Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Ulcerative colitis (≥2%) : Induction : upper respiratory tract infections and arthralgia.
( 6.1 ) Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
( 6.1 ) Crohn's disease (≥5%) : upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1).
In subjects who responded to induction therapy in UC-1, long term safety up to 52 weeks was evaluated in a randomized, double-blind, placebo-controlled maintenance study (UC-2) and a long-term extension study [see Clinical Studies ( 14.1 )] .
In the induction study (UC-1), 1279 subjects were enrolled of whom 958 received OMVOH 300 mg administered as an intravenous infusion at Weeks 0, 4, and
In the maintenance study (UC-2), 581 subjects were enrolled of whom 389 received OMVOH 200 mg administered as a subcutaneous injection every 4 weeks.
Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher frequency than placebo during UC-
Table 2: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 12 in a Placebo-Controlled Induction Study (UC-1) a Reported in at least 2% of subjects and at a higher frequency than placebo.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported.
If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment.
( 5.1 ) Infections : OMVOH may increase the risk of infection.
Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated.
If a serious infection develops, do not administer OMVOH until the infection resolves.
Like all medications, Omvoh can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: