Package leaflet: Information for the user

Hemlibra 30 mg/mL solution for injection

emicizumab
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

In addition to this leaflet, your doctor will provide you with a patient card and a guide (for patients and caregivers) containing important safety information you should be aware of. Always carry the patient card with you and show it to healthcare professionals, pharmacists or laboratory staff you encounter.

Contents of this leaflet

What Hemlibra is and what it is used for
What you need to know before using Hemlibra
How to use Hemlibra
Possible side effects
How to store Hemlibra
Contents of the pack and other information
Instructions for use

1. What Hemlibra is and what it is used for

What Hemlibra is
Hemlibra contains the active substance "emicizumab", which belongs to a group of medicines known as "monoclonal antibodies". Monoclonal antibodies are a type of protein that recognises and binds to a specific target in the body.

What Hemlibra is used for
Hemlibra is a medicine used to treat patients of all ages with haemophilia A (congenital factor VIII deficiency):

who have developed factor VIII inhibitors
who have not developed factor VIII inhibitors and have:
- severe disease (factor VIII level in the blood less than 1%)
- moderate disease (factor VIII level in the blood between 1% and 5%) with a severe bleeding phenotype.

Haemophilia A is an inherited disorder caused by the lack of factor VIII, a substance essential for blood clotting and stopping bleeding.
This medicine prevents bleeding episodes or reduces the number of bleeding episodes in people with this condition.
Some patients with haemophilia A may develop factor VIII inhibitors (antibodies directed against factor VIII) that interfere with the action of replacement factor VIII.

How Hemlibra works
Hemlibra restores the function of missing activated factor VIII, which is necessary for effective blood clotting. Because it has a different structure from factor VIII, Hemlibra is not affected by factor VIII inhibitors.

2. What you need to know before using Hemlibra

Do not use Hemlibra

if you are allergic to emicizumab or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor, pharmacist, or nurse before using Hemlibra.

Warnings and precautions
Before starting Hemlibra, it is very important that you speak with your doctor about the use of “bypassing agents” (medicines that promote blood clotting but work differently from factor VIII). This is because it may be necessary to modify treatment with bypassing agents during treatment with Hemlibra. Examples of bypassing agents include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (rFVIIa). Serious and potentially life-threatening side effects may occur when aPCC is used in patients who are also being treated with Hemlibra.

Potentially serious side effects associated with the use of aPCC during treatment with Hemlibra

Destruction of red blood cells (thrombotic microangiopathy)
- This is a serious and potentially fatal condition.
- In people with this condition, the lining of blood vessels may become damaged and blood clots may form in small vessels. In some cases, this can cause damage to the kidneys and other organs.
- Be cautious if you are at high risk of developing this disease (if you have had this disease in the past or if a family member has had it) or if you are taking medicines that may increase the risk of developing this disease, such as cyclosporine, quinine, or tacrolimus.
- It is important to be aware of the symptoms of thrombotic microangiopathy should this condition develop (for a list of symptoms, see section 4 “Possible side effects”).

Stop using Hemlibra and aPCC and contact a doctor immediately if you or the person caring for you notices any symptoms of thrombotic microangiopathy.

Formation of blood clots (thromboembolism)
- In rare cases, a blood clot may form inside blood vessels and block them; this could potentially be life-threatening.
- It is important to be aware of the symptoms of internal blood clot formation should they occur (for a list of symptoms, see section 4 “Possible side effects”).

Stop using Hemlibra and aPCC and seek immediate medical attention if you or the person caring for you notices any symptoms of blood clot formation in blood vessels.

Other important information about Hemlibra

Formation of antibodies (immunogenicity)
- You may notice that bleeding is no longer controlled with the prescribed dose of this medicine. This could be due to the development of antibodies directed against this medicine.

Contact a doctor immediately if you or your caregiver notice an increase in bleeding episodes. If this medicine no longer works for you, your doctor may decide to change your treatment.

Children under 1 year of age
In children under one year of age, the blood system is still developing. If your child is less than one year old, your doctor may prescribe Hemlibra only after carefully evaluating the expected benefits and risks of using this medicine.

