Cimzia 200 mg solution for injection in pre-filled pen

  • Name:

    Cimzia 200 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Certolizumab Pegol

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/07/20

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Summary of Product Characteristics last updated on medicines.ie: 31/7/2020

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

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1 - 0 of 27 items.Total: Infinity pages

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 31 July 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

section 4.2: additional sentence "After at least 1 year of treatment with Cimzia, in patients with sustained remission, a reduced maintenance dose of 200 mg every 4 weeks may be considered (see section 5.1)" in Axial Spondylorthritis




section 4.8: additional text "Cimzia was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open-label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) for patients in sustained remission (C-OPTIMISE)." in Axial spondylorathritis




section 5.1: additional section "C-Optimise", additional figure (Graph), additional table of data; additional section under "immunogenicity". Section "Axial spondyloarthritis" moved to the end with additional study data related to ASooo6 and C-OPTIMISE; deletion of section "for all indication".




section 10: revision date changed to 07/2020

Updated on 31 July 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

    Axial spondyloarthritis
•    The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4. 
•    This is followed by a maintenance dose of 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8) as instructed by your physician. If you have received Cimzia for at least 1 year and respond to the medicine, your physician may prescribe a reduced maintenance dose of 200 mg every 4 weeks.
 

Updated on 22 April 2020 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 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

4.4       Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

 

4.8       Undesireable effects

Plaque psoriasis

Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months3 years. In the Phase III program, the initial and maintenance periods were followed by a 96-week open-label treatment period (see section 5.1). The long-term safety profile of Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks were was generally similar and consistent with previous experience with Cimzia.

 

Tabulated list of adverse reactions

Adverse reactions reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.


Description of selected adverse reactions

Infections

In the placebo-controlled clinical trials in rheumatoid arthritis, there were more new cases of serious infection in the Cimzia treatment groups (0.07 per patient-year; all doses), compared with placebo (0.02 per patient-year).

Malignancies and lymphoproliferative disorders

Excluding non-melanoma skin cancer, 9 11 malignancies including 1 case of lymphoma were observed in the Cimzia psoriasis clinical trials in which a total of 1112 patients were treated, representing 1481 2300 patient-years.

Autoimmunity

In the rheumatoid arthritis pivotal studies, for subjects who were ANA negative at baseline, 16.7% of those treated with Cimzia developed positive ANA titers, compared with 12.0% of subjects in the placebo group.

 

5.1      Pharmacodynamic properties

Plaque psoriasis

Patients with an inadequate response at Week 16 (PASI 50 non-responders) were eligible to receive Cimzia 400 mg every 2 weeks until Week 48 in an open-label manner for a maximum of 128 weeks.

 

All subjects who did not achieve a PASI 75 response at Week 16 entered an escape arm and received Cimzia 400 mg every 2 weeks in an open-label manner for a maximum of 128 weeks.

 

In all three studies, the blinded 48-week maintenance period was followed by a 96-week open-label treatment period for the patients who were PASI 50 responders at Week 48. All these patients, including those receiving Cimzia 400 mg every 2 weeks, started the open-label period at Cimzia 200 mg every 2 weeks.

 

Maintenance of response

In an integrated analysis of  CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks (N=134 of 175 randomised subjects) or Cimzia 200 mg every other 2 weeks (N=132 of 186 randomised subjects), the maintenance of response rates at Week 48 were was 98.0% and 87.5%, respectively. Among patients who were PGA clear or almost clear at Week 16 and received Cimzia 400 mg every 2 weeks (N=103 of 175) or Cimzia 200 mg every 2 weeks (N=95 of 186), the maintenance of response rate at Week 48 were was 85.9% and 84.3% respectively.

 

After an additional 96 weeks of open-label treatment (Week 144) the maintenance of response was evaluated. Twenty-one percent of all randomised subjects were lost to follow-up before Week 144. Approximately 27% of completer study subjects who entered the open-label treatment between weeks 48 to 144 on Cimzia 200 mg every 2 weeks had their dose increased to Cimzia 400 mg every 2 weeks for maintenance of response. In an analysis in which all patients with treatment failures were considered non-responders, the maintenance of response of the Cimzia 200 mg every 2 weeks treatment group, for the respective endpoint, after an additional 96 weeks of open-label therapy, was 84.5% for PASI 75 for study subjects who were responders at Week 16 and 78.4% for PGA clear or almost clear. The maintenance of response of the Cimzia 400 mg every 2 weeks treatment group, who entered the open-label period at Cimzia 200 mg every 2 weeks, was 84.7% for PASI 75 for study subjects who were responders at Week 16 and 73.1% for PGA clear or almost clear.

These response rates were based on a logistic regression model where missing data were imputed over 48 or 144 weeks, using multiple imputation (MCMC method) combined with NRI for treatment failures.

 

Quality of life / Patient reported outcomes

In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of  0 or 1 (Cimzia 400 mg every 2 weeks, 45.5% and 50.6% respectively; Cimzia 200 mg every 2 weeks, 47.4% and 46.2% respectively, versus placebo, 5.9% and 8.2% respectively).

Improvements in DLQI score were sustained or slightly decreased through Week 144.

Cimzia-treated patients reported greater improvements compared to placebo in the Hospital Anxiety and Depression Scale (HADS)-D.

Improvements in all afore mentioned outcomes were maintained through Week 48.

