fungal, viral, or other opportunistic pathogens reported; may cause reactivation of latent TB or viral infections Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy; unknown impact on chronic viral hepatitis reactivation Consider risks and benefits before initiating in patients with chronic or recurrent infection, history of serious or opportunistic infection, underlying conditions predisposing them to infection, or patients who have been exposed to tuberculosis or have resided or traveled in areas of endemic tuberculosis or mycoses Consider TB therapy for patients with a negative test for latent TB but who have risk factors for TB infection; consultation with a physician with expertise in TB recommended to aid in decision about whether initiating anti-TB therapy is appropriate If a new infection develops during treatment, promptly initiate diagnostic tests appropriate for an immunocompromised patient; if necessary, initiate appropriate antimicrobial therapy and closely monitor; interrupt baricitinib therapy if patient unresponsive to treatment If herpes zoster occurs, interrupt treatment until episode resolves Drug interaction overview Avoid use of live vaccines; update immunizations in agreement with current immunization guidelines before initiating Coadministration with strong OAT3 inhibitors may increase baricitinib systemic exposure; dosage modification recommended Pregnancy Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) Based on findings from animal reproduction studies, therapy may cause fetal harm during pregnancy; available data from clinical trials and postmarketing reports of exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes There are no human data on chronic baricitinib exposure throughout pregnancy; there are risks to mother and the fetus associated with rheumatoid arthritis in pregnancy; consider risks and benefits with chronic use during pregnancy Published data suggest that increased disease activity is associated with risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis; adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth Based on animal studies, therapy may cause fetal harm when administered during pregnancy; consider pregnancy planning and prevention for females of reproductive potential Animal studies In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than ~20 and 84 times the maximum recommended human dose (MRHD), respectively, resulted in reduced fetal body weights, increased embryo lethality (rabbits only), and dose-related increases in skeletal malformations Lactation Unknown if distributed in human breast milk Baricitinib is present in the milk of lactating rats Owing to species-specific differences in lactation physiology, the clinical relevance of these data are not clear Because of the potential for serious adverse reactions in nursing infants, advise women with rheumatoid arthritis not to breastfeed while taking baricitinibPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Janus kinases (JAKs) pathways inhibitor; JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoieses and immune cell function Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which modulate intracellular activity including gene expression; baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs Absorption Absolute bioavailability: 80% Peak plasma time: 1 hr Steady-state achieved: 2-3 days Distribution Protein bound: 50% to plasma proteins and 45% to serum proteins Vd: 76 L Substrate of the P-gp, BCRP, OAT3 and MATE2-K transporters, which play roles in drug distribution Metabolism ~6% of the orally administered baricitinib dose is identified as metabolites (3 from urine and 1 from feces), with CYP3A4 identified as the main metabolizing enzyme No metabolites of baricitinib were quantifiable in plasma Elimination Half-life: 12 hr Total body clearance: 8.9 L/hr Excretion: 75% (69% unchanged) urine; 20% (15% unchanged) feces Oral Administration May take with or without food Unable to swallow whole tablet Oral Disperse tablet(s) for required dose in container with ~10 mL (5 mL minimum) of room temperature water by gently swirling contents; take immediately Rinse container with an additional 5-10 mL of water and administer entire contents to patient Gastrostomy feeding tube Disperse tablet(s) for required dose in container with ~15 mL (10 mL minimum) of room temperature water by gently swirling contents; ensure tablets are sufficiently dispersed to flow through syringe tip Withdraw entire contents from container into an appropriate syringe and immediately administer through gastric tube Rinse container with an additional 10-15 mL of water, withdraw entire content into syringe and administer to patient Nasogastric or orogastric feeding tube Disperse tablet(s) for required dose in container with ~30 mL of room temperature water by gently swirling contents; ensure tablets are sufficiently dispersed to flow through syringe tip Withdraw entire contents from container into an appropriate syringe and immediately administer through nasogastric tube To avoid clogging small diameter tubes (<12 Fr), the syringe can be held horizontally and shaken during administration Rinse container with enough (minimum of 15 mL) room temperature water, withdraw contents into syringe, and administer through nasogastric tube Storage Tablets: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) Dispersed tablets in water: Stable for up to 4 hr Handling Intact tablet: Not hazardous Crushed tablets: Unknown if powder may constitute a reproductive hazard to preparer; use proper control measures (eg, ventilated enclosure) or personal protective equipment (ie, N95 respirator) BRAND FORM. UNIT PRICE PILL IMAGE Olumiant oral- 2 mg tabletCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. Plans Select State: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Done Non-Medicare Plans Medicare Plans Done CLOSE Additional Offers CLOSE Email to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send CLOSE Email Forms to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send