YORVIPATH 294 micrograms/0.98 ml injectable solution in pre-filled pen

Color

Presentation

Blue

Yorvipath 168 micrograms/0.56 ml

Orange

Yorvipath 294 micrograms/0.98 ml

Garnet

Yorvipath 420 micrograms/1.4 ml

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Important Information You Should Know Before Starting to Use Your Yorvipath Pen

Read and follow the leaflet and these instructions for use carefully to be able to inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before applying the injection. This is important to ensure you receive the correct treatment.

For Correct Use

• If you do not follow these instructions, you may not receive the correct dose and, therefore, may not get the full effect of your medicine.
• If you are blind or have visual impairment, or lack concentration do notuse your pen without help. Instead, ask for help from someone who has been trained in the use of the Yorvipath pen.
• Keep out of sight and reach of children.
• The pen and needles are for single-patient use.
• Do notshare your pen or needles with other people. It could cause infection (cross-contamination).
• Always discard your pen after 14 days, even if there is still medication left. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles that come with the Yorvipath pen for your injections.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the needle of the pen.
• Do notchange the angle of injection after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle protector or needle shield is damaged.

Pen Care

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, test the pen flow again (section 2, steps A-C) before the next use.
• Do not apply more force to your pen. It may be empty, damaged, or not functioning correctly.
• Do notattempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you think it may be damaged) to avoid wasting medication. The test checks to ensure the medicine flows through the pen, so you can receive the correct doses of the medicine.

1. I don't see drops after testing the pen flow 5 times. What should I do?

If you don't see drops on the tip of the needle after 5 attempts, it may be because there is no flow in the pen and needle.

Change the needle (see section 5, step 13) and test the pen flow again (see section 2, steps A-C). You can ensure the flow is working correctly if you see the medicine drop. If it still doesn't work, discard the pen and consult your healthcare professional.

1. How do I know I've finished administering the injection?

The injection is only complete when you press the button all the way down and the

dose selector has returned to the "?" and you have left the needle in the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or retreat from the injection site and remain in the skin. Pressing the pen against the skin for 5 secondshelps ensure that all the medicine is injected.

1. I am unable to set the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than the amount left.

If your dose is greater than the amount of medicine left in the pen, you will not be able to set a complete dose. You must discard your pen and take the complete dose of the medicine with a new one.

1. The red cap covers the needle before starting the injection. What should I do?

Unscrew and discard the needle in use (see section 5, step 13). Take a new needle from the box and start again from step 1. All boxes contain an additional needle.

1 Preparing the Pen and Needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the

expiration date.Take a needle and check the

expiration dateon the needle (Figure C).

Note:Remove your pen from the refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the pen cap and check the inspection window to ensure the medicine inside the pen is clear and colorless (Figure D).

Important:If the medicine has visible particles do notuse the pen. Use a new pen.

Figure D

Step 3

Remove the needle shield (Figure E).

This needle can only be used onceand is locked after use.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle directlyto your pen, and then screw the needle onto the pen until it is secure (not fully tightened) (Figure F).

Figure F

Step 5

Remove the needle protector (Figure G) and discard it.

Important:The blue tab should not be touched as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A-C) only the first time you use

a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the

right 2 clicksuntil you see the drop symbol “” in the dose window (Figure H).

Note:You can always correct the selection by turning the dose selector.

Figure H

Step B

Make the air bubbles reach the

top of the pen by pressing the inspection window (Figure I). Keep the pen with the needle tip pointing upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the button and observe as the medicine drops come out of the needle tip.

When pressing, make sure the dose selector turns back to the “?” symbol

(Figure J).

Important:If you do not see medicine drops, repeat this test (steps A-C) up to 5 times.

If you still do not see drops, change the needle and

repeat the test.

Figure J

3 Prepare the Injection and Select the Dose

Step 6

Choose the injection site. There are twoareas of your body where you can apply the injection (Figure K).

Avoid applying the injection in areas of red, swollen, or scarred skin.

Choose a different injection site each time you apply the injection.

Step 7

Wash your hands and clean the injection site with an alcohol swab

(Figure L).

Figure L

Step 8

Select your dose according to your doctor's instructions (6, 9, or 12 micrograms)by turning the dose selector to the right

(Figure M).

