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Brand Name
Olumiant
Generic Name
Baricitinib
View Brand Information FDA approval date: May 31, 2018
Classification: Janus Kinase Inhibitor
Form: Tablet
What is Olumiant (Baricitinib)?
OLUMIANT ® is a Janus kinase inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers.
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Brand Information
Olumiant (baricitinib)
1DOSAGE FORMS AND STRENGTHS
OLUMIANT is available as debossed, film-coated tablets:
- 1 mg tablet contains a recessed area on each face of the tablet surface, is very light pink, round, debossed with “Lilly” on one side and “1” on the other.
- 2 mg tablet contains a recessed area on each face of the tablet surface, is light pink, oblong, debossed with “Lilly” on one side and “2” on the other.
- 4 mg tablet contains a recessed area on each face of the tablet surface, is medium pink, round, debossed with “Lilly” on one side and “4” on the other.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections
- Mortality
- Malignancy and Lymphoproliferative Disorders
- Major Adverse Cardiovascular Events
- Thrombosis
- Hypersensitivity
- Gastrointestinal Perforations
- Laboratory Abnormalities
3.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of OLUMIANT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Immune System Disorders: Drug hypersensitivity (events such as rash, urticaria, and angioedema have been reported) [see Warnings and Precautions (.
4OVERDOSAGE
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 24 hours.
In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
5DESCRIPTION
OLUMIANT (baricitinib) is a Janus kinase (JAK) inhibitor with the chemical name {1-(ethylsulfonyl)-3-[4-(7
OLUMIANT tablets contain a recessed area on each face of the tablet surface and are available for oral administration as debossed, film-coated tablets. The 1 mg tablet is very light pink, round, debossed with “Lilly” on one side and “1” on the other. The 2 mg tablet is light pink, oblong, debossed with “Lilly” on one side and “2” on the other. The 4 mg tablet is medium pink, round, debossed with “Lilly” on one side and “4” on the other.
Each tablet contains 1, 2, or 4 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, ferric oxide, lecithin (soya), magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7PACKAGE LABEL – OLUMIANT 2 mg 30ct Bottle
Rx Only
Always Dispense with Medication Guide
NDC 0002-4182-30
Olumiant
(baricitinib) tablets
2 mg
30 tablets
Lilly
8PACKAGE LABEL – OLUMIANT 1 mg 30ct Bottle
Rx Only
Always Dispense with Medication Guide
NDC 0002-4732-30
Olumiant
(baricitinib) tablets
1 mg
30 tablets
Lilly
9PACKAGE LABEL – OLUMIANT 4 mg 30ct Bottle
Rx Only
Always Dispense with Medication Guide
NDC 0002-4479-30
Olumiant
(baricitinib) tablets
4 mg
30 tablets
Lilly
