GNH USA

Europe — EMA

Neodiset (Calcifediol Monohydrate)

GNH USA supplies Neodiset (Calcifediol), a vitamin D analogue for vitamin D deficiency and secondary hyperparathyroidism in CKD. Request a quote for supply.

Calcifediol Monohydrate

Request sourcing

1
Pack/s

What is 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 USA 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.

What is Calcifediol Monohydrate used for?

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.

What are the side effects of Calcifediol Monohydrate?

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.

What precautions apply to Calcifediol Monohydrate?

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.

What does Calcifediol Monohydrate interact with?

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

What is Neodiset used for?+
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.
How does calcifediol work?+
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.
What is the usual dose of Neodiset?+
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.
Is Neodiset safe in pregnancy or breastfeeding?+
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.
How do I order Neodiset from GNH USA?+
To request Neodiset, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Neodiset compare with other vitamin D analogues?+
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.
What are the storage requirements for Neodiset?+
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.
How is Neodiset administered?+
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.
What are the most serious risks associated with Neodiset?+
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.
Who should not use Neodiset?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
Send a sourcing enquiry for this product →

Product details

Drug
Calcifediol Monohydrate
Route
Oral Use
Manufacturer
Faes Farma, S.A.
Origin
EU

Related products

Calcifediol Faes

Calcifediol Faes

Calcifediol Monohydrate

Faes Farma S.A.
EU
Calcifediol Faes

Calcifediol Faes

Calcifediol Monohydrate

Faes Farma, S.A.
EU
Calcifediol Normogen

Calcifediol Normogen

Calcifediol Monohydrate

Laboratorios Normon, S.A.
EU
Calcifediol Normon

Calcifediol Normon

Calcifediol Monohydrate

Laboratorios Normon, S.A.
EU