Vedolizumab

Vedolizumab is a prescription medication used for the treatment of ulcerative colitis and Crohn's disease.

• Vedolizumab is available under the following different brand names: Entyvio

Adult dosage

Injection, lyophilized powder for reconstitution

• 300mg/vial (300mg/5mL after reconstituted)

Ulcerative Colitis

Adult dosage

• 300 mg IV at weeks 0, 2, and 6, then
• 300 mg IV once in 8 weeks
• Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Crohn's Disease

Adult dosage

• 300 mg IV at weeks 0, 2, and 6, then
• 300 mg IV once in 8 weeks
• Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of vedolizumab include:

• headache, 
• nausea, 
• fever, 
• pain,
• rash,
• joint pain,
• cough,
• fatigue,
• itching, and
• upper respiratory tract infection

Serious side effects of vedolizumab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• fever, 
• shortness of breath,
• trouble breathing, 
• wheezing, 
• dizziness, 
• feeling hot, 
• palpitations, 
• signs of infections such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination
• liver problems
• serious brain infection

Rare side effects of vedolizumab include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vedolizumab has severe interactions with no other drugs.
• Vedolizumab has serious interactions with at least 21 other drugs.
  • adalimumab
  • adenovirus types 4 and 7 live, oral
  • baricitinib
  • BCG vaccine live
  • certolizumab pegol
  • etanercept
  • golimumab
  • infliximab
  • influenza virus vaccine quadrivalent, intranasal
  • lenalidomide
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • natalizumab
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • thalidomide
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Vedolizumab has moderate interactions with at least 10 other drugs.
• Vedolizumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vedolizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vedolizumab?”

Cautions

• Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased BP and HR observed
• Increased risk for developing infections; serious infections have also been reported, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis
• Elevated liver transaminases and/or bilirubin reported; discontinue if jaundice occurs or other evidence of liver injury (e.g., fatigue, anorexia, right upper abdominal discomfort); the combination of elevated transaminase and bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for liver transplantation

Infusion-related reactions and hypersensitivity reactions

• Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate
• May occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion
• If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue immediately and initiate appropriate treatment

Progressive multifocal leukoencephalopathy (PML)

• Another integrin receptor antagonist (natalizumab) has been associated with PML, a rare and often fatal opportunistic infection of the CNS
• Vedolizumab inhibits α4β7 integrin; whereas, natalizumab inhibits both α4β7 (gut integrin) and α4β1 (CNS integrin)
• In vedolizumab clinical trials, monitor for PML with frequent and regular screenings and evaluations of any new, unexplained neurological symptoms, as necessary
• While zero cases of PML were identified among patients with at least 24 months of vedolizumab exposure, the risk of PML cannot be ruled out
• No claims of comparative safety to other integrin receptor antagonists can be made based on this data

Pregnancy and Lactation

• Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Monitors pregnancy outcomes in women exposed to during pregnancy information about the registry can be obtained by calling 1-877-TAKEDA7 (1-877-825-3327)

Disease-associated maternal and embryo/fetal risk

• Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity
• Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth

Fetal/Neonatal adverse reactions

• Administered during pregnancy could affect immune responses in the in utero exposed newborn and infant
• The clinical significance of low levels of vedolizumab in utero-exposed infants is unknown
• The safety of administering live or live-attenuated vaccines in exposed infants is unknown

Lactation

• Available published literature suggests the presence of vedolizumab in human milk
• The mean calculated daily infant dosage was 0.02 mg/kg/day orally; systemic exposure in the breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract
• There are no data on the effects of vedolizumab on the breastfed infant, or effects on milk production
• Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition