IMFINZI 50 mg/mL concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 27 February 2024

File name

20240216 SPC IE MT Imfinzi Uveitis and immune mediated arthritis ONC 24 0005.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

Updated on 27 February 2024

File name

20240216 Package Leaflet IE MT Imfinzi Uveitis and immune mediated arthritis ONC 24 0006.pdf

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 04 January 2024

File name

20231214 SPC IE MT Imfinzi Paediatric Type II ONC 23 0045.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

Re-upload of SmPC uploaded on 2nd Jan 2024, no changes

Updated on 02 January 2024

File name

20231115 SPC IE MT Imfinzi HIMALAYA MONO ONC 23 0044.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

4.2 Posology and method of administration

  • Update to the “Paediatric” section to confirm that there is no paediatric data available for the approved indications. A brief description of the D419EC00001 study population is included along with confirmation that benefit/risk has not been established. A reference is included to the available data in Sections 5.1 and 5.2. 

5.1 Pharmacodynamic properties

  • Update to add a “Paediatric” sub-section describing study D419EC00001, including the number of patients enrolled, primary tumour categories, primary objectives and dose received. Statements confirming that the safety and efficacy in this population has not been established are included.

5.2 Pharmacokinetic properties

  • Update to add a “Paediatric” sub-section describing study D419EC00001, including number of patients enrolled, dose received and exposure.

Updated on 23 November 2023

File name

20231115 SPC IE MT Imfinzi HIMALAYA MONO ONC 23 0044.pdf

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 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.       CLINICAL PARTICULARS

4.1        Therapeutic indications

[…]

IMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

[…]

4.2        Posology and method of administration

Update to  Table 1. Recommended dose of IMFINZI monotherapy and combination therapy  

[…]

4.8     Undesirable effects

Update to Summary of the safety profile

Update to Tabulated list of adverse reactions

Update to Table 3. Adverse drug reactions in patients treated with IMFINZI

Frequency category for Myocarditis updated from Rare to Uncommon.

Frequency category for Hepatitis updated from Uncommon to Common.

Frequency category for Pemphigoid updated from Rare to Uncommon

[…]


Description of selected adverse reactions updated throughout.

Immunogenicity updated

Elderly updated to include HIMALAYA study

5.       PHARMACOLOGICAL PROPERTIES

5.1        Pharmacodynamic properties

[…]

HCC - HIMALAYA Study updated throughout

[…]

10.     DATE OF REVISION OF THE TEXT

23 June 2023 15 November 2023

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

ONC 23 0025 ONC 23 0044

Updated on 23 November 2023

File name

20231115 Package Leaflet IE MT Imfinzi HIMALAYA MONO ONC 23 0043.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

[…]

1.           What IMFINZI is and what it is used for

[…]

IMFINZI is used alone or in combination with tremelimumab is used to treat a type of liver cancer called advanced or unresectable hepatocellular carcinoma (HCC) in adults. It is used when your HCC:

·            cannot be removed by surgery (unresectable), and

·            may have spread within your liver or to other parts of the body.

[…]

4.       Possible side effects

[…]

Frequency category for ‘inflammation of the liver that can cause nausea or feeling less hungry (hepatitis)’ updated from Uncommon to Common.

Frequency category for ‘inflammation of the heart (myocarditis)’ updated from Rare to Uncommon.

[…]

 

6.           Contents of the pack and other information

[…]

This leaflet was last revised in 06/202311/2023

Other sources of information


Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu


ONC 23 0024ONC 23 0043

[…]

Updated on 23 June 2023

File name

20230623 Package Leaflet IE MT Imfinzi Postcode update ONC 23 0024.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

6.      Contents of the pack and other information

[...]

Manufacturer

AstraZeneca AB

Gärtunavägen

SE‑151 85152 57 Södertälje

[...]

This leaflet was last revised in 0406/2023.

Updated on 23 June 2023

File name

20230623 SPC IE MT Imfinzi Postcode update ONC 23 0025.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Addition of date of renewal to section 9

Updated on 08 May 2023

File name

20230424 SPC IE MT Imfinzi License renewal ONC 23 0012.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 6.6 - Special precautions for disposal and other handling
  • 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

Removal of the black triangle symbol and editorial changes throughout the SPC following approval of the license renewal.

Updated on 04 May 2023

File name

20230424 Package Leaflet IE MT Imfinzi License renewal ONC 23 0013.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of the black triangle symbol and editorial updates included throughout the text following the approval of the renewal procedure

Updated on 07 February 2023

File name

20230130 SPC IE MT Imfinzi POSEIDON HIMALAYA ONC 23 0003.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update to the product information following the approval of two new indications and a type II variation to update section 4.2 (Table 2).

Updated on 07 February 2023

File name

20230130 Package Leaflet IE MT Imfinzi POSEIDON HIMALAYA ONC 23 0004 No MIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update to the product information following the approval of two new indications.

Updated on 22 December 2022

File name

20221216 Package Leaflet IE MT TOPAZ-1 (BTC) ONC 22 0029 No MIL.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update to the product information following the approval of a new indication;

IMFINZI is used to treat a type of cancer of the bile ducts (cholangiocarcinoma) and gallbladder that are collectively referred to as biliary tract cancers (BTC). It is used when your BTC:

  •  has spread within your bile ducts and gallbladder (or to other parts of the body).

Updated on 22 December 2022

File name

20221216 SPC IE MT Imfinzi TOPAZ-1 (BTC) ONC 22 0028.pdf

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 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

Update to the product information following the approval of a new indication

IMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC)

Updated on 05 December 2022

File name

20221123 SPC IE MT Imfinzi Transverse Myelitis ONC 22 0026.pdf

Reasons for updating

  • 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 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

Update to section 4.2, 4.4 and 4.8 of the SmPC to include Myelitis Transverse as an immune-mediated adverse reaction.

Updated on 05 December 2022

File name

20221123 Package Leaflet IE MT Imfinzi Transverse Myelitis ON 22 0027 No MIL.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

2.      What you need to know before you are given IMFINZI 

[...]

Warnings and precautions 

[...]

If you have any of the following, call or see your doctor straight away. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:

[...]

·           inflammation of the spinal cord (transverse myelitis): symptoms may include pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation;

[...]

6.      Contents of the pack and other information

[...]

This leaflet was last revised in 0811/2022.

Updated on 17 October 2022

File name

20220929 SPC IE MT Imfinzi CASPIAN OS data ONC 22 0022.pdf

Reasons for updating

  • 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

Minor administrative amendment:

5.      PHARMACOLOGICAL PROPERTIES

 

5.1    Pharmacodynamic properties

[...]

The OS results with the planned long-term OS follow-up analysis (DCO: 22 March 2021) (median follow-up: 39.3 months) are presented in Table 5. IMFINZI + etoposide + platinum (Arm 2) vs. etoposide + platinum (Arm 3) continued to demonstrate sustained improvement in OS. Kaplan-Meier curve for OS is presented in Figure 7.

Updated on 13 October 2022

File name

20220929 SPC IE MT Imfinzi CASPIAN OS data ONC 22 0022.pdf

Reasons for updating

  • 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

Minor administrative errors amended in section 5.1, table 5.

Updated on 11 October 2022

File name

20220929 SPC IE MT Imfinzi CASPIAN OS data ONC 22 0022.pdf

Reasons for updating

  • 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

Summary of Revisions:

Update to the CASPIAN Study Data to include the long-term follow-up OS analysis from data cut-off 22 March 2021. OS data is added to the Efficacy table and also updated into the KM Curve.

