Ranolazine
ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines · Published , updated
420624001
Articles
21 October 2020
Safety in Lactation: Drugs used for angina
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Anti-anginal nitrates Nitrates are indicated for… Cardiovascular system disorders Glyceryl trinitrate Isosorbide dinitrate Isosorbide mononitrate Ivabradine Nicorandil Obstetrics and gynaecology Paediatrics and neonates Ranolazine Safety in BreastfeedingMedicine Compliance Aid Stability
RanexaA Menarini Pharma UK
A Menarini Pharma UK
Ranexa
Tablets m/r 375mg, 500mg, 750mg
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
No special precautions for storage
9 November 2015
Lactation Safety Information
Alternative anti-anginal agents
No published evidence of safety
12 May 2017
New Medicines
RanexaAngina pectoris; incomplete vascularisation post-PCI
Information
Ranexa
Licence extension / variation
Gilead Sciences
Gilead Sciences
Development and Regulatory status
None
None
None
Global PIII study started Oct 11 [1].
May 16: In light of negative trial results, assume licence variation not being pursued.
May 16: Not listed in Gilead pipeline
Category
partial fatty acid oxidation inhibitor
13 April 20128% of men and 3% of women aged 55-64 years have, or have had, angina. 14% of men and 8% of women aged 65-74 years have, or have had, angina. [3]
Angina pectoris; incomplete vascularisation post-PCI
Oral
Trial or other data
01. Nov 11: NCT01442038 The PIII RIVER-PCI study (Ranolazine for Incomplete VEssel Revascularization post-PCI), will assess ranolazine in preventing major adverse cardiovascular events (MACE) at 1 year in 2600 patients with a history of chronic angina who have incomplete revascularization following PCI. Subjects will receive ranolazine 500mg twice daily for 7 days, followed by 1g twice daily for the duration of the study. The study started Oct 11 and is due to complete Mar 14 [1,2].
02. Mar 14: PIII NCT01442038 study is active but no longer recruiting pts. Collection of primary outcome data should be complete Dec 14 [4].
03. Mar 15: RIVER-PCI study completed Feb 15 [5]
04. Oct 15: Results of RIVER-PCI study published in The Lancet Online. The RCT (n=2651) found that after median follow-up of 643 days, ranolazine did not reduce composite rate of ischaemia-driven revascularisation (RV) or hospitalisation without RV in patients with a history of chronic angina who had incomplete RV, compared to placebo [6].
05. Nov 15: Results of RIVER-PCI study published in Circulation journal[7].