SYLVANT 100 mg powder for concentrate for solution for infusion

  • Name:

    SYLVANT 100 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Siltuximab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/04/19

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Summary of Product Characteristics last updated on medicines.ie: 12/4/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Janssen Sciences Ireland

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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 12 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

3.       PHARMACEUTICAL FORM

 

Powder for concentrate for solution for infusion (powder for concentrate).

 

 

4.4     Special warnings and precautions for use

 

 Traceability statement moverd from bottom of section 4.4 to top of the section

 

4.6     Fertility, pregnancy and lactation

 

Administartive change- ‘Women of childbearing potential’ text moved

 

 

4.8     Undesirable effects

 

Summary of the safety profile

Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse drug reactions (ADRs), occurring in > 20% of siltuximab‑treated patients in Castleman’s disease (CD) clinical studies. The most serious adverse reactionADR associated with the use of siltuximab was anaphylactic reaction.

 

Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation.

Table 2 reflects the frequencies of identified adverse reactionsADRs in the 87 MCD patients (Study 1, Study 2 and Study 3) treated at the recommended dosage of 11 mg/kg every 3 weeks (details provided in section 5.1).

In Study 1, a randomised, placebo‑controlled Phase 2 study in MCD, 53 patients were randomised to the siltuximab treatment arm and treated at the recommended dosage of 11 mg/kg every 3 weeks and 26 patients were randomised to the placebo arm. Of the 26 placebo‑treated patients, 18 patients subsequently crossed‑over to receive siltuximab.

In Study 2, a Phase 1 study, 16 of 37 patients with CD were treated with siltuximab, at the recommended dosage of 11 mg/kg every 3 weeks.

In Study 3, an open-label, multicentre, non-randomised Phase 2 study in 60 patients with MCD who were previously enrolled in Study 1 (41 patients) or Study 2 (19 patients), patients were treated with siltuximab, at the recommended dosage of 11 mg/kg every 3 weeks.

 

Tabulated list of adverse reactions

Table 2 lists adverse reactionsADRs observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks. Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000). Within each frequency grouping, adverse reactionsundesirable effects are presented in order of decreasing seriousness.

 

Table 2:      Adverse reactionsUndesirable effects in siltuximab treated patients in MCD clinical studiesa

 

 

4.9     Overdose

 

No case of overdose has been reported in clinical trials. Repeated dosing of 15 mg/kg every 3 weeks has been administered without additional adverse drug reactions. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.

6.1     List of excipients

 

L‑Histidine

L‑Histidine monohydrochloride monohydrate

Polysorbate 80

Sucrose

 

6.5     Nature and contents of container

 

SYLVANT 100 mg powder for concentrate for solution for infusion

8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip‑off button containing 100 mg of siltuximab. Pack size of 1 vial.

 

SYLVANT 400 mg powder for concentrate for solution for infusion

30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip‑off button containing 400 mg of siltuximab. Pack size of 1 vial.

 

Updated on 16 October 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal/change of distributor

Updated on 5 June 2018 PIL

Reasons for updating

  • 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 29 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 29 May 2018 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 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Section 4.4 revision to hepatic impairment paragraph to include post clinical trials’ reports of “transient or intermittent mild-to-moderate elevation of hepatic transaminase levels or other liver function tests”; addition of mandatory traceability statement.
  • Section 4.8 addition of adverse reactions from Study 3: very common: urinary tract infection, hyperuricaemia, dizziness, headache, oropharyngeal pain, nausea, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration, rash, eczema, arthralgia, pain in extremity; common: hypercholesterolaemia. Deletion of maculopapular rash.
  • Section 5.1 addition of information on Study 3.
  • Section 5.2 revision to immunogenicity section.

Updated on 23 May 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

6.3     Shelf life

Unopened vial

SYLVANT 100 mg powder for concentrate for solution for infusion

3 years

 

SYLVANT 400 mg powder for concentrate for solution for infusion

23 years

Updated on 23 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 January 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Addiotnal text in bold

After reconstitution and dilution

Chemical and physical in‑use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 19 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 May 2016 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 5 May 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 8 June 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 20 February 2015 PIL

Reasons for updating

  • New PIL for new product