HEMLIBRA 150 mg/mL Injectable Solution

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Roche Products (Ireland) Ltd.

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Transfer Needle with Filter

Option

(for transferring the medication from the vial to the syringe)

You must read, understand, and follow the instructions for use before injecting Hemlibra. Your healthcare professional should teach you how to prepare, measure, and inject Hemlibra correctly before you use it for the first time. If you are unsure, consult your healthcare professional.

Important Information:

Do not follow these instructions when using a Vial Adapter to transfer Hemlibra from the vial. These instructions are only used with the Transfer Needle

? Do not inject yourself or another person unless your healthcare professional has taught you how to do it.

? Check that the name Hemlibra appears on the box and the vial label.

? Before opening the vial, read the vial label to check that you have the medication of the correct concentration to administer the prescribed dose for you. You may need to use more than 1 vial to administer the correct total dose.

? Check the expiration date on the box and the vial label. Do notuse it after the expiration date.

? Onlyuse the vial once.Once the dose is injected, discard the remaining Hemlibra solution in the vial. Do not store unused medication in the vial for later use.

? Onlyuse the syringes, transfer needles, and injection needles prescribed by your healthcare professional.

? Only usethe syringes, transfer needles, and injection needles once. Discard the caps, vial(s), and used syringes and needles.

? If the prescribed dose is more than 2 ml, you will need to administer more than one subcutaneous injection of Hemlibra; contact your healthcare professional for proper injection instructions.

? You must inject Hemlibra only under the skin.

Storage of Hemlibra Vials:

? Store the vial in the refrigerator (2 ºC to 8 ºC). Do notfreeze.

• Store the vial in its original packaging to protect the medication from light.

• Once removed from the refrigerator, the unopened vial can be stored at room temperature (below 30 ºC) for a maximum of 7 days. After storage at room temperature, unopened vials can be returned to the refrigerator. The total time of storage outside the refrigerator and at room temperature should not exceed 7 days.

? Discard vials that have been stored at room temperature for more than 7 days or have been at a temperature above 30°C.

? Keep vials out of sight and reach of children.

? Remove the vial from the refrigerator 15 minutes before use and let it reach room temperature (below 30 ºC) before preparing an injection.

• Do notshake the vial.

Storage of Needles and Syringes:

? Keep the transfer needle, injection needle, and syringe dry.

• Keep the transfer needle, injection needle, and syringe out of sight and reach of children.

Inspection of Medication and Materials:

? Gather all the materials mentioned below to prepare and administer the injection.

? Checkthe expiration date on the box, vial label, and the materials mentioned below. Do not usethem after the expiration date.

? Do not usethe vial if:

• the medication is cloudy, hazy, or has changed color.
• the medication contains particles.
• the cap that covers the stopper is missing.

? Inspect the materials for damage. Do not use them if they appear damaged or have fallen to the ground.

? Place the materials on a flat, clean, and well-lit work surface.

For injection, you can use:

? The thigh (front and middle).

? The stomach area (abdomen), except for the 5 cm around the navel.

? The outer area of the upper arm (only if the caregiver administers the injection).

? You must use a different injection site each time you apply an injection, at least 2.5 cm away from the one used in any previous injection.

? Do notinject into areas that may be irritated by a belt or band.

• Do notinject into moles, scars, bruises, or areas where the skin is sensitive, red, hardened, or damaged.

Preparing the Syringe for Injection:

? When you have filled the syringe with the medication, you must use it immediately.

? Once the injection needle cap is removed, the medication must be injected under the skin within 5 minutes.

• Do nottouch exposed needles or leave them on a surface once the cap is removed.

• Do notuse the syringe if the needle touches any surface.

Important Information After Injection:

? If you notice blood drops at the injection site, you can press it with a sterile cotton swab or gauze for at least 10 seconds until the bleeding stops.

? If you have a hematoma (a small bleed under the skin), you can also apply ice with gentle pressure. If the bleeding does not stop, contact a healthcare professional.

? Do notrub the injection site after injection.

Disposal of Medication and Materials:

Important: Always keep the sharp object container out of the reach of children.

Discard any used caps, vials, needles, and syringes in a sharp object container.

• Discard used needles and syringes in a sharp object container immediately after use. Do notdiscard caps, vials, needles, or syringes loose in household trash.

? If you do not have a sharp object container, you can use a household trash container that:

• is made of reinforced plastic.
• can be closed with a tight and puncture-resistant lid that does not allow sharp objects to escape.
• is kept upright and stable during use.
• is leak-proof.
• is correctly labeled to indicate that it contains hazardous waste.

? When the sharp object container is almost full, you must follow local guidelines for proper disposal.

? Do notdiscard any used sharp object container in household trash unless local guidelines permit it. Do not recycleyour sharp object container.

1. PREPARATION

Step 1. Remove the Vial Cap and Clean the Top

Step 2. Attach the Transfer Needle with Filter to the Syringe

Step 3. Remove the Transfer Needle Cap

• Do nottouch the tip of the needle or place it on any surface after removing the needle cap.

• Keep the vial on a flat work surface and insert the transfer needle and syringe just into the centerof the vial stopper.

• Keep the needle in the vial and turn it upside down.

• With the needle pointing upward, push the plunger to inject the air from the syringe above the medication.

• Without changing position, continue pushing the syringe plunger with your finger.

• Do notinject air into the medication, as it may form air bubbles or foam inside.

• Slide the tip of the needle downward so that it is inside the medication.
• With the syringe facing upward, slowly pull the plunger back to fill the syringewith more than the amount of medicationneeded for the prescribed dose.
• Hold the plunger firmlyto ensure it does not retract.
• Try not to pull the plunger out of the syringe.

• Keep the needle in the vial and check that there are no large air bubbles in the syringe. Large bubbles can reduce the received dose.

• Remove the larger air bubblesby gently tapping the syringe body with your fingers until the air bubbles rise to the top of the syringe. Move the tip of the needle above the medicationand slowly push the plunger upward to remove the air bubbles from the syringe.
• If the amount of medication in the syringe is now equal to or less than the prescribed dose, move the tip of the needle to the inside of the medicationand slowly pull backthe plunger until you have morethan the amount of medication needed for the prescribed dose.
• Try not to pull the plunger out of the syringe.
• Repeat the above steps until the larger air bubbles have been removed.

• Remove the syringe and transfer needle from the vial.

• Using one hand, insertthe transfer needle into the cap and push upwardto cover the needle.

• Once the needle is covered, push the transfer needle cap toward the syringe to secure it completely with one handto avoid accidentally pricking yourself with the needle.

• Select and cleanthe injection site with an alcohol swab.

• Remove the used transfer needle from the syringe by twisting it counterclockwise and pulling it gently.
• Discard the used transfer needle in a sharps container.

• Push and twist the injection needle clockwise onto the syringe until it is securely attached.

• Remove the safety protector from the needle by sliding it towardthe syringe body.

• Carefully, pull the injection needle cap straight off the syringe.
• Discard the cap in a sharps container.
• Do nottouch the tip of the needle or allow it to touch any surface.
• After removing the injection needle cap, the medication in the syringe must be injected within 5 minutes.

• Hold the syringe with the needle pointing upward and slowly push the plunger until you reach the prescribed dose.

• Check your dose, make sure the top edge of the plunger is aligned with the syringe mark corresponding to the prescribed dose.

• Pinch the selected injection site and insert the needle completely at an angle of between 45° and 90°with a quick and firm motion. Do nothold or push the plunger while inserting the needle.

• Maintain the position of the syringe and release the pinched injection site.

• Slowly inject all the medication by gently pressing the plunger until it reaches the end.

• Remove the needle and syringe from the injection site at the same angle you inserted them.

• Slide the safety protector forward 90°, away from the syringe body.

• Holding the syringe with one hand, press the safety protectordownwardagainst a flat surface with a firm and quick motion until you hear a “click”.

• If you do not hear the click, check that the needle is completely covered by the safety protector.

• Keep your fingers behind the safety protector and away from the needle at all times.

• Do notseparate the injection needle.

