Drug Safety-related Labeling Changes (SrLC)

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OLUMIANT (NDA-207924)

(BARICITINIB)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/08/2020 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Hypersensitivity

(New subsection added)

Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving OLUMIANT, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue OLUMIANT while evaluating the potential causes of the reaction [see Adverse Reactions (6.2)].

6 Adverse Reactions

6.2 Postmarketing Experience

(New subsection added)

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 observed) [see Warnings and Precautions (5.7)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(Additions underlined)

What is the most important information I should know about OLUMIANT?

 OLUMIANT may cause serious side effects, including:

6.   Allergic Reactions.

Symptoms such as rash, swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in patients taking OLUMIANT. Some of these reactions were serious. If any of these symptoms occur while you are taking OLUMIANT, stop taking OLUMIANT and call your healthcare provider right away.

PATIENT COUNSELING INFORMATION

(Additions underlined)

Malignancies and Lymphoproliferative Disorders

Inform patients that OLUMIANT may increase their risk of developing lymphomas and other malignancies, including of the skin. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions (5.2)].

10/08/2019 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.7 Renal Impairment

Additions and/or revisions underlined:
Renal function was found to significantly affect baricitinib exposure. The recommended dose of OLUMIANT in patients with moderate renal impairment (estimated glomerular filtration rate (GFR) between 30 and 60 mL/min/1.73 m2) is 1 mg once daily. OLUMIANT is not recommended for use in patients with severe renal impairment (estimated GFR of less than 30 mL/min/1.73 m2).

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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