Important:Make sure not to press the button when selecting the dose to avoid spilling the medicine.

Note:Always discard your pen and use a new one if you cannot set a complete dose.

Figure M

4 Inject the Dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (steps 9-12) before starting to inject.

Step 9

Hold the pen to place the blue tab on the injection site.

Injection. Make sure you can see the dosing window (Figure N).

Figure N

Step 10

Push the pen directly against the skin until you hear a click and the blue cap can no longer be seen (Figure O).

Figure O

Step 11

Press the button all the way down and hold it firmly for 5 seconds. Make sure the dose selector turns back to the "?" symbol. This means you have administered the full dose (Figure P).

Figure P

Step 12

Slowly pull the pen out of the injection area. The blue cap will automatically lock onto the needle and a red lock will be visible (Figure Q).

Figure Q

5 Dispose of the used needle

Step 13

Unscrew the needle and dispose of it safely according to local regulations (Figure R). Do notattempt to recap the needle, as you may prick yourself on the back.

Figure R

Step 14

Fit the pen cap firmly onto the pen to protect it between injections and protect the medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important:Always dispose of the pen 14 days after the first use, according to local regulations. To know when 14 days have passed, it is recommended to cover the "Date of opening" field on the inner packaging.

Always dispose of your pen and additional needles after 14 days of use, even if there is still medication left. This is important to ensure you receive the full effect of the medication.

Figure T

Important information you should know before starting to use your Yorvipath pen

Read and follow the package insert and these instructions for use carefully to be able to inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before applying the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not obtain the full effect of your medication.
• If you are blind or have visual impairment, or lack concentration do notuse your pen without help. Instead, ask for help from someone who has been trained in the use of the Yorvipath pen.
• Keep out of sight and reach of children.
• The pen and needles are for single-patient use.
• Do notshare your pen or needles with others. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medication left. This is important to ensure you receive the correct effect of the medication.
• Always use the needles that come with the Yorvipath pen for your injections.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do notchange the angle of injection after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle protector or needle shield is damaged.

Special instructions for doses greater than 30 micrograms/

If your dose is greater than 30 micrograms/day:

• Administer two injections, one after the other, in different injection areas (see the recommended schedule table in Section 3 of the Package Insert)
• It is recommended to use a different Yorvipath pen for the second daily injection, even if the two pens have the same color button (same concentration).
• Follow the steps in the instructions for use for each injection.

Pen care

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, test the pen flow again (Section 2, Steps A-C) before the next use.
• Do notapply more force to your pen. It may be empty, damaged, or not functioning correctly.
• Do notattempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (Section 2) the first time you use a new pen (or if you think it may be damaged) to avoid wasting medication. The test checks to ensure the medication flows through the pen, so you can receive the correct doses of the medication.

1. I don't see drops after testing the pen flow 5 times. What should I do?

If you don't see drops at the tip of the needle after 5 attempts, it may be because there is no flow in the pen and needle.

Change the needle (see Section 5, Step 13) and test the pen flow again (see Section 2, Steps A-C). You can ensure the flow is working correctly if you see the medication drop.

If it still doesn't work, dispose of the pen and consult your healthcare professional.

1. How do I know I've finished administering the injection?

The injection is only complete when you press the button all the way down and the dose selector has turned back to the "?" symbol and you have left the needle in the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medication may flow back into the pen or retreat from the injection area and remain in the skin. Pressing the pen against the skin for 5 secondshelps ensure that all the medication has been injected.

1. I'm unable to set the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than the amount of medication left in the pen.

If your dose is greater than the amount of medication left in the pen, you will not be able to set a complete dose. You must dispose of your pen and take the complete dose of the medication with a new one.

1. The red lock covers the needle before starting the injection. What should I do?

Unscrew and dispose of the needle in use (see Section 5, Step 13). Take a new needle from the box and start again from Step 1. All boxes contain an additional needle.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the expiration date. Take a needle and check the expiration dateon the needle (Figure C).

Note:Remove your pen from the refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the cap from the pen and check the inspection window to ensure the medication inside the pen is transparent and colorless (Figure D).

Important:If the medication has visible particles do notuse the pen. Use a new pen.

Figure D

Step 3

Remove the needle shield (Figure E). This needle can only be used onceand will lock after use.

Always use a new needle for each injection.

Figure E

Step 4

Fit the needle directlyonto the pen, and then screw the needle onto the pen to secure it (it will not fully tighten) (Figure F).

Figure F

Step 5

Remove the needle protector (Figure G) and dispose of it.

Important:The blue cap should not be touched as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (Steps A-C) only the first time you use a new pen.

If your pen is already in use, go to Section 3 "Prepare the injection and select the dose".

Step A

Turn the dose selector to the right 2 clicksuntil you see the drop symbol "" in the dose window (Figure H).

Note:You can always correct the selection by turning the dose selector.

Figure H

Step B

Make the air bubbles rise to the top of the pen by pressing the inspection window (Figure I). Keep the pen with the needle tip pointing upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the button and observe as the medication drops come out of the needle tip. When pressing, make sure the dose selector turns back to the "?" symbol (Figure J).

Important:If you don't see medication drops, repeat this test (Steps A-C) up to 5 times. If drops are still not visible, change the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection area. There are twoareas of your body where you can apply the injection (Figure K).

Avoid applying the injection in areas of red, swollen, or scarred skin.

Choose a different injection area each time you apply the injection.

Step 7

Wash your hands and clean the injection area with an alcohol swab (Figure L).

Figure L

Step 8

Select your dose according to your doctor's instructions (15, 18, or 21 micrograms) by turning the dose selector to the right (Figure M).

Important:Make sure not to press the button when selecting the dose to avoid spilling the medication.

Note:Always dispose of your pen and use a new one if you cannot set a complete dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your doctor or nurse.

Read this entire section (Steps 9-12) before starting to inject.

Step 9

Hold the pen to place the blue cap against the injection area. Make sure you can see the dose window (Figure N).

Figure N

Step 10

Push the pen directly against the skin until you hear a click and the blue cap can no longer be seen (Figure O).

Figure O

Step 11

Press the button all the way down and hold it firmly for 5 seconds. Make sure the dose selector turns back to the "?" symbol. This means you have administered the full dose (Figure P).

Figure P

Step 12

Slowly pull the pen out of the injection area. The blue cap will automatically lock onto the needle and a red lock will be visible (Figure Q).

Figure Q

5 Dispose of the used needle

Step 13

Unscrew the needle and dispose of it safely according to local regulations (Figure R). Do notattempt to recap the needle, as you may prick yourself on the back.

Figure R

Step 14

Fit the pen cap firmly onto the pen to protect it between injections and protect the medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important:Always dispose of the pen 14 days after the first use, according to local regulations. To know when 14 days have passed, it is recommended to cover the "Date of opening" field on the inner packaging.

Always dispose of your pen and additional needles after 14 days of use, even if there is still medication left. This is important to ensure you receive the full effect of the medication.

Important information you should know before starting to use your Yorvipath pen

Read and follow the package insert and these instructions for use carefully to be able to inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before administering the injection. This is essential to ensure that you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and, therefore, may not obtain the full effect of your medication.
• If you are blind or have visual impairment, or lack concentration, do notuse your pen without assistance. Instead, ask for help from someone who has been trained in the use of the Yorvipath pen.
• Keep out of sight and reach of children.
• The pen and needles are for use in a single patient.
• Do notshare your pen or needles with other people. This could cause an infection (cross-contamination).
• Always discard your pen after 14 days, even if there is still medication. This is essential to ensure that you receive the correct effect of the medication.
• Always use the needles that come with the Yorvipath pen for your injections.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do notchange the injection angle after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle protector or needle shield is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injections, one after the other, in different injection sites (see the recommended schedule table in section 3 of the Package Insert).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if the two pens have the same color pusher (same concentration).
• Follow the steps in the instructions for use for each injection.

Pen care

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, retest the pen flow (section 2, steps A-C) before the next use.
• Do notapply excessive force to your pen. It may be empty, damaged, or not functioning correctly.
• Do notattempt to repair a damaged pen on your own.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you think it may be damaged) to avoid wasting medication. The test checks to ensure that the medication flows through the pen, so you can receive the correct doses of the medication.

1. I don't see drops after testing the pen flow 5 times. What should I

do?

If you don't see drops at the tip of the needle after 5 attempts, it may be because there is no flow in the pen and needle.

Change the needle (see section 5, step 13) and retest the pen flow (see section 2, steps A-C). You can ensure that the flow is working correctly if you see the medication drop.

If it still doesn't work, discard the pen and consult your healthcare professional.

1. How do I know I've finished administering the injection?

The injection is only complete when you press the pusher all the way down and the dose selector has returned to the "?" and you have left the needle in the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medication may flow back into the pen or retreat from the injection site and remain in the skin. Pressing the pen against the skin for 5 secondshelps ensure that all the medication has been injected.

1. I'm unable to set the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than the amount of medication remaining in the pen.

If your dose is greater than the amount of medication remaining in the pen, you will not be able to set a complete dose. You must discard your pen and take the complete dose of the medication with a new one.

1. The red cap covers the needle before starting the injection. What should I do?

Unscrew and discard the needle in use (see section 5, step 13). Take a new needle from the box and start again from step 1. All boxes contain an additional needle.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the

expiration date. Take a needle and check the

expiration dateon the needle

(Figure C).

Note:Remove your pen from the refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the closure cap from the pen and check the inspection window to ensure that the medication inside the pen is transparent and

colorless (Figure D).

Important:If the medication has visible

particles, do notuse the pen. Use a new pen.

Figure D

Step 3

Remove the needle shield (Figure E).

This needle can only be used onceand is locked after use.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle directlyto your pen, and then screw the needle onto the pen until it is secured (it will not be fully tightened) (Figure F).

Figure F

Step 5

Remove the needle protector (Figure G) and discard it.

Important:The blue cap should not be touched as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A-C) only the first time you use

a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the right 2 clicksuntil you see the drop symbol "" in the dosing window (Figure H).

Note:You can always correct the selection by turning the dose selector.

Figure H

Step B

Make the air bubbles rise to the top of the pen by pressing the inspection window (Figure I). Keep the pen with the needle tip pointing upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the pusher and observe as the medication drops come out of the needle tip. When pressing, make sure the dose selector turns back to the "?" symbol (Figure J).

Important:If you don't see medication drops, repeat this test

(steps A-C) up to 5 times. If drops are still not seen, change the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are twoareas of your body where you can administer the injection (Figure K).

Avoid administering the injection in areas of red, swollen, or scarred skin.

Choose a different injection site each time you administer the injection.

Step 7

Wash your hands and clean the injection site with an alcohol swab

(Figure L).

Figure L

Step 8

Select your dose according to your doctor's instructions (24, 27, or 30 micrograms)by turning

the dose selector to the right

(Figure M).

Important:Make sure not to press the pusher when selecting the dose to avoid spilling the medication.

Note:Always discard your pen and use a new one if you cannot set a complete dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (steps 9-12) before starting to inject.

Step 9

Hold the pen to place the blue cap on the injection site. Make sure you can see the dosing window (Figure N).

Figure N

Step 10

Push the pen directly against the skin until you hear a click and the blue cap can no longer be seen (Figure O).

Figure O

Step 11

Press the pusher all the way down and hold it firmly for 5 seconds. Make sure the dose selector turns back to the "?" symbol. This means that you have administered the complete dose

(Figure P).

Figure P

Step 12

Slowly pull the pen out of the injection site. The blue cap will automatically lock onto the needle and a red cap will be visible (Figure Q).

Figure Q

5 Discard the used needle

Step 13

Unscrew the needle and discard it safely according to local regulations (Figure R).

Do notattempt to recap the needle, as you may prick yourself on the back.

Figure R

Step 14

Fit the closure cap of the pen firmly onto the pen to protect it between injections and protect the medication from light (Figure S).

Figure S

6 Discard the used pen

Important:Always discard the

pen 14 days after the first use in accordance with local regulations. To know when 14 days have passed, it is recommended to cover the "Date of opening" field on the inner packaging.

Always discard your pen and additional needles after 14 days of use, even if there is still medication (Figure T). This is essential to ensure that you receive the full effect of the medication.

