Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® (baricitinib): Dosering för måttlig till svår reumatoid artrit

Den rekommenderade dosen för baricitinib (BARI) hos vuxna patienter med måttligt till svårt aktiv reumatoid artrit är 4mg en gång dagligen.

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Dose Modifications

The recommended dose of baricitinib is 4 mg once daily.1

For some patients, a dose of 2 mg once daily may be acceptable.1

  • The recommended dose of BARI in patients with eGFR between 30 and 60 mL/min/1.73 m2 is 2 mg once daily. 1
  • The recommended dose of BARI in patients taking OAT3 inhibitors with a strong inhibition potential, such as probenecid, is 2 mg once daily.1
  • Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.1

A dose of 2 mg once daily may be appropriate for patients with a history of chronic or recurrent infections.

A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.1

Use of BARI is not recommended in patients with

  • estimated glomerular filtration rate of < 30 mL/min/1.73 m2.
  • severe hepatic impairment
  • absolute lymphocyte count <500 cells/mm3
  • absolute neutrophil count <1000 cells/mm3, or
  • hemoglobin level <8 g/dL.2

Use of BARI is not recommended in pediatric patients.1 

Dose Administration

Route of Administration

Baricitinib is for oral use.1

Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.1

Food Effects

Administration with meals is not associated with a clinically relevant effect on exposure.2

An assessment of food effects in healthy subjects showed that a high-fat meal decreased the mean area under the curve and maximum serum concentration of BARI by approximately 11% and 18%, respectively, and delayed the time to reach maximum serum concentration by 0.5 hours.2

In clinical studies, BARI was administered without regard to meals.2

Timing

Baricitinib can be taken at any time of day or night. It is best to take BARI at the same time every day.1

Use With Other RA Therapies

Baricitinib may be used as monotherapy or in combination with methotrexate.1

Limitation of Use

Combination with

  • biologic DMARDs
  • biologic immunomodulators or
  • other Janus kinase (JAK) inhibitors

is not recommended, as a risk of additive immunosuppression cannot be excluded.1

In rheumatoid arthritis, data concerning use of baricitinib with potent immunosuppressive medicinal products, e.g.

  • azathioprine,
  • tacrolimus,
  • ciclosporin

are limited and caution should be exercised when using such combinations.1

References

1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

eGFR = estimated glomerular filtration rate

JAK = Janus kinase

OAT = organic anion transporter

Datum fӧr senaste ӧversyn 2019 M04 30


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