Other medicines and Hemlibra
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Use of a bypassing agent during treatment with Hemlibra
- Before starting Hemlibra, talk to your doctor and carefully follow their instructions regarding when to use the bypassing agent, as well as the dose and administration regimen. Hemlibra increases the blood's ability to clot. For this reason, the required dose of the bypassing agent may be lower than the dose used before starting treatment with Hemlibra.
- Use aPCC only if no other treatments can be used. If aPCC is required, talk to your doctor if you think you need to receive a total dose exceeding 50 units/kg of aPCC. For more information on the use of aPCC during treatment with Hemlibra, see section 2 “Potentially serious side effects associated with the use of aPCC during treatment with Hemlibra”.
- Despite limited experience with concomitant administration of antifibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should be aware that thrombotic events may occur with intravenous antifibrinolytics administered in combination with aPCC or rFVIIa.

Laboratory tests
Inform your doctor that you are taking Hemlibra before undergoing laboratory tests to measure blood clotting ability. This is because Hemlibra in the blood may interfere with certain tests, leading to inaccurate results.

Pregnancy and breastfeeding

During treatment with Hemlibra and for 6 months after the last injection of the medicine, use an effective method of contraception.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Your doctor will evaluate the benefits you would receive from treatment with Hemlibra against the possible risks to the baby.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.

3. How to use Hemlibra

Hemlibra is supplied in single-use vials as a ready-to-use solution that does not require dilution.
A healthcare professional experienced in the treatment of patients with haemophilia will initiate your treatment with Hemlibra. Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your healthcare provider.
Keep a record
Each time you use Hemlibra, record the name and batch number of the medicine.
How much Hemlibra to use
The dose of Hemlibra depends on body weight, and your doctor will calculate the dose (in mg) and the corresponding volume of Hemlibra solution (in mL) to be injected.

Loading dose: Weeks 1 to 4: the dose is 3 milligrams per kilogram of body weight, administered once weekly.
Maintenance dose: From Week 5 onwards: the dose is 1.5 milligrams per kilogram of body weight, administered once weekly; or 3 milligrams per kilogram of body weight, administered every two weeks; or 6 milligrams per kilogram of body weight, administered every four weeks.

The decision to use a maintenance dose of 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks should be made in consultation with your doctor and your caregiver, if applicable.
Different concentrations of Hemlibra (30 mg/mL and 150 mg/mL) must not be combined in a single injection when preparing the total volume to be administered.
The volume of Hemlibra solution administered per injection must not exceed 2 mL.
How Hemlibra is administered
If you self-inject Hemlibra or if your caregiver administers the injection, you or your caregiver must read carefully and follow the instructions provided in section 7 “Instructions for use”.

Hemlibra is administered by subcutaneous injection (under the skin).
Your doctor or nurse will show you how to inject Hemlibra.
After appropriate training, you should be able to self-administer the medicine at home, either independently or with the help of a caregiver.
To correctly insert the needle under the skin, use your free hand to lift a fold of loose skin by pinching it at the previously disinfected injection site. This step is important to ensure that the injection is delivered under the skin (into the fatty tissue) and not deeper (into the muscle). Injecting into the muscle may cause discomfort.
Prepare and administer the injection under clean, germ-free conditions using an aseptic technique. Your doctor or nurse will provide further information on this.

Where to inject Hemlibra

Your doctor will show you the most suitable body areas for Hemlibra injection.
Recommended injection sites are the front of the waist (lower abdomen), the outer upper arms, or the front of the thighs. Only use the recommended injection sites.
For each injection, select a different body area from the one used previously.
Do not inject in areas where the skin is red, tender, or hardened, or where bruises, moles, or scars are present.
During treatment with Hemlibra, any other subcutaneously injected medicines should be administered in a different area.