Figure T

Important information you should know before starting to use your Yorvipath pen

Read and follow the package insert and these instructions for use carefully to be able to inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before administering the injection. This is essential to ensure that you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and, therefore, may not obtain the full effect of your medication.
• If you are blind or have visual impairment, or lack concentration, do notuse your pen without assistance. Instead, ask for help from someone who has been trained in the use of the Yorvipath pen.
• Keep out of sight and reach of children.
• The pen and needles are for use in a single patient.
• Do notshare your pen or needles with other people. This could cause an infection (cross-contamination).
• Always discard your pen after 14 days, even if there is still medication. This is essential to ensure that you receive the correct effect of the medication.
• Always use the needles that come with the Yorvipath pen for your injections.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do notchange the injection angle after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle protector or needle shield is damaged.

• Use needles for injectables.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do notchange the injection angle after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle shield or needle clip is damaged.

Care of the pen

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, retest the pen flow (Section 2, Steps A-C) before the next use.
• Do not apply more force to your pen. It may be empty, damaged, or not functioning correctly.
• Do notattempt to repair a damaged pen on your own.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (Section 2) the first time you use a new pen (or if you think it may be damaged) to avoid wasting medication. The test checks to ensure that the medication flows through the pen, so you can receive the correct doses of the medication.

1. I don't see drops after testing the pen flow 5 times. What should I do?

If you don't see drops on the tip of the needle after 5 attempts,it may be because there is no flow in the pen and needle.

Change the needle (see Section 5, Step 12) and retest the pen flow (see Section 2, Steps A-C). You can ensure that the flow is working correctly if you see the medication drop. If it still doesn't work, discard the pen and consult your healthcare professional.

1. How do I know I've finished administering the injection?

The injection is only complete when you press the plunger all the way down and the dose selector has returned to the "?" and you have left the needle in the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medication may flow back into the pen or retreat from the injection site and remain in the skin. Pressing the pen against the skin for 5 seconds helps ensure that all of the medication has been injected.

1. I am unable to dial the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than the amount of medication remaining.

If your dose is greater than the amount of medication remaining in the pen, you will not be able to dial a full dose. You must discard your pen and take the full dose of the medication with a new one.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure

it is the correct concentration and

check the expiration date.Take a

needle and check the expiration dateon

the needle (Figure C).

Note:Remove your pen from the

refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the closure cap from the pen and check the inspection window to ensure that the medication inside the pen is transparent and colorless (Figure D).

Important:If the medication has visible particles do notuse the pen. Use

a new pen.

Figure D

Step 3

Remove the needle clip (Figure E).

This needle can only be used 1 time

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle directlyto your

pen, and then screw the needle onto the

pen until it is secure (Figure F).

Figure F

Step 5

Remove the needle shield and the

inner cap of the needle (Figure G)

Important:The blue cap should not be touched as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (Steps A-C) only the first time you use

a new pen.

If your pen is already in use, go to Section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the

right 2 clicksuntil you see the drop

symbol "" in the dosing window (Figure H).

Note:You can always correct the

selection by turning the dose selector.

Figure H

Step B

Make the air bubbles reach the

top of the pen by pressing the

inspection window (Figure I). Keep

the pen with the needle tip pointing

upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the plunger and observe as the

medication drops come out of the

needle tip. When pressing, make sure

that the dose selector turns back to the

symbol "?" (Figure J).

Important:If you don't see medication

drops, repeat this test (Steps A-C) up to 5 times.If you still don't see drops, change the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas of your body where you can apply

the injection (Figure K).

Avoid applying the injection in areas of

red, swollen, or scarred skin.

Choose a different injection site each

time you apply the injection.

Step 7

Wash your hands and clean the injection

site with an alcohol swab (Figure L).

Figure L

Step 8

Select your dose according to your doctor's

indication (6, 9, or 12 micrograms) by turning

the dose selector to the right (Figure M).

Important:Make sure not to press the

plunger when selecting the dose to avoid

spilling the medication.

Note:Always discard your pen and use

a new one if you cannot dial a full dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (Steps 9-11) before starting to inject.

Step 9

Make sure you can see the dosing window

Insert the needle into the skin (Figure N).

Figure N

Step 10

Press the plunger all the way down and

hold it firmly for 5 seconds. Make sure

that the dose selector turns back to the

symbol "?". This means that you have

administered the full dose (Figure O).

