Drugs Details

Drugs Info of Sensipar
Drugs Details
  • Drugs Type  : Multum
  • Date : 1st Apr 2015 11:42 pm
  • Brand Name : Sensipar
  • Generic Name : cinacalcet (Pronunciation: sin ah CAL set)
Descriptions

Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Sensipar tablets contain the hydrochloride salt of cinacalcet. Its empirical formula is C22H22F3N•HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity.

The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water.

Sensipar tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively).

The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:

 

SENSIPAR® (cinacalcet)  Structural Formula Illustration

 

Inactive Ingredients

The following are the inactive ingredients in Sensipar tablets: pre-gelatinized starch, microcrystalline cellulose, povidone, crospovidone, colloidal silicon dioxide and magnesium stearate. Tablets are coated with color (Opadry®II green), clear film coat (Opadry®clear), and carnauba wax.

 

What are the possible side effects of cinacalcet (Sensipar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • seizure (convulsions);
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • feeling like you might pass out.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Sensipar »

What are the precautions when taking cinacalcet (Sensipar)?

Before taking cinacalcet, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low levels of calcium in the blood (hypocalcemia), seizures.

Very low levels of calcium can affect the heart rhythm (QT prolongation, ventricular arrhythmias). This risk may be increased if you have certain conditions or are taking drugs that can affect the heart rhythm. Before taking cinacalcet, tell your doctor of all the drugs you take and if you have heart rhythm problems or other heart problems (such as heart...

Read All Potential Precautions of Sensipar »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

Secondary Hyperparathyroidism

Sensipar is indicated for the treatment of secondary hyperparathyroidism(HPT) in adult patients with chronic kidney disease (CKD) on dialysis [seeClinical Studies].

Limitations of Use

Sensipar is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see WARNINGS ANDPRECAUTIONS].

Parathyroid Carcinoma

Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies].

Primary Hyperparathyroidism

Sensipar is indicated for the treatment of 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 [see Clinical Studies].

Dosage Administration

Sensipar tablets should be taken whole and should not be divided. Sensipar should be taken with food or shortly after a meal.

Dosage must be individualized.

Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis

The recommended starting oral dose of Sensipar is 30 mg once daily. Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar [see Monitoring for Hypocalcemia]. Sensipar should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL. Serum iPTH levels should be assessed no earlier than 12 hours after dosing with Sensipar.

Sensipar can be used alone or in combination with vitamin D sterols and/or phosphate binders.

During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with Sensipar [seeSecondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis, Parathyroid Carcinoma And Primary Hyperparathyroidismand WARNINGS ANDPRECAUTIONS].

Parathyroid Carcinoma And Primary Hyperparathyroidism

The recommended starting oral dose of Sensipar is 30 mg twice daily.

The dose of Sensipar should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, and 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium levels. Serum calcium should be measured within 1 week after initiation or dose adjustment of Sensipar [see Monitoring for Hypocalcemia andWARNINGS AND PRECAUTIONS].

Monitoring For Hypocalcemia

Once the maintenance dose has been established, serum calcium should be measured approximately monthly for patients with secondary hyperparathyroidism with CKD on dialysis, and every 2 months for patients with parathyroid carcinoma or primary hyperparathyroidism [see Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis and Parathyroid Carcinoma And Primary Hyperparathyroidism].

For secondary hyperparathyroidism patients with CKD on dialysis, if serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium. If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withhold administration of Sensipar until serum calcium levels reach 8.0 mg/dL and/or symptoms of hypocalcemia have resolved. Treatment should be reinitiated using the next lowest dose of Sensipar [seeSecondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis].

How Supplied

Dosage Forms And Strengths

Sensipar tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” or “60” or “90” on the opposite side of the 30 mg, 60 mg, or 90 mg strengths, respectively.

Storage And Handling

Sensipar 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-073-30)

Sensipar 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “60” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-074-30)

Sensipar 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “90” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-075-30)

Storage

Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature].

Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799. Revised: Nov 2014.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis

In three double-blind, placebo-controlled clinical trials, 1126 patients with CKD on dialysis received study drug (656 Sensipar, 470 placebo) for up to 6 months. The most frequently reported adverse reactions are listed in Table 1.

Seizures were observed in 1.4% (13/910) of Sensipar-treated patients and 0.7% (5/641) of placebo-treated patients across all completed placebo controlled trials.

Table 1: Adverse Reactions with Frequency ≥ 5% in Patients on Dialysis in Short-Term Studies for up to 6 Months

EVENT*: PLACEBO 
(N = 470) (%)
SENSIPAR
(N = 656) (%)
Nausea 19 31
Vomiting 15 27
Diarrhea 20 21
Myalgia 14 15
Dizziness 8 10
Hypertension 5 7
Asthenia 4 7
Anorexia 4 6
Pain Chest, Non-Cardiac 4 6
Dialysis Access Site Infection 4 5
*Included are events that were reported at a greater incidence in the Sensipar group than in the placebo group.