Updated on 02 September 2022

File name

20220822 SPC IE MT Imfinzi Psoriasis ADR update ONC 22 0016.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to section 4.8 Undesirable effects, Table 3, Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

Addition of Psoriasis as an uncommon ADR


10.    DATE OF REVISION OF THE TEXT

 

23rd June22nd August 2022

Updated on 02 September 2022

File name

20220822 Package Leaflet IE MT Imfinzi Psoriasis ADR update ONC 22 0017 No MIL.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

4.      Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

When you get IMFINZI, you can have some serious side effects (see section 2).

Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with patients receiving IMFINZI alone and includes the serious side effects listed in section 2:

[...]

Uncommon (may affect up to 1 in 100 people)

·  inflammation of thyroid gland

·  decreased secretion of hormones produced by the adrenal glands that can cause tiredness

·  scarring of lung tissue

·  inflammation of the liver that can cause nausea or feeling less hungry

·  blistering of the skin

·  inflammation of the gut or intestine (colitis)

·  inflammation of the muscle

·  inflammation of the kidneys (nephritis) that can decrease the amount of your urine

·  inflammation of the pancreas

·  red, itchy, dry, scaly patches of thickened skin (psoriasis)


[...]

The following side effects have been reported in clinical trials in patients taking IMFINZI in combination with chemotherapy: 

[...]

Uncommon (may affect up to 1 in 100 people)

·  fungal infection in the mouth

·  flu-like illness

·  type 1 diabetes mellitus

·  hoarse voice (dysphonia)

·  scarring of lung tissue

·  inflammation of the gut or intestine (colitis)

·  night sweats

·  red, itchy, dry, scaly patches of thickened skin (psoriasis)

6.      Contents of the pack and other information

[...]

This leaflet was last revised in 0308/2022.

Updated on 05 July 2022

File name

20220623 SPC IE MT Imfinzi Programmatic imAE's ONC 22 0011.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to the SmPC in order to reflect the change from a manual to programmatic process for characterizing immune-mediated Adverse Event (imAE) rates.

Updated on 20 June 2022

File name

20220613 SPC IE MT Imfinzi Myocarditis and Encephalitis ONC 22 0010.pdf

Reasons for updating

  • 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 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

SmPC Section Change

4.2 Posology and method of administration

Update to Table 2 to the management recommendations for immune-mediated myocarditis


4.4 Special warnings and precautions for use

Inclusion of a separate paragraph for immune-mediated myocarditis (and removal from the section of general other immune-mediated adverse reactions)


4.8 Undesirable effects

Update to Table 3 to list the event terms of immune-mediated encephalitis and autoimmune encephalitis as a revision to the footnote “l”

Updated on 01 April 2022

File name

20220321 SPC IE MT Imfinzi Arthralgia PRAC update ONC 22 0005.pdf

Reasons for updating

  • 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

 

4.8     Undesirable effects

[...]

Table 3. Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

 

IMFINZI Monotherapy

IMFINZI Combined with Chemotherapy

 

Any Grade (%)

Grade 3‑4 (%)

Any Grade (%)

Grade 3‑4 (%)

Musculoskeletal and connective tissue disorders

Arthralgia

Very common

10.3

0.3

Common

2.6

0.4

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. ATC code: L01XC28PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. ATC code: L01FF03

10.     DATE OF REVISION OF THE TEXT

 

28th February21st March 2022

 

Updated on 01 April 2022

File name

20220321 Package Leaflet IE MT Imfinzi Arthralgia PRAC update ONC 22 0006 No MIL.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

4.       Possible side effects

[...]

Very common (may affect more than 1 in 10 people)

  • infections of the upper respiratory tract
  • underactive thyroid gland that can cause tiredness or weight gain
  • cough
  • diarrhoea
  • stomach pain
  • skin rash or itchiness
  • fever
  • joint pain (arthralgia)

[...]

