• Moderately to severely active ulcerative colitis or Crohn's disease that has not responded adequately to/lost response to/become intolerant to tumor necrosis factor (TNF) blockers or immunomodulators; or has become intolerant to/dependant on corticosteroids and failed to induce/maintain beneficial response/remission, improved endoscopic appearance (ulcerative colitis) or achieved corticosteroid-free remission.

Contraindicated in:

• Hypersensitivity
• Active severe infection
• Live-virus vaccinations
• Concurrent use of natalizumab
• Concurrent use of TNF blockers.

Use Cautiously in:

• OB: Use during pregnancy only if potential maternal benefits justify potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

Derm: pruritus, rash.

GI: ↑ liver enzymes, oropharyngeal pain.

MS: arthralgia, back pain, extremity pain.

Neuro: headache, fatigue, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).

Resp: cough.

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION, INFUSION REACTIONS.

Drug-Drug:

• May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines (complete immunizations prior to treatment).
• Concurrent use with natalizumab may ↑ risk of infections and PML and should be avoided.
• Concurrent use with TNF blockers may ↑ risk of infections and should be avoided.

• Lyophilized powder for intravenous injection: 300 mg/vial;
• Solution for SUBQ injection (prefilled syringes or pens): 108 mg/0.68 mL;

Ulcerative Colitis

• IV (Adults): 300 mg initially, then 2 and 6 wk later, then every 8 wk; treatment may be continued if beneficial response is obtained by wk 14.
• SC (Adults): 108 mg every 2 wk (may switch to SUBQ dosing at Week 6 after receiving the first two IV doses [at Week 0 and Week 2] if demonstrated clinical response or remission); treatment may be continued if beneficial response is obtained by Week 14.

Crohn's Disease

• IV (Adults): 300 mg initially, then 2 and 6 wk later, then every 8 wk; treatment may be continued if beneficial response is obtained by Week 14.

Entyvio

• A monoclonal antibody that binds to certain integrins, blocking their interaction with substances involved in mucosal cell adhesion, also inhibits migration of memory T-lymphocytes across endothelium into inflamed GI tissue.

• Decreased chronic GI inflammation and symptomatology associated with ulcerative colitis and Crohn's disease.

Therapeutic Classification: gastrointestinal anti-inflammatories

Pharmacologic Classification: monoclonal antibodies, integrin receptor antagonists

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 25 days.

(clinical improvement)

• Explain purpose of vedolizumab to patient. Advise patient to read Medication Guide prior to therapy.
• Instruct patient and/or caregiver in proper technique to administer SUBQ injection. If SUBQ injection is interrupted or if a scheduled dose(s) of SUBQEntyviois missed, inject next SUBQ dose as soon as possible and then every 2 wk thereafter. In the event of incomplete dose administration (patient attempts administration of dose with Entyvio Pen but is uncertain if a full dose was administered), instruct the patient to call their pharmacy or health care professional.
• Instruct patient to report symptoms of PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes), hypersensitivity reactions, hepatotoxicity (yellowing of the skin and eyes, unusual darkening of the urine, anorexia, nausea, feeling tired or weak, vomiting, right upper abdominal pain), or worsening of symptoms (new or sudden change in your thinking, eyesight, balance, or strength or other problems) that persist over several days to health care professional immediately.
• Inform patient of risk of infection. Advise patient to notify health care professional if symptoms of infection (fever, chills, muscle aches, shortness of breath, runny nose, cough, sore throat, red or painful skin or open cuts or sores, tiredness, pain during urination) occur.
• Advise patient to avoid live and oral vaccines during therapy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Encourage pregnant women to join Entyvio Pregnancy Registry by calling 1-877-825-3327. Registry monitors pregnancy outcomes in women exposed to vedolizumab during pregnancy.

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NDC Code^*

• 64764- Takeda Pharmaceuticals America, Inc.
  • 64764-300- Entyvio
    • 64764-300-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) > 5 mL in 1 VIAL, SINGLE-DOSE