 

In a randomized, double-blind placebo controlled study of 3,883 patients with secondary HPT and CKD receiving dialysis in which patients were treated for up to 64 months (mean duration of treatment was 21 months in the Sensipar group), the most frequently reported adverse reactions (incidence of ≥ 5% in the Sensipar group and a difference ≥ 1% compared to placebo) are listed in Table 2.

Table 2: Frequency of Adverse Reactions in Dialysis Patients Treated for up to 64 Months in a Long-Term Study1

ADVERSE REACTIO PLACEBO (N=1923) SENSIPAR (N=1938)
3699 SUBJECT-YEARS 4044 SUBJECT-YEARS
Percent of subjects reporting Adverse Reactions (%) 90.9 93.2
Nausea 15.5 29.1
Vomiting 13.7 25.6
Diarrhea 18.7 20.5
Dyspnea 11.5 13.4
Cough 9.8 11.7
Hypotension 10.5 11.6
Headache 9.6 11.5
Hypocalcaemia 1.4 11.2
Muscle spasms 9.2 11.1
Abdominal pain 9.6 10.9
Abdominal pain upper 6.3 8.2
Hyperkalemia 6.1 8.1
Upper respiratory tract infection 6.3 7.6
Dyspepsia 4.6 7.4
Dizziness 4.7 7.3
Decreased appetite 3.5 5.9
Asthenia 3.8 5.4
Constipation 3.8 5.0
1Adverse reactions that occurred in ≥ 5% Frequency in the Sensipar group and a difference ≥ 1% compared to the placebo group (Safety Analysis Set) 
Crude incidence rate = 100 * Total number of subjects with event/ N 
N=Number of subjects receiving at least one dose of study drug

 

Additional adverse reaction rates from the long-term, randomized, double-blind placebo controlled study for Sensipar versus placebo are as follows:seizure (2.5%, 1.6%), rash (2.2%, 1.9%), hypersensitivity reactions (9.4%, 8.3%).

Parathyroid Carcinoma and Primary Hyperparathyroidism

The safety profile of Sensipar in these patient populations is generally consistent with that seen in patients with CKD on dialysis. Forty six patients were treated with Sensipar in a single arm study, 29 with ParathyroidCarcinoma and 17 with intractable pHPT. Nine (20%) of the patients withdrew from the study due to adverse events. The most frequent adverse reactions and the most frequent cause of withdrawal in these patient populations were nausea and vomiting. Severe or prolonged cases of nausea and vomiting can lead to dehydration and worsening hypercalcemiaso careful monitoring of electrolytes is recommended in patients with these symptoms.

Eight patients died during treatment with Sensipar in this study, 7 with Parathyroid Carcinoma (24%) and 1 (6%) with intractable pHPT. Causes of death were cardiovascular (5 patients), multi-organ failure (1 patient),gastrointestinal hemorrhage (1 patient) and metastatic carcinoma (1 patient). Adverse events of hypocalcemia were reported in three patients (7%).

Seizures were observed in 0.7% (1/140) of cinacalcet-treated patients and 0.0% (0/46) of placebo-treated patients in all clinical studies.

Table 3: Adverse Reactions with Frequency ≥ 10% in a Single Arm, Open-Label Study in Patients with Primary Hyperparathyroidism or Parathyroid Carcinoma

  SENSIPAR
PARATHYROID CARCINOMA 
(N=29) 
N (%)
INTRACTABLE PHPT 
(N=17) 
N (%)
TOTAL 
(N=46) 
N (%)
Number of Subjects Reporting Adverse Reactions 28 (97) 17 (100) 45 (98)
Nausea 19 (66) 10 (59) 29 (63)
Vomiting 15 (52) 6 (35) 21 (46)
Paresthesia 4 (14) 5 (29) 9 (20)
Fatigue 6 (21) 2 (12) 8 (17)
Fracture 6 (21) 2 (12) 8 (17)
Hypercalcemia 6 (21) 2 (12) 8 (17)
Anorexia 6 (21) 1 (6) 7 (15)
Asthenia 5 (17) 2 (12) 7 (15)
Dehydration 7 (24) 0 (0) 7 (15)
Anemia 5 (17) 1 (6) 6 (13)
Arthralgia 5 (17) 1 (6) 6 (13)
Constipation 3 (10) 3 (18) 6 (13)
Depression 3 (10) 3 (18) 6 (13)
Headache 6 (21) 0 (0) 6 (13)
Infection Upper Respiratory 3 (10) 2 (12) 5 (11)
Pain Limb 3 (10) 2 (12) 5 (11)
N=Number of subjects receiving at least one dose of study drug. 
pHPT=primary hyperparathyroidism

 

In a randomized double-blind, placebo-controlled study of 67 patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery, the most common adverse reactions are listed in Table 4.