Common (may affect up to 1 in 10 people)

  • diarrhoea
  • fever
  • low number of white blood cells with signs of fever
  • skin rash or itchiness
  • underactive thyroid gland; overactive thyroid gland; inflammation of thyroid gland
  • serious lung infections (pneumonia)
  • tooth and mouth soft tissue infections
  • abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)
  • swelling of legs (oedema peripheral)
  • stomach pain
  • inflammation of the mouth or lips
  • muscle pain (myalgia)
  • inflammation of the lungs (pneumonitis)
  • infection of the upper respiratory tract
  • low number of red blood cells, white blood cells, and platelets (Pancytopenia)
  • decreased secretion of hormones produced by the adrenal glands that can cause tiredness
  • inflammation of the liver that can cause nausea or feeling less hungry
  • abnormal kidney function tests (blood creatinine increased)
  • painful urination
  • reaction to the infusion of the medicine that can cause fever or flushing
  • joint pain (arthralgia)

6.       Contents of the pack and other information

[...]

This leaflet was last revised in 0203/2022.

Updated on 04 March 2022

File name

20220228 SPC IE MT Imfinzi Pancreatitis update ONC 22 0003.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

[...]

Other immune-mediated adverse reactions

Given the mechanism of action of IMFINZI, other potential immune‑mediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with IMFINZI monotherapy: myasthenia gravis, myocarditis, myositis, polymyositis, meningitis, encephalitis, Guillain-Barré syndrome, immune thrombocytopenia and, cystitis noninfective and pancreatitis (see section 4.8). Events of pancreatitis have been reported in patients in the clinical study programme. Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2.

 

4.8     Undesirable effects

[...]

Table 3. Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

Gastrointestinal disorders

Diarrhoea

Very common

16.3

0.6

Common

9.8

1.1

Abdominal painn

Very common

12.7

1.8

Common

8.7

0.4

Colitiso

Uncommon

0.9

0.3

Uncommon

0.8

0

Nausea

 

 

 

Very common

33.6

0.4

Constipation

 

 

 

Very common

16.6

0.8

Vomiting

 

 

 

Very common

14.7

0

Stomatitisp

 

 

 

Common

6.0

0.4

Pancreatitis

Uncommon

0.2

0.2

 

 

 

 

10.     DATE OF REVISION OF THE TEXT

17th28th February 2022

Updated on 04 March 2022

File name

20220228 Package Leaflet IE MT Imfinzi Pancreatitis update ONC 22 0004 No MIL.pdf

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

Free text change information supplied by the pharmaceutical company

2.       What you need to know before you are given IMFINZI

[...]

If you have any of the following, call or see your doctor straight away. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:

[...]

  • inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): symptoms may include fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches, abdominal pain, nausea and vomiting;

[...]

4.       Possible side effects

[...]

Uncommon (may affect up to 1 in 100 people)

  • inflammation of thyroid gland
  • decreased secretion of hormones produced by the adrenal glands that can cause tiredness
  • scarring of lung tissue
  • inflammation of the liver that can cause nausea or feeling less hungry
  • blistering of the skin
  • inflammation of the gut or intestine (colitis)
  • inflammation of the muscle
  • inflammation of the kidneys (nephritis) that can decrease the amount of your urine
  • inflammation of the pancreas

6.       Contents of the pack and other information

[...]

This leaflet was last revised in 10/202102/2022.

Updated on 24 February 2022

File name

20220217 SPC IE MT Imfinzi Pacific 5yr OS data ONC 22 0002.pdf

Reasons for updating

  • 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

Addition of  PACIFIC 5 year follow up Overall Survival (OS) data in Section 5.1 of the SmPC.

10.     DATE OF REVISION OF THE TEXT

 

19th October 2021

17th February 2022

Updated on 27 October 2021

File name

20211019 SPC IE MT Imfinzi Diabetic Ketoacidosis ONC 21 0034.pdf

Reasons for updating

  • 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 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

This approval includes the following significant changes:

 

Section 4.2 Posology and method of administration

Table 2 was revised to align with updated clinical practice, National Comprehensive Cancer Network (NCCN) guidelines and competitor information.

 

Section 4.4 Special warnings and precautions for use

Imposition by EMA to add additional language that Diabetic ketoacidosis can be the debut-symptom of diabetes without any preceding diagnosis, history, signs or symptoms of diabetes and that fatal cases have been registered.

 

4.8 Undesirable effects

Addition of footnote ‘c including fatal outcome’ below the ADR’s table 3

Updated on 27 October 2021

File name

20211019 Package Leaflet IE MT Imfinzi Diabetic Ketoacidosis ONC 21 0035 No MIL.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

2.       What you need to know before you are given IMFINZI

[...]

If you have any of the following, call or see your doctor straight away. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:

[...]

  • type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual, fast and deep breathing, confusion, or a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat;

[...]

6.       Contents of the pack and other information

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

 

This leaflet was last revised 0910/2021.

Updated on 15 September 2021

File name

20210904 SPC IE MT Imfinzi Noninfective Cystitis ONC 21 0030.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

[..]

Other immune-mediated adverse reactions

Given the mechanism of action of IMFINZI, other potential immune‑mediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with IMFINZI monotherapy: myasthenia gravis, myocarditis, myositis, polymyositis, meningitis, encephalitis, Guillain-Barré syndrome and, immune thrombocytopenia. and cystitis noninfective (see section 4.8). Events of pancreatitis have been reported in patients in the clinical study programme.

[..]

4.8     Undesirable effects

Addition of cystitis noninfective to table 3. Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

10.     DATE OF REVISION OF THE TEXT

7th July4th September 2021

Updated on 15 September 2021

File name

20210904 Package Leaflet IE MT Imfinzi Noninfective Cystitis ONC 21 0031 No MIL.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

4.       Possible side effects

[..]

Rare (may affect up to 1 in 1000 people)

  • a condition leading to high blood sugar levels (type 1 diabetes mellitus)
  • underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine
  • inflammation of the heart
  • a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis)
  • inflammation of the membrane around the spinal cord and brain (meningitis)
  • low number of platelets caused by an immune reaction (immune thrombocytopenia)
  • Inflammation of the bladder. Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen.

6.       Contents of the pack and other information

[..]

This leaflet was last revised in 0709/2021.

Updated on 14 July 2021

File name

20210707 SPC IE MT Imfinzi Site deletion & Shelf life update ONC 21 0024.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

(Inserted text/ Deleted text)

4.8     Undesirable effects

[...]

Reporting of suspected adverse reactions

[...]

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

6.3     Shelf life

 

Unopened vial

3 years.

 

Diluted solution

 

If not used immediately, cChemical and physical in-use stability of IMFINZI has been demonstrated for up to 30 daysno more than 24 hours at 2°C to 8°C and for up toor 2412 hours at room temperature (up to 25°C) from the time of preparationvial puncture to the start of administration.

 

From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C or 12 hours at room temperature (up to 25°C), unless dilution has taken place in controlled and validated aseptic conditions.

10.     DATE OF REVISION OF THE TEXT

11th February7th July 2021

Updated on 14 July 2021

File name

20210707 Package Leaflet IE MT Imfinzi Site deletion & Shelf life update ONC 21 0025 No MIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to date of revision

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(Inserted text, Deleted Text)

4.       Possible side effects

[...]

 

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[...]

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

6.       Contents of the pack and other information

[...]

United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

 

 

This leaflet was last revised in 12/2020.07/2021.

Updated on 24 February 2021

File name

20210211 SPC IE MT Imfinzi Pacific OS ONC 21 0011.pdf

Reasons for updating

  • 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)

Updated on 19 January 2021

File name

20210111 SPC IE MT Imfinzi Fixed dosing regimen ONC 21 0001.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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(Inserted Text; Deleted Text)

4.2     Posology and method of administration

...

