RINVOQ 15 mg prolonged-release tablets *
Pharmacy Only: Prescription

  • Company:

    AbbVie Limited
  • Status:

    Updated
  • 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

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.

EDM Updated on 18 January 2022

File name

RINVOQ_Patient Alert_Card_V2_Jan2022_1642526473.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 18 January 2022

File name

RINVOQ_HCP_Guide_V3_Jan2022_1642526473.pdf

Reasons for updating

  • Add New Doc

Updated on 21 December 2021

File name

PL_Rinvoq tabs_diverticulitis_16Dec21_1640111272.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_1640111049.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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_1632216418.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_1629826822.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • 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 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 24 August 2021

File name

SPC_Rinvoq 15mg-30mg tab_Atopic dermatitis_20Aug21_1629826581.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Description of changes

The SmPC has been updated to reflect the approval of atopic dermatitis (AD) indication and a new 30 mg tablet.  The SmPC has been revised as follows:

Section 1 – Name of the Medicinal Product

RINVOQ 30 mg prolonged-release tablets added

Section 2 – Qualitative and Quantitative Composition

Updated to reflect addition of  Rinvoq 30 mg prolonged release tablets to the SmPC

Section 3 - Pharmaceutical Form

Updated to reflect addition of  Rinvoq 30 mg prolonged release tablets to the SmPC

Section 4.1 - Therapeutic Indications

Updated to reflect approval of Atopic dermatitis indication:

Section 4.2 – Posology and method of administration

Updated to include dosing for adults and and adolescents (12 to 17 years) with Atopic dermatitis.

Section 4.5 – Interaction with other medicinal products and other forms of interaction

Sub-section: Coadministration with CYP3A4 inhibitors
The following has been added:
Upadacitinib 30 mg once daily dose is not recommended for patients receiving chronic treatment with strong CYP3A4 inhibitors.

Section 4.6 – Fertility, pregnancy and Lactation
The following has been added:

Female paediatric patients and/or their parents/caregivers should be informed about the need to contact the treating physician once the patient experiences menarche while taking upadacitinib.

Section 4.8 – Undesirable effects

The summary of safety profile has been updated.

Table 2  (Adverse reactions) has been updated.  Please refer to SmPC for full details.

Information under “Description of selected adverse reactions” has been updated; this includes a new section for Atopic dermatitis.  Please refer to SmPC for full details.

Section 5.1 Pharmacodynamic properties

“Mechanism of action” section has been updated to reflect information for atopic dermatitis.

Clinical Efficacy and Safety section updated to reflect Atopic dermatitis indication.

Section 5.2 - Pharmacokinetic properties

Special Populations:

  • “Renal Impairment” and “Paediatric Population” subsections updated.

Section 5.3 – Preclinical Safety Data

  • Updated to reflect Rinvoq 30mg dose – please refer to SmPC document for full details

Section 6.3 – Shelf-life

  • Updated to include Rinvoq 30mg tablet presentation

Section 6.5 -  Nature and contents of container

  • Updated to include Rinvoq 30mg tablet presentation

Section 8 – Marketing Authorisation Numbers

  • Updated to reflect MA numbers for Rinvoq 30mg

    EU/1/19/1404/006

            EU/1/19/1404/007

            EU/1/19/1404/008

          EU/1/19/1404/009

Section 10 – Date of Revision of the Text

  • Updated to 08/2021

Updated on 25 June 2021

File name

PL_Rinvoq 15mg tabs_PSUR-HZ Japan_21May21_1624617534.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Correction to file name 

 

No change made to actual PIL itself

Updated on 25 June 2021

File name

SmPC_Rinvoq 15mg tabs_PSUR-HZ Japan_21May21_1624617376.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

Change to file name 

No change to actual SmPC itself

Updated on 25 June 2021

File name

PL_Rinvoq 15mg tabs_PSUR-HZ Japan_21May21_1624617035.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Correction to file name 

No change made to PIL tex

Updated on 25 June 2021

File name

SmPC_Rinvoq 15mg tabs_PSUR-HZ Japan_21May21_1624610579.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

File name of previous uploaded document was incorrectly named

Updated on 01 June 2021

File name

PL_Rinvoq 25mg tabs_PSUR-HZ Japan_21May21_1622577800.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Addition of marketing authorisation holder

Updated on 01 June 2021

File name

SmPC_Rinvoq 25mg tabs_PSUR-HZ Japan_21May21_1622577488.pdf

Reasons for updating

  • 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

Section 4.4 Special warnings and Precautions for Use

  • Section 4.4 has been updated with addition of the following sentence: “The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib.”

Section 10 - Date of Revision of Text

  • Updated to 05/2021

 

 

Updated on 27 January 2021

File name

PL_Rinvoq 15mg tabs_AS-PsA_22Jan21_1611749811.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

Updated on 27 January 2021

File name

SmPC_Rinvoq 15mg tabs_AS-PsA_22Jan21_1611749543.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

Updates made to sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and section 10 due to approval of Psoriatic Arthritis and Ankylosing Sponylitis indications

Updated on 20 November 2020

File name

SmPC_RINVOQ 15 mg tabs_shelf-life ext bottle_13Nov20_1605884957.pdf

Reasons for updating

  • 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

Section 6.3

Shelf life of bottle presentation has changed from 2 years to 3 years
The shelf life of the  blister presentation is unchanged (still 2 years)

Section 10.0
Date of revision: 11/2020

Updated on 30 March 2020

File name

SmPC_RINVOQ 15 mg tabs_ATC code_27Mar20_1585579312.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

ATC code added - L04AA44

Section 9 

Date of first authoriastion  - 16 December 2019

 

Section 10

Date of Revision of Text:  02/2020

 

Updated on 17 January 2020

File name

PL_RINVOQ 15mg tabs_Initial MAA_18Dec19_NOT MKT_1579256558.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New Product

Updated on 17 January 2020

File name

SmPC_RINVOQ 15mg tabs_Initial MAA_18Dec19_NOT MKT_1579256481.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New product