Table 4: Adverse Reactions Occurring in ≥ 10% of Subjects in a Double-Blind, Placebo-Controlled Study in Patients with Primary Hyperparathyroidism

ADVERSE REACTION PLACEBO 
(N = 34)
N (%)
CINACALCET 
(N = 33) 
N (%)
Nausea 6 (18) 10 (30)
Muscle spasms 0 (0) 6 (18)
Headache 2 (6) 4 (12)
Back pain 2 (6) 4 (12)
N=Number of subjects receiving at least one dose of study drug Coded using MedDRA version 16.0

 

Hypocalcemia

In 26-week studies of patients with secondary HPT and CKD on dialysis 66% of patients receiving Sensipar compared with 25% of patients receiving placebo developed at least one serum calcium value less than 8.4 mg/dL, whereas, 29 % of patients receiving Sensipar compared with 11% of patients receiving placebo developed at least one serum calcium value less than 7.5 mg/dL. Less than 1% of patients in each group permanently discontinued study drug due to hypocalcemia.

In a randomized, double-blind, placebo-controlled study in patients with secondary HPT and CKD receiving dialysis in which patients were treated for up to 64 months (mean duration of treatment was 21 months in the cinacalcet group), 75% of patients receiving Sensipar compared with 29% of patients receiving placebo developed at least one serum calcium value less than 8.4 mg/dL and 33% of cinacalcet patients compared with 12% of patients receiving placebo had at least one serum calcium value less than 7.5 mg/dL. Most of the cases of severe hypocalcemia less than 7.5mg/dL (21/33=64%) occurred during the first 6 months. In this trial, 1.1% of patients receiving Sensipar and 0.1% of patients receiving placebo permanently discontinued study drug due to hypocalcemia.

During a placebo-controlled part of a 52-week study in patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium ( > 11.3 mg/dl [2.82 mmol/L] and ≤ 12.5 mg/dl [3.12 mmol/L]), serum calcium less than 8.4 mg/dL was observed in 6.1% (2/33) of Sensipar treated patients and 0% (0/34) of placebo treated patients.

Postmarketing Experience With Sensipar

The following adverse reactions have been identified during postapproval use of Sensipar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Rash and hypersensitivity reactions (including angioedema, and urticaria), and myalgia have been identified as adverse reactions during post approval use of Sensipar. Isolated, idiosyncratic cases of hypotension, worseningheart failure, and/or arrhythmia have been reported in Sensipar-treated patients with impaired cardiac function in postmarketing safety surveillance [see WARNINGS AND PRECAUTIONS].

Read the Sensipar (cinacalcet) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Strong CYP3A4 Inhibitors

Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of Sensipar may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients [seeCLINICAL PHARMACOLOGY].

CYP2D6 Substrates

Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see CLINICAL PHARMACOLOGY].

Read the Sensipar Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Hypocalcemia

Sensipar lowers serum calcium and, therefore, patients should be carefully monitored for the occurrence of hypocalcemia during treatment [seeDOSAGE AND ADMINISTRATION and ADVERSE REACTIONS]. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including pediatric patients [see Pediatric Use]. Potential manifestations of hypocalcemia include paresthesias, myalgias, muscle cramping, tetany, and convulsions.

Sensipar is not indicated for patients with CKD not on dialysis [seeINDICATIONS AND USAGE]. In patients with secondary HPT and CKD not on dialysis, the long term safety and efficacy of Sensipar have not been established. Clinical studies indicate that Sensipar-treated patients with CKD not on dialysis have an increased risk for hypocalcemia compared with Sensipar-treated patients with CKD on dialysis, which may be due to lower baseline calcium levels. In a phase 3 study of 32 weeks duration and including 404 patients with CKD not on dialysis (302 cinacalcet, 102 placebo), in which the median dose for cinacalcet was 60 mg per day at the completion of the study, 80% of Sensipar-treated patients experienced at least one serum calcium value < 8.4 mg/dL compared with 5% of patients receiving placebo.

QT Prolongation

Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with Sensipar.

Seizures

In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of Sensipar-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference inseizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Therefore, serum calcium levels should be closely monitored in patients receiving Sensipar, particularly in patients with a history of a seizure disorder.

Hypotension and/or Worsening Heart Failure

In postmarketing safety surveillance, isolated, idiosyncratic cases ofhypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function, in which a causal relationship to Sensipar could not be completely excluded and which may be mediated by reductions in serum calcium levels [see ADVERSE REACTIONS].

Adynamic Bone Disease

Adynamic bone disease may develop if iPTH levels are suppressed below 100 pg/mL. One clinical study evaluated bone histomorphometry in patients treated with Sensipar for 1 year. Three patients with mild hyperparathyroid bone disease at the beginning of the study developed adynamic bone disease during treatment with Sensipar. Two of these patients had iPTH levels below 100 pg/mL at multiple time points during the study. In three 6-month, phase 3 studies conducted in patients with CKD on dialysis, 11% of patients treated with Sensipar had mean iPTH values below 100 pg/mL during the efficacy-assessment phase. If iPTH levels decrease below 150 pg/mL in patients treated with Sensipar, the dose of Sensipar and/or vitamin D sterols should be reduced or therapy discontinued.