Table 1. Recommended Dose of IMFINZI

Indication

Recommended IMFINZI dose

Duration of Therapy

Locally Advanced NSCLC

10 mg/kg every 2 weeks or 1500 mg every 4 weeksa

Until disease progression, unacceptable toxicity, or a maximum of 12 monthsba

ES-SCLC

1500 mgbc in combination with chemotherapyc,d,e every 3 weeks (21 days) for 4 cycles,

 

followed by 1500 mg every 4 weeks as monotherapy

 

Until disease progression or unacceptable toxicity

 

a Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.

 bIt is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.

c Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.

d Administer IMFINZI prior to chemotherapy on the same day.

e  When IMFINZI is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

5.       PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Clinical efficacy and safety

Durvalumab doses of 10 mg/kg every 2 weeks or 1500 mg every 4 weeks were evaluated in NSCLC and ES-SCLC clinical studies. Based on the modeling and simulation of exposure, exposure-safety relationships and exposure-efficacy data comparisons, there are no anticipated clinically significant differences in efficacy and safety between durvalumab doses of 10 mg/kg every 2 weeks or 1500 mg every 4 weeks.

 

10.     DATE OF REVISION OF THE TEXT

11th January 2021 10 December 2020

Updated on 17 December 2020

File name

20201210 Package Leaflet IE MT Imfinzi ITP ONC 20 0042 No MIL.pdf

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

Free text change information supplied by the pharmaceutical company

2. What you need to know before you are given IMFINZI

Warnings and Precautions

  • low number of platelets: symptoms may include bleeding (nose or gum bleeding) and/or bruising.

 

4. Possible side effects

Aligned with the SmPC; meningitis was omitted from a previous PRAC imposition (EMEA/H/C/PSUSA/00010723/201910).

Rare (may affect up to 1 in 1000 people)

    • inflammation of the membrane around the spinal cord and brain (meningitis)

low number of platelets caused by an immune reaction (immune thrombocytopenia)

This leaflet was last revised in 0812/2020.

Updated on 17 December 2020

File name

20201210 SPC IE MT Imfinzi ITP ONC 20 0041.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4  Special warnings and precautions for use

Other immune-mediated adverse reactions

Given the mechanism of action of IMFINZI, other potential immune‑mediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with IMFINZI monotherapy: myasthenia gravis, myocarditis, myositis, polymyositis, meningitis, encephalitis, and Guillain-Barré syndrome and immune thrombocytopenia. Events of pancreatitis have been reported in patients in the clinical study programme. Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2

Section 4.8 Undesirable effects

Table 3. Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

 

IMFINZI Monotherapy

IMFINZI Combined with Chemotherapy

 

Any Grade (%)

Grade 3‑4 (%)

Any Grade (%)

Grade 3‑4 (%)

Blood and lymphatic system disorders

 

Immune thrombocytopenia

Rare

<0.1

<0.1

 

 

 

             

 

10.     DATE OF REVISION OF THE TEXT

27 Aug 2020

10 December 2020

Updated on 17 December 2020

File name

20201210 SPC IE MT Imfinzi ITP ONC 20 0041 based on ONC 20 0031.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4  Special warnings and precautions for use

Other immune-mediated adverse reactions

Given the mechanism of action of IMFINZI, other potential immune‑mediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with IMFINZI monotherapy: myasthenia gravis, myocarditis, myositis, polymyositis, meningitis, encephalitis, and Guillain-Barré syndrome and immune thrombocytopenia. Events of pancreatitis have been reported in patients in the clinical study programme. Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2

 

Section 4.8 Undesirable effects

Table 3. Adverse drug reactions in patients treated with IMFINZI monotherapy and IMFINZI in combination with chemotherapy

 

IMFINZI Monotherapy

IMFINZI Combined with Chemotherapy

 

Any Grade (%)

Grade 3‑4 (%)

Any Grade (%)

Grade 3‑4 (%)

Blood and lymphatic system disorders

 

Immune thrombocytopenia

Rare

<0.1

<0.1

 

 

 

             

 

10.     DATE OF REVISION OF THE TEXT

27 August 2020

10 December 2020

 

Updated on 04 September 2020

File name

20200827 Package Leaflet IE MT Imfinzi CASPIAN ONC 20 0032 No MIL.pdf

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

Free text change information supplied by the pharmaceutical company

The revision reflects the inclusion of the CASPIAN study data (IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC)).