Use of syringes and needles

To withdraw Hemlibra solution from the vial and administer it subcutaneously, a syringe, a 5-micron filter transfer needle or a vial adapter with a 5-micron filter, and an injection needle are used.
Syringes, filter transfer needles or vial adapters with filter, and injection needles are not included in this package. For further information, see section 6 “What is needed for the administration of Hemlibra and is not included in this package”.
Always use a new injection needle for each injection and dispose of it after a single use.
For injecting up to a maximum of 1 mL of Hemlibra solution, use a 1 mL syringe.
For injecting doses of Hemlibra solution greater than 1 mL up to 2 mL, use a 2 mL to 3 mL syringe.

Use in children and adolescents
Hemlibra can be used in adolescents and children of all ages.

A child may self-inject the medicine provided that a healthcare professional and one of the child's parents or caregivers agree. Self-injection is not recommended for children under 7 years of age.

If you use more Hemlibra than you should
If you use more Hemlibra than prescribed, inform your doctor immediately. This is because you may be at increased risk of developing side effects such as blood clots. Always use Hemlibra exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
If you forget to use Hemlibra

If you miss a scheduled injection, administer the missed dose as soon as possible, provided it is before the day of your next scheduled dose. Then continue with your regular dosing schedule. Do not administer two doses on the same day to make up for a missed dose.
If you are unsure what to do, consult your doctor, pharmacist, or nurse.

If you stop using Hemlibra
Do not stop treatment with Hemlibra without first discussing it with your doctor. Stopping treatment with Hemlibra may leave you unprotected against potential bleeding episodes.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects associated with aPCC use during treatment with Hemlibra
Stop using Hemlibra and aPCC and contact a doctor immediately if you or the person caring for you notices any of the following side effects:

Destruction of red blood cells (thrombotic microangiopathy):
- confusion, weakness, swelling in the arms and legs, yellowing of the skin and eyes, vague abdominal or back pain, nausea, vomiting, or reduced need to urinate; these symptoms could be signs of thrombotic microangiopathy.
Formation of blood clots (thromboembolism):
- swelling, warmth, pain or redness; these symptoms could be signs of a blood clot forming in a vein near the surface of the skin.
- headache, facial numbness, eye pain or swelling, or vision problems; these symptoms could be signs of a blood clot forming in a vein at the back of the eye.
- blackening of the skin; this symptom could be a sign of severe skin tissue damage.

Other side effects associated with the use of Hemlibra
Very common: may affect more than 1 in 10 people

reaction at the injection site (redness, itching, pain)
headache
joint pain.

Common: may affect up to 1 in 10 people

fever
muscle pain
diarrhoea
itchy rash or hives
rash.

Uncommon: may affect up to 1 in 100 people

destruction of red blood cells (thrombotic microangiopathy)
formation of a blood clot in a vein at the back of the eye (cavernous sinus thrombosis)
severe skin tissue damage (skin necrosis)
formation of a blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, together with breathing difficulties indicating angioedema
lack of effect or reduced response to treatment
allergic reaction.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemlibra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after the wording “Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
After removal from the refrigerator, unopened vials may be stored at room temperature (below 30 °C) for up to 7 days. After storage at room temperature, unopened vials may be returned to the refrigerator. The total storage time of the medicine at room temperature must not exceed 7 days.
Discard vials that have been stored at room temperature for more than 7 days or that have been exposed to temperatures above 30 °C.
Once transferred from the vial to the syringe, use Hemlibra immediately. Do not refrigerate the solution in the syringe.
Before using the medicine, inspect the solution for the presence of particles or changes in colour. The solution should be colourless to slightly yellow. Do not use this medicine if it is cloudy, shows changes in colour, or contains visible particles.
Dispose of any unused solution appropriately. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Hemlibra contains

The active substance is emicizumab. Each Hemlibra vial contains 12 mg (0.4 mL at a concentration of 30 mg/mL) or 30 mg (1 mL at a concentration of 30 mg/mL) of emicizumab.
The other components are L-arginine, L-histidine, L-aspartic acid, poloxamer 188, and water for injections.

Description of the appearance of Hemlibra and contents of the pack
Hemlibra is an injectable solution. It is a colourless to slightly yellow liquid.
Each Hemlibra pack contains 1 glass vial.
Not all pack sizes may be marketed.

