Cabometyx Tablets

  • Name:

    Cabometyx Tablets

  • Company:
    info
  • Active Ingredients:

    Cabozantinib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/04/21

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 29/4/2021
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.

Click on this link to Download PDF directly

Ipsen Pharmaceuticals Limited

Ipsen Pharmaceuticals Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Cabometyx Tablets Active Ingredients Cabozantinib
Medicine Name Decapeptyl (triptorelin) 3-month Active Ingredients triptorelin pamoate
Medicine Name Decapeptyl (triptorelin) SR Active Ingredients triptorelin acetate
Medicine Name Decapeptyl 6 Month 22.5mg Active Ingredients triptorelin pamoate
Medicine Name Dysport Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex
Medicine Name INCRELEX Active Ingredients Mecasermin
Medicine Name Mucodyne 375mg Capsules- Discontinued Active Ingredients Carbocisteine
Medicine Name NutropinAq Active Ingredients Somatropin
Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe Active Ingredients Lanreotide acetate
Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
1 - 0 of 11 items.Total: Infinity pages

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

Updated on 29 April 2021 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 6 - date of revision
  • Removal of Black Inverted Triangle
  • Change to further information section

Free text change information supplied by the pharmaceutical company

The following sections were changed in the PIL:

 

The black triangle warning has been removed

 

1. What CABOMETYX is and what it is used for

Clarification regarding the wording of the indication liver cancer in line with SmPC

 

2. What you need to know before you take CABOMETYX

Addition of sodium warning

 

6. Contents of the pack and other information

An update is being made to the list of the local representatives.

Updated on 29 April 2021 PIL

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 - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The following sections are being changed in the PIL:

The black triangle warning has been removed.

 

1. What CABOMETYX is and what it is used for

Clarification regarding the wording of the indication liver cancer in line with SmPC

 

2. What you need to know before you take CABOMETYX

Addition of sodium warning

 

6. Contents of the pack and other information

An update is being made to the list of the local representatives.

Updated on 29 April 2021 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

The following changes are being made in the SmPC:

The black triangle warning has been removed

4.1 Therapeutic indications

The authorised indication in renal cell carcinoma has been further clarified and reworded in the section 4.1 in line with the SmPC guidelines and the EMA assessors guide for the wording of therapeutic indication

 

4.2 Posology and method of administration

Minor re-wording of the following sentence ‘’CABOMETYX tablets and cabozantinib capsules are not bioequivalent and should not be used interchangeably (see section 5.2)’’ and other minor editorial changes.

 

4.4 Special warnings and precautions for use

Addition of sodium warning as below.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Minor re-wording of lactose warning

Lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose‑galactose malabsorption should not take this medicinal product.

 

4.5      Interaction with other medicinal products and other forms of interaction

Minor re-wording relating to the fact that the effect of cabozantinib on the pharmacokinetics of warfarin has not been investigated.

 

4.8 Undesirable effects

Section 4.8 has been updated to add “erythema” in the tabulated list of adverse drug reactions.   Also deletion and addition of footnotes at the end of Table 2.

 

5.1 Pharmacodynamic properties

Section 5.1 is being updated so that baseline and demographics data of hepatocellular carcinoma patients randomized in the CELESTIAL study is being rephrased to harmonize with other studies data.

 

5.2 Pharmacokinetic properties

Additional information relating to Pharmacokinetics in special patient populations (Renal Impairment) relating to unbound plasma cabozantinib

 

6.5 Nature and contents of container

Minor correction are being made to section 6.5 of the SmPC (to add “polyester coil”).

 

Updated on 12 April 2021 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

The following sections were changed in the PIL:

1 What Cabometyx is and what it is used for

Information on the use of Cabometyx in combination with nivolumab has been added to section 1.

 

2 What you need to know before you take CABOMETYX

Warnings and precautions section has been updated with precaution wording to inform doctor or pharmacist in the case of thyroid problems.

 

3 How to take Cabometyx

Information on the use and dosage recommended for Cabometyx when used in combination with nivolumab has been added to section 3.

 

4 Possible side effects

Section 4 has been updated to include information on possible side effects as a result of Cabometyx use as monotherapy and, possible side effects as a result of Cabometyx use in combination with nivolumab.

