Endolet Tablets / Film-coated
Cinacalcet
30mg
TABUK PHARMACEUTICAL MANUFACTURING CO
| Pack size | 28's (14's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | ALPHAMED CO. (AUH) LTD. |
| Retail Price | 397.50 AED |
Available as:
Indications
Endolet Tablets / Film-coated is used for:
Hyperparathyroidism, Hypercalcemia, Parathyroid carcinoma
Adult Dose
Secondary Hyperparathyroidism (HPT)
Indicated for secondary HPT in patients with chronic kidney disease on dialysis
Initial dose: 30 mg PO qDay
May increase if needed by titrating at 2-4 week intervals through sequential doses of 60, 90, 120, or 180 mg qDay
Hypercalcemia in Patients with Parathyroid Carcinoma
Initial dose: 30 mg PO q12hr
May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels
Hypercalcemia With Primary Hyperparathyroidism (HPT)
Indicated for severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy
Initial dose: 30 mg PO q12hr
May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels
Child Dose
Renal Dose
Renal Impairment
Dose adjustment not necessary
Administration
Should be taken with food. Take w/ food or shortly after food. Swallow whole, do not divide.
Contra Indications
Hypersensitivity.
Precautions
Moderate-to-severe hepatic impairment, CV diseases. Not indicated for chronic kidney disease patients who are not receiving dialysis. Do not initiate Cinacalcet in hypocalcaemic patients. For secondary hyperparathyroidism, measure serum calcium and phosphorus (prior to- and within 1 wk after initiation/dose adjustment; mthly during maintenance) and iPTH (prior to- and within 1-4 wk after initiation/dosage adjustment; every 1-3 mth during maintenance). iPTH levels should drawn at least 12 hr after Cinacalcet dosing.
For parathyroid carcinoma and primary parathyroidism, measure serum calcium prior-to and within 1 wk after initiation/dose adjustment; and every 2-3 mth during maintenance. Vitamin D sterols, calcium-containing phosphate binder and/or adjustment of calcium contents of dialysis fluid can be used to raise serum calcium in the event of hypocalcaemia. Reduce dose or withhold therapy if hypocalcaemia persists; may reinstate treatment at the next lowest dose after calcium levels normalised. Significant reduction in serum calcium may lower seizure threshold. Adynamic bone disease may develop if iPTH level is suppressed to < 100 pg/mL. May decrease total and free testosterone levels. Safety and efficacy not established in patients ?18 yr. Pregnancy and lactation.
Lactation: excretion in milk unknown/not recommended
Pregnancy-Lactation
Pregnancy
Limited case reports of use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes; in animal reproduction studies, when female rats were exposed to the drug during the period of organogenesis through to weaning at 2-3 times systemic drug levels (based on AUC) at maximum recommended human dose (MRHD) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia
Lactation
There are no data regarding presence in human milk or effects on breastfed infant or on milk production; studies in rats showed that cinacalcet was excreted in milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Cinacalcet is a strong CYP2D6 inhibitor and may increase serum concentrations of amitriptyline, nortriptyline and desipramine. Cinacalcet may decrease serum concentrations of tacrolimus. CYP3A4 inhibitors such as ketoconazole, erythromycin may increase plasma concentrations of Cinacalcet.
Adverse Effects
Side effects of Cinacalcet :
>10%
Secondary Parathyroidism
Diarrhea (20%), Nausea (19%), Vomiting (15%), Myalgia (14%)
1-10%
Secondary Parathyroidism
Dizziness (8%), Hypertension (5%), Access infection (4%), Anorexia (4%), Asthenia (4%), Noncardiac chest pain (4%), Seizures 1.4%
Frequency Not Defined
Parathyroid CA
Nausea/vomiting, Hypocalcemia
Potentially Fatal: Hypersensitivity reaction including angioedema.
Mechanism of Action
Cinacalcet is a calcimimetic agent. It lowers parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor of the parathyroid gland to activation by extracellular calcium. PTH reduction leads to concomitant decrease in serum calcium and phosphorus concentrations.
Note
Endolet 30mg Tablets / Film-coated manufactured by TABUK PHARMACEUTICAL MANUFACTURING CO. Its generic name is Cinacalcet. Endolet is availble in United Arab Emirates.
Farmaco UAE drug index information on Endolet Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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