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Suggestions for Therapeutic Drug Monitoring in Adults in Primary Care

29 September 2020This document is intended to support local discussions on how to monitor commonly prescribed high risk medicines in primary care.    The monitoring parameters cited…

Safety in Lactation: Non-steroidal anti-inflammatory drugs

23 September 2020There is very limited information on the use of NSAIDs during breastfeeding; ibuprofen and diclofenac are the preferred choices due to their extensive safe use…

What medicines should be avoided by patients suffering from “sulfa allergy”?

12 June 2020This updated Medicines Q&A evaluates the limited evidence available on cross-sensitivity between sulfonamide-containing medicines and lists classes of medication that contain a sulfonamide in their…
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Medicine Compliance Aid Stability

CelebrexPfizer Ltd

Pfizer Ltd
Celebrex
Capsules 100mg, 200mg
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.
Protect from light
Protect from moisture
Protect from light. Protect from moisture.
12 August 2015

genericZentiva

Zentiva
generic
Capsules 100mg, 200mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from moisture
Protect from light. Protect from moisture.
14 September 2015

Lactation Safety Information

Yes
Moderate level of published evidence of use in breastfeeding
Small amounts in breast milk
18 September 2020

New Medicines

Elyxyb Episodic migraine, with or without aura - oral solution formulation

Information

Elyxyb
New formulation repurposed medicine
Promius
Promius

Development and Regulatory status

None
None
Approved (Licensed)
May 20Approved in the US for the acute treatment of migraine with or without aura in adults [6].
Jun 19Nil in Dr Reddy annual report re: development plans for celecoxib [5].
Nov 18Promius Pharma is a wholly owned subsidiary of Dr. Reddy ’s Laboratories [3].

Category

Cyclo-oxygenase 2 (COX-2) inhibitor and a nonsteroidal anti-inflammatory drug (NSAID). COX-2 enzyme is responsible for the production of prostaglandins, which play important role in migraine headaches. Oral solution 25mg/ml.
Migraine affects about 6% of men and 18% of women, although numbers may be misleading, as many who experience migraine do not consult their GP [1].
Episodic migraine, with or without aura - oral solution formulation
Oral

Trial or other data

Oct 19Efficacy and safety data from a PII trial presented at the 71th Annual Meeting of the American Academy of Neurology (AAN-2019) [4].
Oct 18PIII studies (NCT03006276 and NCT03009019) have completed recruitment & collection of primary outcome data [2].
Dec 16PIII study to evaluate the safety and efficacy of DFN-15 in patients with episodic migraine, with or without aura starts (NCT03009019). 631 adults will be recruited in the US. Primary outcomes are proportion of subjects who are pain-free at 2 hours postdose and proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose. Collection of these data is due to complete Nov 17 [2].
Dec 16PIII study to evaluate the safety and efficacy of DFN-15 in patients with episodic migraine, with or without aura starts (NCT03006276). 622 adults will be enrolled in the US. Primary outcomes are proportion of subjects who are pain-free at 2 hours postdose and proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose. Collection of these data is due to complete Nov 17 [2].

Evidence based evaluations