EVRYSDI 0.75 mg/ml ORAL SOLUTION POWDER

Czech Republic

Roche s.r.o.

Tel: +420 - 2 20382111

Hungary

Roche (Magyarország) Kft.

Tel: +36 1 279 4500

Denmark

Roche Pharmaceuticals A/S

Tlf: +45 - 36 39 99 99

Malta

(see Ireland)

Germany

Roche Pharma AG

Tel: +49 (0) 7624 140

Netherlands

Roche Nederland B.V.

Tel: +31 (0) 348 438050

Estonia

Roche Eesti OÜ

Tel: + 372 - 6 177 380

Norway

Roche Norge AS

Tlf: +47 - 22 78 90 00

Greece

Roche (Hellas) A.E.

Τηλ: +30 210 61 66 100

Austria

Roche Austria GmbH

Tel: +43 (0) 1 27739

Spain

Roche Farma S.A.

Tel: +34 - 91 324 81 00

Poland

Roche Polska Sp.z o.o.

Tel: +48 - 22 345 18 88

France

Roche

Tél: +33 (0) 1 47 61 40 00

Portugal

Roche Farmacêutica Química, Lda

Tel: +351 - 21 425 70 00

Croatia

Roche d.o.o.

Tel: +385 1 4722 333

Romania

Roche România S.R.L.

Tel: +40 21 206 47 01

Ireland

Roche Products (Ireland) Ltd.

Tel: +353 (0) 1 469 0700

Slovenia

Roche farmacevtska družba d.o.o.

Tel: +386 - 1 360 26 00

Iceland

Roche Pharmaceuticals A/S

c/o Icepharma hf

Sími: +354 540 8000

Slovakia

Roche Slovensko, s.r.o.

Tel: +421 - 2 52638201

Italy

Roche S.p.A.

Tel: +39 - 039 2471

Finland

Roche Oy

Puh/Tel: +358 (0) 10 554 500

Cyprus

Γ.Α.Σταμ?της & Σια Λτδ.

Τηλ: +357 - 22 76 62 76

Sweden

Roche AB

Tel: +46 (0) 8 726 1200

Latvia

Roche Latvija SIA

Tel: +371 - 6 7039831

United Kingdom (Northern Ireland)

Roche Products (Ireland) Ltd.

Tel: +44 (0) 1707 366000

Important Information about Evrysdi

? Ask your doctor or pharmacist to show you which oral syringe to use and how to measure the prescribed daily dose.

? Always use the reusable oral syringes provided in the packaging to measure the daily dose.

? Contact your doctor or pharmacist if the oral syringe(s) are lost or damaged. They will tell you how to continue taking the medication.

? Refer to “How to Select the Correct Oral Syringe for the Evrysdi Dose”. Ask your pharmacist if you have any doubts about how to select the correct oral syringe.

? If the bottle adapter is not on the bottle, do notuse Evrysdi and contact your pharmacist.

• The oral solution can be stored at room temperature (below 40°C) for a maximum of 120 hours (5 days) in total. Monitor the total time it is out of the refrigerator (below 40°C).

? Do notuse Evrysdi after the Discard afterdate on the bottle label or if you or your caregiver have kept the bottle at room temperature (below 40°C) for more than 120 hours (5 days) in total. Ask your pharmacist for the Discard afterdate if it is not written on the bottle label.

• Discard the medication if the bottle has been stored above 40°C at any time.

? Do notmix Evrysdi with milk or powdered milk.

? Do notuse Evrysdi if the bottle or oral syringe is damaged.

? Avoidcontact between Evrysdi and skin. If Evrysdi comes into contact with skin, wash the area with water and soap.

? If you spill Evrysdi, wipe the area with a dry paper towel and then wash it with water and soap. Throw the paper towel away and wash your hands well with water and soap.

? If there is not enough Evrysdi left in the bottle for the prescribed dose, discard the bottle with the remaining Evrysdi and the used oral syringe according to local requirements; use a new bottle of Evrysdi to get a full dose. Do not mixEvrysdi from the new bottle with the bottle you are currently using.

