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RINVOQ Extended-release tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

AbbVie Inc.

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1. Indications and Usage

1.1 Rheumatoid Arthritis RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. ...

2. Dosage and Administration

2.1 Dosage in Rheumatoid Arthritis The recommended oral dose of RINVOQ is 15 mg once daily with or without food <em>[see Clinical Pharmacology (12.3)]</em>. RINVOQ may be used as monotherapy or in combination ...

3. Dosage Forms and Strengths

RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 8 mm, and debossed with a15 on one side.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Serious Infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections <em>[see Warnings and Precautions (5.1)]</em> Malignancy <em>[see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Strong CYP3A4 Inhibitors Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole) <em>[see Clinical Pharmacology (12.3)]</em>. RINVOQ should be used ...

8.1. Pregnancy

Risk Summary The limited human data on use of RINVOQ in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib ...

8.2. Lactation

Risk Summary There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Available pharmacodynamic/toxicological data in animals ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ <em>[see Use in Specific Populations (8.1)]</em>. Contraception Females Based ...

8.4. Pediatric Use

The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established. No data are available.

8.5. Geriatric Use

Of the 4381 patients treated in the five Phase 3 clinical studies, a total of 906 rheumatoid arthritis patients were 65 years of age or older, including 146 patients 75 years and older. No differences ...

8.6. Renal Impairment

No dose adjustment is required in patients with mild, moderate or severe renal impairment. The use of RINVOQ has not been studied in subjects with end stage renal disease <em>[see Clinical Pharmacology ...

8.7. Hepatic Impairment

No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. RINVOQ is not recommended for use in patients with severe hepatic impairment (Child Pugh ...

10. Overdosage

Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities ...

11. Description

RINVOQ is formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3<em>S</em>,4<em>R</em>)-3-Ethyl-4-(3<em>H</em>imidazo[1,2<em>a</em>]pyrrolo[2,3-<em>e</em>]pyrazin-8-yl) ...

12.1. Mechanism of Action

Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence ...

12.2. Pharmacodynamics

Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation In healthy volunteers, the administration of upadacitinib (immediate release formulation) resulted in a dose- and concentration-dependent ...

12.3. Pharmacokinetics

Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range. Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis The carcinogenic potential of upadacitinib was evaluated in Sprague-Dawley rats and Tg.rasH2 mice. No evidence of tumorigenicity was observed in male or female rats that received upadacitinib ...

14. Clinical Studies

The efficacy and safety of RINVOQ 15 mg once daily were assessed in five Phase 3 randomized, double-blind, multicenter studies in patients with moderately to severely active rheumatoid arthritis and fulfilling ...

16.1. How Supplied

RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 8 mm, and debossed with a15 on one side. 30 tablets in a bottle; NDC: 0074-2306-30

16.2. Storage and Handling

Store at 2˚C to 25˚C (36˚F to 77˚F). Store in the original bottle in order to protect from moisture.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Serious Infections Inform patients that they may be more likely to develop infections when taking RINVOQ. Instruct patients ...

BOXED WARNING SECTION

<b>WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS</b> SERIOUS INFECTIONS Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or ...
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