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Rinvoq

24 January 2020

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name
Rinvoq
Active ingredients
Upadacitinib
ATC codes
L04AA44
Decision
Approved
Date of decision
17 January 2020
Date of entry onto ARTG
17 January 2020
ARTG numbers
312687
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Sponsor
AbbVie Pty Ltd
Sponsor address
241 O'Riordan St, Mascot NSW 2020
Dose forms
Modified release tablet
Strength
15 mg
Other ingredients

Each tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, mannitol, tartaric acid, colloidal anhydrous silica, and magnesium stearate.

Film coating contains polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), ferrosoferric oxide (E172) and iron oxide red (E172).

Containers
Blister pack
Pack sizes
7 tablets (starter pack) and 28 tablets (monthly pack)
Routes of administration
Oral
Dosage

Therapy with Rinvoq should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.

The recommended oral dose of Rinvoq is 15 mg once daily with or without food.

Rinvoq should not be initiated in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have haemoglobin levels less than 8 g/dL (see Product Information Sections 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.8 ADVERSE EFFECTS).

Rinvoq may be used as monotherapy or in combination with methotrexate or other csDMARDs.

Combination with other JAK inhibitors or potent immunosuppressants has not been studied and is not recommended.

For further information refer to the Product Information.

Pregnancy category

D

Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Rinvoq (upadacitinib hemihydrate) was approved for the following therapeutic use:

Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).

Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Rinvoq (upadacitinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Rinvoq must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Rinvoq European Union-Risk Management Plan (EU-RMP) (version 1.6, dated October 2019, data lock point 13 September 2018), with Australian Specific Annex (version 1.4, dated November 2019), included with submission PM-2018-05603-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  • The final study reports for the following studies must be submitted to the TGA, as soon as possible after completion, for evaluation as Category 1 submission(s):
    • MI3-545
    • MI3-549
    • MI4-465
    • MI5-555
    • MI3-542

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.