Each Box of EVRYSDI Contains (see FigureA):

1. 1 bottle of Evrysdi with bottle adapter and cap
2. 1 12-ml oral syringe (in a bag)
3. 2 6-ml oral syringes (in bags)
4. 2 1-ml oral syringes (in bags)
5. 1 Instructions for Use leaflet (not shown)
6. 1 package insert (not shown)

Figure A

Storage of Evrysdi

Refer to section 5 “Storage of Evrysdi” of the package insert for complete information.

• Withdrawal of dose volume

How to Select the Correct Oral Syringe for the Evrysdi Dose

How to Withdraw the Evrysdi Dose

Figure B

Step A1

Remove the cap by pushing down and then twisting the cap to the left (counterclockwise) (see Figure B). Do not discard the cap.

Figure C

Step A2

Push the plunger of the oral syringe down to the bottom to remove air from the oral syringe (see Figure C).

Figure D

Step A3

Hold the bottle upright and insert the tip of the oral syringe into the bottle adapter (see Figure D).

Figure E

Step A4

Carefully turn the bottle upside down with the tip of the oral syringe firmly inserted into the bottle adapter (see Figure E).

Figure F

Step A5

Slowly pull the plunger to withdraw the Evrysdi dose. The top of the black plunger should align with the ml mark on the oral syringe corresponding to the daily dose (see Figure F).

Once the correct dose is withdrawn, keep the plunger in place to avoid it moving.

Figure G

Step A6

Continue to keep the plunger in place so it does not move.Leave the oral syringe in the bottle adapter and turn the bottle upright. Place the bottle on a flat surface. Remove the oral syringe from the bottle adapter by gently pulling it upwards (see Figure G).

Figure H

Step A7

Hold the oral syringe with the tip facing upwards. Inspect the medication inside the oral syringe. Ifthere are large air bubbles in the oral syringe (see Figure H) oryou have withdrawn an incorrect Evrysdi dose, insert the tip of the oral syringe firmly into the bottle adapter. Push the plunger down to the bottom to return the medication to the bottle and repeat from Step A4 to A7.

Take or administer Evrysdi immediately after withdrawing it with the oral syringe.

If it is not taken within 5minutes, discard the medication from the oral syringe and withdraw a new dose.

Figure I

Step A8

Put the cap back on the bottle. Twist the cap to the right (clockwise) to close the bottle properly (see Figure I). Do not remove the bottle adapter from the bottle.

If you are going to take the Evrysdi dose by mouth, follow the instructions given in “B) How to Take the Evrysdi Dose by Mouth”.

If you are going to take the Evrysdi dose through a gastrostomy tube, follow the instructions given in “C) How to Administer the Evrysdi Dose through a Gastrostomy Tube (G-tube)”.

If you are going to take the Evrysdi dose through a nasogastric tube, follow the instructions given in “D) How to Administer the Evrysdi Dose through a Nasogastric Tube (NG-tube)”.

The Evrysdi oral syringes are designed to be compatible with the ENFit® system. If the feeding tube is not compatible with ENFit®, you may need an ENFit® transition connector to connect the Evrysdi syringe to the G-tube or NG-tube.

• How to Take the Evrysdi Dose by Mouth

Stay seated and upright when taking the Evrysdi dose by mouth.

Figure J

Step B1

Place the oral syringe inside the mouth with the tip against either cheek.

Slowlypush the plunger down to the bottom to administer the complete Evrysdi dose (see Figure J).

Administering Evrysdi in the back of the throat or too quickly can cause choking.

Figure K

Step B2

Check that no medication is left in the oral syringe (see Figure K).

Figure L

Step B3

Drinka little water immediately after taking the Evrysdi dose (see Figure L).

Go to StepE to clean the syringe.

• How to Administer the Evrysdi Dose through a Gastrostomy Tube

If you are going to administer Evrysdi through a gastrostomy tube, ask your doctor or nurse to show you how to inspect the gastrostomy tube before administering Evrysdi.

Figure M

Step C1

Place the tip of the oral syringe into the gastrostomy tube. Slowly push the plunger down to the bottom to administer the complete Evrysdi dose (see Figure M).

