Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe

  • Name:

    Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Anakinra

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/04/19

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Summary of Product Characteristics last updated on medicines.ie: 30/4/2019

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Swedish Orphan Biovitrum Ltd

Swedish Orphan Biovitrum Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 30 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 30 April 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of section 4.4 of the SmPC in order to add a warning on pulmonary events based on post-marketing data. The package leaflet is updated accordingly.

Furthermore, the Sobi took the opportunity to move the text about macrophage activation syndrome (MAS) and malignancies from section 4.8 to 4.4 of the SmPC.

Updated on 24 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 28 June 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 January 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

10.       DATE OF REVISION OF THE TEXT

 

Inserted: 05/10/2017

Deleted: 28th January 2016

Updated on 8 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 December 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

The inner needle cover of the pre

 

filled syringe contains dry natural rubber (a derivative of latex), which may cause

 

severe allergic reactions.

[Text deleted]

4.8 Undesirable effects

Blood and lymphatic system

disorders

Common (

 

1/100 to < 1/10) Thrombocytopenia [added]

 

[Added]

Investigations Very common (

 

1/10) Blood cholesterol increased

 

[Added]

Thrombocytopenia

In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in

the placebo group. The thrombocytopenias have been mild, i.e. platelet counts have been >75 x10

 

9/L. Mild

 

thrombocytopenia has also been observed in CAPS patients.

During post

 

marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating

 

severe thrombocytopenia (i.e. platelet counts <10 x10

 

9/L).

 

[Added]

Blood cholesterol increase

In clinical studies of RA, 775 patients treated with daily Kineret doses of 30mg, 75mg, 150mg, 1mg/kg or 2mg/kg, there

was an increase of 2.4% to 5.3% in total cholesterol levels 2 weeks after start of Kineret treatment, without a doseresponse

relationship. A similar pattern was seen after 24 weeks Kineret treatment. Placebo treatment (n=213) resulted

in a decrease of approximately 2.2% in total cholesterol levels at week 2 and 2.3% at week 24. No data are available on

LDL or HDL cholesterol.

6.5 Nature and contents of container

[Inserted text] and 29 gauge needle

[Inserted text] None of the syringe or needle shield components are made with natural rubber latex.

[Deleted text] The inner needle cover contains dry natural rubber (a derivative of latex). See section 4.4.

Updated on 28 September 2015 SmPC

Reasons for updating

  • Previous version of SPC reinstated

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Rolled back to previous version

Updated on 23 September 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 The former needle shield of natural rubber is replaced by a synthetic rubber shield, not manufactured using natural rubber latex.

 

As a consequence of this change the warning related to latex allergies in section 4.4 of SmPC

Updated on 11 November 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

This now a joint SPC for 2 indications.
info added:

4.1 . Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including:

 

-        Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)

-        Muckle-Wells Syndrome (MWS)

-        Familial Cold Autoinflammatory Syndrome (FCAS)

 4.2

CAPS: Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above

 

Starting dose:

The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection. The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

 

Maintenance dose in mild CAPS (FCAS, mild MWS):

Patients are usually well-controlled by maintaining the recommended starting dose (1-2 mg/kg/day).

 

Maintenance dose in severe CAPS (MWS and NOMID/CINCA):

Dose increases may become necessary within 1-2 months based on therapeutic response. The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.

In addition to the evaluation of clinical symptoms and inflammatory markers in severe CAPS, assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified. When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.

 

4.4

Hepatic Events

In clinical studies in RA and CAPS patients, transient elevations of liver enzymes have been seen uncommonly. These elevations have not been associated with signs or symptoms of hepatocellular damage. During post-marketing use isolated case reports indicating non-infectious hepatitis have been received. Hepatic events during post marketing use have mainly been reported in patients with predisposing factors, e.g history of transaminase elevations before start of Kineret treatment.

The efficacy and safety of Kineret in patients with AST/ALT ≥1.5 x upper level of normal have not been evaluated.


4.8

Adverse reactions data in CAPS patients are based on an open-label study of 43 patients with NOMID/CINCA treated with Kineret for up to 5 years, with a total Kineret exposure of 159.8 patient years. During the 5-year study 14 patients (32.6%) reported 24 serious events. Eleven serious events in 4 (9.3%) patients were considered related to Kineret. No patient withdrew from Kineret treatment due to adverse reactions. There are no indications either from this study or from post marketing adverse reaction reports that the overall safety profile in CAPS patients is different from that in RA patients. The adverse reactions table below therefore applies to Kineret treatment both in RA and CAPS patients.

 


Spontaneous mutations in the CIAS1/NLRP3 gene have been identified in a majority of patients with CAPS. CIAS1/NLRP3 encodes for cryopyrin, a component of the inflammasome. The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has a broad range of effects including systemic inflammation. Untreated CAPS patients are characterized by increased CRP, SAA and IL-6 relative to normal serum levels. Administration of Kineret results in a decrease in the acute phase reactants and a decrease in IL-6 expression level has been observed. Decreased acute phase protein levels are noted within the first weeks of treatment.

5.1

Clinical efficacy and safety in CAPS

The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity. In a clinical study including 43 adult and paediatric patients (36 patients aged 8 months to < 18 years) with severe CAPS (NOMID/CINCA and MWS), a clinical response to anakinra was seen within 10 days after initiation of treatment in all patients and was sustained for up to 5 years with the continued administration of Kineret.

 

Kineret treatment significantly decreases the manifestations of CAPS, including a reduction in frequently occurring symptoms as fever, rash, joint pain, headache, fatigue, and eye redness. A rapid and sustained decrease in the levels of the inflammatory biomarkers; serum amyloid A (SAA), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a normalization of inflammatory hematological changes are seen. In the severe form of CAPS, long-term treatment improves the systemic inflammatory organ manifestations of the eye, inner ear, and CNS. Hearing and visual acuity did not deteriorate further during anakinra treatment.

 

Analysis of treatment-emergent AEs classified by presence of CIAS1 mutation showed that there were no major differences between the CIAS1 and non-CIAS1 groups in overall AE reporting rates, 7.4 and 9.2, respectively. Similar rates were obtained for the groups on the SOC level, except for eye disorders with 55 AEs (rate 0.5), whereof 35 ocular hyperemia (which could also be a symptom of CAPS) in the CIAS1 group, and 4 AEs in the non-CIAS1 group (rate 0.1).

 

Paediatric population

Overall, the efficacy and safety profile of Kineret is comparable in adult and paediatric CAPS patients. 

 

The European Medicines Agency has waived the obligation to submit the results of studies with Kineret in one or more subsets of the paediatric population in CAPS and RA (JIA) (see section 4.2 for information on paediatric use).

 

Safety in pediatric RA (JIA) patients

Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA; ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg. The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks. A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study. An adverse event profile similar to that seen in adult RA patients was observed in these studies. These study data are insufficient to demonstrate efficacy and, therefore, Kineret is not recommended for pediatric use in Juvenile Rheumatoid Arthritis.

 

5.2

 

In general the pharmacokinetics in CAPS patients is similar to that in RA patients. In CAPS patients approximate dose linearity with a slight tendency to higher than proportional increase has been noted. Pharmacokinetic data in children < 4 years are lacking, but clinical experience is available from 8 months of age, and when started at the recommended daily dose of 1-2 mg/kg, no safety concerns have been identified. Pharmacokinetic data are lacking in older CAPS patients. Distribution into the cerebrospinal fluid has been demonstrated.

10.

06/2014

Updated on 30 August 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Formatting only

Updated on 27 July 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

change of MA holder name (merger)
reformatting and slight rewording of text

Updated on 16 August 2010 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided