General Information
Manufacturer: Takeda Pharmaceuticals
Medical Name: Vedolizumab
Purpose: Entyvio is a prescription medicine used in adults for the treatment of:
- moderately to severely active ulcerative colitis (UC).
- moderately to severely active Crohn’s disease (CD).
Possible Side Effects
| Side Effect | Likelihood (%) |
|---|---|
| Nasopharyngitis (cold symptoms) | 13% |
| Headache | 12% |
| Arthralgia (joint pain) | 12% |
| Nausea | 9% |
| Pyrexia (fever) | 9% |
| Upper respiratory tract infection | 7% |
| Fatigue | 6% |
| Cough | 5% |
| Bronchitis | 4% |
| Influenza (flu) | 4% |
| Back pain | 4% |
| Rash | 3% |
| Pruritus (itching) | 3% |
| Sinusitis (sinus infection) | 3% |
| Oropharyngeal pain (sore throat) | 3% |
| Pain in extremities (arms/legs) | 3% |
| For patients using the subcutaneous injection (Entyvio Pen), injection site reactions (e.g., pain, swelling, redness, bruising) were reported in 10% of ulcerative colitis patients and 3% of Crohn's disease patients. | |
Serious but Less Common Side Effects
- Serious Infections: Entyvio can increase the risk of serious infections, including sepsis, tuberculosis, and Listeria meningitis. The rate of serious infections was low, at 0.07 per patient-year in clinical trials (compared to 0.06 per patient-year with placebo).
- Progressive Multifocal Leukoencephalopathy (PML): This is a rare, serious, and often fatal brain infection caused by the JC virus. While the risk with Entyvio is considered very low and no cases were observed in the initial controlled trials, it is a potential risk associated with this class of medication.
- Infusion-Related Reactions (IRRs) and Allergic Reactions: These can occur during or several hours after an infusion. Symptoms may include trouble breathing, hives, flushing, rash, or a fast heart rate. About 4% of patients experienced an IRR in clinical trials, but severe reactions (anaphylaxis) were very rare (1 case out of 1,434 patients).
- Liver Injury: Elevations of liver enzymes have been reported. Symptoms of liver damage can include yellowing of the skin or eyes (jaundice), abdominal pain, nausea, and dark urine.
Contraindications
- History of a serious or severe hypersensitivity reaction or anaphylaxis to vedolizumab or any of its ingredients.
Preconditions
- Active, severe infections: Entyvio is not recommended in patients with active, severe infections (including tuberculosis (TB), sepsis, Listeria meningitis, or anal abscesses) until the infection is controlled. Your doctor may test for latent TB before starting treatment.
- Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, life-threatening brain infection. While the risk with Entyvio is low, it generally occurs in immunocompromised patients. The use of Entyvio is not recommended if PML is suspected or confirmed.
- Liver problems: Entyvio has been associated with elevated liver enzymes and/or bilirubin. Patients with jaundice or other evidence of significant liver injury should discontinue use.
- Combination with other specific medications: Concomitant use with other targeted immunomodulators or certain other medications may increase the risk of serious infections and is generally avoided:
- Natalizumab (Tysabri), due to an increased risk of PML.
- TNF blockers (e.g., adalimumab, infliximab).
- Vaccinations: Patients should be up to date with all immunizations before starting Entyvio. Live vaccines (e.g., MMR, chickenpox, nasal flu vaccine) should be avoided during treatment due to the weakened immune response.
- Pregnancy and breastfeeding: The safety of Entyvio during pregnancy and breastfeeding is not fully established. A healthcare provider will weigh the potential benefits against the risks in these situations.
- Immune system disorders/conditions: Patients with conditions that weaken the immune system, such as HIV or cancer, have a higher potential risk for infections and should discuss the risks with their doctor.