ve-doe-LIZ-yoo-mab

Therapeutic Classification: gastrointestinal anti-inflammatories

Pharmacologic Classification: monoclonal antibodies, integrin receptor antagonists

• 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.

• 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.

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 25 days.

(clinical improvement)

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.

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.

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

• Assess abdominal pain and frequency, quantity, and consistency of stools at beginning and during therapy.
• Assess for signs of hypersensitivity or infusion-related reactions (dyspnea, bronchospasm, urticaria, flushing, rash, swelling of lips, tongue, throat, or face, wheezing, hypertension, tachycardia). If anaphylaxis or serious allergic reactions occur, discontinue vedolizumab and treat symptoms.
• Assess for new signs or symptoms suggestive of PML, an opportunistic infection of the brain caused by the JC virus, leading to death or severe disability; hold dose and notify health care professional promptly. Monitor during therapy and for at least 6 mo following discontinuation. PML symptoms may begin gradually but usually over days to wk and leads to death or severe disability over wk to mo. Symptoms include progressive weakness on one side of body or clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation leading to confusion and personality changes. Diagnosis is usually made via gadolinium-enhanced MRI and CSF analysis. Withhold vedolizumab at first sign of PML.

• May cause ↑ AST, ALT, and serum bilirubin. Discontinue in patients with jaundice or other evidence of liver injury.

• Perform test for latent tuberculosis (TB). If positive, begin treatment for TB prior to starting vedolizumab therapy. Monitor for TB throughout therapy, even if latent TB test is negative.
• Ensure patient is up to date according to current immunization guidelines before starting therapy.
• Following the first two IV doses administered at Week 0 and Week 2, may be switched to SUBQ injection at Week 6. Week 6 and thereafter: Administer 108 mg SUBQ once every 2 wk. Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14. May be switched from IV infusion to SUBQ injection, for patients in clinical response or remission beyond Week 6. To switch patients to SUBQ injection, administer first SUBQ dose in place of the next scheduled IV infusion and every 2 wk thereafter. Inspect the solution visually for particulate matter and discoloration prior to administration. Solution in Entyvio in prefilled syringe or Entyvio Pen is clear to moderately opalescent, colorless to slightly yellow solution; do not use with visible particulate matter or discoloration.
• SC: Administer each SUBQ injection at a different anatomic location (such as thighs, any quadrant of abdomen, or upper arms) than the previous injection. Do not inject into moles, scars, bruises, or areas where the skin is tender, erythematous, or indurated.

IV Administration:

• Intermittent Infusion: Reconstitution: Reconstitute with 4.8 mL sterile water for injection, 0.9% NaCl, or LR using 21- to 25-gauge needle. Direct stream to wall of vial to prevent excessive foaming. Gently swirl vial for at least 15 sec to dissolve; do not invert of shake vigorously. Allow to sit for up to 20 min at room temperature for reconstitution and settling of foam. If not fully dissolved after 20 min, allow another 10 min. Do not use vial if not dissolved within 30 min. Solution is clear or opalescent, colorless to light brownish-yellow; do not administer solutions that are cloudy, discolored or contain particulate matter. Swirl gently and invert vial 3 times prior to withdrawing. Use immediately after reconstitution. Reconstituted solution is stable for 8 hr if refrigerated. Withdraw 5 mL (300 mg) using 21- to 25-gauge needle. Discard unused portion.
  Diluent: 250 mL 0.9% NaCl or LR. Gently mix bag. Use as soon as possible. Use solutions diluted with LR immediately or store in refrigerator up to 6 hr. Solutions diluted with 0.9% NaCl are stable up to 12 hr at room temperature or 24 hr if refrigerated; do not freeze.
• Rate: Infuse over 30 min; do not administer as IV push or bolus. Flush line with 30 mL of 0.9% NaCl or LR after infusion.
• Y-Site Incompatibility: Do not administer with other solutions or medications.

• 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.

• Decreased chronic GI inflammation and symptomatology associated with ulcerative colitis and Crohn's disease. Discontinue therapy if no improvement by Week 14.

Entyvio

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