Evrysdi Patient Counseling Information

INSTRUCTIONS FOR CONSTITUTION (0.75 MG/ML) (FOR HEALTHCARE PROFESSIONALS ONLY): Each EVRYSDI carton contains: 1. 1 Cap.
2. 1 EVRYSDI bottle.
3. 1 Oral syringe 12 mL (in a pouch).
4. 2 Oral syringes 6 mL (in pouches).
5. 2 Oral syringes 1 mL (in pouches).
6. 1 Press-in bottle adaptor.
7. 1 Package Leaflet (not shown).
8. 1 Instructions for Constitution (not shown).
9. 1 Instructions for Use (not shown).
Important information about EVRYSDI: Avoid inhaling EVRYSDI powder.
Use gloves.
Do not use if the powder expiry date has passed. The powder expiration date is printed on the bottle label.
Do not dispense the constituted solution if the solution's Discard After date exceeds the original powder expiration date.
Avoid getting contact with the medicine on your skin. If the medicine gets on your skin, wash the area with soap and water.
Do not use the medicine if any of the supplies are damaged or missing.
Use Purified Water or Water for Injection (WFI) to constitute the medicine.
Do not add oral syringes other than the ones provided in the carton.
How to store EVRYSDI: Store the powder (unconstituted medicine) in a refrigerator between 2°C to 8°C (35°F to 46°F) and keep it in the carton.
Store the solution (constituted medicine) in a refrigerator between 2°C to 8°C (35°F to 46°F).
Keep the oral solution in the original bottle and always keep the bottle in an upright position with the cap tightly closed.
Constitution: Step 1: Gently tap the bottom of the bottle to loosen the powder.
Step 2: Remove the cap by pushing it down and then twisting to the left (counter-clockwise).
Do not throw away the cap.
Step 3: Carefully pour 79 mL of Purified Water or Water for Injection (WFI) into the medicine bottle.
Step 4: Hold the medicine bottle on a table with one hand.
Insert the press-in bottle adaptor into the opening by pushing it down with the other hand. Ensure it is completely pressed against the bottle lip.
Step 5: Put the cap back on the bottle. Turn the cap to the right (clockwise) to close the bottle.
Ensure it is completely closed and then shake well for 15 seconds.
Wait for 10 minutes. You should have obtained a clear solution.
Afterwards, shake well again for another 15 seconds.
Step 6: Calculate the Discard After date as 64 days after constitution (Note: the day of constitution is counted as day 0. For example, if constitution is on the 1^st of April, the Discard After date will be the 4^th of June).
Write the Discard After date of the solution on the bottle label and carton.
Put the bottle back in its original carton, with syringes (in pouches), Package Leaflet. Store the carton into the refrigerator.
INSTRUCTIONS FOR USE - ADMINISTRATION (0.75 MG/ML): Instructions for Use: Be sure to read and understand this Instructions for Use before you start using EVRYSDI for information on how to prepare and give EVRYSDI through an oral syringe, gastrostomy tube (G-tube), or nasogastric tube (NG-tube).
If you have any questions about how to use EVRYSDI, contact your healthcare provider.
EVRYSDI should come as a liquid in a bottle when you receive it. Do not use if the medicine in the bottle is a powder and contact your healthcare provider.
Important information about EVRYSDI: Ask your healthcare provider to show you the correct syringe you should use and how to measure your prescribed daily dose.
Always use the re-usable oral syringes provided in the pack to measure your prescribed daily dose. The oral syringe protects the medicine from light.
Contact your healthcare provider if your oral syringe(s) are lost or damaged. They will advise you on how to continue to take your medicine.
See "How to select the correct oral syringe to use for your prescribed daily dose of EVRYSDI" for the correct oral syringe you should use. Ask your healthcare professional if you have questions on how to select the right oral syringe.
If the bottle adaptor is not in the bottle, do not use EVRYSDI and then contact your healthcare professional.
Do not use EVRYSDI after the Discard after date written on the bottle label. Ask your healthcare professional for the Discard after date if it is not written on the bottle label.
Do not mix EVRYSDI into food or liquids (e.g. milk or formula milk).
Do not use EVRYSDI if the bottle or oral syringes are damaged.
Avoid getting EVRYSDI on your skin. If EVRYSDI gets on your skin, wash the area with soap and water.
If you spill EVRYSDI, dry the area with a dry paper towel and clean with soap and water. Throw away the paper towel in the waste and wash your hands well with soap and water.
If there is not enough EVRYSDI left in the bottle for your prescribed dose, discard the bottle with remaining EVRYSDI and used oral syringes according to your local requirements; use a new bottle of EVRYSDI to obtain your prescribed daily dose. Do not mix EVRYSDI from the new bottle with the bottle you are currently using.
Each EVRYSDI carton contains: 1. 1 EVRYSDI bottle with bottle adaptor and cap.
2. 1 Oral syringe 12 mL (in a pouch).
3. 2 Oral syringes 6 mL (in pouches).
4. 2 Oral syringes 1 mL (in pouches).
5. 1 Instructions for Use booklet (not shown).
6. 1 Package Leaflet (not shown).