Hepatic Impairment

Cinacalcet exposure, as defined by the Area Under the Plasma Drug Concentration Time Curve (AUC0-infinite), is increased by 2.4 and 4.2 fold in patients with moderate and severe hepatic impairment, respectively. These patients should be monitored throughout treatment with Sensipar [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Carcinogenicity

Standard lifetime dietary carcinogenicity bioassays were conducted in mice and rats. Mice were given cinacalcet at dietary doses of 15, 50, and 125 mg/kg/day in males and 30, 70, and 200 mg/kg/day in females (exposures up to 2 times those resulting with a human oral dose of 180 mg/day based on AUC comparison). Rats were given dietary doses of 5, 15, and 35 mg/kg/day in males and 5, 20, and 35 mg/kg/day in females (exposures up to 2 times those resulting with a human oral dose of 180 mg/day based on AUC comparison). No increased incidence of tumors was observed following treatment with cinacalcet.

Mutagenicity

Cinacalcet was not genotoxic in the Ames bacterial mutagenicity assay, nor in the Chinese Hamster Ovary (CHO) cell HGPRT forward mutation assay and CHO cell chromosomal aberration assay, with and without metabolic activation, nor in the in vivo mouse micronucleus assay.

Impairment of Fertility

Female rats were given oral gavage doses of 5, 25, and 75 mg/kg/day cinacalcet beginning 2 weeks before mating and continuing through gestation day 7. Male rats were given oral doses 4 weeks prior to mating, during mating (3 weeks) and 2 weeks postmating. No effects were observed in male or female fertility at 5 and 25 mg/kg/day (exposures up to 3 times those resulting with a human oral dose of 180 mg/day based on AUC comparison). At 75 mg/kg/day, there were slight adverse effects (slight decreases in body weight and food consumption) in males and females.

Use In Specific Populations

Pregnancy

Category C

In pregnant female rats given oral gavage doses of 2, 25, 50 mg/kg/day cinacalcet during gestation, no teratogenicity was observed at doses up to 50 mg/kg/day (exposure 4 times those resulting with a human oral dose of 180 mg/day based on Area Under the Curve [AUC] comparison). Decreased fetal body weights were observed at all doses (less than 1 to 4 times a human oral dose of 180 mg/day based on AUC comparison) in conjunction with maternal toxicity (decreased food consumption and body weight gain).

In pregnant female rabbits given oral gavage doses of 2, 12, 25 mg/kg/day cinacalcet during gestation, no adverse fetal effects were observed (exposures less than with a human oral dose of 180 mg/day based on AUC comparisons). Reductions in maternal food consumption and body weight gain were seen at doses of 12 and 25 mg/kg/day. Sensipar has been shown to cross the placental barrier in rabbits.

In pregnant rats given oral gavage doses of 5, 15, 25 mg/kg/day cinacalcet during gestation through lactation, no adverse fetal or pup (post-weaning) effects were observed at 5 mg/kg/day (exposures less than with a human therapeutic dose of 180 mg/day based on AUC comparisons). Higher doses of 15 and 25 mg/kg/day cinacalcet (exposures 2 to 3 times a human oral dose of 180 mg/day based on AUC comparisons) were accompanied by maternal signs of hypocalcemia (periparturient mortality and early postnatal pup loss), and reductions in postnatal maternal and pup body-weight gain.

There are no adequate and well-controlled studies of Sensipar in pregnant women. Sensipar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who become pregnant during Sensipar treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Nursing Mothers

Studies in rats have shown that Sensipar is excreted in the milk with a high milk-to-plasma ratio. It is not known whether this drug is excreted in human milk. Considering these data in rats, and because many drugs are excreted in human milk and there is a potential for clinically significant adverse reactions in infants who ingest Sensipar, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the lactating woman.

Women who choose to continue Sensipar treatment while nursing are encouraged to enroll in Amgen's Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Pediatric Use

The safety and efficacy of Sensipar in pediatric patients have not been established. Sensipar is not indicated for use in pediatric patients. A fatal outcome was reported in a pediatric clinical trial patient with severe hypocalcaemia [see WARNINGS AND PRECAUTIONS].

Geriatric Use

Of the total number of subjects (n=1136) in clinical studies of Sensipar, 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 out [see Clinical Studies and CLINICAL PHARMACOLOGY].

Renal Impairment

No dosage adjustment is necessary for renal impairment [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

Patients with moderate and severe hepatic impairment should have serum calcium, serum phosphorus, and iPTH levels monitored closely throughout treatment with Sensipar because cinacalcet exposure (AUC0-infinite) is increased by 2.4 and 4.2 fold, respectively, in these patients [seeWARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Doses titrated up to 300 mg once daily have been safely administered to patients on dialysis. Overdosage of Sensipar 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].

Since Sensipar is highly protein bound, hemodialysis is not an effective treatment for overdosage of Sensipar.

ContrainDications

Sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see WARNINGS AND PRECAUTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

The calcium-sensing receptor on the surface of the chief cell of theparathyroid gland is the principal regulator of PTH synthesis and secretion.Cinacalcet, the active ingredient in Sensipar, directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellularcalcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.

Pharmacodynamics

Reduction in iPTH levels correlated with the plasma cinacalcet concentrations in patients with CKD. The nadir in iPTH level occurs approximately 2 to 6 hours post dose, corresponding with the maximum plasma concentration (Cmax) of cinacalcet. After steady-state cinacalcet concentrations are reached (which occurs within 7 days of dose change), serum calcium concentrations remain constant over the dosing interval in patients with CKD.

Reductions in PTH are associated with a decrease in bone turnover and bone fibrosis in patients with CKD on dialysis and uncontrolled secondary HPT.

Pharmacokinetics

Absorption and Distribution

After oral administration of cinacalcet, Cmax is achieved in approximately 2 to 6 hours. Cinacalcet Cmax and AUC(0-infinite) were increased by 82% and 68%, respectively, following administration with a high-fat meal compared with fasting in healthy volunteers. The Cmax and AUC(0-infinite) of cinacalcet were increased by 65% and 50%, respectively, when cinacalcet was administered with a low-fat meal compared with fasting.

After absorption, cinacalcet concentrations decline in a biphasic fashion with a terminal half-life of 30 to 40 hours. Steady-state drug levels are achieved within 7 days, and the mean accumulation ratio is approximately 2 with once daily oral administration. The median accumulation ratio is approximately 2 to 5 with twice daily oral administration. The AUC and Cmax of cinacalcet increase proportionally over the dose range of 30 to 180 mg once daily. The pharmacokinetic profile of cinacalcet does not change over time with once daily dosing of 30 to 180 mg. The volume of distribution is approximately 1000 L, indicating extensive distribution. Cinacalcet is approximately 93% to 97% bound to plasma protein(s). The ratio of blood cinacalcet concentration to plasma cinacalcet concentration is 0.80 at a blood cinacalcet concentration of 10 ng/mL.

Metabolism and Excretion

Cinacalcet is metabolized by multiple enzymes, primarily CYP3A4, CYP2D6, and CYP1A2. After administration of a 75 mg radiolabeled dose to healthy volunteers, cinacalcet was metabolized via: 1) oxidative N-dealkylation to hydrocinnamic acid and hydroxy-hydrocinnamic acid, which are further metabolized via β-oxidation and glycine conjugation; the oxidative N-dealkylation process also generates metabolites that contain the naphthalene ring; and 2) oxidation of the naphthalene ring on the parent drug forming dihydrodiols, which are further conjugated with glucuronic acid. The plasma concentrations of the major circulating metabolites, including the cinnamic acid derivatives and glucuronidated dihydrodiols, markedly exceed the parent drug concentrations. The hydrocinnamic acid metabolite and glucuronide conjugates have minimal or no calcimimetic activity. Renal excretion of metabolites was the primary route of elimination of radioactivity. Approximately 80% of the dose was recovered in the urine and 15% in the feces.

Specific Populations
Age: Geriatric Population

The pharmacokinetic profile of cinacalcet in geriatric patients (age ≥ 65 years, n = 12) is similar to that for patients who are < 65 years of age (n = 268) [see Use In Specific Populations].

Age: Pediatric Population

The pharmacokinetics of cinacalcet has not been studied in patients < 18 years of age [see Use in Specific Populations].

Hepatic Impairment

The disposition of a 50 mg Sensipar single dose was compared between patients with hepatic impairment and patients with normal hepatic function. Cinacalcet exposure (AUC(0-infinite)) was comparable between healthy volunteers and patients with mild hepatic impairment. However, in patients with moderate and severe hepatic impairment (as indicated by the Child-Pugh method), cinacalcet exposures (AUC(0-infinite)) were 2.4 and 4.2 fold higher, respectively, than that in healthy volunteers. The mean half-life of cinacalcet increased from 49 hours in healthy volunteers to 65 hours and 84 hours in patients with moderate and severe hepatic impairment, respectively. Protein binding of cinacalcet is not affected by impaired hepatic function [seeWARNINGS AND PRECAUTIONS and Use in Specific Populations].

Renal Impairment

The pharmacokinetic profile of a 75 mg Sensipar single dose in patients with mild, moderate, and severe renal impairment, and those on hemodialysis orperitoneal dialysis is comparable with that in healthy volunteers [see Use In Specific Populations].

Drug Interactions

In vitro studies indicate that cinacalcet is a strong inhibitor of CYP2D6, but not an inhibitor of CYP1A2, CYP2C9, CYP2C19, and CYP3A4. In vitro induction studies indicate that cinacalcet is not an inducer of CYP450 enzymes. Tables 5 and 6 list the findings from in vivo drug-drug interaction studies.

Table 5: Effect of co-administered drugs on cinacalcet

CO-ADMINISTERED DRUG AND DOSING REGIMEN CINACALCET
DOSE* MEAN CHANGE IN AUC (0-INF) MEAN CHANGE IN CMAX
200 mg ketoconazole twice daily for 7 days 90 mg on day 5 ↑127% ↑116%
1500 mg calcium carbonate, single dose 100 mg ↓6% ↓5%
80 mg pantoprazole daily for 3 days 90 mg on day 3 ↑1% ↓3%
2400 mg sevelamer HCl three times a day for 2 days 90 mg on day 1 with first dose of sevelamer ↓4% ↓7%
*Single dose.

