Cinacalcet
ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines · Published , updated
409391006
Articles
5 November 2020
Safety in Lactation: Minerals
Maternal mineral supplements pose no risk to breastfed infants when taken in normal doses, although their use should be unnecessary unless the mother’s nutritional status… Aluminium hydroxide Calcium acetate Calcium carbonate Cinacalcet Magnesium sulfate Phosphate Selenium Sevelamer Zinc
29 May 2020
Which medicines are considered safe for use in the acute porphyrias?
This updated Medicines Q&A presents a table of the medicines considered safe for use in the acute porphyrias. Inclusion of a drug does not guarantee… Anidulafungin Aripiprazole Benralizumab Betahistine Calcium polystyrene sulfonate Cefepime Cefoxitin Cinacalcet Demeclocycline Diclofenac Diclofenac potassium Diclofenac sodium Dimeticone Ertugliflozin Ivabradine Linaclotide Meropenem Midodrine Nutritional and metabolic disorders Paliperidone Prazosin Prucalopride Quetiapine Simeticone Sodium zirconium cyclosilicate TigecyclineMedicine 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].