What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Olumiant (Baricitinib)
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Product Details
Description
Olumiant (baricitinib) is classified as a Janus kinase (JAK) inhibitor for the treatment of moderate to severe rheumatoid arthritis in adults who did not respond well or tolerate at least one tumor necrosis factor (TNF) blocker.
Olumiant is available in 1 mg and 2 mg tablets.
Fact Table
Formula
C16H17N7O2S
License
EU EMA, US DailyMed
Bioavailability
79%
Legal status
Rx-Only
Chemical Name
Baricitinib
Elimination half-life
12.5 hours
Dosage (Strength)
2mg, 4mg
Pregnancy
Contraindicated
Brands
Olumiant
Protein binding
50%
PubChem CID
44205240
MedlinePlus
a618033
ChEBI
95341
ATC code
L04AA37
DrugBank
DB11817
KEGG
D10308
Routes of administration
By mouth
Directions
The recommended dose is 2 mg by mouth once daily with or without food.
Your dose may be 1 mg by mouth once daily if you have kidney problems or are taking strong Organic Anion Transporter 3 (OAT3) inhibitors such as probenecid.
Ingredients
Each tablet contains the active ingredient, Baricitinib.
Cautions
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS
See full prescribing information for complete boxed warning.
- Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB tests.
- Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.
- Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
- Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.
- Thrombosis has occurred in patients treated with OLUMIANT. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.
Tell your doctor if you have tuberculosis or if you have any other active infections or an infection that keeps coming back. Olumiant may increase the risk for serious infections and opportunistic infections, especially in those taking medications that suppress the immune system. Once you are prescribed and buy Olumiant, immediately tell your doctor if you develop a fever, cough, shortness of breath, muscle aches, diarrhea, stomach pain, tiredness, bloody phlegm, skin problems, sores on your body, weight loss, burning with urination, or the need to urinate more frequently.The risk of all-cause death is increased in patients who are at least 50 years old who have one or more risk factors for cardiovascular disease and are taking a JAK inhibitor.
Olumiant may increase your risk of developing certain cancers such as skin cancer, lung cancer, and lymphoma.
Tell your doctor if you have heart problems or if you've ever had a stroke or heart attack. It is important to tell your doctor if you smoke. The risk of major cardiovascular events is increased in patients who are at least 50 years old who have one or more risk factors for cardiovascular disease and are taking a JAK inhibitor. Seek medical care immediately if you feel chest discomfort, nausea, vomiting, lightheadedness, shortness of breath, slurred speech, weakness in one part or on one side of your body, cold sweat, pain or discomfort in your arms, back, jaw, neck, or stomach, or tightness, heaviness, pain, or pressure in your chest, throat, neck, or jaw.
Tell your doctor if you have had blood clots in your legs or lungs. Thrombosis has been reported with the use of Olumiant. Immediately tell your doctor if you experience leg pain, tenderness, or swelling, chest pain, or shortness of breath.
Tell your doctor if you have stomach or intestinal problems. Tears in the stomach and intestines have occurred with Olumiant treatment. Immediately tell your doctor if you develop a fever, persistent stomach pain, and bowel changes.
Abnormal blood counts may occur with Olumiant treatment.
You should not receive live vaccines while being treated with Olumiant.
Olumiant may cause hypersensitivity reactions such as itching, swelling, or a rash. Some reactions may be more severe. Discuss your allergies with your doctor.
Tell your doctor if you are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed.
Olumiant may interact with certain medications that can lead to serious reactions. So, tell your doctor about all the medications that you take.
Side Effects
Olumiant can cause side effects including:
- Cold sores
- Nausea
- Shingles
- Upper respiratory tract infections
References:
- Olumiant (baricitinib). Accessed January 3, 2022.
- Olumiant (baricitinib) Prescribing Information. Indianapolis, IN: Lilly USA, LLC; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13231
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