Consumer medicine information

1. Why am I using Entyvio?

Entyvio pre-filled pen for subcutaneous injection contains the active ingredient vedolizumab. Entyvio is used to treat the signs and symptoms of moderate to severe ulcerative colitis or moderate to severe Crohn's disease in adults who have not responded well enough or are intolerant to other treatments.
For more information, see Section 1. Why am I using Entyvio? in the full CMI.

2. What should I know before I use Entyvio?

Do not use if you have ever had an allergic reaction to vedolizumab or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
For more information, see Section 2. What should I know before I use Entyvio? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Entyvio and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Entyvio pre-filled pen?

Entyvio solution for injection is given by injection just under the skin (subcutaneous injection).
More instructions can be found in Section 4. How do I use Entyvio? in the full CMI.

5. What should I know while using Entyvio?

6. Are there any side effects?

Very common: common cold, joint pain, headache. Common: fever, flu (influenza), nose or throat infection, bronchitis, chest infection, cough, throat pain, nausea, itching, rash and redness, pain in the extremities, back pain, tiredness, injection site reactions (including pain, swelling, redness or itching. Serious side effects: allergic reactions, infections, liver injury.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Vedolizumab.

2 Qualitative and Quantitative Composition

Intravenous infusion. Each vial of Entyvio contains 300 mg of vedolizumab.
The powder is intended to be reconstituted with 4.8 mL of sterile water for injections. After reconstitution, each mL contains 60 mg of vedolizumab and the pH is approximately 6.3. Five (5) mL of the reconstituted solution is to be diluted into 250 mL sterile 0.9% sodium chloride solution or 250 mL of sterile lactated Ringer's solution prior to use.
Subcutaneous injection. Each Entyvio pre-filled syringe or pre-filled pen contains 108 mg of vedolizumab in 0.68 mL.
Entyvio 108 mg is supplied as a sterile, clear, colourless to yellow, preservative free solution for subcutaneous administration with a pH of 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Intravenous infusion. Entyvio 300 mg powder for injection for intravenous infusion is supplied as a white to off white lyophilised cake or powder for injection, in a single-use vial.
Subcutaneous injection. Entyvio 108 mg solution for injection is supplied as single-dose pre-filled syringe with needle safety device or single-dose pre-filled pen. The solution is colourless to yellow.

4 Clinical Particulars

4.9 Overdose

Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered intravenously in clinical trials. No dose limiting toxicity was seen in clinical trials.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genotoxicity studies have not been conducted with vedolizumab. As vedolizumab is a monoclonal antibody, it would not be expected to have genotoxic potential.
Carcinogenicity. Carcinogenicity studies with vedolizumab have not been conducted. Act-1, the murine homologue predecessor of vedolizumab, at concentrations up to 20 microgram/mL, did not stimulate the in vitro proliferative rate of a human B-cell lymphoma cell line expressing the α₄β₇ integrin. In a tissue cross reactivity study using human colon adenocarcinoma cryosections, there was no evidence that Act-1 at concentrations up to 20 microgram/mL bound to the tumour tissue.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Vedolizumab, an integrin receptor antagonist, is a humanized IgG1 monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α₄β₇ integrin. Entyvio has an approximate molecular weight of 147 kilodaltons.
CAS number. 943609-66-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

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