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: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
( 6.1 ) Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc.
at 1-877-TAKEDA-7 (1-877-825-3327) 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.
The data described below reflect exposure to intravenous ENTYVIO in 3,326 patients and healthy volunteers in clinical trials, including 1,396 exposed for greater than one year, and 835 exposed for greater than two years.
Intravenous Infusion The safety data described in Table 2 are derived from four controlled Phase 3 trials (UC Trials I and II and CD Trials I and III);
data from adult patients receiving open-label intravenous ENTYVIO treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (non-responders at Week 6 of UC Trial I and CD Trial I) are included [see Clinical Studies (14.1 , 14.2) ] .
In these trials, 1,434 patients received ENTYVIO 300 mg intravenously for up to 52 weeks, and 297 patients received placebo for up to 52 weeks.
Of these, 769 patients had ulcerative colitis and 962 patients had Crohn's disease.
5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions and Hypersensitivity Reactions : Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur.
( 5.1 ) Infections : Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
If a serious infection develops, ENTYVIO should not be administered until the infection resolves.
( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) : Although unlikely, a risk of PML cannot be ruled out.
Monitor patients for any new or worsening neurological signs or symptoms.
Like all medications, Entyvio 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: