Vedolizumab - Subcutaneous

Vedolizumab is used to treat inflammatory bowel diseases (long-term inflammation of the digestive tract) such as ulcerative colitis (a disease that causes inflammation and sores in the linings of the large intestine and rectum) or Crohn's disease (a long-term inflammatory disease of the digestive tract that usually affects the small intestine and colon).

Vedolizumab is to be injected subcutaneously (into the fatty layer under the skin, usually in the thigh, upper arm, or abdomen area).

Your doctor or nurse will administer the injection for you. If you or your caregiver had been given the proper training on the preparation and injection techniques of this medicine, you or your caregiver may do the administration.

This medicine is available as a pre-filled pen or syringe. Make sure you know how to use the specific device you have been given. If you have problems or do not understand the instructions, ask your doctor or pharmacist.

Use Vedolizumab exactly as directed by your doctor or according to the instructions on the label. Do not use more or less than instructed by your doctor.

Remember to rotate the injection sites. Do not inject into the same area all the time. New injection sites should be at least 1.5 inches away from the previous injection site. Do not inject near the navel (belly button) and into moles, or areas where the skin is tender, bruised, red, hard, scarred, or affected by psoriasis.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your condition and your response to the medication.

Vedolizumab must be administered regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it unless instructed by the doctor.

Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Vedolizumab.

If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.

If you or a caregiver had been trained to administer this medicine and missed a dose, inject the missed dose as soon as you remember and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

Inform your doctor or pharmacist immediately if you forgot to administer your dose.

Do not use Vedolizumab if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to this medicine or any of its ingredients.

Alert your doctor if you have an active and/or worsening severe infection (e.g. TB [lung infection known as tuberculosis]) as this medicine may not be suitable for you.

Inform your doctor if you have the following conditions:

• liver problems
• long-term severe infection or history of recurrent infection

Let your doctor know if you are pregnant or breastfeeding. It is important that you do not get pregnant while being treated with this medicine. You may wish to discuss birth control methods with your doctor or pharmacist.

Inform your doctor if you have been recently vaccinated. Do not receive any vaccinations without first asking your doctor.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests and tuberculosis screening must be done before treatment, to know if this medicine is suited for you to use.
• Routine tests (e.g. liver function) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring for signs or symptoms of hypersensitivity, infections, liver problems, and worsening brain or nerve function may also be needed.

Vedolizumab may cause mild dizziness. If affected, do not drive or take part in any activity in which you need to be alert.

Other side effects include any of the following: headache, nausea, common cold, stuffy nose, cough, sore throat, constipation, bloated stomach, fever, fatigue, back pain, muscle or joint pain.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• rashes, breathlessness, wheezing, swelling of the face, eyes or mouth
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles
• weakness on one side of the body, vision problems, confusion, forgetfulness, changes in behaviour or personality

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are using medicines which may suppress your immune system e.g. natalizumab, infliximab.

Avoid vaccinations with live vaccines during treatment with Vedolizumab. Inform your doctor if you have been recently vaccinated or if you are planning to get vaccinated.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in the refrigerator, between 2-8°C. If removed from the refrigerator, Vedolizumab may be stored at room temperature not exceeding 25°C away from direct sunlight. It will expire 7 days after removal from the refrigerator. Throw away any unused solution.

Do not freeze Vedolizumab otherwise, it will no longer be effective and should not be used.

Protect from light.

If you notice that the injection has changed colour or has become cloudy, do not use it. Throw it away and use a new injection.

Medicines must not be used past the expiry date.