Consumer medicine information

Velsipity 2 mg Tablets

Etrasimod

BRAND INFORMATION

Brand name

Velsipity

Active ingredient

Etrasimod

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Velsipity 2 mg Tablets.

1. Why am I using VELSIPITY?


VELSIPITY contains the active ingredient etrasimod. VELSIPITY is used to treat ulcerative colitis (UC). It is used when a patient's UC is still active after other medicines have not worked or were not tolerated.
For more information, see Section 1. Why am I using VELSIPITY? in the full CMI.

2. What should I know before I use VELSIPITY?


Do not use if you have ever had an allergic reaction to etrasimod 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, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use VELSIPITY? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with VELSIPITY 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 VELSIPITY?

  • The recommended dose of VELSIPITY is one 2 mg tablet taken once a day
  • VELSIPITY should be swallowed whole and can be taken with or without food

More instructions can be found in Section 4. How do I use VELSIPITY? in the full CMI.

5. What should I know while using VELSIPITY?

Things you should do
  • Remind any doctor, dentist, pharmacist, or optometrist you visit that you are taking VELSIPITY.
  • Use effective contraception while taking VELSIPITY. Tell your doctor if you become pregnant.
  • Contact your doctor immediately if you notice changes in your skin or vision, or experience a severe headache, dizziness or if you develop any signs or symptoms of an infection.
  • Check with your doctor before receiving any vaccinations.
  • Make regular appointments to monitor your skin and blood pressure and check your blood results.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not breastfeed while taking VELSIPITY.
Driving or using machines
  • VELSIPITY may cause dizziness in some people.
  • Be careful before you drive or use any machines or tools until you know how VELSIPITY affects you.
Looking after your medicine
  • Store tablets below 30°C.

For more information, see Section 5. What should I know while using VELSIPITY? in the full CMI.

6. Are there any side effects?


All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. Common (less serious) sides effects include headache and dizziness. More serious side effects include serious infections (e.g., urinary tract), slow or irregular heartbeat, high blood pressure, low white blood cells disturbance or loss of vision, progressive weakness, clumsiness, memory loss or confusion, severe headache, seizures (fits). 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.

BRAND INFORMATION

Brand name

Velsipity

Active ingredient

Etrasimod

Schedule

S4

 

1 Name of Medicine

Etrasimod.

2 Qualitative and Quantitative Composition

Each film-coated tablet contains 2.762 mg of etrasimod arginine, equivalent to 2 mg etrasimod.
Excipient(s) with known effect. Contains tartrazine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Film-coated tablet.
Velsipity is a green, round, film-coated tablet of approximately 6 mm diameter, debossed with "ETR" on one side and "2" on the other side.

4 Clinical Particulars

4.9 Overdose

In patients with overdosage of etrasimod, monitor for signs and symptoms of bradycardia, which may include overnight monitoring. Regular measurements of heart rate, blood pressure, and ECGs should be performed. There is no specific antidote to etrasimod available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Etrasimod was negative in a battery of in vitro (Ames, chromosomal aberration in human peripheral blood lymphocytes) and in vivo (rat micronucleus) assays.
Carcinogenicity. Oral carcinogenicity studies of etrasimod were conducted in mice and rats. In mice administered etrasimod for up to 104 weeks, there was an increase in hemangiosarcoma and hemangioma at 6 and 20 mg/kg/day in males and females. Systemic exposure at the no-observed-effect-level (NOEL) of 2 mg/kg/day was approximately 22 times that in humans at the MRHD of 2 mg/day. In rats, oral administration of etrasimod (up to 20 mg/kg/day) for up to 91 weeks, did not result in an increase in tumours. Plasma etrasimod exposure (AUC) at the highest dose tested is approximately 90 and 200 (males and females, respectively) times that in humans at the MRHD of 2 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure of etrasimod L-arginine:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSESTRAS.gif CAS number. 1206123-37-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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