What is needed for Hemlibra administration but not included in this pack
To withdraw the Hemlibra solution from the vial with a syringe and inject it under the skin, a syringe, a filter transfer needle or a filtered vial adapter, and an injection needle are required (see section 7 “Instructions for use”).

Syringes

1 mL syringe: transparent syringe made of polypropylene or polycarbonate with Luer-lock tip, graduated scale in 0.01 mL increments, or
2 mL to 3 mL syringe: transparent syringe made of polypropylene or polycarbonate with Luer-lock tip, graduated scale in 0.1 mL increments.

NB: If using a filtered vial adapter, syringes with low dead space (LDS) plungers must be used.

Transfer devices and needles

Filter transfer needle: stainless steel with Luer-lock connection, 18 G gauge, 35 mm long, containing a 5-micron filter, preferably with a semi-blunt tip, or
Filtered vial adapter: made of polypropylene with Luer-lock connection and integrated 5-micron filter, compatible with vial necks with an outer diameter of 15 mm, and
Injection needle: stainless steel with Luer-lock connection, 26 G (acceptable range: 25–27 G), preferably 9 mm long or up to a maximum of 13 mm long, preferably equipped with a needle safety device.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Lietuva
Luxembourg/Luxemburg UAB “Roche Lietuva”
N.V. Roche S.A.
Tel: +370 5 2546799
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

България
Рош България ЕООД
Тел: +359 2 474 54 44

Česká republika, Magyarország
Roche s.r.o.
Roche (Magyarország) Kft.
Tel: +420 – 2 20382111
Tel: +36 – 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 – 36 39 99 99

Deutschland, Nederland
Roche Pharma AG
Roche Nederland B.V.
Tel: +49 (0) 7624 140
Tel: +31 (0) 348 438050

Eesti, Norge
Roche Eesti OÜ
Roche Norge AS
Tel: +372 – 6 177 380
Tlf: +47 – 22 78 90 00

Ελλάδα, Κύπρος, Österreich
Roche (Hellas) A.E.
Roche Austria GmbH
Tel: +30 210 61 66 100
Tel: +43 (0) 1 27739

España, Polska
Roche Farma S.A.
Roche Polska Sp. z o.o.
Tel: +34 – 91 324 81 00
Tel: +48 – 22 345 18 88

France, Portugal
Roche
Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00
Tel: +351 – 21 425 70 00

Hrvatska, România
Roche d.o.o.
Roche România S.R.L.
Tel: +385 1 4722 333
Tel: +40 21 206 47 01

Ireland, Malta, Slovenija
Roche Products (Ireland) Ltd.
Roche farmacevtska družba d.o.o.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700
Tel: +386 – 1 360 26 00

Ísland, Slovenská republika
Roche Pharmaceuticals A/S
Roche Slovensko, s.r.o.
c/o Icepharma hf
Sími: +354 540 8000
Tel: +421 – 2 52638201

Italia, Suomi/Finland
Roche S.p.A.
Roche Oy
Tel: +39 – 039 2471
Puh/Tel: +358 (0) 10 554 500

Sverige
Roche AB
Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 – 6 7039831

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

7. Instructions for use

Option
Transfer needle with filter
(for transferring the medicine from the vial to the syringe)

Medical device shaped like a syringe or injection pen with a black plunger at the

Instructions for use

Hemlibra

Injection
Single-dose vial(s)

Before injecting Hemlibra, you must read, understand, and follow the instructions for use. Your healthcare provider must show you how to properly prepare, measure, and inject Hemlibra before you use it for the first time. If you have any questions, consult your healthcare provider.

Important information:
Do not use these instructions when using a vial adapter to withdraw Hemlibra from the vial.
These instructions are intended solely for use with the transfer needle.