Updated on 12 April 2021 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 4.8 - 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

The following sections were changed in the SmPC:

4.1 Therapeutic indications

Information on the use of Cabometyx in combination with nivolumab for the treatment of advanced renal cell carcinoma in adults has been added to section 4.1.

 

4.2 Posology and method of administration

Section 4.2 has been updated to include information on the posology of Cabometyx as monotherapy and in combination with nivolumab in first line advanced RCC.

 

4.4 Special warnings and precautions for use

Section 4.4 has been updated to include special warnings and precautions on the use of Cabometyx in combination with nivolumab.

Warnings on Hepatotoxicity have also been updated in relation to the use of Cabometyx as combination therapy.

 

4.8 Undesirable side effects

Section 4.8 has been updated to differentiate between adverse events occurring with Cabometyx use as monotherapy or in combination with nivolumab.

 

5.1 Pharmacodynamic properties

Section 5.1 has been updated to include information on clinical trials involving treatment with Cabometyx in combination with nivolumab.

Updated on 19 November 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

The following PIL section has been updated:

-Section 6: Addition of manufacturer Rottendorf Pharma GmbH

Updated on 17 June 2020 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Changes have been made to the following sections of the PIL:

  • Section 5, to remove details of blister packaging
  • Section 6, to remove details of blister packaging

Updated on 17 June 2020 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

The following changes have been made to the SmPC:

  • Update of section 6.5 to remove details of blister packaging.
  • Update to section 8 to remove Marketing Authorisation Numbers associated with blister packaging

Updated on 27 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • In section 2 Warnings and Precautions, a sentence was added regarding oral healthcare
  • In section 2 Interactions with other medicines, was updated to include medicines for the treatment of angina pectoris
  • In section 4 Possible side effects, a sentence was added regarding side effects related to osteonecrosis and additionally;
    • to remove Anaemia, Oral pain and Dry mouth from the list of adverse reactions (ADRs),
    • to add Dysphagia and Hyperkeratosis to the existing ADR, 
    • to replace Peripheral sensory neuropathy by Peripheral neuropathy in order to reflect the broader medical concept and to add DVT (Deep vein thrombosis) to the existing ADR venous thrombosis in order to alert prescribers to the most frequently reported type of venous thrombosis.
  • In section 6, update to name  and addresses of local affiliates 

Updated on 27 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

  • Update of section 4.2 to remove sentence regarding switching from capsule to tablet 
  • Update of section 4.4 of the SmPC to include the addition of the risk of Osteonecrosis.
  • Update of Section 4.8 of the SmPC based on the new version of the Company Core Safety Information (CCSI v4):
    • to remove Anaemia, Oral pain and Dry mouth from the list of adverse reactions (ADRs),
    • to add Dysphagia and Hyperkeratosis to the existing ADR, 
    • to replace Peripheral sensory neuropathy by Peripheral neuropathy in order to reflect the broader medical concept and to add DVT (Deep vein thrombosis) to the existing ADR venous thrombosis in order to alert prescribers to the most frequently reported type of venous thrombosis.
  • Changes to the frequency categorisation of some ADRs are also proposed based on new pooled data.
  • Update to section 5.1 to update Clinical efficacy and safety 

Updated on 11 November 2019 SPC

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

Correction to table in section 4.8 to reinstate AEs.

Updated on 5 November 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 section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Type IAin variation to update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PIL to implement the recommendation of the PRAC further to artery dissections and aneurysms signal on Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration

Updated on 5 November 2019 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

Type IAin variation to update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PIL to implement the recommendation of the PRAC further to artery dissections and aneurysms signal on Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration

Updated on 27 August 2019 PIL

Reasons for updating

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

Updated on 16 November 2018 PIL

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
  • Change to other sources of information section

Updated on 16 November 2018 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 4.8 - 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 sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 10 due to additon of new indication for the treatment of hepatocellular carcinoma

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 3 September 2018 SPC

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 to include additional adverse events after review of PSUR for cabozantinib.

Updated on 22 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 June 2018 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Update to SmPC to include indication for treatment for 1st line RCC patients.

Updated on 15 November 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 15 November 2017 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 Sections 4.5, 5.1 and 5.3:

Section 4.5: addition of interaction between warfarin and cabozantanib

Sections 5.1 and 5.3: additional data on OS for patients


Updated on 14 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 18 October 2016 SPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 September 2016 PIL

Reasons for updating

  • New PIL for new product