 

Table 6: Effect of cinacalcet co-administration on other drugs

CINACALCET DOSING REGIMEN CO-ADMINISTERED DRUG
NAME AND DOSE MEAN CHANGE IN AUC(0-INF) MEAN CHANGE IN CMAX
30 mg twice daily for 8 days 25 mg warfarin* tablet† ↑1 % for R-warfarin 
↓1% S-warfarin
↑10 % for R-warfarin 
↑12 % for S-warfarin
90 mg daily for 7 days to CYP2D6 extensive metabolizers 50 mg desipramine† ↑264% ↑75%
90 mg daily for 5 days 2 mg midazolam† ↑5% ↓5%
25 or 100 mg single dose to CYP2D6 extensive metabolizers 50 mg amitriptyline single dose ↑21 -22% for amitriptyline 
↑17-23% for nortriptyline‡
↑13-21% for amitriptyline 
↑11-15% for nortriptyline‡
*No significant change in prothrombin time. 
†Single dose on day 5.
‡Nortriptyline is an active metabolite of amitriptyline.

 

Clinical Studies

Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease On Dialysis

Three 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies of similar design were conducted in patients with CKD on dialysis. A total of 665 patients were randomized to Sensipar and 471 patients to placebo. The mean age of the patients was 54 years, 62% were male, and 52% were Caucasian. The average baseline iPTH level by the Nichols IRMA was 712 pg/mL, with 26% of the patients having a baseline iPTH level > 800 pg/mL. The mean baseline Ca x P product was 61 mg2/dL2. The average duration of dialysis prior to study enrollment was 67 months. Ninety-six percent of patients were on hemodialysis and 4% on peritonealdialysis. At study entry, 66% of the patients were receiving vitamin D sterols and 93% were receiving phosphate binders. Sensipar (or placebo) was initiated at a dose of 30 mg once daily and titrated every 3 or 4 weeks to a maximum dose of 180 mg once daily to achieve an iPTH of < 250 pg/mL. The dose was not increased if a patient had any of the following: iPTH < 200 pg/mL, serum calcium < 7.8 mg/dL, or any symptoms of hypocalcemia. If a patient experienced symptoms of hypocalcemia or had a serum calcium < 8.4 mg/dL, calcium supplements and/or calcium-based phosphate binders could be increased. If these measures were insufficient, the vitamin D dose could be increased. Approximately 70% of patients in the Sensipar arm and 80% of the patients in the placebo arm completed the 6-month studies. In the primary efficacy analysis, 40% of the patients on Sensipar and 5% of placebo-treated patients achieved an iPTH < 250 pg/mL (p < 0.001) (Table 7, Figure 1). These studies showed that Sensipar reduced iPTH while lowering Ca x P, calcium, and phosphorus levels (Table 7, Figure 2). The median dose of Sensipar at the completion of the studies was 90 mg. Patients with milder disease typically required lower doses.

Similar results were observed when either the iPTH or biointact PTH (biPTH) assay was used to measure PTH levels in CKD patients on dialysis; treatment with cinacalcet did not alter the relationship between iPTH and biPTH.

Table 7: Effects of Sensipar on iPTH, Ca x P, Serum Calcium, and Serum Phosphorus in 6-month Phase 3 Studies (Patients on Dialysis)

View Enlarged Table

 

Figure 1: Mean (SE) iPTH Values (Pooled Phase 3 Studies)

View Enlarged Table

 

Data are presented for patients who completed the studies; Placebo (n = 342), Sensipar (n = 439).

Figure 2: Mean (SE) Ca x P Values (Pooled Phase 3 Studies)

View Enlarged Table

 

Data are presented for patients who completed the studies; Placebo (n = 342), Sensipar (n = 439).

Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment.

Sensipar decreased iPTH and Ca x P levels regardless of disease severity (i.e., baseline iPTH value), duration of dialysis, and whether or not vitamin D sterols were administered. Approximately 60% of patients with mild (iPTH ≥ 300 to < 500 pg/mL), 41% with moderate (iPTH > 500 to 800 pg/mL), and 11% with severe (iPTH > 800 pg/mL) secondary HPT achieved a mean iPTH value of < 250 pg/mL. Plasma iPTH levels were measured using the Nichols IRMA.

Parathyroid Carcinoma

Twenty-nine patients with Parathyroid Carcinoma were enrolled in a single-arm, open-label study. The study consisted of two phases, a dose-titration phase and a maintenance phase. Patients initially received 30 mg cinacalcet twice daily and then were titrated every 2 weeks to a maximum dose of 90 mg four times daily. Dosage escalation during the variable-length (2 to 16 weeks) titration phase continued until the serum calcium concentration was < 10 mg/dL (2.5 mmol/L), the patient reached the highest possible dosage, or adverse events precluded further dosage increases.

Twenty-nine patients entered the study. The median exposure to cinacalcet was 229 days (range: 1 to 1051). At baseline the mean (SE) serum calcium was 14.1 (0.4) mg/dL. At the end of the titration phase, the mean (SE) serum calcium was 12.4 (0.5) mg/dL, which is a mean reduction of 1.7 (0.6) mg/dL from baseline. Figure 3 illustrates mean serum calcium (mg/dL) over time for all patients still on study at each time point from the beginning of titration to study visit week 80. Daily dose during the study ranged from 30 mg twice daily to 90 mg four times daily.

