GNH USA

Europe — EMA

Micalcet

GNH USA supplies Micalcet (Cinacalcet), a calcimimetic for secondary hyperparathyroidism in CKD, hyperparathyroidism and hypercalcemia. Request a quote.

Cinacalcet Hydrochloride

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What is Cinacalcet Hydrochloride?

Cinacalcet hydrochloride, the active ingredient in Micalcet, is a calcimimetic presented as an oral tablet for oral use. It is used to treat secondary hyperparathyroidism in dialysis patients, primary hyperparathyroidism when surgery is not feasible, and hypercalcemia associated with parathyroid carcinoma.

GNH USA supplies Micalcet as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for healthcare providers across multiple regions. Its distribution network ensures timely delivery and regulatory compliance.

What is Cinacalcet Hydrochloride used for?

Micalcet (cinacalcet) acts on the calcium‑sensing receptor pathway to control abnormal parathyroid hormone activity.

- Secondary hyperparathyroidism (CKD dialysis): lowers PTH levels and helps normalize serum calcium and phosphorus. - Primary hyperparathyroidism (non‑surgical): reduces PTH secretion when surgery is not an option. - Hypercalcemia associated with parathyroid carcinoma: decreases serum calcium by inhibiting PTH release.

What are the side effects of Cinacalcet Hydrochloride?

Cinacalcet may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Nausea - Vomiting - Diarrhea - Muscle cramps

Serious or Rare Side Effects: - Severe hypocalcemia with risk of seizures or arrhythmia - Pancreatitis - Stevens‑Johnson syndrome or other severe skin reactions

What precautions apply to Cinacalcet Hydrochloride?

When prescribing Micalcet, clinicians should observe several safety measures.

- Monitor serum calcium: check levels regularly to avoid hypocalcemia. - Monitor PTH levels: adjust dose based on therapeutic response. - Adjust dose in renal impairment: consider reduced clearance in severe kidney dysfunction. - Use with caution in pregnancy: safety not established, weigh benefits and risks. - Avoid in patients with known hypersensitivity to cinacalcet. - Store at room temperature: keep in original container, protect from moisture and light.

What does Cinacalcet Hydrochloride interact with?

Cinacalcet interacts with several medicines; awareness of the interaction level guides clinical decisions.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase cinacalcet exposure. - Strong CYP3A4 inducers (e.g., rifampin, phenytoin): decrease cinacalcet effectiveness.

Moderate Interactions (Monitor Closely): - Vitamin D analogs and calcium supplements: may blunt calcium‑lowering effect. - Bisphosphonates: additive effect on calcium levels. - Loop diuretics: can enhance calcium loss. - ACE inhibitors: monitor blood pressure and renal function.

Frequently asked questions

What is Micalcet used for?+
Micalcet contains cinacalcet, a calcimimetic indicated for secondary hyperparathyroidism in patients receiving dialysis, for primary hyperparathyroidism when surgery cannot be performed, and for hypercalcemia linked to parathyroid carcinoma. In each case the drug helps lower elevated parathyroid hormone and serum calcium levels.
How does cinacalcet work?+
Cinacalcet binds to the calcium‑sensing receptor on parathyroid cells and increases its sensitivity to extracellular calcium. This heightened sensitivity suppresses parathyroid hormone secretion, which in turn reduces calcium release from bone, renal reabsorption of calcium, and activation of vitamin D, leading to lower blood calcium concentrations.
What determines the dose of Micalcet?+
The exact dose of Micalcet is individualized by the prescribing clinician based on the patient’s serum calcium, phosphorus, and parathyroid hormone levels, as well as renal function and concomitant therapies. Dose adjustments are made during treatment to maintain target laboratory values while minimizing adverse effects.
Is Micalcet safe in pregnancy or breastfeeding?+
Safety of cinacalcet during pregnancy and lactation has not been established. The drug should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a qualified healthcare professional after careful assessment.
How do I order Micalcet from GNH USA?+
To request Micalcet, 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 cold‑chain requirements) and the necessary import documentation.
How does Micalcet compare with the main alternative drug or class?+
The primary alternative to oral cinacalcet is etelcalcetide, an injectable calcimimetic used in dialysis patients. Etelcalcetide is administered intravenously after each dialysis session, whereas cinacalcet is taken orally, offering greater convenience but requiring daily adherence. Both share a similar mechanism of calcium‑sensing‑receptor activation.
What are the storage and handling requirements for Micalcet?+
Micalcet tablets should be stored at room temperature, below 25 °C, in their original packaging to protect them from moisture and light. Keep the container tightly closed and out of reach of children. No refrigeration is required.
How is Micalcet administered?+
Micalcet is taken by mouth, usually with a glass of water. The tablet should be swallowed whole and not split or crushed unless specifically instructed by a healthcare professional. Administration timing (e.g., with or without food) follows the prescriber’s guidance.
What are the most serious risks to watch for while taking Micalcet?+
The most serious risks include severe hypocalcemia, which can cause seizures, cardiac arrhythmias, or muscle tetany, and rare but severe skin reactions such as Stevens‑Johnson syndrome. Patients should be educated to report symptoms like muscle cramps, tingling, or unexplained rashes promptly.
Who should not use Micalcet?+
Micalcet should be avoided in individuals with known hypersensitivity to cinacalcet or any of its excipients. Caution is also advised for patients with uncontrolled cardiac arrhythmias, severe liver disease, or those who are pregnant or breastfeeding unless the benefits clearly outweigh the risks.
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.

Product details

Drug
Cinacalcet Hydrochloride
Route
Oral Use
Manufacturer
Zentiva, K.S.
Origin
EU

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