Please read the accompanying instructions for use before administering the mirikizumab pen.1

Please note the following information for patients:

IMPORTANT:1

• 2 injections are required for a full dose to treat Crohn’s disease: one pen with 100 mg and one pen with 200 mg.
• 2 injections are required for a full dose to treat Ulcerative Colitis: one pen with 100 mg and one pen with 100 mg.
• Inject one pen followed right away by the other pen.1

For the treatment of Ulcerative Colitis:

For the treatment of Crohn's Disease:

Take the pens from the refrigerator.1

• Take 2 Omvoh pens from the refrigerator.
• Leave the grey base caps on until you are ready to inject.
• To treat Ulcerative Colitis: Leave the pens at room temperature for 30 minutes before injecting.
• To treat Crohn's Disease: Leave the pens at room temperature for 45 minutes before injecting.
• Do not microwave the pens, run hot water over them, or leave them in direct sunlight.
• Do not use the pens if the medicine is frozen.
• Do not shake.

• Each Omvoh pen is for one-time use only.1
• Omvoh pens should not be shared or reused.
• Patients with visual or hearing problems should not use the pen without help from a caregiver.

• The medicine should be clear. It may be colourless to slightly yellow.1

• Do not inject within 5 centimetres of the belly button (navel).1
• If injecting in front of the thighs, the injection site should be at least 5 centimetres above the knee and 5 centimetres below the groin.
• Do not inject in the same site/spot every time, i.e. if 1st injection is administered to the abdomen, the second injection may be administered at a different location on the abdomen.
• Do not inject into areas where the skin is tender, bruised, red or hard.

1. Uncap the pen.1

Make sure the pen is locked (Make sure the pen is locked).
Leave the grey base cap on until the dose is ready to be injected.

• Twist off the grey base cap and throw it away into household waste (Twist off the grey base cap).
• Do not put the grey base cap back on – this could damage the needle.
• Do not touch the needle.

2. Place and unlock.1

• Place and hold the clear base flat and firmly against the skin.
• Keep the base on the skin and turn the lock ring to the unlock position (Place and unlock).
  

For Ulcerative Colitis:

3. Press and Hold for up to 10 Seconds1

• Press and hold the blue injection button. A loud click will be heard (injection started).
• Keep holding the clear base firmly against the skin. A second loud click will be heard about 10 seconds after the first one (injection completed).
• The injection is complete when the grey plunger is visible.
• Remove the pen from the skin.
• If there is bleeding at the injection site, press a cotton ball or gauze over the injection site.
• Do not rub the injection site.

For Crohn's Disease:

3. Press and Hold for up to 15 Seconds1

• Press and hold the blue injection button. You will hear a loud click (injection started).
• Keep holding the clear base firmly against your skin. You will hear a second loud click in about 15 seconds after the first one (injection completed).
• You will know the injection is complete when the grey plunger is visible.
• Remove the pen from your skin.
• If you have bleeding at the injection site, press a cotton ball or gauze over the injection site.
• Do not rub the injection site.

Repeat the steps above to administer the second pen. 1

Remember: 2 injections are required for a full dose. Inject one pen immediately followed by the other pen.

Listen for the second click which occurs about 10 seconds after the first one and confirms the injection is complete. The grey plunger is visible, when the injection is complete, see Grey plunger. 1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.