IMFINZI 50 mg/mL concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 December 2022
File name
63a4869856cb3.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
63a4858ecfa05.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
638e525a5318f.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
638e507584b0d.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
634d26234c614.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
6348128b1d900.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
634550da335b8.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
6311d5d16156a.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
6311c8fecf1d1.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
62c43d79ad3ca.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
62b09f7199764.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_1648813145.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 antibodiesPD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. ATC code: L01FF03. ATC code: L01XC28
10. DATE OF REVISION OF THE TEXT
21st March 202228th February
Updated on 01 April 2022
File name
20220321 Package Leaflet IE MT Imfinzi Arthralgia PRAC update ONC 22 0006 No MIL_1648812689.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 03/2022.02
Updated on 04 March 2022
File name
20220228 SPC IE MT Imfinzi Pancreatitis update ONC 22 0003_1646392253.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, cystitis noninfective and pancreatitis (see section 4.8). and Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2. Events of pancreatitis have been reported in patients in the clinical study programme.
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
28th February 202217th
Updated on 04 March 2022
File name
20220228 Package Leaflet IE MT Imfinzi Pancreatitis update ONC 22 0004 No MIL_1646391769.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_1645716855.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_1635344562.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_1635344289.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_1631713438.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 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
4th September 20217th July
Updated on 15 September 2021
File name
20210904 Package Leaflet IE MT Imfinzi Noninfective Cystitis ONC 21 0031 No MIL_1631713006.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 09/2021.07
Updated on 14 July 2021
File name
20210707 SPC IE MT Imfinzi Site deletion & Shelf life update ONC 21 0024_1626285157.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
Chemical and physical in-use stability If not used immediately, cof IMFINZIhas been demonstrated for up to 30 days at 2°C to 8°C and for up tono more than 24 hours 24or hours at room temperature (up to 25°C) from the time of preparation12.vial 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
7th July 202111th February
Updated on 14 July 2021
File name
20210707 Package Leaflet IE MT Imfinzi Site deletion & Shelf life update ONC 21 0025 No MIL_1626278416.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to date of revision
Free text change information supplied by the pharmaceutical company
(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_1614176645.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_1611059413.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
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)
4.2 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 monthsb |
ES-SCLC |
1500 mg
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_1608219587.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_1608218340.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_1608217769.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_1599234627.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_1599213188.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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 06 August 2020
File name
20200727 SPC IE MT Imfinzi PRAC Encephalopathy Update ONC 20 0025_1596728804.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
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_1596727673.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_1588691314.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_1582733414.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 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_1582729860.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_1575633550.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
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_1575633206.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
Free text change information supplied by the pharmaceutical company
Update to include side effect of Myasthenia gravis
Updated on 19 September 2019
File name
20190912-SmPC-Imfinzi-shelf-life-ONC 19 0006_1568890676.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_1568890536.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_1556206507.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_1537966624.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_1537966571.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)