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Olumiant is a brand name for Baricitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis Baricitinib 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). Baricitinib may be used as monotherapy or in combination with…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of the conditions for which this medicinal product is indicated. Posology Rheumatoid arthritis The recommended dose of baricitinib is 4 mg once daily.
4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. 1). Atopic dermatitis Adults The recommended dose of baricitinib is 4 mg once daily. 4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose.
1). Baricitinib can be used with or without topical corticosteroids. 1). Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.
4 Children and adolescents (2 years of age and older) The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.
A reduction to half the dose should be considered for patients who have achieved sustained control of disease activity with the recommended dose and are eligible for dose tapering. Baricitinib can be used with or without topical corticosteroids.
Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.
Alopecia areata Adults The recommended dose of baricitinib is 4 mg once daily. 4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. 1). Once a stable response has been achieved, it is recommended to continue treatment for at least several months, in order to avoid relapse.
The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 36 weeks of treatment.
9 %). 2 %) occurred uncommonly in patients with rheumatoid arthritis.
Tabulated list of adverse reactions Frequency estimate:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000). The frequencies in Table 2 are based on integrated data from clinical trials in adults and/or postmarketing setting across rheumatoid arthritis, atopic dermatitis, and alopecia areata indications unless stated otherwise; where notable differences in frequency between indications are observed, these are presented in the footnotes below the table.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 2. Adverse reactions System organ class Very common Common Uncommon Infections and infestations Upper respiratory tract infections Pneumoniad Herpes zosterb Urinary tract infections Gastroenteritis Herpes simplex Folliculitisg Blood and lymphatic system disorders Thrombocytosis > 600 x 109 cells/La, d Neutropenia < 1 x 109 cells/La Immune system disorders Swelling of the face, Urticaria Metabolism and nutrition disorders Hypercholesterolaemiaa Hypertriglyceridaemiaa Nervous system disorders Headache Vascular disorders Deep vein thrombosisb Respiratory, thoracic, mediastinal disorders Pulmonary embolismf Gastrointestinal disorders Abdominal paind Nausead Diverticulitis Hepatobiliary disorders ALT increased ≥ 3 x ULNa, d AST increased ≥ 3 x ULNa, e Skin and subcutaneous tissue disorders Rash Acnec Investigations Creatine phosphokinase increased > 5 x ULNa, c Weight increased a Includes changes detected during laboratory monitoring (see text below).
13 b Frequency for herpes zoster and deep vein thrombosis is based on rheumatoid arthritis clinical trials. c In rheumatoid arthritis clinical trials, the frequency of acne and creatine phosphokinase increased > 5 x ULN was uncommon.
g. current malignancy or history of malignancy) Use of JAK inhibitors in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), baricitinib should only be used in these patients if no suitable treatment alternatives are available.
Infections Serious and sometimes fatal infections, including opportunistic infections, have been reported in patients receiving other JAK inhibitors. 8). In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.
2). If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age, baricitinib should only be used if no suitable treatment alternatives are available.
Tuberculosis Patients should be screened for tuberculosis (TB) before starting therapy. Baricitinib should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of treatment in patients with previously untreated latent TB.
5 x 109 cells/L, and haemoglobin < 8 g/dL were reported in clinical trials. 2). The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. 8). In rheumatoid arthritis clinical studies, herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and synthetic conventional DMARDs.
1. 6).
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Adolescents (12 years of age and older) The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. 2 Paediatric population below for information on patients weighing less than 30 kg. A dose of 2 mg once daily should be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.
Once a stable response has been achieved, it is recommended to continue treatment for at least several months, in order to avoid relapse. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 36 weeks of treatment. Juvenile idiopathic arthritis (from 2 to less than 18 years of age) The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more.
For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 12 weeks of treatment. 5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a 5 haemoglobin value less than 8 g/dL.