Figure 3: Serum Calcium Values in Patients With Parathyroid Carcinoma Receiving Sensipar at Baseline, Titration, and Maintenance Phase

View Enlarged Table

 

n = Number of patients with non-missing values at the timepoint. End of Titration (EOT) phase could occur at any visit from week 2 to 16. Patients at EOT are those who completed titration.

Patients With Hypercalcemia Due To Primary Hyperparathyroidism

Seventeen patients with severe hypercalcemia due to primary HPT, who had failed or had contraindications to parathyroidectomy, participated in an open-label, single-arm study. The study consisted of two phases, a dose-titration phase and a maintenance phase. In this trial, severe hypercalcemia was defined as a screening serum calcium level of > 12.5 mg/dL. Patients initially received 30 mg cinacalcet twice daily and then were titrated every 2 weeks to a maximum dose of 90 mg 4 times daily. Dosage escalation during the variable-length (2 to 16 weeks) titration phase continued until the serum calcium concentration was < 10 mg/dL (2.5 mmol/L), the patient reached the highest possible dosage, or adverse events precluded further dosage increases.

Seventeen patients entered the study. The median exposure to cinacalcet was 270 days (range: 32 to 1,105). At baseline the mean (SE) serum calcium was 12.7 (0.2) mg/dL. At the end of the titration phase the mean (SE) serum calcium was 10.4 (0.3) mg/dL, which is a mean reduction of 2.3 (0.3) mg/dL from baseline. Figure 4 illustrates mean serum calcium (mg/dL) over time for all patients still on study at each time point from the beginning of titration to study visit week 80. Daily dose during the study ranged from 30 mg twice a day to 90 mg four times a day.

Figure 4: Mean Serum Calcium (SE) at Baseline, End of Titration, and Scheduled Maintenance Visits (Patients with Severe intractable primary HPT)

View Enlarged Table

 

n = Number of patients with non-missing values at the timepoint. End of Titration (EOT) phase could occur at any visit from week 2 to 16. Patients at EOT are those who completed titration.

Sixty-seven patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium ( > 11.3 mg/dl [2.82 mmol/L] and < 12.5 mg/dl [3.12 mmol/L]), but who were unable to undergo parathyroidectomy participated in a randomized, double-blind, placebo-controlled study. A total of 33 patients were randomized to Sensipar and 34 patients randomized to placebo. The mean age of the patients was 72 years, 52% were female, 61% were Caucasian, and 5% were Blacks. The study started with a 12-week titration phase, followed by a 16-week efficacy assessment phase. Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum calcium concentration within the normal range. During the efficacy period a significantly higher percentage of cinacalcet treated patients compared with the placebo treated patients achieved mean corrected total serum calcium concentration ( ≤ 10.3 mg/dL [2.57 mmol/L], 75.8% vs 0%, p < 0.001) and ≥ 1 mg/dL [0.25 mmol/L] decrease from baseline in mean corrected total serum calcium concentration (84.8% vs 5.9%, p < 0.001). The median dose of Sensipar at the completion of the study was 60 mg/day.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

  • Take with Food: Patients should be advised to take Sensipar with food or shortly after a meal. Tablets should be taken whole and should not be divided.
  • Laboratory Monitoring: Patients should be informed of the importance of regular blood tests, in order to monitor the safety and efficacy of Sensipar therapy.
  • Common Serious Adverse Reactions: Patients should be advised to report nausea, vomiting, and potential symptoms of hypocalcemia, including tingling/numbness of the skin, muscle pain, and muscle cramping.
  • Seizures: Patients should be queried if they are taking medication to prevent seizures or have had seizures in the past and be advised to report any seizure episodes while on Sensipar therapy.
  • Lactation Surveillance Program: Encourage patients who are nursing while on Sensipar treatment to enroll in Amgen's Lactation Surveillance Program. To enroll patients should call 1-800-77-AMGEN (1-800-772-6436).

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CINACALCET - ORAL

 

(SIN-a-KAL-set)

 

COMMON BRAND NAME(S): Sensipar

 

USES: Cinacalcet is used to treat increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. It is also used to treat increased amounts of calcium in people with an overactive parathyroid gland or in people with cancer of the parathyroid gland. Cinacalcet works by decreasing the amount of parathyroid hormone, calcium, and phosphorus in your body. Having the right amount of these substances in your body helps to prevent bone disease.

 

HOW TO USE: Take this medication by mouth with food or shortly after a meal, as directed by your doctor.

The manufacturer directs not to split the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's directions on how to take this medication.

The dosage is based on your medical condition, response to treatment, and laboratory tests.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time(s) each day.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, or unusual tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Cinacalcet can cause low calcium blood levels. Your doctor will check your calcium blood levels while your are taking this medication. Tell your doctor right away if you have any of the following symptoms of low calcium levels: numb/tingling skin, severe muscle spasms, seizures, unusual tiredness, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Sensipar (cinacalcet) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking cinacalcet, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low levels of calcium in the blood (hypocalcemia), seizures.