Figure O

Step 11

Slowly remove the pen from the injection

site (Figure P)

Figure P

5 Discard the used needle

Step 12

Put the needle shield back on and carefully

remove the needle. Insert the needle tip

into the shield and secure the shield on

the needle (Figure Q).

Important:Always put the needle

shield back on before removing the needle

to reduce the risk of needlestick injury

and cross-contamination.

Figure Q

Step 13

Unscrew the needle and dispose of it

safely according to local regulations (Figure R).

Figure R

Step 14

Put the pen cap back on the pen firmly to

protect it between injections and protect

the medication from light (Figure S).

Figure S

6 Discard the used pen

Important:Always discard the

pen 14 days after the first use according to local regulations. To know when 14 days have passed, it is recommended to cover the "Date of opening" field on the inner packaging.

Always discard your pen after 14 days of use, even if there is still medication. This is important to ensure that you receive the full effect of the medication.

Note: If the pen packaging includes needles, remember to throw away the additional needle when you dispose of the pen.

Figure T

Important information you should know before starting to use your Yorvipath pen

Read and follow the package insert and these instructions for use carefully to be able to inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before applying the injection. This is important to ensure that you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and, therefore, may not obtain the full effect of your medication.
• If you are blind or have visual impairment, or lack concentration do notuse your pen without help. Instead, ask someone who has been trained in the use of the Yorvipath pen for assistance.
• Keep out of sight and reach of children.
• The pen and needles are for use in a single patient.
• Do notshare your pen or needles with others. It could cause infection (cross-contamination).
• Always discard your pen after 14 days, even if there is still medication. This is important to ensure that you receive the correct effect of the medication.
• Always use the needles that come with the Yorvipath pen for your injectables.
• Remove the needle after each use. Do notstore the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do notchange the injection angle after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle shield or needle clip is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injectables, one after the other, in different injection sites (see the recommended schedule table in Section 3 of the Package Insert).
• It is recommended to use a different Yorvipath pen for the second daily injectable, even if the two pens have the same color plunger (same concentration).
• Follow the steps in the instructions for use for each injection

Care of the pen

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, retest the pen flow (Section 2, Steps A-C) before the next use.
• Do not apply more force to your pen. It may be empty, damaged, or not functioning correctly.
• Do notattempt to repair a damaged pen on your own.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (Section 2) the first time you use a new pen (or if you think it may be damaged) to avoid wasting medication. The test checks to ensure that the medication flows through the pen, so you can receive the correct doses of the medication.

1. I don't see drops after testing the pen flow 5 times. What should I do?

If you don't see drops on the tip of the needle after 5 attempts,it may be because there is no flow in the pen and needle.

Change the needle (see Section 5, Step 12) and retest the pen flow (see Section 2, Steps A-C). You can ensure that the flow is working correctly if you see the medication drop. If it still doesn't work, discard the pen and consult your healthcare professional.

1. How do I know I've finished administering the injection?

The injection is only complete when you press the plunger all the way down and the dose selector has returned to the "?" and you have left the needle in the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medication may flow back into the pen or retreat from the injection site and remain in the skin. Pressing the pen against the skin for 5 seconds helps ensure that all of the medication has been injected.

1. I cannot mark the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than what remains.

If your dose is greater than the amount of medication left in the pen, you will not be able to mark a complete dose. You must discard your pen and take the complete dose of the medication with a new one.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the expiration date.Take a needle and check the expiration dateon the needle (Figure C).

Note:Remove your pen from the

refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the closure capsule from the pen and check the inspection window to ensure that the medication inside the pen is transparent and colorless (Figure D).

Important:If the medication has visible do notuse the pen. Use a new pen.

Figure D

Step 3

Remove the needle shield (Figure E).

This needle can only be used 1 time

Always use a new needle for each injection.

Figure E

Step 4

Place the needle directlyinto your

pen, and then screw the needle into the pen until it is secured

(Figure F).

Figure F

Step 5

Remove the needle protector and the inner

cover of the needle (Figure G)

Immediately discard the inner cover of the needle and keep the needle protector for later.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A - C) only the first time you use

a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the

right 2 clicksuntil you see the symbol

of a drop "" in the dosing window (Figure H).

Note:You can always correct the

selection by turning the dose selector.

Figure H

Step B

Make the air bubbles reach the

top of the pen by pressing the

inspection window (Figure I). Hold the pen with the needle tip

pointing upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the button and observe as the medication drops come out of the

needle tip. When pressing, make sure

that the dose selector turns back

to the “?” symbol (Figure J).

Important:If you do not see medication

drops, repeat this test

(steps A - C) up to 5 times.If you still do not see drops, change the needle and repeat the

test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas of your body where you can apply

the injection (Figure K).

Avoid applying the injection in areas of

red, swollen, or scarred skin.

Choose a different injection site each time you apply the injection.

Step 7

Wash your hands and clean the injection site with an alcohol swab (

Figure L).

Figure L

Step 8

Select your dose according to the doctor's indication (15, 18 or 21 micrograms)

by turning the dose selector to the

right

(Figure M).

Important:Make sure not to press

the button when selecting the dose

to avoid spilling the medication.

Note:Always discard your pen and use

a new one if you cannot mark a complete dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (steps 9 - 11) before starting to inject.

Step 9

Make sure you can see the dosing window Introduce the needle into the

skin (Figure N).

Figure N

Step 10

Press the button to the bottom and

hold it firmly

for 5 seconds. Make sure that the

dose selector turns back to the

“?” symbol. This means that you have

administered the complete dose

(Figure O).

Figure O

Step 11

Slowly withdraw the pen from the injection site.(Figure P)

Figure P

5 Discard the used needle

Step 12

Put the needle protector back on to carefully remove the needle.

Insert the needle tip into the protector and secure the protector on the needle (Figure Q).

Important:Always put the needle protector back on before removing the needle to reduce the risk of pricking and cross-contamination.

Figure Q

Step 13

Unscrew the needle and discard it

safely according to local regulations (Figure R).

Figure R

Step 14

Fit the closure capsule of the pen firmly onto the pen to protect it between injections and protect the medication from light (Figure S).

Figure S

6 Discard the used pen

Important:Always discard the

pen 14 days after the first use according to local regulations. To know

when 14 days have passed, it is recommended to cover the "Opening Date" field on the packaging.

Always discard your pen after 14 daysof use, even if there is still medication. This is

important to ensure that you receive the full effect of the medication.

Figure T

Important information you should know before starting to use your Yorvipath pen

Read and follow the package insert and these instructions for use carefully to be able to inject Yorvipath properly.

Make sure you have received training from your doctor or nurse before applying the injection. This is important to ensure that you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and, therefore, may not obtain the full effect of your medication.
• If you are blind or have visual impairment, or lack concentration do notuse your pen without help. Instead, ask for help from someone who has been trained in the use of the Yorvipath pen.
• Keep out of sight and reach of children.
• The pen and needles are for use in a single patient.
• Do notshare your pen or needles with other people. It could cause an infection (cross-contamination).
• Always discard your pen after 14 days, even if there is still medication. This is important to ensure that you receive the correct effect of the medication.
• Always use the needles that come with the Yorvipath pen for your injections.
• Remove the needle after each use. Do notkeep the pen with the needle on.
• Avoid bending or breaking the pen needle.
• Do notchange the injection angle after inserting the needle into the skin. Changing the angle can cause the needle to bend or break. A bent or broken needle can become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do notuse needles if the needle protector or needle shield is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injections, one after the other, in different injection sites (see the recommended schedule table in section 3 of the Package Insert).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if the two pens have the same color button (same concentration).
• Follow the steps in the instructions for use for each injection

Care of the pen

• Handle the pen with care.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do notdrop your pen or hit it against hard surfaces. If this happens, test the pen flow again (section 2, steps A - C) before the next use.
• Do not apply more force to your pen. It may be empty, damaged, or not function properly.
• Do notattempt to repair a damaged pen on your own.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you think it might be damaged) to avoid wasting medication. The test performs checks to ensure that the medication flows through the pen, so you can receive the correct doses of the medication.

1. I don't see drops after testing the pen flow 5 times. What should I

do?

If you do not see drops on the needle tip after 5 attempts,it may be because there is no flow in the pen and needle.