Do not inject the medicine yourself or inject it into another person unless your healthcare provider has first shown you how to do so.
Ensure that the name Hemlibra appears on both the box and the vial label.
Before opening the vial, check the label to confirm you have the correct formulation(s) of the medicine required to administer your prescribed dose. You may need to use more than one vial to receive your correct dose.
Check the expiration date printed on the box and vial label. Do not use the medicine if the expiration date has passed.
Use the vial only once. After injecting the dose, discard any unused portion of Hemlibra remaining in the vial. Do not store unused medicine in the vial for future use.
Use only the syringes, transfer needles, and injection needles prescribed by your healthcare provider.
Use syringes, transfer needles, and injection needles only once. Dispose of any caps, vials, syringes, and used needles.
If your prescribed dose is greater than 2 mL, you will need to perform more than one subcutaneous injection of Hemlibra; contact your healthcare provider for instructions regarding the injection.
You must inject Hemlibra only under the skin.

Storage of Hemlibra vials:

Store the vial in the refrigerator (at a temperature between 2 °C and 8 °C). Do not freeze.
Keep the vial in its original packaging to protect the medicine from light.
Once removed from the refrigerator, the unopened vial may be stored at room temperature (below 30 °C) for up to 7 days. After storage at room temperature, unopened vials may be returned to the refrigerator. The total time outside the refrigerator and stored at room temperature must not exceed 7 days.
Discard vials that have been stored at room temperature for more than 7 days or exposed to temperatures above 30 °C.
Store vials out of sight and reach of children.
Remove the vial from the refrigerator 15 minutes before use and allow it to reach room temperature (below 30 °C) before preparing the injection.
Do not shake the vial.

Storage of needles and syringes:

Store the transfer needle, injection needle, and syringe in a dry place.
Keep the transfer needle, injection needle, and syringe out of sight and reach of children.

Inspection of medicine and materials:

Gather all the materials listed below to prepare and administer the injection.
Check the expiration date printed on the box, vial label, and listed materials below. Do not use the medicine or devices if the expiration date has passed.
Do not use the vial if:
- the medicine appears cloudy, not clear, or colored;
- the medicine contains particles;
- the closure cap is missing.
Inspect materials for any damage. Do not use materials if they appear damaged or have been dropped.
Place materials on a flat, clean, and well-lit work surface.

Included in the package:

Vial containing the medicine

Stylized drawing of a glass medical vial with a gray cap and partially filled liquid content

Instructions for use of Hemlibra

Stylized drawing of a white rectangular box with two horizontal black lines at the top and a thin line at the base

Not included in the package:

Alcohol wipes

Stylized drawing of two square adhesive bandages, a mesh gauze, and a white cotton ball on a neutral background

Note: If you need to use more than one vial to inject the prescribed dose, use a new alcohol wipe for each vial.

Gauze pad
Cotton ball
Syringe

Diagram of a syringe with parts labeled as plunger at the top and cylinder on the graduated body of the syringe

For injection of a dose up to 1 mL, use a 1 mL syringe.
For injection of a dose between 1 mL and 2 mL, use a 2 mL or 3 mL syringe.
Note: do not use 2 mL or 3 mL syringes for doses up to 1 mL.
18 G transfer needle with 5-micron filter

Technical drawing of a medical device with the

Note: If you need to use more than one vial to inject the prescribed dose, use a new transfer needle for each vial.
Do not use the transfer needle to inject the medicine.

Safety-protected injection needle

Technical schematic of a medical device with a cap containing the

(used to administer the medicine).

Do not use the injection needle to withdraw medicine from the vial.
Sharps disposal container

White container with a flat lid displaying at the center the black biohazard symbol for disposal of medical waste

Preparation:

Before use, place the vial(s) on a

Medicine vial next to a clock with an arrow indicating the passage of 15 minutes

flat, clean surface, protected from direct sunlight, for about 15 minutes, allowing it to reach room temperature.

Do not attempt to warm the vial by other means.
Wash your hands thoroughly with soap and water.

Selection and preparation of the injection site:

Clean the selected injection site area with an

Medical diagram indicating injection sites on a human body: abdomen, thigh, and upper arm with an enlarged detail of the shoulder

alcohol wipe.

