Entyvio Pen (Vedolizumab)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
vedolizumab
Drug Class
monoclonal antibody
Used For
moderate to severe ulcerative colitis or Crohn’s disease
How Taken
subcutaneous injection every 2 weeks

What Is Entyvio Pen Used For?

Entyvio Pen contains vedolizumab, a monoclonal antibody that helps treat inflammatory bowel diseases by targeting specific proteins that cause inflammation.

Primary Uses

Entyvio is used to treat moderate to severe ulcerative colitis or moderate to severe Crohn’s disease in adults who haven’t responded well enough to other treatments or can’t tolerate them. Ulcerative colitis affects the large bowel, while Crohn’s disease can affect any part of the digestive tract.

How It Works

Vedolizumab is a monoclonal antibody that specifically binds to a protein called integrin α4β7 found on certain white blood cells. This protein can increase inflammation in ulcerative colitis and Crohn’s disease. By blocking these integrins, Entyvio reduces inflammation in the bowel.

How to Take Entyvio Pen

Entyvio treatment begins with intravenous infusions given by your healthcare provider, followed by self-administered subcutaneous injections using the pre-filled pen.

Dosage Instructions

You’ll first receive at least 2 intravenous infusions at a hospital or clinic. After that, you’ll use the pre-filled pen to inject 108 mg of Entyvio under your skin every 2 weeks. The pen should be at room temperature for 30 minutes before injection. Inject into your thigh, stomach area (avoiding 5 cm around the belly button), or back of upper arm (if someone else is giving the injection). Use a new injection site each time.

What If You Miss a Dose?

If you forget or miss a dose, inject the next dose as soon as possible, then continue with your regular every-2-weeks schedule. Don’t take a double dose to make up for the missed one.

Important: Never take a double dose to make up for a missed dose. Always follow your regular dosing schedule.

Available Tablet Strengths

108 mg
108 mg Tablet Colourless to yellow solution, Pre-filled pen • glass pre-filled pen with automated needle shield

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • Common cold
  • Joint pain
  • Headache
  • Fever
  • Flu
  • Nose or throat infection
  • Bronchitis
  • Chest infection
  • Cough
  • Throat pain
  • Nausea
  • Itching
  • Rash and redness
  • Pain in arms or legs
  • Back pain
  • Tiredness
  • Injection site reactions (pain, swelling, redness, or itching)

Seek immediate medical attention if you experience:

  • Allergic reactions (wheezing, difficulty breathing, hives, skin itching, swelling, vomiting, dizziness)
  • Infections (chills, shivering, high fever, rash)
  • Liver injury (dark urine, yellowing of eyes and skin)
  • Inflammation of the pancreas (severe upper stomach pain with nausea and vomiting)
  • Kidney inflammation (changes in urine output, blood in urine, swelling, lower back pain)

Important Warnings

There are several important safety considerations before starting Entyvio treatment.

Who Should Not Take Entyvio Pen

Don’t use Entyvio if you’re allergic to vedolizumab or any ingredients in the medication, if you have an active severe infection (like tuberculosis, blood poisoning, or serious abscesses), or if the medication has expired or the packaging is damaged.

Medical Conditions to Discuss

Tell your doctor if you have any infection or think you might have one, are scheduled for any vaccinations or recently had one, have allergies to other medicines or foods, or take any other medications. You may be at risk for certain side effects during treatment.

Pregnancy and Breastfeeding

The effects of Entyvio in pregnant women are not known, so it’s not recommended during pregnancy unless you and your doctor decide the benefits clearly outweigh the risks. Entyvio passes into breast milk, and the effects on babies are unknown. Discuss with your doctor whether to use Entyvio while breastfeeding.

Serious Brain Condition: Contact your doctor immediately if you experience blurred vision, difficulty speaking, weakness, balance problems, numbness, or memory loss – these may be symptoms of a serious brain condition called progressive multifocal leukoencephalopathy (PML).

Drug Interactions

Some medications may interfere with how Entyvio works or increase your risk of side effects.

  • Other biologic medicines that suppress the immune system
  • Natalizumab (medicine for multiple sclerosis)
  • Rituximab (medicine for certain cancers and rheumatoid arthritis)

Alcohol & Driving

Be cautious when driving or operating machinery until you know how Entyvio affects you.

Alcohol

No specific alcohol interactions are mentioned in the prescribing information.

Driving and Operating Machinery

Entyvio may have a minor influence on your ability to drive or use tools or machines. Some patients have felt dizzy after receiving Entyvio. If you feel dizzy, don’t drive or use tools or machines.

Storage

Store Entyvio pens in the refrigerator at 2°C to 8°C. Don’t freeze them. Keep the pens in their original box to protect from light. If needed, one pen can be left out of the refrigerator at room temperature (up to 25°C) for up to 7 days, but must be discarded if not used within that time. Don’t use if you notice particles in the liquid or if it’s not colorless to yellow.

Overdose Information

If you think you’ve used too much Entyvio, seek urgent medical attention immediately. Call the Poisons Information Centre (13 11 26), contact your doctor, or go to the nearest hospital emergency department, even if you don’t feel unwell.

Frequently Asked Questions

The medication information doesn’t specify how long Entyvio takes to work. You’ll start with intravenous infusions before switching to the pen injections, and your doctor will monitor your response to treatment.

Yes, after receiving at least 2 intravenous infusions from your healthcare provider, you can give yourself the subcutaneous injections using the pre-filled pen, or have a caregiver do it after proper training.

If you miss a dose, inject the next dose as soon as possible, then continue with your regular every-2-weeks schedule. Never take a double dose to make up for the missed one.

Store the pens in the refrigerator at 2°C to 8°C in their original box. Don’t freeze them. If needed, one pen can be kept at room temperature (up to 25°C) for up to 7 days, but discard it if not used within that time.

Serious allergic reaction symptoms include wheezing or difficulty breathing, hives, skin itching, redness, swelling, vomiting, or dizziness. Seek immediate medical attention if you experience these symptoms.

Tell your doctor if you’re scheduled for any vaccination or recently had one, as Entyvio may affect how you respond to vaccinations. Your doctor will advise you on the best timing.

Contact your doctor immediately if you have or think you have an infection, especially if you develop chills, shivering, persistent cough, or high fever. Some infections can become serious if left untreated.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.