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Olumiant

Last reviewed on RxList: 5/26/2020
Olumiant Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Olumiant?

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist.

What Are Side Effects of Olumiant?

Common side effects of Olumiant include:

Dosage for Olumiant

The recommended dose of Olumiant is 2 mg once daily.

What Drugs, Substances, or Supplements Interact with Olumiant?

Olumiant may interact with probenecid. Tell your doctor all medications and supplements you use.

Olumiant During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Olumiant; it is unknown how it would affect a fetus. It is unknown of it is unknown if Olumiant passes into breast milk. Because of the potential for serious adverse reactions in nursing infants, Olumiant is not recommended or use while breastfeeding.

Additional Information

Our Olumiant (baricitinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer
Olumiant Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sweating;
  • skin sores;
  • tiredness, muscle pain;
  • increased urination, pain or burning when you urinate;
  • stomach pain, diarrhea, weight loss; or
  • cough, shortness of breath, coughing up pink or red mucus.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

  • shingles--burning pain, numbness, tingling, itching, skin rash or blisters;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg--swelling, warmth, or redness in an arm or leg;
  • signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits; or
  • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

  • sores on your lips (cold sores);
  • nausea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Olumiant (Baricitinib Tablets)

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
Olumiant Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.

The following data include six randomized double-blind placebo-controlled studies (three Phase 2, three Phase 3) and a long-term extension study. All patients had moderately to severely active RA. Patients were randomized to placebo (1070 patients), OLUMIANT 2 mg (479 patients), or baricitinib 4 mg (997 patients).

Patients could be switched to baricitinib 4 mg from placebo or OLUMIANT 2 mg from as early as Week 12 depending on the study design. All patients initially randomized to placebo were switched to baricitinib 4 mg by Week 24.

During the 16-week treatment period, adverse events leading to discontinuation of treatment were reported by 35 patients (11.4 events per 100 patient-years) treated with placebo, 17 patients (12.1 events per 100 patient-years) with OLUMIANT 2 mg, and 40 patients (13.4 events per 100 patient-years) treated with baricitinib 4 mg.

During 0 to 52 week exposure, adverse events leading to discontinuation of treatment were reported by 31 patients (9.2 events per 100 patient-years) with OLUMIANT 2 mg, and 92 patients (10.2 events per 100 patient-years) treated with baricitinib 4 mg.

Overall Infections

During the 16-week treatment period, infections were reported by 253 patients (82.1 events per 100 patient-years) treated with placebo, 139 patients (99.1 events per 100 patient-years) treated with OLUMIANT 2 mg, and 298 patients (100.1 events per 100 patient-years) treated with baricitinib 4 mg.

During 0 to 52 week exposure, infections were reported by 200 patients (59.6 events per 100 patients-years) treated with OLUMIANT 2 mg, and 500 patients (55.3 events per 100 patient-years) treated with baricitinib 4 mg. In the 0 to 52 week exposure population, the most commonly reported infections with OLUMIANT were viral upper respiratory tract infection, upper respiratory tract infection, urinary tract infection, and bronchitis. Serious Infections - During the 16-week treatment period, serious infections were reported in 13 patients (4.2 events per 100 patient-years) treated with placebo, 5 patients (3.6 events per 100 patient-years) treated with OLUMIANT 2 mg, and 11 patients (3.7 events per 100 patient-years) treated with baricitinib 4 mg. During 0 to 52 week exposure, serious infections were reported in 14 patients (4.2 events per 100 patient-years) treated with OLUMIANT 2 mg and 32 patients (3.5 events per 100 patient-years) treated with baricitinib 4 mg. In the 0 to 52 week exposure population, the most commonly reported serious infections with OLUMIANT were pneumonia, herpes zoster, and urinary tract infection [see WARNINGS AND PRECAUTIONS].

Tuberculosis

During the 16-week treatment period, no events of tuberculosis were reported.

During 0 to 52 week exposure, events of tuberculosis were reported in 0 patients treated with OLUMIANT 2 mg and 1 patient (0.1 per 100 patient-years) treated with baricitinib 4 mg [see WARNINGS AND PRECAUTIONS].

Cases of disseminated tuberculosis were also reported.

Opportunistic Infections (excluding tuberculosis)

During the 16-week treatment period, opportunistic infections were reported in 2 patients (0.6 per 100 patient-years) treated with placebo, 0 patients treated with OLUMIANT 2 mg and 2 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg.

During 0 to 52 week exposure, opportunistic infections were reported in 1 patient (0.3 per 100 patient-years) treated with OLUMIANT 2 mg and 5 patients (0.6 per 100 patient-years) treated with baricitinib 4 mg [see WARNINGS AND PRECAUTIONS].

Malignancy

During the 16-week treatment period, malignancies excluding non-melanoma skin cancers (NMSC) were reported in 0 patients treated with placebo, 1 patient (0.7 per 100 patient-years) treated with OLUMIANT 2 mg, and 1 patient (0.3 per 100 patient-years) treated with baricitinib 4 mg.

During the 0 to 52 week treatment period, malignancies excluding NMSC were reported in 2 patients (0.6 per 100 patient-years) treated with OLUMIANT 2 mg and 6 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg [see WARNINGS AND PRECAUTIONS].

Venous Thrombosis

During the 16-week treatment period, venous thromboses (deep vein thrombosis or pulmonary embolism) were reported in 0 patients treated with placebo, 0 patients treated with OLUMIANT 2 mg, and 5 patients (1.7 per 100 patient-years) treated with baricitinib 4 mg.

