baricitinib

REMS

Moderately to severely active rheumatoid arthritis (RA) in patients who have had an inadequate response/intolerance to ≥1 tumor necrosis factor inhibitor therapies (as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs [DMARDs]) (not to be used with other Janus kinase [JAK] inhibitors, biologic DMARDs, or potent immunosuppressants, including azathioprine and cyclosporine).
Coronavirus disease 2019 (COVID-19) in hospitalized patients requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Severe alopecia areata (not to be used with other JAK inhibitors, biologic immunomodulates, cyclosporine, or other potent immunosuppressants).

Action ⬆ ⬇

Acts as a JAK inhibitor, which prevents the activation of signal transducers and activators of transcription, resulting in a reduction in immunoglobulins and C-reactive protein.

Therapeutic effects:

Improvement in clinical and symptomatic parameters of RA.
Shortened time to recovery and reduction in death from COVID-19.
Improvement in scalp hair coverage in alopecia areata.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration (80%).

Distribution: Widely distributed into tissues.

Metabolism/Excretion: Metabolized by the liver by CYP3A4; primarily excreted in the urine (69% as unchanged drug); 15% excreted in feces as unchanged drug.

Half-Life: 12 hr.

Time/Action Profile ⬆ ⬇

(clinical improvement)

ROUTE	ONSET	PEAK	DURATION
PO	1 wk	3 mo	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infection;
Severe renal impairment (for RA);
Patients with end-stage renal disease (ESRD), acute kidney injury, or receiving dialysis (for COVID-19);
Severe hepatic impairment (for RA or alopecia areata);
↑risk for thrombosis;
Absolute lymphocyte count (ALC) <500 cells/mm³, ANC <1000 cells/mm³, or hemoglobin <8 g/dL;
Lactation: Lactation.

Use Cautiously in:

Patients who are >50 yr old and have ≥1 cardiovascular risk factor (↑ risk of all-cause mortality, cardiovascular death, MI, stroke, and thrombosis);
Current or past history of smoking (↑ risk of malignancy, cardiovascular death, MI, or stroke);
Malignancy (other than successfully treated nonmelanoma skin cancer);
Chronic or recurrent infection;
Previously exposed to tuberculosis (TB);
History of serious or opportunistic infection;
Resided or traveled in areas of endemic tuberculosis or endemic mycoses;
Underlying conditions that predispose to infection;
Severe hepatic impairment (use for treatment of COVID-19 only if potential benefit outweighs potential risk);
Diverticulitis (↑ risk of GI perforation);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children;
Geri: Infection risk may be ↑ in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: CARDIOVASCULAR DEATH, DEEP VEIN THROMBOSIS (DVT), MI

GI: ↑liver enzymes, GI PERFORATION, nausea

GU: ↑serum creatinine

Hemat: anemia, lymphopenia, neutropenia, thrombocytosis

Metab: ↑lipids

MS: ↑CK

Neuro: STROKE

Resp: PULMONARY EMBOLISM (PE)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA), INFECTION (INCLUDING SERIOUS BACTERIAL, FUNGAL, VIRAL, OR OPPORTUNISTIC INFECTIONS, INCLUDING TB), MALIGNANCY (INCLUDING NONMELANOMA SKIN CANCER)

Interactions ⬆ ⬇

Drug-drug:

Organic anion transporter 3 (OAT3) inhibitors, including probenecid, may ↑ levels and risk of toxicity; avoid concurrent use.

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis

PO (Adults ): 2 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 2 mg once daily): 1 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 1 mg once daily): Consider discontinuing OAT3 inhibitor. Concurrent use of OAT3 inhibitors: 1 mg once daily.

Renal Impairment

PO (Adults ): eGFR 30–<60 mL/min/m²: 1 mg once daily. eGFR <30 mL/min/m²: Not recommended.

COVID-19

PO (Adults ): 4 mg once daily for 14 days or until hospital discharge, whichever occurs first. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 4 mg once daily): 2 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 2 mg once daily): 1 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 1 mg once daily): Consider discontinuing OAT3 inhibitor.

Renal Impairment

PO (Adults ): eGFR 30–<60 mL/min/m²: 2 mg once daily. eGFR 15–<30 mL/min/m²: 1 mg once daily. eGFR <15 mL/min/m²: Not recommended.