• Dispose of used needles and syringes in a sharps container immediately after use. For more information, refer to the section “Disposal of medication and materials”.

• Do notattempt to remove the used injection needle from the syringe.

• Do notrecapthe injection needle.

• Important:Always keep the sharps container out of the reach of children.

• Discard any caps, vial(s), needles, and syringes in the sharps container.

Combining vials

If you need to use more than 1 vial to reach the prescribed dose, follow these steps after withdrawing the medication from the first vial as described in step 5. You must use a new transfer needle for each vial.

• Remove the syringe and transfer needle from the first vial.

• Usingonehand, insert the transfer needle into the cap and push upwardto cover the needle.

• Once the needle is covered, push the transfer needle cap toward the syringe to secure it completely with one handto avoid accidentally pricking yourself with the needle.

• Remove the used transfer needle from the syringe by twisting it counterclockwise and pulling it gently.
• Discard the used transfer needle in a sharps container.

• Push and twist a new transfer needle clockwise onto the syringe until it is securely attached.
• Slowly pull the plunger back and introduce a little air into the syringe.

• Hold the syringe body with the transfer needle cap pointing upward.
• Carefully remove the transfer needle cap, keeping it away from you. Do not discard the cap.You will need to recapture the transfer needle after transferring the medication.
• Do nottouch the tip of the needle.

• With the new vial on a flat work surface, insert the new transfer needle and syringe just into the centerof the vial stopper.

• Keep the transfer needle in the vial and turn it upside down.

• With the needle pointing upward, inject the air from the syringe above the medication.

• Keep your finger pressing on the plunger in the same position.

• Do notinject air into the medication, as it may form air bubbles or foam inside.

• Slide the tip of the needle downward so that it is inside the medication.
• With the syringe facing upward, slowly pull the plunger back to fill the syringe bodywith more than the amount of medicationneeded for the prescribed dose.
• Hold the plunger firmlyto ensure it does not retract.
• Try not to pull the plunger out of the syringe.

Note: Make sure you have enough medication in the syringe to complete the dose before proceeding to the next steps. If you cannot withdraw all the medication, turn the vial upside down to reach the remaining amount.

Repeat steps A to F with each additional vial until you have more than the amount of medication needed for your prescribed dose. When you have finished, keep the transfer needle inserted in the vial and return to step 6 “Remove air bubbles”. Continue with the remaining steps.

Vial adapter with filter

Option

(for transferring medication from the vial to the syringe)

Instructions for Use

Hemlibra

Injection

Single-dose vial(s)

You must read, understand, and follow the Instructions for Use before injecting Hemlibra. Your healthcare professional should teach you how to prepare, measure, and inject Hemlibra correctly before you use it for the first time. If you have any questions, consult your healthcare professional.

Important information:

Do not follow these instructions when using a transfer needle to transfer Hemlibra from the vial. These instructions are only used with the vial adapter.

• Do notinject yourself or another person unless your healthcare professional has taught you how to do it.
• Check that the name Hemlibra appears on the box and the vial label.
• Before opening the vial, read the vial label to check that you have the correct concentration of the medication to administer the prescribed dose for you. You may need to use more than 1 vial to administer the correct total dose.
• Check the expiration date on the box and the vial label. Do not useit after the expiration date.
• Use the vial only once.Once the dose is injected, discard the remaining Hemlibra solution in the vial. Do notstore unused medication in the vial for later use.
• Only use the syringes, vial adapters, and injection needles prescribed by your healthcare professional.
• Only use the syringes, vial adapters, and injection needles once. Discard used caps, vial(s), syringes, and needles.
• If the prescribed dose is greater than 2 ml, you will need to administer more than one subcutaneous injection of Hemlibra; contact your healthcare professional for proper injection instructions.
• You must inject Hemlibra only under the skin.

Storage of Hemlibra vials:

• Store the vial in the refrigerator (2°C to 8°C). Do notfreeze.
• Store the vial in its original packaging to protect the medication from light.
• Once removed from the refrigerator, the unopened vial can be stored at room temperature (below 30°C) for at least 7 days. After storage at room temperature, unopened vials can be returned to the refrigerator. The total time of storage at room temperature should not exceed 7 days.

Prepare:

• Before using it/them, leave the vial(s) for about 15 minutes on a flat, clean, and sun-protected surface to reach room temperature.
• Do notattempt to heat the vial in any other way.
• Wash your handsthoroughly with water and soap.

Selection and preparation of the injection site:

• Clean the injection site area with an alcohol wipe.
• Let the skin dry for about 10 seconds.
• Do nottouch, fan, or blow on the cleaned area before injection.

For injection, you can use:

• The thigh (front and middle).
• The stomach area (abdomen), except for the 5 cm around the navel.
• The outer area of the upper arm (only if the caregiver administers the injection).
• You must use a different injection site each time you apply an injection, at least 2.5 cm away from the one used in any previous injection.
• Do notinject into areas that may be irritated by a belt or girdle.

• Do notinject into moles, scars, bruises, or areas where the skin is sensitive, red, hardened, or damaged.

Preparing the syringe for injection:

• When you have filled the syringe with the medicine, the injection must be administered immediately.
• Once the injection needle cap is removed, the medicine must be injected under the skin within 5 minutes.
• Do nottouch exposed needles or leave them on any surface after removing the cap.
• Do notuse the syringe if the needle touches any surface.

Important information after injection:

• If you notice blood droplets at the injection site, you can press it with a sterile cotton ball or gauze for at least 10 seconds until the bleeding stops.
• If you have a hematoma (a small bleed under the skin), you can also apply ice with gentle pressure. If the bleeding does not stop, contact a healthcare professional.
• Do notrub the injection site after injection.

Disposal of medicine and materials:

Important: Always keep the sharps container out of the reach of children.

• Discard any used cap(s), vial(s), vial adapters, needles, and syringes in a sharps container.
• Dispose of vial adapters, needles, and syringes in a sharps container. Do notdiscard caps, vials, needles, or syringes loose in household trash.
• If you do not have a sharps container, you can use a household trash container that:
• • is made of reinforced plastic.
  • can be closed with a tight and puncture-resistant lid that does not allow sharps to escape.
  • is kept upright and stable during use.
  • is leak-proof.
  • is properly labeled as containing hazardous waste.
• When the sharps container is almost full, you must follow local guidelines for proper disposal.
• Do notdiscard any used sharps container in household trash unless local guidelines permit it. Do not recycleyour sharps container.

1. PREPARE

Step 1. Remove the vial cap and clean the top

• Remove the cap from the vial(s).
• Discard the cap(s) in the sharps container.

• Clean the top of the stopper of the vial(s) with an alcohol wipe.

Step 2. Insert the vial adapter into the vial

• Open the blister pack by peeling off the cover.

Do not removethe vial adapter from the transparent plastic blister.

• Press the plastic blister with the vial adapter firmly down onto the new vial until you hear a “click”.

• Remove and discard the plastic blister.
• Do not touchthe tip of the vial adapter.

Step 3. Connect the syringe to the vial adapter

• Remove the syringe cap(if applicable).
• Push and turn the syringe clockwiseonto the vial adapter until it is fully secured.

Step 4. Transfer the medicine to the syringe

• Hold the vial adapter in place on the syringe and turn the vial upside down.

• With the syringe facing up, slowly pull back the plunger to fill the syringewith more than the required amount of medicinefor the prescribed dose.
• Hold the plunger firmly in placeto ensure it does not retract.
• Try not to pull the plunger out of the syringe.

Important:if the prescribed dose is more than the amount of Hemlibra in the vial, withdraw all the medicineand consult the “Vial combination”section now.

Step 5. Remove air bubbles

• Hold the vial in place on the syringe and check that there are no large air bubbles. Large air bubbles can reduce the dose received.

• Remove large air bubbles by gently tappingthe syringe body with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plungerto remove the large air bubbles from the syringe.
• If the amount of medicine in the syringe is now equal to or less than the prescribed dose, slowly pull back the plunger until you have morethan the required amount of medicine for the prescribed dose.
• Try not to pull the plunger out of the syringe.
• Repeat the above steps until the large air bubbles have been removed.

