatigue.
  • Constipation.

Serious or Rare Side Effects

  • Severe hypercalcemia leading to cardiac arrhythmia.
  • Renal impairment or nephrolithiasis.
  • Allergic reactions such as rash or angioedema.
  • Soft tissue calcification.
  • Granulomatous disease exacerbation.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Monitor serum calcium and phosphate: adjust dose based on laboratory values.
  • Adjust dosing in renal impairment: reduced clearance may increase risk of hypercalcemia.
  • Avoid concurrent high‑dose vitamin D or calcium supplements: may potentiate hypercalcemia.
  • Use caution during pregnancy and lactation: safety data are limited; consult a physician.
  • Review patient history for hyperparathyroidism or granulomatous disorders.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Calcifediol can interact with several medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Thiazide diuretics: may increase calcium retention and risk of hypercalcemia.
  • Calcium supplements: additive effect on serum calcium levels.
  • High‑dose vitamin A: synergistic hypercalcemic potential.

Moderate Interactions (Monitor Closely)

  • Anticonvulsants (e.g., phenytoin, phenobarbital): accelerate vitamin D metabolism, reducing efficacy.
  • Glucocorticoids: increase catabolism of vitamin D metabolites.
  • Bile acid sequestrants: impair intestinal absorption of calcifediol.

Frequently Asked Questions

Neodiset contains calcifediol, a vitamin D analogue indicated for correcting vitamin D deficiency and for managing secondary hyperparathyroidism in patients with chronic kidney disease. It helps normalize calcium and phosphate metabolism, supporting bone health in these clinical situations.

Calcifediol is the 25‑hydroxy form of vitamin D3. After oral absorption, it circulates as a pre‑hormone and is converted in the kidneys to the active hormone calcitriol. Calcitriol binds the vitamin D receptor, increasing intestinal absorption of calcium and phosphate and influencing bone remodeling.

The appropriate dose of Neodiset is determined by a qualified prescriber based on the patient’s serum 25‑hydroxyvitamin D level, renal function, and clinical condition. Dosing may vary widely, and clinicians tailor the regimen to achieve target vitamin D status while avoiding excess calcium.

Safety data for calcifediol during pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and only under medical supervision. Patients should discuss their individual situation with a healthcare professional.

To request Neodiset, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any temperature control) and necessary import documentation.

Neodiset (calcifediol) is a 25‑hydroxyvitamin D3, which is more rapidly converted to the active form than cholecalciferol (vitamin D3) and does not require hepatic activation. This can result in a faster rise in serum 25‑hydroxyvitamin D levels, making it useful in patients with impaired liver function or those needing a quicker therapeutic effect.

Neodiset should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, excessive heat, and direct sunlight to maintain stability and potency throughout its shelf life.

Neodiset is taken orally, usually as a tablet or capsule, with or without food as directed by the prescribing clinician. The exact administration instructions, including timing and whether to take with meals, are provided by the healthcare professional based on individual patient needs.

The most serious adverse events involve excessive calcium levels (hypercalcemia), which can cause cardiac arrhythmias, kidney stones, or soft‑tissue calcification. Severe hyperphosphatemia and renal impairment may also occur, especially in patients with underlying kidney disease or when combined with high calcium intake.

Neodiset should be avoided in patients with known hypercalcemia, severe renal failure, active granulomatous diseases (e.g., sarcoidosis), or a documented hypersensitivity to calcifediol or any excipients. Clinicians must assess individual risk factors before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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