Entyvio Shortage: What Providers and Prescribers Need to Know in 2026

Entyvio Shortage: What Providers and Prescribers Need to Know in 2026

For gastroenterologists and other providers prescribing Entyvio (Vedolizumab) for inflammatory bowel disease, staying current on supply dynamics is essential to patient care. When access to a biologic becomes unreliable, treatment continuity suffers — and so do patient outcomes.

This briefing covers the current Entyvio supply landscape, prescribing implications, cost and coverage realities, and tools available to help your patients maintain access to this critical medication.

Current Supply Status

As of March 2026, Vedolizumab is not listed on the FDA Drug Shortage Database. Takeda Pharmaceuticals has not disclosed a formal supply disruption.

However, anecdotal reports from patients and practice administrators indicate intermittent access challenges at specialty pharmacies and infusion centers across the United States. These are not uniform — some regions experience more difficulty than others, and availability can fluctuate week to week.

The disconnect between "no official shortage" and real-world access barriers is a familiar pattern with specialty biologics, where distribution complexity, insurance logistics, and demand surges can create localized unavailability.

Timeline: Entyvio's Evolving Landscape

• May 2014: FDA approves Entyvio IV for ulcerative colitis and Crohn's disease
• 2020: FDA approves subcutaneous formulation (Entyvio Pen) for UC maintenance
• April 2024: FDA approves SC formulation for Crohn's disease maintenance
• 2025: Global Entyvio revenue reaches approximately $6.4 billion
• February 2026: Alvotech reports positive Phase 3 PK data for vedolizumab biosimilar (AVT16/AVT80)
• 2028-2032: Earliest projected biosimilar entry

Prescribing Implications

Formulation Flexibility

With both IV infusion (300 mg every 8 weeks after induction) and subcutaneous injection (108 mg every 2 weeks for maintenance) now approved for both UC and CD, providers have flexibility to match the formulation to the patient's clinical needs and access realities.

Consider the following when choosing between formulations:

• IV infusion ensures adherence through supervised administration but requires infusion center access and scheduling
• SC pen offers patient convenience and home administration, which may be easier to source through mail-order specialty pharmacies
• If one formulation faces supply constraints, transitioning to the other may maintain treatment continuity

Induction Protocol

Regardless of intended maintenance formulation, induction remains IV-based: 300 mg at weeks 0, 2, and 6. Ensure infusion center availability before initiating a new patient on Entyvio to avoid interruptions during the critical induction phase.

Monitoring and Drug Interactions

Key prescribing considerations:

• PML risk: While rare, progressive multifocal leukoencephalopathy remains a labeled risk. Monitor for new or worsening neurological symptoms.
• Hepatotoxicity: Monitor transaminases and bilirubin. Cases of hepatic injury have been reported.
• CYP450 substrates: Initiation or discontinuation of Entyvio in patients on CYP450 substrates may require dose adjustments of the concomitant medication.
• Live vaccines: Avoid live vaccines during treatment. Update vaccinations prior to initiating therapy when possible.
• Combination with other immunosuppressants: Use caution when combining with natalizumab or other integrin antagonists. The manufacturer recommends against concurrent use with TNF blockers.

Availability Picture

Entyvio flows through a specialty distribution model:

• IV vials are typically procured by infusion centers, hospital outpatient pharmacies, and physician office buy-and-bill programs
• SC pens are dispensed through specialty pharmacies, often via mail order
• No retail pharmacy distribution

Practices with in-house infusion suites and buy-and-bill arrangements may have more reliable access than those relying on external infusion centers. If your practice doesn't operate its own infusion suite, establishing relationships with multiple infusion center partners can provide backup when one location faces stock limitations.

Cost and Access Considerations

Current 2026 pricing:

• IV 300 mg vial: ~$9,882 (cash/coupon price)
• SC 108 mg pen: ~$3,500 (cash/coupon price)
• SC two-pen pack WAC: $6,239.94

Insurance landscape:

• Prior authorization is required by virtually all commercial and government payers
• Step therapy is common — many plans require documented failure of conventional therapies (aminosalicylates, corticosteroids, immunomodulators) and sometimes TNF inhibitors before approving Entyvio
• Medical vs. pharmacy benefit: IV Entyvio typically processes under medical benefit; SC Entyvio may process under pharmacy benefit, which can have different cost-sharing structures
• Medicare: Part B covers IV infusions (20% coinsurance after deductible); Part D may cover SC formulation with projected brand drug OOP cap ~$2,100 in 2026

Tools and Resources for Your Practice

Medfinder for Providers

Medfinder offers a provider-facing tool to check real-time availability of Entyvio (and other specialty medications) at pharmacies and infusion centers. This can be integrated into your care coordination workflow to proactively identify supply issues before they affect patients.

EntyvioConnect

Takeda's EntyvioConnect program (1-844-368-9846) provides:

• Benefits verification and prior authorization support
• Copay assistance for commercially insured patients ($0 per dose for eligible patients)
• Patient Assistance Program for uninsured or coverage-denied patients (free medication)
• Nurse support and infusion coordination

Additional Patient Assistance Resources

• PAN Foundation (panfoundation.org)
• HealthWell Foundation
• Crohn's & Colitis Foundation patient resources
• NeedyMeds.org and RxAssist.org for additional programs

Looking Ahead

The biosimilar pipeline offers a medium-term outlook for improved supply and competition. Alvotech's AVT16 (IV) and AVT80 (SC) candidates showed positive Phase 3 results in early 2026. Polpharma is also advancing a biosimilar candidate. However, regulatory approval, patent considerations, and market launch timelines suggest biosimilar availability no earlier than 2028.

In the near term, the key strategy for providers is proactive supply management: verifying availability before prescribing, establishing multiple pharmacy and infusion center relationships, and leveraging formulation flexibility to keep patients on therapy.

Final Thoughts

While there is no official Entyvio shortage in 2026, the practical realities of specialty biologic access mean that providers must remain vigilant. Proactive coordination — using tools like Medfinder for Providers, engaging EntyvioConnect early in the prescribing process, and maintaining awareness of alternative formulations and biologics — can prevent treatment gaps that lead to disease flares and loss of response.

Related provider resources:

• How to Help Your Patients Find Entyvio in Stock
• How to Help Patients Save Money on Entyvio
• Alternatives to Entyvio
• Entyvio Drug Interactions: What to Avoid