RINVOQ 30 mg prolonged-release tablets

*
Pharmacy Only: Prescription
  • Company:

    AbbVie Limited
  • Status:

    No Recent Update
  • Legal 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 21 December 2023

File name

PL_Rinvoq_PSUR 7_19Dec2023.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 December 2023

File name

SmPC_Rinvoq_PSUR 7_19Dec2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

The following text has been added:

Hypoglycaemia in patients treated for diabetes

There have been reports of hypoglycaemia following initiation of JAK inhibitors, including upadacitinib, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycaemia occurs.

Updated on 25 July 2023

File name

SmPC_Rinvoq_Shingrix update_20July2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

EDM Updated on 07 July 2023

File name

RINVOQ_Patient_Card_03Jul23.pdf

Reasons for updating

  • Replace File

EDM Updated on 07 July 2023

File name

RINVOQ_HCP_Guide_03Jul23.pdf

Reasons for updating

  • Replace File

Updated on 17 April 2023

File name

PL_Rinvoq_Crohns Disease_12Apr2023.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

Updated on 17 April 2023

File name

SmPC_Rinvoq_Crohns Disease_12Apr2023.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 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

Section 4.1

  • The following indication has been added:

Crohn’s disease

 RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Section 4.2

  • Dosing information updated to reflect Crohn's disease indication.

 

Section 4.4

  • Information added regarding gastrointestinal perforation

 

Section 4.5

  • The paragraph relating to "Coadministration with CYP3A4 inhibitors" has been updated to include patients with Crohn's disease.

 

Section 4.8

  • Updated to include the most commonly reported adverse reactions in placebo-controlled Crohn's disease induction and maintenance clinical trials.
  • Table 3 - Adverse reactions table has been updated as follows:
  • Frequency of pneumonia changed from Uncommon to Common
  • Gastrointestinal perforation added as an uncommon adverse reaction
  • Section added regarding safety information in patients with Crohn's disease (serious infections, gastrointestinal perforation, laboratory abnormalities)

 

Section 5.1

  • Mechanism of action paragraph: ulcerative colitis amended to inflammatory bowel disease.
  • Section added regarding clinical efficacy and safety for Crohn's disease indication

 

Section 5.2

  • Minor editorial changes to "Renal impairment" section
  • Crohn's disease added to Paediatric population section

 

Section 5.3

  • Updates made to clinical exposure dosing information

 

Section 10.0

  • Date of revision of text updated to 04/2023


Updated on 15 March 2023

File name

PL_Rinvoq_Art 20_NMSC_10Mar2023.pdf

Reasons for updating

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

Updated on 15 March 2023

File name

SmPC_Rinvoq_Art 20_NMSC_10Mar2023.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

Section 4.2

Atopic dermatitis and Ulcerative colitis sections updated.

Section 4.4

The following warning has been added

"Upadacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;

patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);

patients with malignancy risk factors (e.g. current malignancy or history of malignancy)"

Section added regarding use in patients 65 years of age and older

Serious infections section updated.

Malignancy and non-melanoma skin cancer section updated.

Section on Major Adverse cardiovascular events (MACE) added

Venous thromboembolism section updated.

Section 4.8

Non-melanoma skin cancer added as a common Adverse reaction.

Sepsis added an Uncommon adverse reaction.

Updated on 18 November 2022

File name

PL_Rinvoq_Hypersensitivity_10Nov2022.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 18 November 2022

File name

SPC_Rinvoq_Hypersensitivity_10Nov2022.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

The following has been added:

Hypersensitivity reactions

Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving upadacitinib. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy (see sections 4.3 and 4.8).


Section 4.8

Table 3 Adverse Reactions

Urticaria moved to Immune System Disorders (System Organ Class)

Serious hypersensitivity reactions added as an uncommon side effect


Section 10

Date of revision of text updated to 11/2022

EDM Updated on 15 November 2022

File name

RINVOQ_HCP Guide_V4_Nov 2022.pdf

Reasons for updating

  • Add New Doc

Updated on 29 July 2022

File name

ie-spc-rinvoq-15mg-30mg-45mg tab_nrAxspa_July 22.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 29 July 2022

File name

ie-pl-rinvoq-15mg-30mg-45mg tab_nrAxspa_July 22.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to date of revision

Updated on 01 July 2022

File name

SmPC_Rinvoq _AS bDMARD-IR-bDMARD naive 2yr data_23June22.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.8

  • "Neutropaenia (2.8%) added to the list of the most commonly reported adverse reactions in the placebo-controlled clinical trials for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.


Section 5.1

  • Updated to include 2 year data for bDMARD-inadequate responders & bDMARD-naïve patients (ankylosing spondylitis (AS) indication)


Updated on 10 June 2022

File name

PL_Rinvoq 15mg-30mg tabs_grapefruit interaction_02Jun2022.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 10 June 2022

File name

SPC_Rinvoq 15mg-30mg tabs_grapefruit interaction_02Jun2022.pdf

Reasons for updating

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

  • Inclusion of grapefruit as a strong CYP3A4 inhibitor

 

Section 10 - Date of Revision of the Text

  • Updated to 06/2022


Updated on 03 June 2022

File name

PL_Rinvoq 15mg-30mg Tabs_4th PSUR-UTI_30May2022.pdf

Reasons for updating

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

Updated on 03 June 2022

File name

SmPC_Rinvoq 15mg-30mg Tabs_4th PSUR-UTI_30May2022.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Summary of changes

Section 4.8

Table 2. Adverse reactions - urinary tract infection added as a common AE


Section 10

Date of revision updated to 05/2022

Updated on 28 April 2022

File name

SmPC_Rinvoq 15mg-30mg Tabs_Long term RA data_22Apr2022.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

Section 5.1 (pharmacodynamic properties) of the SmPC updated to include long-term rheumatoid arthritis data , including clinical response, physical function, and health-related outcome measures through Week 156 (3 years) and radiographic response data through Week 96 (2 years) from the SELECT-Compare and SELECT-Early studies

EDM Updated on 18 January 2022

File name

RINVOQ_Patient Alert_Card_V2_Jan2022.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 18 January 2022

File name

RINVOQ_HCP_Guide_V3_Jan2022.pdf

Reasons for updating

  • Add New Doc

Updated on 21 December 2021

File name

PL_Rinvoq tabs_diverticulitis_16Dec21.pdf

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 6 - date of revision

Updated on 21 December 2021

File name

SPC_Rinvoq tabs_diverticulitis_16Dec21.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

Updated to include the following:

 

Diverticulitis

Events of diverticulitis have been reported in clinical trials and from post‑marketing sources. Diverticulitis may cause gastrointestinal perforation. Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis: nonsteroidal anti‑inflammatory drugs, corticosteroids, and opioids. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis to prevent gastrointestinal perforation.

 

Section 4.8

The following has been added as an Uncommon adverse reaction:

Diverticulitis

 

Section 10

Date of revision of text updated to 12/2021

Updated on 21 September 2021

File name

SPC_Rinvoq 15mg-30mg_vaccine update_16Sep2021.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

..........................................................

Vaccination

No data are available on the response to vaccination with live or inactivated vaccines in patients receiving upadacitinib. Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended. Prior to initiating upadacitinib, it is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement with current immunisation guidelines. (see section 5.1 for data on inactivated pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) and concomitant use with upadacitinib).

 

 

5.1     Pharmacodynamic properties

.................................................................................

hsCRP

In patients with rheumatoid arthritis, treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as week 1 which were maintained with continued treatment.

Vaccine study

The influence of upadacitinib on the humoral response following the administration of inactivated pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) was evaluated in 111 patients with rheumatoid arthritis under stable treatment with upadacitinib 15 mg (n=87) or 30 mg (n=24). 97% of patients (n=108) were on concomitant methotrexate. The primary endpoint was the proportion of patients with satisfactory humoral response defined as ≥ 2-fold increase in antibody concentration from baseline to Week 4 in at least 6 out of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Results at Week 4 demonstrated a satisfactory humoral response in 67.5% (95% CI: 57.4, 77.5) and 56.5% (95% CI: 36.3, 76.8) of patients treated with upadacitinib 15 mg and 30 mg, respectively.

 

10.     DATE OF REVISION OF THE TEXT

09/2021

Updated on 24 August 2021

File name

PL_Rinvoq 15mg-30mg tab_Atopic dermatitis_20Aug21.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 August 2021

File name

SPC_Rinvoq 15mg-30mg tab_Atopic dermatitis_20Aug21.pdf

Reasons for updating

  • New SPC for new product

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