IMFINZI 50 mg/mL concentrate for solution for infusion

  • Name:

    IMFINZI 50 mg/mL concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    durvalumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/20

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Summary of Product Characteristics last updated on medicines.ie: 24/2/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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

Updated on 24 February 2021 SPC

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 SPC

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 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 PIL

Reasons for updating

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

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 SPC

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 SPC

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 4 September 2020 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 - 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 4 September 2020 SPC

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 6 August 2020 SPC

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 6 August 2020 PIL

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 5 May 2020 SPC

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 SPC

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 PIL

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 6 December 2019 SPC

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 6 December 2019 PIL

Reasons for updating

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

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 PIL

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 PIL

Reasons for updating

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

Updated on 26 September 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 September 2018 SPC

Reasons for updating

  • New SPC for new product

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