How to store EVRYSDI: Please see "How to store EVRYSDI" of the Patient Information Leaflet for full information.
A) Preparing and withdrawing your daily dose: How to select the correct oral syringe to use for your prescribed daily dose of EVRYSDI: If your prescribed daily dose of EVRYSDI is between 0.3 mL and 1 mL, use a 1 mL oral syringe (yellow label).
If your prescribed daily dose of EVRYSDI is between 1 mL and 6 mL, use a 6 mL oral syringe (grey label).
If your prescribed daily dose of EVRYSDI is 6.2 mL or higher, use a 12 mL oral syringe (brown label).
Ask your HCP about rounding you or your child's daily dose to the nearest syringe marking.
How to prepare your daily dose of EVRYSDI: Step A1: Remove the cap by pushing it down and then twisting the cap to the left (counter-clockwise). Do not throw away the cap.
Step A2: Push the plunger of the oral syringe all the way down to remove any air in the oral syringe.
Step A3: Keeping the bottle in an upright position, insert the syringe tip into the bottle adaptor.
Step A4: Carefully turn the bottle upside down with the syringe tip firmly inserted into the bottle adaptor.
Step A5: Slowly pull back on the plunger to withdraw your prescribed daily dose of EVRYSDI. The top of the black plunger stopper must line up with the mL marking on the oral syringe for your prescribed daily dose.
After the correct dose is withdrawn, hold the plunger in place to keep the plunger from moving.
Step A6: Continue to hold the plunger in place to keep the plunger from moving. Leave the oral syringe in the bottle adaptor and turn the bottle to an upright position. Place the bottle onto a flat surface. Remove the oral syringe from the bottle adaptor by gently pulling straight up on the oral syringe.
Step A7: Hold the oral syringe with the syringe tip pointing up. Check the medicine in the oral syringe. If there are large air bubbles in the oral syringe or if you have drawn up the wrong daily dose of EVRYSDI, insert the syringe tip firmly into the bottle adaptor. Push the plunger all the way down so that the medicine flows back into the bottle and repeat Steps A4 through A7.
Take or give EVRYSDI immediately after it is drawn up into the oral syringe.
If it is not taken within 5 minutes, discard from oral syringe and prepare a new dose.
Step A8: Put the cap back on the bottle. Turn the cap to the right (clockwise) to tightly close the bottle. Do not remove the bottle adaptor from the bottle.
If you are taking your daily dose of EVRYSDI by mouth, follow the instructions in "B) How to take a daily dose of EVRYSDI by mouth".
If you are taking your daily dose of EVRYSDI through a gastrostomy tube, follow the instructions in "C) How to give a daily dose of EVRYSDI through a gastrostomy tube (G-tube)".
If you are taking your daily dose of EVRYSDI through a nasogastric tube, follow the instructions in "D) How to give a daily dose of EVRYSDI through a nasogastric tube (NG-tube)".
Evrysdi's oral syringes are specifically designed to be compatible with the ENFit system. If your feeding tube is not ENFit compatible, you may need an ENFit transition connector to connect the Evrysdi syringe to your G-tube or NG-tube.
B) How to take a daily dose of EVRYSDI by mouth: Sit upright when taking a daily dose of EVRYSDI by mouth.
Step B1: Place the oral syringe into the mouth with the tip along either cheek.
Slowly push the plunger all the way down to take the full dose of EVRYSDI.
Giving EVRYSDI into the throat or too fast may cause choking.
Step B2: Check that there is no medicine left in the oral syringe.
Step B3: Drink some water right after taking the prescribed dose of EVRYSDI.
Go to Step E for cleaning of the syringe.
C) How to give a daily dose of EVRYSDI through a gastrostomy tube: If you are giving EVRYSDI through a gastrostomy tube, ask your doctor to show you how to inspect the gastrostomy tube before giving EVRYSDI.
Step C1: Place the oral syringe tip into the gastrostomy tube. Slowly push the plunger all the way down to give the full dose of EVRYSDI.
Step C2: Check that there is no medicine left in the oral syringe.
Step C3: Flush the gastrostomy tube with 10-20 mL of water right after giving the prescribed dose of EVRYSDI.
Go to Step E for cleaning of the syringe.
D) How to give a daily dose of EVRYSDI through a nasogastric tube: If you are giving EVRYSDI through a nasogastric tube, ask your doctor to show you how to inspect the nasogastric tube before giving EVRYSDI.
Step D1: Place the oral syringe tip into the nasogastric tube. Slowly press the plunger all the way down to give the full dose of EVRYSDI.
Step D2: Check that there is no medicine left in the oral syringe.
Step D3: Flush the nasogastric tube with 10-20 mL of water right after giving the prescribed dose of EVRYSDI.
Go to Step E for cleaning of the syringe.
E) How to clean the oral syringe after use: Step E1: Remove the plunger from the oral syringe.
Rinse the oral syringe barrel well under clean water.
Step E2: Rinse the plunger well under clean water.
Step E3: Check that the oral syringe barrel and plunger are clean.
Place the oral syringe barrel and plunger on a clean surface in a safe place to dry.
Wash your hands.
Once dry, reassemble the plunger into the oral syringe barrel and store the syringe with your medicine.