Cinacalcet

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
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Articles

Medicine Compliance Aid Stability

MimparaAmgen Ltd

Amgen Ltd
Mimpara
Tablets f/c 30mg, 60mg, 90mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
Nil relevant.
29 March 2015

Lactation Safety Information

Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Monitor infant’s calcium levels if maternal treatment is prolonged
22 September 2020

New Medicines

Mimpara (EU), Sensipar (US)Secondary hyperparathyroidism in children aged 3 years and older on dialysis for end-stage kidney disease - add-on to standard care

Information

Mimpara (EU), Sensipar (US)
Licence extension/variation and new formulation
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
August 2019
Aug 19Mimpara 1mg, 2.5mg and 5mg granules available in the UK (hospital only). Price: 30 capsules for opening (all strengths) £161.16 [6,7].
Sep 17Approved in EU; the product is a new pharmaceutical form - granules in capsule for opening [6].
Jun 17EU positive opinion for a licence change to recommend use to treat secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy [5].

Category

Calcium channel agonist and calcimimetic - granules in capsules formulation.
Secondary hyperparathyroidism is seen in almost all patients with dialysis-dependent CKD. Most patients with CKD stage 5 develop SHPT [2]. Incidence of CKD (dialysis and transplant patients) is 8.1 per million age related population (pmarp) in children per annum <16 yrs* (reference 14th UK Renal Registry report July 2012 [3].
Secondary hyperparathyroidism in children aged 3 years and older on dialysis for end-stage kidney disease - add-on to standard care
Oral

Trial or other data

Jan 17Estimated primary completion date of PIII (NCT02341417) is now Mar 17 [4].
Jun 15Single-arm PIII (NCT02341417) study begins. It will enrol 78 children aged up to 17 years with CKD on dialysis. Patients with be recruited from sites globally including US & EU. Collection of primary outcome data (safety) is expected to complete Jun 17 [1].

Evidence based evaluations