Alopecia Areata

PO (Adults ): 2 mg once daily; may ↑ to 4 mg once daily if response inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider starting treatment with 4 mg once daily. In patients receiving 4 mg once daily (as initial therapy or after a dose ↑), ↓ to 2 mg once daily once adequate response achieved. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 4 mg once daily): 2 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 2 mg once daily): 1 mg once daily. Concurrent use of OAT3 inhibitors (if recommended baricitinib dose is 1 mg once daily): Consider discontinuing OAT3 inhibitor.

Renal Impairment

PO (Adults ): eGFR 30–<60 mL/min/m² (if recommended baricitinib dose is 4 mg once daily): 2 mg once daily. eGFR 30–<60 mL/min/m² (if recommended baricitinib dose is 2 mg once daily): 1 mg once daily. eGFR <30 mL/min/m²: Not recommended.

Availability ⬆ ⬇

(Generic available)

Film-coated tablets: 1 mg; 2 mg; 4 mg

Assessment ⬆ ⬇

Assess pain and range of motion before and periodically during therapy.
Determine TB infection status. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB before starting baricitinib. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test.
Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis and hepatitis B virus, prior to and periodically during therapy. New infections should be monitored closely (upper respiratory tract infections, bronchitis, urinary tract infections). Infections may be fatal, especially in patients taking immunosuppressive therapy.
Monitor for signs and symptoms of major adverse cardiac events. Patients who are current or past smokers and patients with other cardiovascular risk factors are at greatest risk.
Monitor for thrombosis, including DVT, PE, and arterial thrombosis. If symptoms of thrombosis occur, discontinue therapy and evaluate and treat patients.
Monitor for signs and symptoms of hypersensitivity reactions (hives; rash; pruritus; swelling of lips, face, or tongue; dyspnea) during therapy. Discontinue if symptoms occur.

Lab Test Considerations:

May cause neutropenia. Monitor ANC at baseline and periodically during therapy. Patients with RA or alopecia areata: If ANC ≥1000 cells/mm³, maintain dose. If ANC <1000 cells/mm³, hold therapy until ANC ≥1000 cells/mm³. Patients with COVID-19: Do not start therapy if ANC <500 cells/mm³.
- May cause lymphopenia. Patients with RA or alopecia areata: Monitor ALC at baseline and periodically during therapy. If ALC ≥500 cells/mm³, maintain dose. If ALC <500 cells/mm³, hold therapy until ALC ≥500 cells/mm³. Do not start therapy if ALC <500 cells/mm³. Patients with COVID-19: Do not start therapy if ALC <200 cells/mm³.
- May cause anemia. Patients with RA or alopecia areata: Monitor hemoglobin at baseline and periodically during therapy. If hemoglobin ≥8 g/dL, maintain dose. If hemoglobin <8 g/dL, hold therapy until hemoglobin ≥8 g/dL. Do not start therapy if hemoglobin <8 g/dL.
- Monitor liver enzymes at baseline and periodically during therapy. If ↑ in AST or ALT and liver injury are suspected, hold therapy until cause determined.
- May cause elevations in serum lipids. Monitor total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol 12 wk after starting therapy.
- Monitor renal function at baseline and periodically during therapy.

