Ciclosporin

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
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Articles

Medicine Compliance Aid Stability

NeoralNovartis Pharmaceuticals UK Ltd

Novartis Pharmaceuticals UK Ltd
Neoral
Capsules 10mg, 25mg, 50mg, 100mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from light and store in airtight containers to prevent ethanol vehicle evaporation.
17 October 2015

CapsorinMorningside Healthcare Ltd

Morningside Healthcare Ltd
Capsorin
Capsules 25mg, 50mg, 100mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Soft capsules. Keep in original packaging.
18 September 2015

CapimuneMylan Pharmaceuticals

Mylan Pharmaceuticals
Capimune
Capsules 25mg, 50mg, 100mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Soft capsules. Keep in original packaging.
18 September 2015

DeximuneDexcel Pharma Ltd

Dexcel Pharma Ltd
Deximune
Capsules 25mg, 50mg, 100mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Soft capsules. Keep in original packaging.
23 September 2015

Lactation Safety Information

In transplantation

In transplantation
See summary
Limited published evidence of safety
Small amounts in breast milk
Monitor infant plasma levels if there is a concern about toxicity
21 September 2020

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Limited published evidence of safety
Small amounts in breast milk
Monitor infant plasma levels if there is a concern about toxicity
21 September 2020

For eczema or psoriasis

For eczema or psoriasis
Topical eczema/psoriasis preparation / corticosteroid if appropriate
Limited published evidence of safety
Small amounts in breast milk
Monitor for signs of infection, immunosuppression, and infant plasma levels (if there is a concern about toxicity)
21 September 2020

For inflammatory bowel disease

For inflammatory bowel disease
See summary
Limited published evidence of safety
Small amounts in breast milk
Monitor infant plasma levels if there is a concern about toxicity
21 September 2020

New Medicines

Restaysis (EU); Restasis (US)Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe

Information

Restaysis (EU); Restasis (US)
New formulation
Allergan
Allergan

Development and Regulatory status

Discontinued
Discontinued
Launched
Jan 19No longer listed in Allergan pipeline, and no new information available to suggest there are plans to launch in the EU; assume development discontinued in EU [13,14].
May 18Allergan have withdrawn the marketing authorisation application. At the time of withdrawal, the CHMP had notified the company that it was of the provisional opinion that the application could not have been approved. The Committee felt that the results presented by the company were not robust enough to demonstrate effectiveness, in particular the way that results for moderate dry eye disease had been analysed. The company´s letter to the CHMP leaves open the possibility of re-submission in the future [12].
Aug 17Currently pre-registration in EU [11].
Aug 17No information available on current plans for a EU licence [10].
Oct 16Allergan launches new multidose, preservative-free formulation of ciclosporin 0.05% ophthalmic emulsion (Restasis Multidose) in the US [9].
Mar 16FDA issues a complete response letter on a multidose, preservative-free formulation of Restasis, asking for more information about the bottle--a "first-of-its-kind" container, Allergan says, with a uni-directional valve and air filter technology that the company has patented [8].
Mar 15Listed as PIII in EU in Allergen´s pipeline [6].
Mar 13PIII in the EU [1].
Jul 09Orphan designation (EU/3/09/651) granted by the European Commission to Allergan for ciclosporin eye drops for treatment of atopic keratoconjunctivitis [5].
Apr 03Launched in the US for treatment of moderate-to-severe dry eye due to ocular inflammation (keratoconjunctivitis sicca) [2].

Category

A 0.05% ophthalmic emulsion formulation of ciclosporin, a partial immunomodulator and anti-inflammatory agent
Keratoconjunctivitis sicca, also known as dry eye syndrome, is a common condition caused by a disorder of the tear film. Reported prevalence rates are 15-33% in people aged 65 and over. It is around 50% more common in women than in men, & can have significant effects on quality of life & common vision-related daily activities, such as driving & reading [3].
Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe
Topical

Trial or other data

Jan 16From US Product Label: Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS® ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs [7].
Mar 13Data from pivotal PIII trials indicates that Restasis produces significant & clinically relevant increases in Schirmer scores of wetting at 6 months, compared with vehicle. The Schirmer test measures the amount of tears produced in the eye. No increases in tear production were observed in pts taking topical anti-inflammatories or using punctal plugs [2].

Evidence based evaluations

Bronchiolitis obliterans syndrome (BOS) following lung transplant

Information

New formulation (liposomal for inhalation)
Breath Therapeutics / PARI
Breath Therapeutics / PARI

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Calcineurin inhibitor designed for inhaled delivery to the lungs via eFlow® nebulizer. Allows for high local concentration in lungs with low systemic exposure.
Bronchiolitis obliterans syndrome is a rare condition which can occur due to chronic GVHD that causes damage to lungs or following lung transplant and allogeneic hematopoietic stem cell transplants.[1,2]
Bronchiolitis obliterans syndrome (BOS) following lung transplant
Inhalation