Allow the skin to dry for about 10 seconds.
Do not touch, fan, or blow on the cleaned area before injection.

You may use the following sites for injection:

Thigh (central front area).
Abdominal area (except within 5 cm around the navel).
Upper outer arm (only if the injection is administered by a caregiver).
Use a different injection site for each injection, at least 2.5 cm away from the area used for the previous injection.
Do not inject the medicine into areas that may be irritated by a belt or waistband.
Do not inject the medicine into moles, scars, bruises, or areas where the skin is painful, red, hardened, or damaged.

Preparation of the syringe for injection:

Once the syringe is filled with medicine, the injection must be administered immediately.
After removing the injection needle cap, the medicine in the syringe must be injected under the skin within 5 minutes.
After removing the cap, do not touch the exposed needles or place them on any surface.
Do not use the syringe if the needle comes into contact with any surface.

Important information after injection:

If blood droplets appear at the injection site, press a cotton ball or sterile gauze pad over the site for at least 10 seconds until bleeding stops.
If bruising occurs (a small area of bleeding under the skin), you may apply an ice pack gently to the site. If bleeding does not stop, contact your healthcare provider.
Do not rub the injection site after administration.

Disposal of medicine and materials:
Important: Always keep the sharps disposal container out of reach of children.

Dispose of all used caps, vials, needles, and syringes in a sharps disposal container or puncture-resistant container.
Place used needles and syringes into a sharps disposal container immediately after use. Do not dispose of loose caps, vials, needles, or syringes in household waste.
If you do not have a sharps disposal container, you may use a designated household collection container that:
- is made of heavy-duty plastic;
- has a tight, puncture-resistant lid that prevents leakage of sharp objects;
- remains upright and stable during use;
- is leak-proof;
- is properly labeled with a warning indicating the presence of hazardous waste inside.
When the sharps disposal container is nearly full, follow local regulations for proper disposal of the container.
Do not dispose of used sharps disposal containers in household waste, unless permitted by local regulations. Do not recycle the sharps disposal container.

1. PREPARATION

Step 1. Remove the vial cap and clean the top

Remove the cap(s) from the vial(s).

Two hands holding a small vial with liquid and removing the protective cap on top for drug preparation

Dispose of the vial cap(s) in the sharps disposal container.

Schematic drawing of a glass vial with liquid and a square protective cover being removed with a curved arrow pointing

Disinfect the top of the vial closure with an alcohol wipe.

Step 2. Attach the transfer needle with filter to the syringe

Technical drawing of a syringe being pushed toward a vial and then rotated with a circular arrow and a horizontal arrow pointing left

Push and screw the transfer needle with filter onto the syringe clockwise until it is securely attached.

Slowly pull back the plunger to draw an amount of air into the syringe equal to the prescribed dose.

Step 3. Remove the cap from the transfer needle

Hold the syringe by the barrel, with the transfer needle pointing upward.

Two hands screwing a needle onto a syringe with a double-headed arrow indicating the rotational assembly movement

Carefully remove the cap from the transfer needle, keeping it away from your body. Do not discard the cap. Place the transfer needle cap on a clean, flat surface. After transferring the medication, you will need to replace this cap on the transfer needle.
Do not touch the tip of the needle or place it on any surface after removing the cap.

Step 4. Inject air into the vial

Place the vial on a flat work surface and insert the transfer needle (attached to the syringe) into the center of the vial stopper.

A hand holds a syringe with needle pointing toward the cap of a glass vial containing liquid with a downward arrow

Invert the vial, holding it with the needle and syringe still attached.

Technical drawing showing a syringe with needle directed toward a vial and a curved arrow indicating rotation toward the

With the needle pointing upward, push the plunger to inject the air previously drawn into the syringe above the medication level.

Technical drawing showing a hand holding a glass vial while the

Keep your finger pressed on the plunger of the syringe.
Do not inject air into the medication itself, as this may cause air bubbles or foaming.

Step 5. Transfer the medication into the syringe

Move the tip of the needle downward so that it is positioned below the level of the medication.

