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Articles

Safety in Lactation: Gout and cytotoxic-induced hyperuricaemia

21 October 2020Colchicine and canakinumab are normally used to treat the symptoms of acute attacks of gout. Allopurinol, febuxostat and sulfinpyrazone are used for the long-term control…

Safety in Lactation: Other immunomodulating drugs

21 September 2020Several drugs in this section (dimethyl fumerate, interferon beta, fingolimod, glatiramer, natalizumab) are used in multiple sclerosis (MS) but are not normally interchangeable as they…
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Refrigerated Storage

IlarisNovartis Pharmaceuticals

Novartis Pharmaceuticals
Ilaris
150 mg/mL solution for injection

Contact Novartis Pharmaceuticals in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

26 January 2022
London MI Service

Lactation Safety Information

For inherited auto-inflammatory disorders

For inherited auto-inflammatory disorders
-
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties. However, long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
17 September 2020

For acute gout

For acute gout
NSAIDs
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties. However, long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
17 September 2020

New Medicines

IlarisSchnitzler syndrome - first-line in adults

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

None
Pre-registration (Filed)
None
Nov 21An application to extend the Ilaris indication to include treatment of adult patients with Schnitzler syndrome is currently under review in the EU. The CHMP has asked for additional information [3].

Category

A human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype
Schnitzler syndrome is a rare disorder characterized by a chronic reddish rash that resembles hives (urticaria) and elevated levels of a specific protein in the blood (monoclonal IgM gammopathy). Only approximately 160 cases of this rare disorder have been reported in the medical literature. Most of the reported cases of Schnitzler syndrome have been from Europe, particularly France, but cases from Australia, Japan and the United States have been reported too [1].
Schnitzler syndrome - first-line in adults
Subcutaneous injection

Further information

Yes

Trial or other data

May 18PII ILESCH trial completes [2].
Apr 17Results of PII ILESCH trial published in J Allergy Clin Immunol. 20 patients with active disease were enrolled in 4 German study centers. Patients were randomly assigned to receive single subcutaneous canakinumab 150 mg or placebo injections for 7 days, followed by a 16-week open-label phase with canakinumab injections on confirmed relapse of symptoms. The primary end point was the proportion of patients with complete clinical response evaluated by physician global assessment at day 7. Key secondary end points included changes in patient-reported disease activity (Schnitzler activity score), inflammation markers (C-reactive protein and serum amyloid A), and quality-of-life assessments (Dermatology Life Quality Index and 36-item short form health survey). The proportion of patients with complete clinical response at day 7 was significantly higher (P = 0.001) in the canakinumab-treated group (n = 5 of 7) than in the placebo group (n = 0 of 13). Levels of inflammation markers C-reactive protein and serum amyloid A and quality-of-life scores were significantly reduced in canakinumab-treated but not in placebo-treated individuals. Positive effects continued up to 16 weeks. Adverse events were manageable and included respiratory tract infections, gastrointestinal symptoms, and hypertension [4].
Jun 11PII ILESCH trial to assess the efficacy and safety of canakinumab in patients with Schnitzler syndrome starts (NCT01390350). 20 adults will be recruited in Germany. Primary outcome is proportion of patients with complete response (based on physician´s global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group; collection of these data is due to complete Dec 17 [2].

Evidence based evaluations

IlarisNon-small cell lung cancer (NSCLC), II-IIIA and the subset of IIIB (T>5cm N2 disease) completely resected - adjuvant therapy

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Interleukin 1-beta antagonist, first-in-class in non-small cell lung cancer
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers)
Non-small cell lung cancer (NSCLC), II-IIIA and the subset of IIIB (T>5cm N2 disease) completely resected - adjuvant therapy
Subcutaneous injection

Evidence based evaluations

Ilaris Metastatic non-small cell lung cancer (NSCLC) - first-line maintenance therapy

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Discontinued
Phase III Clinical Trials
Phase III Clinical Trials
Dec 21The company is no longer pursuing a Marketing Authorisation Application from the MHRA for this indication at this time [8].

Category

Interleukin 1-beta antagonist, first-in-class in non-small cell lung cancer
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers).
Metastatic non-small cell lung cancer (NSCLC) - first-line maintenance therapy
Subcutaneous injection

Further information

Yes

Trial or other data

Oct 21PIII CANOPY-1 trial fails to meet primary end points [6].

Ilaris Metastatic non-small cell lung cancer (NSCLC) - second- or third-line

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 21Development discontinued [6].

Category

Interleukin 1-beta antagonist, first-in-class in non-small cell lung cancer
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers).
Metastatic non-small cell lung cancer (NSCLC) - second- or third-line
Subcutaneous injection

Trial or other data

Mar 21PIII CANOPY-2 trial of canakinumab failed to meet the primary endpoint of overall survival (OS). The company plans to continue to analyse the data. [5]