 

Plaque psoriasis
 

In the Phase III placebo- and active-controlled studies, the percentages of patients who were positive for  antibodies to Cimzia on at least one occasion during treatment up to Week 48 were 8.3 % (22/265) and  19.2% (54/281) for the Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks respectively. In CIMPASI-1 and CIMPASI-2, sixty patients were antibody positive, 27 of these patients were evaluable for neutralizing antibodies and tested positive. First occurrences of antibody positivity in the open-label treatment period were observed in 2.8% (19/668) of patients. Antibody positivity was associated with lowered drug plasma concentration and in some patients with reduced efficacy.

 

 

10.      DATE OF REVISION OF THE TEXT

{MM/YYYY}April 2020

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Updated on 1 August 2019 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 26 July 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

In section 4.1 & 5.1: 

- additional description added

In section 4.8:

- additional clinical study data added

- additional description added

In section 5.2:

- additional clinical study data added

Updated on 20 March 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 March 2019 SmPC

Reasons for updating

  • 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 not be renewed (A)

Updated on 7 September 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 7 September 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

18 months. 2 years.

See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.

 

6.4     Special precautions for storage

 

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

The pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light. At the end of this period the pre-filled syringes must be used or discarded.

Updated on 15 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

-‘’Plaque psoriasis” information has been added in the following sections ‘’ 4.1 Therapeutic indications’’,’’ 4.2 Posology and method of administration’’, ‘’ 4.8 Undesirable effects”, 5.1 Pharmacodynamic properties’’;
-‘’Posology’’ and ‘’Latex-sensitivity’’ information has also been updated in section ’’ 4.2 Posology and method of administration’’;
-‘’Rheumatoid arthritis”, ‘’Tabulated list of adverse reactions”, ‘’Description of selected adverse reactions-Infections, Malignancies and lymphoproliferative disorders” has been updated in section ‘’4.8 Undesirable effects”;
-‘’Maintenance of response”, ‘’Quality of life / Patient reported outcomes”,’’Immunogenicity” has been updated in section ‘’5.1 Pharmacodynamic properties’’;
-‘’Distribution’’, ’’Pharmacokinetic/pharmacodynamic relationship” has been updated in section’’ 5.2 Pharmacokinetic properties’’;

- The section “6.5 Nature and contents of container’’ has been updated;
-‘’Section 10. DATE OF REVISION OF THE TEXT’’ has been updated {MM/YYYY} 06/2018.

Updated on 15 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 3 - how to take/use
  • Change to date of revision

Updated on 18 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 January 2018 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

$0Section 4.6 Fertility, Pregnancy and lactation updated regarding women of childbearing age.$0$0$0$0$04.6 Fertility, Pregnancy and lactation$0$0$0$0$0Women of childbearing potential$0$0$0$0$0Women of childbearing potential should use adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Cimzia administration.$0$0$0$0$0The use of adequate contraception should be considered for women of childbearing potential. For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate (see section 5.2), but the need for treatment of the woman should also be taken into account (see below).$0$0$0$0$0Pregnancy$0$0There are no adequate data from the use of Cimzia in pregnant women.$0$0Data from more than 500prospectively collected pregnancies exposed to Cimzia with known pregnancyoutcomes, including more than 400 pregnancies exposed during the firsttrimester, does not indicate a malformative effect of Cimzia. However, theavailable clinical experience is too limited to, with a reasonable certainty,conclude that there is no increased risk associated with Cimzia administrationduring pregnancy.$0$0Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus. However, these are insufficient with respect to human reproductive toxicity (see section 5.3). Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.$0$0Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus. However, these are insufficient with respect to human reproductive toxicity (see section 5.3). Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn. Therefore, Cimzia is not recommended during pregnancy.$0$0$0$0Cimzia should only be used during pregnancy if clinically needed.$0$0$0$0$0Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region) (see section 5.3). $0$0$0$0$0Limited clinical data show low levels of certolizumab pegol in plasma of an infant born by a treated woman. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to certolizumab pegol in utero is not recommended for a minimum of 5 months following the mother’s last Cimzia administration during pregnancy (see section 4.4).$0$0$0$0$0In a clinical study 16 women were treated with certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0,.09%. At Week 4 and Week 8, all infant concentrations were BLQ. The clinical significance of low levels certolizumab pegol for infants is unknown. It is recommended to wait a minimum of 5 months following the mother’s last Cimzia administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.$0$0$0$0$0Breastfeeding$0$0There is insufficient information on the excretion of certolizumab pegol in human or animal breast milk. Since immunoglobulins are excreted into human breast milk, a risk to the breastfeeding child cannot be excluded. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Cimzia should be made taking into account the benefit of breastfeeding to the child and the benefit of Cimzia therapy to the woman.$0$0In a clinical study in 17 lactating women treated with Cimzia, minimal transfer of certolizumab pegol from plasma to breast milk was observed. The percentage of the maternal certolizumab pegol dose that  reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %. In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant.$0$0$0$0$0Consequently, Cimzia can be used during breastfeeding.$0$0  $0$0Fertility$0$0Effects on sperm motility measures and a trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility (see section 5.3). $0$0$0$0

Updated on 17 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 January 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 22 May 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes in section: 4.2 and 5.1.

Updated on 19 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to information for healthcare professionals

Updated on 6 January 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SmPC changes: in sections 4.8 and 5.1: to add information about the long-term data, following the submission of two final study reports.

 

 

Updated on 6 January 2017 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 22 September 2016 SmPC

Reasons for updating

  • New SPC for new product

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 21 September 2016 PIL

Reasons for updating

  • New PIL for new product