4). 5). Special populations Renal impairment The recommended dose is 2 mg once daily in adult patients with creatinine clearance between 30 and 60 mL/min. In paediatric patients with creatinine clearance between 30 and 60 mL/min, the recommended dose of baricitinib should be reduced by half.
2). Hepatic impairment No dose adjustment is required in patients with mild or moderate […]
d In atopic dermatitis clinical trials, the frequency of nausea, and ALT ≥3 x ULN was uncommon. In alopecia areata clinical trials, the frequency of abdominal pain was uncommon. In atopic dermatitis and alopecia areata clinical trials, the frequency of pneumonia and thrombocytosis > 600 x 109 cells/L was uncommon.
e In alopecia areata clinical trials, the frequency of AST ≥ 3 x ULN was common. f Frequency for pulmonary embolism is based on rheumatoid arthritis and atopic dermatitis clinical trials. g Folliculitis was observed in alopecia areata clinical trials.
It was usually localized in the scalp region associated with hair regrowth. 4 %). In the integrated data from rheumatoid arthritis, atopic dermatitis and alopecia areata clinical trials, nausea was most frequent during the first 2 weeks of treatment.
Cases of abdominal pain were usually mild, transient, not associated with infectious or inflammatory gastrointestinal disorders, and did not lead to treatment interruption. Infections In the integrated data from rheumatoid arthritis, atopic dermatitis and alopecia areata clinical trials, most infections were mild to moderate in severity.
7 % of patients in the 4 mg, 2 mg and placebo groups, respectively. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy. Frequency of herpes zoster was common in rheumatoid arthritis, very rare in atopic dermatitis and uncommon in alopecia areata.
In atopic dermatitis clinical trials, there were less skin infections requiring antibiotic treatment with baricitinib than with placebo. The incidence of serious infections with baricitinib was similar to placebo. The incidence of serious infections remained stable during long-term exposure.
8 in alopecia areata. Serious pneumonia and serious herpes zoster occurred uncommonly in patients with rheumatoid arthritis. Hepatic transaminase elevations Dose dependent increases in blood ALT and AST activity were reported in studies extended over week 16.
Elevations in mean ALT/AST remained stable over time. Most cases of hepatic transaminase elevations ≥ 3 x ULN were asymptomatic and transient. In patients with rheumatoid arthritis, the combination of baricitinib with potentially hepatotoxic medicinal products, such as methotrexate, resulted in increased frequency of these elevations.
Lipid elevations In the integrated data from rheumatoid arthritis, atopic dermatitis and alopecia areata clinical trials, baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, LDL cholesterol, and high density lipoprotein (HDL) cholesterol.
There was no change in the LDL/HDL ratio. Elevations were observed at 12 weeks and remained stable thereafter at a higher value than baseline including in the long-term extension study in rheumatoid arthritis. Mean total and LDL cholesterol increased through week 52 in patients with atopic dermatitis and alopecia areata.
In 14 rheumatoid arthritis clinical trials, baricitinib treatment was associated with dose-dependent increases in triglycerides. There was no increase in triglycerides […]
If a patient develops herpes zoster, treatment should be temporarily interrupted until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with baricitinib.
Patients with evidence of active hepatitis B or C infection were excluded from clinical trials. Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate. Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted. Vaccination No data are available on the response to vaccination with live vaccines in patients receiving baricitinib.
Use with live, attenuated vaccines during or immediately prior to baricitinib therapy is not recommended. Prior to initiating treatment, it is recommended that all patients, and particularly paediatric patients, be brought up to date with all immunisations in agreement with current immunisation guidelines.
8). Elevations in low density lipoprotein (LDL) cholesterol decreased to pre-treatment levels in response to statin therapy in adults. In both paediatric and adult patients, lipid parameters should be assessed approximately 12 weeks following initiation of therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.
8). Increases in ALT and AST to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in clinical trials. 8). If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, treatment should be temporarily interrupted until this diagnosis is excluded.
Malignancy Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including baricitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of […]