Figure N

Step C2

Check that no medication is left in the oral syringe (see Figure N).

Figure O

Step C3

Flush the gastrostomy tube with 10-20 ml of water immediately after administering the Evrysdi dose (see Figure O).

Go to StepE to clean the syringe.

• How to Administer the Evrysdi Dose through a Nasogastric Tube

If you are going to administer Evrysdi through a nasogastric tube, ask your doctor or nurse to show you how to inspect the nasogastric tube before administering Evrysdi.

Figure P

Step D1

Place the tip of the oral syringe into the nasogastric tube. Slowly push the plunger down to the bottom to administer the complete Evrysdi dose (see Figure P).

Figure Q

Step D2

Check that no medication is left in the oral syringe (see Figure Q).

Figure R

Step D3

Flush the nasogastric tube with 10-20 ml of water immediately after administering the Evrysdi dose (see Figure D).

Go to StepE to clean the syringe.

• How to Clean the Oral Syringe after Use

Figure S

Step E1

Remove the plunger from the oral syringe.

Rinse the oral syringe body well with clean water (see Figure S).

Figure T

Step E2

Rinse the plunger well with clean water (see Figure T).

Figure U

Step E3

Check that the oral syringe body and plunger are clean.

Place the oral syringe body and plunger on a clean surface, in a safe place, to dry (see Figure U).

Wash your hands.

Once dry, reassemble the plunger into the oral syringe body and store the syringe with the medication.

Each Evrysdi box contains (see figureA):

1. 1 Stopper
2. 1 Evrysdi Vial
3. 1 12 ml oral syringe (in bag)
4. 2 6 ml oral syringes (in bag)
5. 2 1 ml oral syringes (in bag)
6. 1 Vial adapter
7. 1 Leaflet (not shown)
8. 1 Reconstitution Instructions (not shown)
9. 1 Instructions for Use (not shown)

Figure A

Important Information about Evrysdi

? Avoid inhalingEvrysdi powder.

? Wear gloves.

?Do notuse it after the powder's expiration date has passed. The powder's expiration date is printed on the vial label.

? Do notdispense the reconstituted solution if the "Discard after" date of the solution is later than the expiration date of the original powder.

? Avoid skin contactwith the medication. If the medication comes into contact with the skin, wash the area with water and soap.

? Do notuse the medication if any of the supplies are missing or damaged.

? Use purified water or water for injectable preparations to reconstitute the medication.

? Do not add oral syringes other than those supplied in the packaging.

Storage of Evrysdi

? Store the powder (unreconstituted medication) at room temperature and in the packaging.

? Store the solution (reconstituted medication) in the refrigerator (between 2 °C and 8 °C) and in the packaging in a vertical position.

? Store the oral solution in the original vial and always keep the vial in a vertical position with the cap perfectly closed.

Reconstitution

Figure B

Step1

Gently tap the bottom of the vial to loosen the powder (see figure B).

Figure C

Step2

Remove the cap by pressing down and then turning it to the left (counterclockwise) (see figure C). Do not discard the cap.

Figure D

Step3

Carefully pour 79 ml of purified water or water for injectable preparations into the medication vial (see figure D).

Figure E

Step4

Hold the medication vial with one hand on a table.

Insert the vial adapter into the opening by pushing it down with the other hand. Make sure it is fully pressed against the edge of the vial (see figure E).

Figure F

Step5

Put the cap back on the vial. Turn the cap to the right (clockwise) to close the vial.

Make sure it is perfectly closed and shake it well for 15 seconds (see figure F).

Wait 10 minutes. You should have obtained a clear solution.

Then, shake it well again for 15 seconds.

Figure G

Step6

Calculate the "Discard after" date in 64daysafter reconstitution (Note: the day of reconstitution is counted as day 0. For example, if reconstitution takes place on April 1, the "Discard after" date will be June 4).

Write the "Discard after" dateof the solution on the vial label (see figure G) and on the packaging.

Put the vial back in its original packaging, with the syringes (in bags), the leaflet, and the Instructions for Use. Store the packaging in the refrigerator (between 2 °C and 8 °C).