Baricitinib

Class and Category

Pharmacologic class: Janus kinase inhibitor

Therapeutic class: Antirheumatic

Indications and Dosages

To treat moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies

TABLETS

Adults. 2 mg once daily.

• DOSAGE ADJUSTMENT For patients with moderate renal impairment (estimated glomerular filtration rate between 30 and 60 ml/min) or patients taking strong organic anion transporter 3 (OAT3) inhibitors such as probenecid, dosage reduced to 1 mg once daily. For patients who develop an absolute lymphocyte count (ALC) less than 500 cells/mm3, drug withheld until ALC is 500 cells/mm3 or greater. For patients who develop an absolute neutrophil count (ANC) less than 1,000 cells/mm3, drug withheld until ANC is 1,000 cells/mm3 or greater.
• For patients who develop a hemoglobin value less than 8 g/dl, drug withheld until hemoglobin is 8 g/dl or greater.

Mechanism of Action

Janus kinases are intracellular enzymes that influence cellular processes of hematopoiesis and immune cell function. Janus kinase inhibitors interfere with these actions, thereby reducing the signs and symptoms of rheumatoid arthritis, which is thought to be an autoimmune disorder.

Contraindications

Hypersensitivity to baricitinib or its components

Interactions

DRUGS

Strong organic anion transporter 3 inhibitors, such as probenecid: Increased baricitinib exposure, increasing risk of adverse reactions

Live vaccines: Decreased effectiveness of vaccine.

Adverse Reactions

CV: Elevated lipid levels, thrombosis (including arterial and deep vein thrombosis)

GI: Elevated liver enzymes, gastrointestinal perforation, nausea

GU: UTI

HEME: Anemia, elevated platelet count, lymphopenia, neutropenia

MS: Elevated creatine phosphokinase (CPK) levels

RESP: Bronchitis, pneumonia, pulmonary embolus, upper respiratory infections

SKIN: Acne, nonmelanoma skin cancers

Other: Infections such as bacterial, fungal (invasive), mycobacterial, viral, or other opportunistic infections; lymphomas and other malignancies

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Childbearing Considerations

PREGNANCY

• It is not known if drug can cause fetal harm.
• Use with caution only if benefit to mother outweighs potential risk to fetus.

LACTATION

• It is not known if drug is present in breast milk.
• Breastfeeding should be avoided during drug therapy.

Nursing Considerations

• Be aware that baricitinib should not be used in patients with an ALC less than 500 cells/mm3, ANC less than 1,000 cells/mm3, or hemoglobin level less than 8 g/dl.
• Know that baricitinib therapy should also be avoided in patients with an active, serious infection, including localized infections. In addition, drug is not recommended in patients with a glomerular filtration rate less than 30 ml/min or patients who have severe hepatic impairment.
• Test patients for latent tuberculosis, as ordered, prior to initiating baricitinib therapy. If positive, expect patient to receive treatment. Monitor all patients for signs and symptoms of tuberculosis throughout therapy, including patients who were negative for latent tuberculosis infection prior to initiating therapy. Know that tuberculosis therapy also may be prescribed for patients with a history of active or latent tuberculosis in whom an adequate course of treatment cannot be confirmed and for patients with a negative test for latent tuberculosis but who have risk factors for tuberculosis.
• Expect liver enzymes to be determined prior to baricitinib therapy and periodically throughout therapy, because drug can affect liver function. Know that if increases in liver enzymes occur and liver injury is suspected, drug therapy should be stopped until liver dysfunction is ruled out.

• Be aware that viral reactivation, including herpes zoster, may occur. If patient develops herpes zoster during therapy with baricitinib, expect drug therapy to be interrupted until the episode has been resolved. Know that patients should be screened for viral hepatitis before initiating therapy with baricitinib.
• Use baricitinib cautiously in patients who may be at increased risk for gastrointestinal perforation or thrombosis, as drug use may increase the risk for these life-threatening disorders.

WARNING: Monitor the patient’s complete blood count closely, as a drug may cause anemia, lymphopenia, or neutropenia. Expect drug to be withheld if a patient develops an ALC less than 500 cells/mm3 until ALC is 500 cells/mm3 or greater; an ANC less than 1,000 cells/mm3 until ANC is 1,000 cells/mm3 or greater, or a hemoglobin value becomes less than 8 g/dl until the hemoglobin level is 8 g/dl or greater.

• Assess patient regularly for signs and symptoms of infection, because serious and sometimes fatal infections due to bacterial, invasive fungal, mycobacterial, viral, or other opportunistic pathogens may occur. Patients at higher risk are those who are taking immunosuppressants such as corticosteroids or methotrexate. Notify prescriber if infection is suspected and expect antibiotic therapy to be prescribed, if confirmed. Know that baricitinib may be temporarily stopped if patient is not responding to antibiotic therapy and not restarted until the infection is under control.
• Be aware that baricitinib increases the risk of cancer. Assess the patient regularly, especially for nonmelanoma skin cancers.

WARNING: Assess patient regularly for thrombosis, including arterial, deep venous thrombosis, and pulmonary embolism, as drug increases risk of thrombus formation.

• Monitor patient for new-onset abdominal symptoms, especially patients with a history of diverticulitis, because baricitinib increases the risk for gastrointestinal perforation.

• Monitor patient’s lipid profile periodically, as ordered, during baricitinib therapy. Know that a lipid profile should be performed about 12 weeks into baricitinib therapy to determine if management of hyperlipidemia is needed.
• Avoid giving patient live vaccines during baricitinib therapy because drug may reduce effectiveness of the vaccination.

PATIENT TEACHING

• Instruct patient to take baricitinib exactly as prescribed.
• Inform patient of her risk for infections. Review signs and symptoms of infection and stress importance of notifying prescriber if an infection is suspected or develops. Also tell patient that herpes zoster may also occur. Because it could become quite serious, it should be reported.
• Tell patient that baricitinib therapy increases the risk of certain cancers. Encourage her to report any unusual, persistent, or severe signs or symptoms to prescriber. Also instruct patient to periodically examine her skin for signs of skin cancer.
• Review signs and symptoms of a blood clot with patient and stress importance of seeking immediate medical attention if suspected.
• Alert patient that laboratory abnormalities such as an elevated lipid profile or liver enzymes may occur during baricitinib therapy and may require treatment. Stress importance of complying with ordered laboratory tests.
• Advise mothers not to breastfeed during treatment with baricitinib. Instruct women of childbearing age to report suspected or known pregnancy to prescriber, as fetal effects of baricitinib are unknown.
• Instruct patient not to receive vaccinations containing live virus during baricitinib therapy.

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