Cinacalcet

Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. …

• Cinacalcet tablets should be taken with food or shortly after a meal
• Tablets should always be taken whole and not divided Secondary HPT in patients with CKD on dialysis : Starting dose is 30 mg once daily
• Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels. iPTH levels should be measured no earlier than 12 hours after most recent dose
• Hypercalcemia in patients with PC or hypercalcemia in patients with primary HPT : Starting dose is 30 mg twice daily
• Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels
• Once the maintenance dose has been established, monitor serum calcium approximately monthly for patients with secondary HPT and every 2 months for patients with PC or primary HPT Administration Cinacalcet tablets should be taken with food or shortly after a meal
• Cinacalcet tablets are administered orally and should always be taken whole and not chewed, crushed, or divided
• Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. …

Cinacalcet Tablets 30 mg: Light green colored, oval shaped, biconvex film coated tablets debossed with 'CL' on one side and '410' on other side. Cinacalcet Tablets 60 mg : Light green colored, oval shaped, biconvex film coated tablets debossed with 'CL' on one side and '411' on other side. …

• The safety and efficacy of cinacalcet tablets have not been established
• In pediatric patients
• The use of Cinacalcet
• For the treatment of secondary HPT
• In pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies (Pediatric Study 1 and Study 2) where 47
• Pediatric patients aged 6 years to less than 18 years received at least one dose of Cinacalcet and in one single-arm study (Pediatric Study 3) where 17
• Pediatric patients aged 28 days to less than 6 years received at least one dose of Cinacalcet. …

Of the total number of subjects (n=1136) in clinical studies of cinacalcet tablets, 26 percent were 65 and over, and 9 percent were 75 and over. No overall differences in the safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled o …

• Hypocalcemia: Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider [see Warnings and Precautions ]
• Upper Gastrointestinal Bleeding : Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider [see Warnings and Precautions ]
• Heart Failure: Advise patients with heart failure that use of cinacalcet tablets may worsen their heart failure and additional monitoring may be required [see Warnings and Precautions ]
• Advise patients to report nausea and vomiting to their health care provider [see Adverse Reactions ] . …

• Cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions ]
• Cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range

Co-administration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment and monitoring of iPTH serum phosphorus and serum calcium may be required. ( 7.1 ) Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6. ( 7.2 ) 7.1 Strong CYP3A4 Inhibitors Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet tablets may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). …

Hypocalcemia: Life threatening events and fatal outcomes were reported. Hypocalcemia can prolong QT interval, lower the threshold for seizures, and cause hypotension, worsening heart failure, and/or arrhythmia. Monitor serum calcium carefully for the occurrence of hypocalcemia during treatment. ( 2.4 , 5.1 ). Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk. Monitor patients and promptly evaluate and treat any suspected GI bleeding. ( 5.2 ). …

The following adverse reactions are discussed in greater detail in other sections of labeling: Hypocalcemia [see Warnings and Precautions ( 5.1 )] Upper Gastrointestinal Bleeding [see Warnings and Precautions ( 5.2 )] Hypotension, Worsening Heart Failure and/or Arrhythmias [ see Warnings and Precautions ( 5.3 )] Adynamic Bone Disease [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd., at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

IN SPECIFIC POPULATIONS Pediatric Use: A fatal outcome was reported in a pediatric clinical trial patient with severe hypocalcemia. Cinacalcet tablets is not indicated for use in pediatric patients. ( 8.4 ). 8.1 Pregnancy Risk Summary Limited case reports of cinacalcet use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. …

Overdosage of cinacalcet may lead to hypocalcemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcemia and appropriate measures taken to correct serum calcium levels [see Warnings and Precautions ( 5.1 )] . Since cinacalcet is highly protein bound, hemodialysis is not an effective treatment for overdosage of cinacalcet tablets.

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.