cinacalcet (Sensipar, Mimpara)
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Introduction
Tradename: Sensipar (new 2004)
Indications
- secondary hyperparathyroidism in dialysis patients
- role in patients with chronic kidney disease is uncertain[5]
- hypercalcemia due to primary hyperparathyroidism (unlabeld use)
- parathyroid carcinoma
Contraindications
- not indicated for hypercalcemia of malignancy[6]
Dosage
- start 30 mg PO QD, administer with food
- increase every 2-4 weeks (30 mg)
- maximum dose 180 mg, 360 mg (parathyroid carcinoma)
- no dosage adjustment in the elderly
- may be taken with vitamin D &/or phosphate binders
Tabs: 30, 20, 90 mg
Pharmacokinetics
- metabolized by cyt P450 3A4, cyt P450 1A2 & cyt P450 2D6
- inhibits cyt P450 2D6
- volume of distribution 1000 L
- terminal 1/2life of 30-40 hours
- nadir in serum PTH (intact) level 2-6 hours after dose
- 80% excreted in the urine as inactive metabolites, 15% excreted in the feces
elimination by hemodialysis = -
Monitor
- serum Ca+2 prior to initiation & within 1 week of initiation or dosage adjustment
- maintanence serum Ca+2 every 2 months
Adverse effects
- common > 10%
- less common 1-10%
- hypertension (7%), dizziness (10%), seizure (1%) anorexia (6%), weakness (7%), chest pain (6%)
- other
- pediatric clinical trials halted because of death of a 14 year old patient; it is unknown whether cinacalcet played a role in the death[3]
Drug interactions
- cinacalcet is increased by cyt P450 3A4 inhibitors
- cinacalcet can increase levels of drugs metabolized by cyt P450 2D6
Mechanism of action
- calcimimetic
- increases sensitivity of parathyroid Ca+2-sensing receptors[2]
- generally normalizes parathyroid hormone, serum Ca+2 & serum phosphate
Notes
- Manufacturer: Amgen
- very expensive[5]
More general terms
References
- ↑ New Drug: Cinacalcet (Sensipar) Prescriber's Letter 11(4):23-24 2004 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200412&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 2.0 2.1 Journal Watch 24(11):90, 2004 Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drueke TB, Goodman WG. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15071126
Curhan G. Fooling the parathyroid gland--will there be health benefits? N Engl J Med. 2004 Apr 8;350(15):1565-7. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15071132 - ↑ 3.0 3.1 FDA MedWatch. Feb 26, 2013 Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm341255.htm
- ↑ Lexi-Comp
- ↑ 5.0 5.1 5.2 Medical Knowledge Self Assessment Program (MKSAP) 16, American College of Physicians, Philadelphia 2012
- ↑ 6.0 6.1 NEJM Knowledge+ Question of the Week June 13, 2017 https://knowledgeplus.nejm.org/question-of-week/1011/