Implementation ⬆ ⬇

Administer a tuberculin skin test before starting therapy. Patients with active latent TB should be treated for TB prior to therapy.
- Immunizations for patients with RA and alopecia areata should be current prior to initiating therapy. Patients may receive concurrent vaccinations, except for live vaccines.
PO: Administer once daily without regard to food.
- For patients unable to swallow tablets, tablets may be dispersed in water. Place tablets in a container with 10 mL (5 mL minimum) of room temperature water, disperse by gently swirling the tablet(s), and administer immediately orally. Rinse container with 10 mL (5 mL minimum) of water and swallow entire contents.
- Administration via G tube: Place tablet(s) in a container with approximately 15 mL (10 mL minimum) of room temperature water and disperse with gentle swirling. Ensure tablet(s) are sufficiently dispersed to allow free passage through tip of syringe. Withdraw entire contents into an appropriate syringe and immediately administer through gastric feeding tube. Rinse container with approximately 15 mL (10 mL minimum) of room temperature water, withdraw contents into syringe, and administer through the tube.
- Administration via NG or OG tube: Place tablet(s) into a container with approximately 30 mL of room temperature water and disperse with gentle swirling. Ensure tablet(s) are sufficiently dispersed to allow free passage through tip of syringe. Withdraw entire contents into an appropriate syringe and immediately administer through enteral feeding tube. To avoid clogging of small diameter tubes (smaller than 12 Fr), syringe can be held horizontally and shaken during administration. Rinse container with at least 15 mL of room temperature water, withdraw contents into syringe, and administer through the tube.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take baricitinib as directed.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient to notify health care provider if signs and symptoms of infection (fever, sweating, or chills; blood in phlegm; diarrhea or stomach pain; muscle aches; weight loss; burning during urination or urinating more often than usual; cough or shortness of breath; warm, red, or painful skin or sores on body; feeling very tired) occur.
Caution patients with signs and symptoms of a heart attack or stroke (discomfort in the center of chest that lasts for more than a few min or that goes away and comes back; severe tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw; pain or discomfort in arms, back, neck, jaw, or stomach; weakness in one part or on one side of the body; slurred speech; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; light-headedness) to notify health care provider immediately.
Inform patient of ↑ risk of DVT and PE. If signs and symptoms (swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing) occur, stop therapy and get immediate medical care. Advise patient to notify health care provider if they have had blood clots in the legs or lungs in the past.
May ↑ risk of cancer. Advise patient to have skin checked for skin cancer during therapy. Limit amount of time spent in sunlight. Avoid using tanning beds or sunlamps. Wear protective clothing and use sunscreen with a high protection factor (SPF 30 and above); especially important for patients with very fair skin or with a family history of skin cancer. Instruct patient to notify health care provider if they have ever had any type of cancer.
Educate patient on smoking cessation. Those who are current or past smokers are at ↑ risk for major adverse cardiovascular events.
Advise patient to avoid live vaccines during therapy.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected and to avoid breastfeeding during and for 4 days after last dose of therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased pain and swelling with decreased rate of joint destruction in patients with RA.
Shortened time to recovery and reduction in death from COVID-19.
Improvement in scalp hair coverage in alopecia areata.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0002- Eli Lilly and Company
- 0002-4182- Olumiant
  - 0002-4182-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30)

0002- Eli Lilly and Company
- 0002-4182- Olumiant
  - 0002-4182-61- 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61)

0002- Eli Lilly and Company
- 0002-4479- Olumiant
  - 0002-4479-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-4479-30)

0002- Eli Lilly and Company
- 0002-4479- Olumiant
  - 0002-4479-61- 30 TABLET, FILM COATED in 1 BOTTLE (0002-4479-61)

0002- Eli Lilly and Company
- 0002-4732- Olumiant
  - 0002-4732-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)

0002- Eli Lilly and Company
- 0002-6885- Baricitinib
  - 0002-6885-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-6885-30)

0110- Lilly del Caribe, Inc.
- 0110-4182-
  - 0110-4182-71- 200000 TABLET, FILM COATED in 1 DRUM (0110-4182-71)

0110- Lilly del Caribe, Inc.
- 0110-4479-
  - 0110-4479-71- 200000 TABLET, FILM COATED in 1 DRUM (0110-4479-71)

0110- Lilly del Caribe, Inc.
- 0110-4732-
  - 0110-4732-71- 400000 TABLET, FILM COATED in 1 DRUM (0110-4732-71)

13612- Wisdom Pharmaceutical Co.,Ltd
- 13612-0032-
  13612-0032-0- 5 kg in 1 BAG (13612-0032-0)

14501- MSN Laboratories Private Limited
- 14501-0104-
  14501-0104-2- 50 kg in 1 DRUM (14501-0104-2)

52076- Chunghwa Chemical Synthesis & Biotech. Ltd
- 52076-6225-
  52076-6225-1- 5 kg in 1 DRUM (52076-6225-1)

52076- Chunghwa Chemical Synthesis & Biotech. Ltd
- 52076-6225-
  52076-6225-2- 50 kg in 1 DRUM (52076-6225-2)

52076- Chunghwa Chemical Synthesis & Biotech. Ltd
- 52076-6225-
  52076-6225-3- 200 kg in 1 DRUM (52076-6225-3)

59651- Aurobindo Pharma Limited
- 59651-639-
  59651-639-37- 50 kg in 1 DRUM (59651-639-37)

63419- Eli Lilly Kinsale Limited
- 63419-0552-
  63419-0552-1- 50 kg in 1 DRUM (63419-0552-1)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