Dosage, how to use the drug
Dosage, how to use the drug
Blog Article
The recommended dose of Barigen is 2 mg taken once daily, with or without food. An alternative route of administration may be used for patients who are unable to swallow tablets [see Alternative Route of Administration for Patients Who Are Unable to Swallow Tablets]. Barigen may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
Dosage Recommendations in COVID-19
The recommended dose of Barigen for adults is 4 mg taken once daily, with or without food, for 14 days or until hospital discharge, whichever occurs first. An alternative route of administration may be used for patients who are unable to swallow tablets.
Dosage recommendations in alopecia areata
The recommended dose of Barigen 4 mg (Baricitinib) taken once daily, with or without food. Increase to 4 mg once daily if response to treatment is inadequate.
For patients with near-total or total hair loss, with or without significant loss of eyelashes or eyebrows, consider treatment with 4 mg once daily, with or without food.
When the patient achieves an adequate response to treatment with 4 mg, reduce the dose to 2 mg, once daily.
Contraindications
Do not use the drug in the following cases:
Hypersensitivity to Baricitinib or any ingredient of the drug.
Pregnant.
What precautions should be taken when using Barigen?
Serious infection
Serious and occasionally fatal infections due to bacteria, mycobacteria, invasive fungi, viruses, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving Barigen. The most common serious infections reported with Barigen include pneumonia, herpes zoster, and urinary tract infections. Among opportunistic infections, tuberculosis, cutaneous herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus have been reported with Barigen. Some patients presented with disseminated rather than localized disease and were often concomitantly treated with immunosuppressants such as methotrexate or corticosteroids.
Avoid using Barigen in patients with serious, active infections, including localized infections. Consider the risks and benefits of treatment before initiating Barigen in patients with:
chronic or recurrent infection
people who have been exposed to tuberculosis
history of serious or opportunistic infections
persons who have resided in or traveled to areas where tuberculosis or fungal diseases are endemic; or
with underlying conditions that may predispose them to infection.
In patients with rheumatoid arthritis or alopecia areata, closely monitor for signs and symptoms of infection during and after treatment with Barigen. Interrupt the dose in patients with rheumatoid arthritis or alopecia areata if the patient develops a serious infection, opportunistic infection or sepsis. Patients who develop a new infection during treatment with Barigen should undergo prompt and complete diagnostic testing, appropriate for immunocompromised patients; appropriate antibiotic therapy should be initiated, the patient should be closely monitored and Barigen should be discontinued if the patient fails to respond to treatment. Do not reinstitute Barigen until the infection is controlled.
In patients with COVID-19, monitor for signs and symptoms of new infection during and after treatment with Barigen. There is limited information regarding the use of Barigen in patients with COVID-19 and other serious infections. The risks and benefits of treatment with Barigen should be considered in patients with other serious infections who develop COVID-19.
Tuberculosis
Assess the patient for active infection before administering Barigen. The drug should not be used in patients with active tuberculosis.
Test patients with rheumatoid arthritis or alopecia areata for latent tuberculosis. Patients with rheumatoid arthritis or alopecia areata and latent tuberculosis (TB) should be treated with standard anti-TB therapy before starting Barigen. Consider anti-TB therapy before starting the drug in patients with a history of latent or active TB disease in whom appropriate treatment cannot be confirmed and in patients with negative latent TB tests but with risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB should be sought to assist in deciding whether initiation of anti-TB therapy is appropriate for an individual patient.
During use of Barigen, monitor patients for signs and symptoms of tuberculosis, including those who test negative for latent tuberculosis infection prior to initiation of therapy.
Reactivate virus
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), has been reported in clinical studies with Barigen. If the patient develops herpes zoster, discontinue treatment until the disease has cleared.
The effect of Barigen on reactivation of chronic viral hepatitis is unknown. Patients with evidence of active hepatitis B or C infection were excluded from clinical trials. In clinical trials of patients with rheumatoid arthritis or alopecia areata, patients who were positive for hepatitis C antibodies but negative for hepatitis C virus RNA were allowed to enroll. Patients who were positive for hepatitis B surface antibodies and hepatitis B core antibodies, but not hepatitis B surface antigen, were allowed to enroll; these patients should be monitored for hepatitis B virus (HBV) DNA. If HBV DNA is detected, consult a hepatologist. Perform viral hepatitis screening according to clinical guidelines before initiating treatment with Barigen.
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