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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = ''N''-[(1''R'')-1-(1-naphthyl)ethyl]-3-<br>[3-(trifluoromethyl)phenyl]propan-1-amine
|authorTag=
| image = Cinacalcet.svg
 
| CAS_number = 226256-56-0
 
| ATC_prefix = H05
<!--Overview-->
| ATC_suffix = BX01
 
| ATC_supplemental =  
|genericName=
| PubChem = 156419
 
| DrugBank = APRD00872
 
| C = 22 | H = 22 | F = 3 | N = 1
 
| molecular_weight = 357.412 g/mol
|aOrAn=
| bioavailability = 20 to 25%<br>Increases if taken with food
 
| protein_bound = 93 to 97%
a
| metabolism = [[Liver|Hepatic]] ([[CYP3A4]]-, [[CYP2D6]]- and [[CYP1A2]]-mediated)
 
| elimination_half-life = 30 to 40 hours
|drugClass=
| excretion = [[Kidney|Renal]] (80%) and fecal (15%)
 
| licence_EU = Mimpara
 
| licence_US = Cinacalcet
 
| pregnancy_AU = B3
|indication=
| pregnancy_US = C
 
| legal_status = Rx-only
 
| routes_of_administration = Oral
 
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|alcohol=


==[[Cinacalcet (patient information)|For patient information click here]]==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


==Overview==
<!--Brand Names-->
'''Cinacalcet''' ([[International Nonproprietary Name|INN]]) is a [[medication|drug]] that acts as a calcimimetic (i.e. it mimics the action of [[calcium in biology|calcium]] on [[tissue (biology)|tissue]]s) by allosteric activation of the [[calcium-sensing receptor]] that is expressed in various human organ tissues. It is sold by [[Amgen]] under the trade name '''Sensipar®''' in North America and Australia and as '''Mimpara®''' in Europe. Cinacalcet is used to treat [[hyperparathyroidism]] (elevated [[parathyroid hormone]] levels), a consequence of [[parathyroid]] tumors and [[chronic renal failure]].<ref name="pmid16825031">{{cite journal | author = Torres PU | title = Cinacalcet HCl: a novel treatment for secondary hyperparathyroidism caused by chronic kidney disease | journal = Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation | volume = 16 | issue = 3 | pages = 253-8 | year = 2006 | pmid = 16825031 | doi = 10.1053/j.jrn.2006.04.010 | issn = }}</ref>


==Clinical uses==
|brandNames=
Cinacalcet is indicated for the treatment of secondary hyperparathyroidism in patients
with Chronic Kidney Disease on dialysis and hypercalcemia in patients with parathyroid
carcinoma.


==Dosage==
* ®<ref>{{Cite web | title = | url = }}</ref>
'''Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis'''


The recommended starting oral dose is 30 mg once daily. Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. It should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 60, 90, 120, and 180 mg once daily to target iPTH consistent with the NKF-K/DOQI recommendation for CKD patients on dialysis of 150-300 pg/mL. PTH levels should be assessed no earlier than 12 hours after dosing with cinacalcet.
<!--Look-Alike Drug Names-->


Cinacalcet can be used alone or in combination with vitamin D sterols and/or phosphate binders.
|lookAlike=


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 cinacalcet.
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


'''Parathyroid Carcinoma'''
<!--Drug Shortage Status-->


The recommended starting oral dose is 30 mg twice daily.
|drugShortage=
}}


The dosage of cinacalcet should be titrated 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.
<!--Pill Image-->


NOTE: Cinacalcet should be taken whole and should not be divided. It should be taken with food or shortly after a meal.
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
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==Contraindications==
<!--Label Display Image-->
* [[Hypersensitivity]]


==References==
{{LabelImage
{{Reflist|2}}
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


==External links==
{{LabelImage
*[http://www.sensipar.com/ Sensipar website] run by [[Amgen]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
*[http://www.sensipar.com/professional/pdf/sensipar_pi.pdf Prescribing information]
}}
*[http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/500521.html Cinacalcet] - Medlineplus.org
*[http://www.drugdigest.org/DD/DVH/Uses/0,3915,8207%7CCinacalcet,00.html Cinacalcet] - Drug Digest.
{{Calcium homeostasis}}
[[Category:Drugs]]
[[Category:Endocrinology]]


[[de:Cinacalcet]]
<!--Category-->


{{WikiDoc Help Menu}}
[[Category:Drug]]
{{WikiDoc Sources}}

Revision as of 19:43, 19 August 2014

Cinacalcet
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Cinacalcet is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cinacalcet in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cinacalcet in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Cinacalcet in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cinacalcet in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cinacalcet in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cinacalcet in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cinacalcet in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cinacalcet in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cinacalcet during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cinacalcet with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cinacalcet with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cinacalcet with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cinacalcet with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cinacalcet with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cinacalcet in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cinacalcet in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cinacalcet in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cinacalcet in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Cinacalcet in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Cinacalcet in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cinacalcet in the drug label.

Pharmacology

There is limited information regarding Cinacalcet Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cinacalcet in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cinacalcet in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cinacalcet in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cinacalcet in the drug label.

How Supplied

Storage

There is limited information regarding Cinacalcet Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Cinacalcet |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Cinacalcet |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cinacalcet in the drug label.

Precautions with Alcohol

  • Alcohol-Cinacalcet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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