During the 0 to 52 week treatment period, venous thromboses were reported in 2 patients (0.6 per 100 patient-years) treated with OLUMIANT 2 mg and 7 patients (0.8 per 100 patient-years) treated with baricitinib 4 mg.

Arterial Thrombosis

During the 16-week treatment period, arterial thromboses were reported in 1 patient treated with placebo (0.3 per 100 patient-years), 2 patients (1.4 per 100 patient-years) treated with OLUMIANT 2 mg, and 2 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg.

During the 0 to 52 week treatment period, arterial thromboses were reported in 3 patients (0.9 per 100 patient-years) treated with OLUMIANT 2 mg and 3 patients (0.3 per 100 patient-years) treated with baricitinib 4 mg.

Laboratory Abnormalities

Neutropenia

During the 16-week treatment period, neutrophil counts below 1000 cells/mm³ occurred in 0% of patients treated with placebo, 0.6% of patients treated with OLUMIANT 2 mg, and 0.3% of patients treated with baricitinib 4 mg. There were no neutrophil counts below 500 cells/mm³ observed in any treatment group [see WARNINGS AND PRECAUTIONS].

Platelet Elevations

During the 16-week treatment period, increases in platelet counts above 600,000 cells/mm³ occurred in 1.1% of patients treated with placebo, 1.1% of patients treated with OLUMIANT 2 mg, and 2.0% of patients treated with baricitinib 4 mg. Mean platelet count increased by 3000 cells/mm³ at 16 weeks in patients treated with placebo, by 15,000 cells/mm³ at 16 weeks in patients treated with OLUMIANT 2 mg and by 23,000 cells/mm³ in patients treated with baricitinib 4 mg.

Liver Enzyme Elevations

Events of increases in liver enzymes greater than or equal to 3x ULN were observed in patients treated with OLUMIANT [see WARNINGS AND PRECAUTIONS].

  • During the 16-week treatment period, ALT elevations greater than or equal to 3x ULN occurred in 1.0% of patients treated with placebo, 1.7% of patients treated with OLUMIANT 2 mg, and 1.4% of patients treated with baricitinib 4 mg.
  • During the 16-week treatment period, AST elevations greater than or equal to 3x ULN occurred in 0.8% of patients treated with placebo, 1.3% of patients treated with OLUMIANT 2 mg, and 0.8% of patients treated with baricitinib 4 mg.
  • In a phase 3 study of DMARD naive patients, during the 24-week treatment period, ALT and AST elevations ≥3x ULN occurred in 1.9% and 0% of patients treated with methotrexate monotherapy, 1.9% and 1.3% of patients treated with baricitinib 4 mg monotherapy, and 4.7% and 1.9% of patients treated with baricitinib 4 mg plus methotrexate.
Lipid Elevations

In controlled clinical trials, OLUMIANT treatment was associated with dose-related increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. Elevations were observed at 12 weeks and remained stable thereafter. During the 12-week treatment period, changes in lipid parameters are summarized below:

  • Mean LDL cholesterol increased by 8 mg/dL in patients treated with OLUMIANT 2 mg and by 14 mg/dL in patients treated with baricitinib 4 mg.
  • Mean HDL cholesterol increased by 7 mg/dL in patients treated with OLUMIANT 2 mg and by 9 mg/dL in patients treated with baricitinib 4 mg.
  • The mean LDL/HDL ratio remained stable.
  • Mean triglycerides increased by 7 mg/dL in patients treated with OLUMIANT 2 mg and by 15 mg/dL in patients treated with baricitinib 4 mg. [See WARNINGS AND PRECAUTIONS].
Creatine Phosphokinase (CPK)

OLUMIANT treatment was associated with increases in CPK within one week of starting OLUMIANT and plateauing after 8 to 12 weeks. At 16 weeks, the mean change in CPK for OLUMIANT 2 mg and baricitinib 4 mg was 37 IU/L and 52 IU/L, respectively.

Creatinine

In controlled clinical trials, dose-related increases in serum creatinine were observed with OLUMIANT treatment. At 52 weeks, the mean increase in serum creatinine was less than 0.1 mg/dL with baricitinib 4 mg. The clinical significance of the observed serum creatinine increases is unknown.

Other Adverse Reactions

Other adverse reactions are summarized in Table 4.

Table 4: Adverse Reactions occurring in greater than or equal to 1% of OLUMIANT 2 mg and Baricitinib 4 mg Treated Patients in Placebo-Controlled Trials

Events Weeks 0-16
Placebo
n=1070 (%)
OLUMIANT 2 mg
n=479 (%)
Baricitinib 4 mg
n=997 (%)
Upper respiratory tract infectionsa 11.7 16.3 14.7
Nausea 1.6 2.7 2.8
Herpes simplexb 0.7 0.8 1.8
Herpes zoster 0.4 1.0 1.4
a Includes acute sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, sinusitis, tonsillitis, tracheitis, and upper respiratory tract infection.
b Includes eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, and oral herpes.

Additional adverse drug reactions occurring in fewer than 1% of patients: acne.

Read the entire FDA prescribing information for Olumiant (Baricitinib Tablets)

Related Resources for Olumiant

Related Health

© Olumiant Patient Information is supplied by Cerner Multum, Inc. and Olumiant Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer

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