Two hands holding a vial and a syringe while the plunger is pulled down to aspirate liquid through the

With the syringe pointing upward, slowly pull back the plunger to fill the syringe with an amount of medication greater than the prescribed dose.
Firmly hold the plunger to prevent it from moving back.
Be careful not to pull the plunger out of the syringe.

Important: If the prescribed dose exceeds the amount of Hemlibra contained in one vial,
withdraw all the medication and proceed to the section “Combining vials”.

Step 6. Remove air bubbles

Two hands holding a syringe to aspirate liquid from a vial with an enlarged detail of the

Keep the needle in the vial and inspect the syringe for large air bubbles. Large air bubbles may result in an incomplete dose being administered.
Remove larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. Move the needle tip above the medication level and gently press the plunger to expel the air bubbles from the syringe.

Two vertical syringes with gray liquid; the one on the left has a control checkmark, the one on the right has an error cross above air bubbles

If the amount of medication in the syringe is equal to or less than the prescribed dose, move the needle tip into the medication and slowly pull back the plunger until the amount of medication in the syringe is greater than the prescribed dose.
Be careful not to completely remove the plunger from the syringe.
Repeat the previous steps until the larger air bubbles are removed.

Note: Before proceeding to the next step, ensure that the amount of medication in the syringe is sufficient to administer the full dose. If you are unable to withdraw all the medication, return the vial to an upright position to access the remaining volume.

Hazard symbol composed of a black exclamation mark at the

Do not use the transfer needle to inject the medication, as this may cause pain and bleeding.

2. INJECTION

Step 7. Replace the cap on the transfer needle

Remove the syringe attached

from the transfer needle.

With one hand, insert the transfer needle into the cap and lift it up to cover the needle.
Once the needle is covered, push with one hand the transfer needle cap onto the syringe to secure it firmly, to avoid accidental needle injury.

Step 8. Disinfect the injection site

Choose the injection site and disinfect it

with an alcohol wipe.

Step 9. Remove the used transfer needle from the syringe

Technical drawing of a syringe with arrows indicating to rotate the terminal part and pull to separate the two components with underlying text

* Remove the used transfer needle from the syringe by rotating it counterclockwise and gently pulling it off. * Dispose of the used transfer needle in a sharps disposal container.

Step 10. Attach the injection needle to the syringe

Diagram showing a syringe to be connected to a device via a horizontal arrow and a circular arrow with the text 'Push and screw'

* Push the injection needle onto the syringe and rotate it clockwise until it is securely attached.

Step 11. Move the safety shield

A hand rotates a plastic device downward to attach it to the terminal end of a medical injection pen

* Slide the safety shield away from the needle, moving it **toward** the syringe barrel.

Step 12. Remove the cap from the injection needle

Carefully and firmly, remove the

injection needle cap from the syringe.

Dispose of the cap in a sharps disposal container.
Do not touch the tip of the needle and avoid contact with any surface.
After removing the injection needle cap, the medicine in the syringe must be injected within 5 minutes.

Step 13. Position the plunger at the prescribed dose level

Hold the syringe with the needle pointing

upward and slowly push the plunger until the prescribed dose is reached.

Verify the dose, ensuring that the upper edge of the plunger aligns with the mark on the syringe corresponding to the prescribed dose.

Step 14. Subcutaneous injection (under the skin)

Pinch the selected injection site and insert the needle fully at an angle

between 45° and 90°, with a quick and
decisive motion. Do not hold or press the plunger
during needle insertion.

Keep the syringe in position and release the pinched injection site.

Step 15. Injecting the medicine

Inject the full amount of medicine slowly by gently pressing the plunger

to its full extent.

Remove the needle and syringe from the injection site, maintaining the same angle used during insertion.

3. DISPOSAL

Step 16. Cover the needle with the safety shield

Slide the safety shield forward by 90°, moving it away from the syringe barrel.

A hand holds a tilted syringe being pushed downward onto a medical device with an arrow indicating the downward movement

Holding the syringe in one hand, press downward firmly and quickly with the safety shield onto a flat surface until you hear a "click".
If you do not hear a "click", check that the needle is completely covered by the safety shield.

