Downsides

If you are between the ages of 18 and 60, do not take any other medications, and have no other medical conditions, you are more likely to experience the following side effects:

• The most common side effects reported with this medication are infections (such as a cold, flu, sinus infections, or bronchitis), headache, pain (in the throat, joints, arms, or legs), nausea, fever, tiredness, cough, rash, and itching.
• Weight gain was not reported as a side effect of Entyvio in the manufacturer's clinical trials. When gastrointestinal diseases such as Crohn's disease or ulcerative colitis improve, patients who had previously lost weight may gain some weight.
• Entyvio is linked to a higher risk of infections, some of which may be serious, despite the fact that it is not regarded as a whole-body immunosuppressant. Anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, listeria meningitis, giardiasis, and cytomegaloviral colitis were among the serious infections reported in patients treated with Entyvio. The common cold (13%) and upper respiratory tract infections (7%), respectively, were the infections that were most frequently reported in clinical trials. Other infections included sinusitis (3%), bronchitis (4%), and influenza (4%). Tysabri (natalizumab) and corticosteroids are additional medications that raise the risk of contracting Entyvio infection (eg, prednisone or methylprednisolone).
• Entyvio carries a risk of progressive multifocal leukoencephalopathy (PML). PML is a fatal or severely disabled opportunistic viral infection of the brain caused by the JC virus (JCV).
• Serious allergic reactions can occur during an Entyvio infusion or for several hours after treatment. Side effects should be monitored in all patients during and shortly after the Entyvio infusion.
• Some people may develop liver problems as a result of Entyvio. Liver problems may cause a loss of appetite, which may result in weight loss.
• Entyvio is expensive, with a supply of one 300 mg vial of powder for injection costing around $6,700. Entyvio may be available for as little as $5 per dose for those with private commercial insurance. If you do not have insurance, Takeda may be able to help you financially. Patients with government-sponsored insurance, such as Medicare, Medicaid, or TriCare, are not eligible for the $5 copay program, but they may be able to get help from an independent copay foundation.
• A healthcare provider must administer it as an intravenous infusion over approximately 30 minutes. It cannot be administered as a push, IM, or SC injection.
• A small number of people who receive Entyvio may develop antibodies to it. In the UC and CD trials, 4% (56) of patients developed antibodies to Enyvio, with 9 remaining positive. Entyvio concentrations were undetectable in six of the nine patients, with two having lower concentrations. In the controlled trials, none of these nine patients achieved clinical remission at Weeks 6 or 52.
• A person's vaccination status should be up to date before receiving Entyvio.
• If a person is not benefiting from Entyvio after 14 weeks, the medication should be stopped.
• Entyvio use in pregnant women has not been linked to an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Uncontrolled inflammatory bowel disease poses a risk to both the mother and the fetus. Calculate the risks versus the benefits. Any woman who becomes pregnant should call 1-877-TAKEDA7 (1-877-825-3327) to join the pregnancy registry. According to the data, Entyvio is detectable in breast milk. The consequences of this exposure on a nursing infant are unknown. Consider the advantages and disadvantages.
• There is currently no generic Entyvio available.

Seniors and children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures), or people who take other medications are more likely to experience a broader range of side effects.