Note:make sure you have enough medicine in the syringe to complete the dose before proceeding to the next step.

1. INJECTION

Step 6. Clean the injection site

• Select and cleanthe injection site with an alcohol wipe.

Step 7. Remove the syringe from the vial adapter

• Remove the syringe from the vial adapter by turning it counterclockwise and gently pulling it.
• Discard the used vial/vial adapter in a sharps container.

Step 8. Place the injection needle on the syringe

• Push and turn the injection needle clockwise onto the syringe until it is fully secured.
• Do notinsert the injection needle into the vial adapter to extract the medicine from the vial.

Step 9. Remove the safety protector

• Remove the safety protector from the needle by sliding it towardthe syringe body.

Step 10. Uncover the injection needle

• Carefully, pull the needle cap straight off the syringe.
• Discard the cap in a sharps container.
• Do nottouch the needle tip or allow it to touch any surface.
• After removing the needle cap, the medicine in the syringe must be injected within 5 minutes.

Step 11. Adjust the plunger according to the prescribed dose

• Hold the syringe with the needle facing up and slowly push the plunger until you reach the prescribed dose.
• Check your doseand make sure the top edge of the plunger is aligned with the syringe mark corresponding to the prescribed dose.

Step 12. Subcutaneous injection (under the skin)

• Pinch the selected injection site and insert the needle completely at an angle of between 45° and 90°with a quick and firm motion. Do not hold or push the plunger while inserting the needle.
• Maintain the position of the syringe and release the pinched injection site.

Step 13. Inject the medicine

• Slowly inject all the medicine by gently pressing the plunger until it reaches the end.
• Remove the needle and syringe from the injection site at the same angle you inserted them.

1. DISPOSAL

Step 14. Cover the needle with the safety protector

• Slide the safety protector forward 90°, away from the syringe body.
• Holding the syringe with one hand, press the safety protector downagainst a flat surface with a firm and quick motion until you hear a “click”.

• If you do not hear the click, check that the needle is completely covered by the safety protector.

? Keep your fingers behind the safety protector and away from the needle at all times.

? Do notseparate the injection needle.

Step 15. Discard the syringe and needle

• Dispose of used needles and syringes in a sharps container immediately after use. For more information, see the section “Disposal of medicine and materials”.
• Do notattempt to remove the used injection needle from the syringe.
• Do notrecap the injection needle.
• Important:always keep the sharps container out of the reach of children.
• Discard any cap(s), vial(s), needles, and syringes in the sharps container.

Vial Combination

If you need to use more than 1 vial to reach the prescribed dose, follow these steps after extracting the medication from the first vial as described in step 4. You must use a new vial adapter for each vial.

Step A. Insert a new vial adapter into the new vial

• Peel off the cap to open the blister.

Do not removethe vial adapter from the transparent plastic blister.

• Press the plastic blister firmly downwards with the vial adapter on the new vial, until you hear a “click”.

• Remove and discard the plastic blister.
• Do not touchthe tip of the vial adapter.

Step B. Extract the syringe from the used vial adapter

• Remove the syringe from the used vial adapter by turning it counterclockwise and pulling gently.
• Discard the used vial and vial adapter in a sharps container.

Step C. Place the syringe on the new vial adapter

• Push and turn the same syringe clockwiseon the new vial adapter until it is fully secured.

Step D. Transfer the medication to the syringe

• Hold the vial adapter secured on the syringe and turn the vial upside down.

• With the syringe facing upwards, slowly pull back the plunger to fill the syringewith more than the amount of medicationneeded for the prescribed dose.
• Hold the plunger firmlyto ensure it does not retract.

• Try not to pull the plunger out of the syringe.

Note:Check that you have enough medication in the syringe to complete the dose before proceeding to the next step.

Repeat steps A to D with each additional vial until you have more than the amount of medication needed for your prescribed dose. When finished, keep the vial adapter on the vial and return to step 5 “Extract air bubbles”. Continue with the remaining steps.