vedolizumab

Contraindicated in:

Hypersensitivity;
Active severe infection.

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

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; avoid concurrent use.
Concurrent use with TNF blockers may ↑ risk of infections; avoid concurrent use.
May affect activity of CYP450 enzymes and may alter the effectiveness/toxicity of CYP450 substrate.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

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 (beginning after ≥2 IV doses [at Week 0 and Week 2]); treatment may be continued if beneficial response is obtained by Week 14.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: gastrointestinal anti-inflammatories

Pharmacologic Classification: monoclonal antibodies, integrin receptor antagonists

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 25 days.

Time/Action Profile ⬆ ⬇

(clinical improvement)

ROUTE	ONSET	PEAK	DURATION
IV	within 6 wk	unknown	up to 8 wk

Patient/Family Teaching ⬆ ⬇

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 SUBQ Entyvio is 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 unilateral weakness; changes in vision, memory, orientation, and personality), 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) 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, 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 women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