Very low levels of calcium can affect the heart rhythm (QT prolongation, ventricular arrhythmias). This risk may be increased if you have certain conditions or are taking drugs that can affect the heart rhythm. Before taking cinacalcet, tell your doctor of all the drugs you take and if you have heart rhythm problems or other heart problems (such as heart failure, low blood pressure).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe muscle spasms, seizures.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as calcium, phosphorus, parathyroid hormone levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Sensipar

Generic Name: cinacalcet (Pronunciation: sin ah CAL set)

  • What is cinacalcet (Sensipar)?
  • What are the possible side effects of cinacalcet (Sensipar)?
  • What is the most important information I should know about cinacalcet (Sensipar)?
  • What should I discuss with my healthcare provider before taking cinacalcet (Sensipar)?
  • How should I take cinacalcet (Sensipar)?
  • What happens if I miss a dose (Sensipar)?
  • What happens if I overdose (Sensipar)?
  • What should I avoid while taking cinacalcet (Sensipar)?
  • What other drugs will affect cinacalcet (Sensipar)?
  • Where can I get more information?

What is cinacalcet (Sensipar)?

 

Cinacalcet decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body.

Cinacalcet is used to treat hyperparathyroidism (overactive functioning of the parathyroid glands) in people who are on long-term dialysis for kidney disease.

Cinacalcet is also used to lower calcium levels in people with cancer of the parathyroid gland.

Cinacalcet may also be used for purposes not listed in this medication guide.

Sensipar 60 mg

oval, green, imprinted with AMGEN, 60

What are the possible side effects of cinacalcet (Sensipar)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • seizure (convulsions);
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • feeling like you might pass out.

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite;
  • muscle pain, mild chest pain;
  • dizziness; or
  • weakness;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Sensipar (cinacalcet) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about cinacalcet (Sensipar)?

 

You should not take this medication if you are allergic to cinacalcet.

Before you take cinacalcet, tell your doctor if you have high blood pressure, heart disease, heart failure, a heart rhythm disorder, liver disease, or a history of seizures.

There are many other medicines that can interact with cinacalcet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Cinacalcet works best if you take it with food or shortly after eating a meal.

Do not crush or break a cinacalcet tablet. Swallow the pill whole.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Call your doctor at once if you have a serious side effect such as numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes, seizure, feeling short of breath, swelling, rapid weight gain, or feeling like you might pass out.

Side Effects Centers
  • Sensipar

Patient Detailed How Take

What should I discuss with my healthcare provider before taking cinacalcet (Sensipar)?

 

You should not take this medication if you are allergic to cinacalcet.

To make sure you can safely take cinacalcet, tell your doctor if you have any of these other conditions:

  • high blood pressure;
  • heart disease, heart failure, heart rhythm disorder;
  • a history or seizures;
  • low levels of calcium in your blood (hypocalcemia); or
  • liver disease.

FDA pregnancy category C. It is not known whether cinacalcet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether cinacalcet passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking cinacalcet.

Do not give this medication to a child without a doctor's advice.

How should I take cinacalcet (Sensipar)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Cinacalcet works best if you take it with food or shortly after eating a meal.

Do not crush or break a cinacalcet tablet. Swallow the pill whole.

To be sure your calcium and phosphorous levels do not get too low, your blood will need to be tested 1 week after you start taking cinacalcet or whenever your dose is changed. You may also need blood tests on a regular basis during treatment. Do not miss any follow-up visits to your doctor.

Store at room temperature away from moisture, light, and heat.

Side Effects Centers
  • Sensipar

Patient Detailed Avoid Taking

What happens if I miss a dose (Sensipar)?

 

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Sensipar)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking cinacalcet (Sensipar)?

 

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect cinacalcet (Sensipar)?

 

Many drugs can interact with cinacalcet. Below is just a partial list. Tell your doctor if you are using:

  • chloroquine (Arelan);
  • conivaptan (Vaprisol);
  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • bladder medication such as tamsulosin (Flomax) or tolterodine (Detrol);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • an antidepressant such as amitriptyline (Elavil, Vanatrip), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), and others
  • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
  • ADHD medication such as atomoxetine (Strattera), dextroamphetamine (Adderall), or methylphenidate (Ritalin, Daytrana, Metadate, Concerta);
  • cancer medicine such as doxorubicin (Adriamycin, Doxil), lomustine (CeeNU), tamoxifen (Soltamox);
  • cough medicine (narcotic or over-the-counter);
  • heart or blood pressure medication such as carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), flecainide (Tambocor), labetalol (Normodyne), metoprolol (Lopressor), nifedipine (Nifedical, Procardia), procainamide (Procan, Pronestyl), propafenone (Rythmol), propranolol (Inderal), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);
  • medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), promethazine (Phenergan), or thioridazine (Mellaril); or
  • pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Percocet), or tramadol (Ultram, Ultracet).

There are many other medicines that can interact with cinacalcet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

 

Your pharmacist can provide more information about cinacalcet.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.01. Revision date: 10/31/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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