Updated on 04 September 2020

File name

20200827 SPC IE MT Imfinzi CASPIAN ONC 20 0031.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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The revision reflects the inclusion of the CASPIAN study data (IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC)).

 

Updated on 06 August 2020

File name

20200727 SPC IE MT Imfinzi PRAC Encephalopathy Update ONC 20 0025.pdf

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 not be renewed (A)

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Updates to section 4.4, sub-section Other immune-mediated adverse reactions, to include information on encephalitis, meningitis and Guillain-Barre syndrome

Updates made to table 2 in section 4.8 (addition of noninfective encephalitis, meningitis and Guillain-Barre syndrome)

Date of revision of the text updated to 27th July 2020

Updated on 06 August 2020

File name

20200727 Package Leaflet IE MT Imfinzi PRAC Encephalopathy Update ONC 20 0026 MIL Removed.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Green = added text

2. What you need to know before you are given IMFINZI

Warnings and precautions

....

If you have any of the following, call or see your doctor straight away. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:

....

  • inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): symptoms may include seizures, neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness.
  • inflammation of the nerves: symptoms may include pain, weakness, and paralysis in the extremities (Guillain-Barré syndrome)

....

Date of revision updated to July 2020

Updated on 05 May 2020

File name

20200416 SPC IE MT Imfinzi PRAC Tuberculosis update ONC 20 0014.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

New text: Green

Deleted text: Red strikethrough

4.2 Posology and method of administration

Editorial change in Table 1. Recommended treatment modifications for IMFINZI and management recommendations

4.4 Special warnings and precautions for use

Patients should be monitored for signs and symptoms of pneumonitis or radiation pneumonitis. Patients with sSuspected pneumonitis should be evaluatedconfirmed with radiographic imaging and other infectious and disease-related aetiologies excluded, and managed as recommended in section 4.2.

10. DATE OF REVISION OF THE TEXT

21 February 202016 April 2020

Updated on 26 February 2020

File name

20200221 SPC IE MT Imfinzi PRAC Pemphigoid Update ONC 20 0005.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

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Update to text with information on 'pemphigoid' as an adverse drug reaction

Updated on 26 February 2020

File name

20200221 Package Leaflet IE MT Imfinzi PRAC Pemphigoid Update ONC 20 0006_Medicines.ie.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition of 'blistering of the skin' as an uncommon side effect

Updated on 06 December 2019

File name

20191121-IM-SmPC-Imfinzi-Myasthenia-gravis-ONC 19 0016.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

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Change to include Myasthenia gravis as a possible side effect

Updated on 06 December 2019

File name

20191121-IM-Package-Leaflet-Imfinzi-Myasthenia-gravis-ONC 19 0017.pdf

Reasons for updating

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

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Update to include side effect of Myasthenia gravis

Updated on 19 September 2019

File name

20190912-SmPC-Imfinzi-shelf-life-ONC 19 0006.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 19 September 2019

File name

20190912-Package-Leaflet-Imfinzi-shelf-life-ONC 19 0005.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 25 April 2019

File name

20190408-uim-pl-imfinzi brexit update-ONC 19 0003-no mil.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 September 2018

File name

2018-09-21 UIM PIL Imfinzi 50mgml ONC 18 0026-no hcp section.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 September 2018

File name

2018-09-21 UIM SmPC Imfinzi 50mgml ONC 18 0025.pdf

Reasons for updating

  • New SPC for new product

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