Change the needle (see section 5, step 12) and test the pen flow again (see section 2, steps A-C). You can ensure that the flow works correctly if you see the medication drop.

If it still does not work, discard the pen and consult your healthcare professional.

1. How do I know I have finished applying the injection?

The injection application is only complete when you press the button to the bottom and the

dose selector has turned back to the “?” and you have left the needle in the skin for 5 seconds.

1. Why do I have to keep pressing the pen on the skin for 5 seconds?

Part of the medication may flow back into the pen or back from the injection site and remain in the skin. Pressing the pen on the skin for 5 secondshelps ensure that all the medication has been injected.

1. I cannot mark the dose selector to the required dose. What should I do?

The pen does not allow setting a dose greater than what remains.

If your dose is greater than the amount of medication left in the pen, you will not be able to mark a complete dose. You must discard your pen and take the complete dose of the medication with a new one.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure

it is the correct concentration and

check the expiration date.Take a

needle and check the expiration dateon

the needle (Figure C).

Note:Remove your pen from the

refrigerator 20 minutes before the first use.

Figure C

Step 2

Remove the closure capsule from the pen and check the inspection window to ensure that the medication

inside the pen is transparent and colorless (Figure D).

Important:If the medication has

visible particles do notuse the pen. Use

a new pen.

Figure D

Step 3

Remove the needle shield (Figure E).

This needle can only be used 1 time

Always use a new needle for each injection.

Figure E

Step 4

Place the needle directlyinto your

pen, and then screw the needle into the pen until it is secured

(Figure F).

Figure F

Step 5

Remove the needle protector and the inner

cover of the needle (Figure G)

Immediately discard the inner cover of the needle and keep the needle protector for later.

Figure G

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A - C) only the first time you use

a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the

right 2 clicksuntil you see the drop

symbol "" in the dosing window (Figure H).

Note:You can always correct the

selection by turning the dose selector.

Figure H

Step B

Make the air bubbles reach the

top of the pen by pressing the

inspection window (Figure I). Hold

the pen with the needle tip

pointing upwards.

Note:Small air bubbles are acceptable.

Figure I

Step C

Press the plunger and observe as the

medication drops come out of the

needle tip. When pressing, make sure

the dose selector turns back to the

symbol "?" (Figure J).

Important:If you do not see medication

drops, repeat this test

(steps A - C) up to 5 times.If drops are still

not visible, change the needle and repeat the

test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas of your body where you can apply

the injection (Figure K).

Avoid applying the injection in areas of

red, swollen, or scarred skin.

Choose a different injection site each

time you apply the injection.

Step 7

Wash your hands and clean the injection site with an alcohol swab

(Figure L).

Figure L

Step 8

Select your dose according to the doctor's

indication (24, 27 or 30 micrograms)

by turning the dose selector to the

right

(Figure M).

Important:Make sure not to press the plunger when selecting the dose

to avoid spilling the medication.

Note:Always discard your pen and use

a new one if you cannot mark a complete dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (steps 9 - 11) before starting to inject.

Step 9

Make sure you can see the dosing window Insert the needle into the

skin (Figure N).

Figure N

Step 10

Press the plunger all the way down and hold it firmly

for 5 seconds. Make sure the dose selector turns back to the symbol "?". This means you have already administered the complete dose

(Figure O).

Figure O

Step 11

Slowly withdraw the pen from the

injection site (Figure P)

Figure P

5 Dispose of the used needle

Step 12

Put the needle protector back on to carefully remove the needle.

Insert the needle tip into the protector and secure the protector on the

needle (Figure Q).

Important:Always put the needle protector back on before removing the

needle to reduce the risk of pricking and cross-contamination.

Figure Q

Step 13

Unscrew the needle and dispose of it

safely according to local regulations

(Figure R).

Figure R

Step 14

Fit the pen cap firmly onto the pen to protect it

between injections and protect the

medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important:Always discard the

pen 14 days after the first use according to local regulations. To know

when 14 days have passed, it is recommended to cover the "Date of opening" field

on the inner packaging.

Always discard your pen after

14 days of use, even if there is still

medication (Figure T). This is

important to ensure you receive the

full effect of the medication.

Note: If the pen packaging includes

needles, remember to throw away the additional needle when disposing of the pen.

Figure T