Stylized drawing of a hand holding a graduated syringe with an arrow indicating the

Always keep your fingers behind the safety shield and away from the needle.
Do not unscrew the injection needle from the syringe.

Step 17. Dispose of the syringe and needle

Place used needles and syringes immediately after use into a

Stylized drawing of a syringe with needle being inserted into a biological waste container marked with the biohazard symbol

sharps disposal container. For further information, refer to the section "Disposal of the medicine and materials".

Do not attempt to remove the used injection needle from the syringe.
Do not recap the injection needle.
Important: Always keep the sharps disposal container out of the reach of children.
Discard all caps, vials, needles, and syringes into a sharps or puncture-resistant disposal container.

Combining vials
If more than one vial is needed to achieve the prescribed dose, follow these steps after withdrawing medicine from the first vial as described in Step 5. A new transfer needle must be used for each vial.
Step A. Recap the transfer needle

Remove the syringe and transfer needle

A hand holds a syringe on a flat surface while another cylindrical component is inserted into the top of the syringe

from the first vial.

With one hand, insert the transfer needle into its cap and lift the cap up to cover the needle.
After covering the needle, press with one hand the transfer needle cap onto the syringe to secure it firmly, to prevent accidental needlestick injury.

Step B. Remove the used transfer needle from the syringe

Remove the used transfer needle

Technical drawing of a syringe with arrows indicating to rotate the right component and pull it toward the

from the syringe by turning it counterclockwise and pulling gently.

Discard the used transfer needle into a sharps disposal container.

Step C. Attach a new filtered transfer needle to the syringe

Push a new transfer needle with filter

Technical drawing of a syringe being assembled by joining the barrel to the connector with a curved arrow indicating the screwing motion

onto the same syringe, turning it clockwise until it is securely attached.

Slowly pull back the plunger to draw a small amount of air into the syringe.

Step D. Remove the cap from the transfer needle

Hold the syringe barrel with the

transfer needle cap pointing upward.

Carefully but firmly pull off the transfer needle cap, keeping it away from your body. Do not discard the cap—after transferring the medicine, you will need to recap the transfer needle.
Do not touch the tip of the needle.

Step E. Inject air into the vial

Place the new vial on a

flat working surface and insert the new transfer needle, attached to the syringe, into the center of the vial stopper.

Invert the vial, keeping the needle

Technical drawing showing a syringe with needle inserted into a glass vial to withdraw content via a rotational movement

attached to the syringe in place.

With the needle pointing upward, press the

Line drawing of a hand holding a glass vial with a syringe needle inserted into the rubber stopper for drug withdrawal

plunger to inject the air previously drawn into the syringe above the medicine.

Keep your finger pressed on the syringe plunger.
Do not inject air into the medicine, as this may cause air bubbles or foaming.

Step F. Transfer medicine into the syringe

Move the needle tip downward so that it is

Two hands holding a vial and a syringe with a needle inserted into the stopper to aspirate liquid downward

positioned below the level of the medicine.

With the syringe pointing upward, slowly pull back the plunger to fill the syringe with an amount of medicine greater than the prescribed dose.
Hold the plunger firmly to prevent it from moving back.
Be careful not to pull the plunger out of the syringe.

Note: Before proceeding to the next step, ensure that the amount of medicine in the syringe is sufficient for the full dose. If you cannot withdraw all the medicine, return the vial to an upright position to access the remaining amount.

Warning symbol composed of a black exclamation mark at the

Do not use the transfer needle to inject the medicine, as this may cause pain and bleeding.
Repeat steps A to F for each additional vial, until you have withdrawn a total amount of medicine exceeding the prescribed dose. Once completed, keep the transfer needle inserted in the vial and return to Step 6, "Remove air bubbles". Continue with the remaining steps.
Option
Filtered vial adapter
(for transferring medicine from vial to syringe)

Technical drawing of a cylindrical vial with a top cap and wide base characterized by small circular holes arranged on both sides

Instructions for use