This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
How to use HEMLIBRA 30 mg/mL Injectable Solution
Introduction
Package Leaflet: Information for the User
Hemlibra 30mg/ml solution for injection
emicizumab
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 further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In addition to this leaflet, your doctor will give you a patient information card that contains important safety information you need to know. Keep this card with you.
Contents of the package leaflet
What is Hemlibra and what is it used for
What you need to know before you use Hemlibra
How to use Hemlibra
Possible side effects
Storage of Hemlibra
Contents of the pack and other information
Instructions for use
1. What is Hemlibra and what is it used for
What is Hemlibra
Hemlibra contains the active substance “emicizumab”. This belongs to a group of medicines called “monoclonal antibodies”. Monoclonal antibodies are a type of protein that recognizes and binds to a target in the body.
What Hemlibra is used for
Hemlibra is a medicine that can be used to treat patients of all ages with hemophilia A (congenital factor VIII deficiency):
who have developed factor VIII inhibitors
who have not developed factor VIII inhibitors with:
severe disease (factor VIII level in blood is less than 1%)
moderate disease (factor VIII level in blood is 1% to 5%) with a severe bleeding phenotype.
Hemophilia A is a hereditary condition caused by the lack of factor VIII, a substance essential for blood to form clots and to stop any bleeding.
The medicine prevents bleeding or reduces bleeding episodes in people with this condition.
Some patients with hemophilia A may develop factor VIII inhibitors (antibodies against factor VIII) that prevent replacement factor VIII from working.
How Hemlibra works
Hemlibra restores the function of activated factor VIII that is missing and necessary for effective blood coagulation. Its structure is different from factor VIII, so Hemlibra is not affected by factor VIII inhibitors.
2. What you need to know before you use Hemlibra
Do not use Hemlibra
if you are allergic to emicizumab or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist, or nurse before using Hemlibra.
Warnings and precautions
Before you start using Hemlibra, it is very important that you talk to your doctor about the use of “bypassing agents”(medicines that help blood to clot, but work in a different way to factor VIII). This is because you may need to change your treatment with bypassing agents while receiving Hemlibra. Examples of bypassing agents are activated prothrombin complex concentrate (aPCC) and recombinant factor VIIa (rFVIIa). Serious and potentially life-threatening side effects can occur when aPCC is used in patients who are also receiving Hemlibra:
Potentially serious side effects of using aPCC while receiving Hemlibra.
Destruction of red blood cells (thrombotic microangiopathy)
This is a serious and potentially life-threatening condition.
When a person has this condition, the lining of the blood vessels can be damaged and blood clots can form in the small blood vessels. In some cases, this can cause damage to the kidneys or other organs.
You should be cautious if you are at high risk of having this condition (you have had this condition in the past, or a family member has had it), or if you are taking medicines that may increase the risk of developing this condition, such as cyclosporin, quinine, and tacrolimus.
It is important to know the symptoms of thrombotic microangiopathy in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms).
Stop using Hemlibra and aPCC and talk to your doctor immediatelyif you or your caregiver notice any symptoms of thrombotic microangiopathy.
Blood clots (thromboembolism)
In rare cases, a blood clot can form inside the blood vessels and block them, and could be potentially life-threatening.
It is important to know the symptoms of such internal blood clots in case they form (see section 4, “Possible side effects” for a list of symptoms).
Stop using Hemlibra and aPCC and talk to your doctor immediatelyif you or your caregiver notice any symptoms of blood clots in the blood vessels.
Other important information about Hemlibra
Formation of antibodies (immunogenicity)
You may notice that your bleeding is not being controlled with the prescribed dose of this medicine. This may be due to the development of antibodies to this medicine.
Talk to your doctor immediatelyif you or your caregiver notice an increase in bleeding. Your doctor may decide to change your treatment if this medicine stops working for you.
Children under 1 year of age
In children under 1 year of age, the blood system is still developing. If your child is under 1 year of age, your doctor may prescribe Hemlibra only after carefully weighing the expected benefits and risks of using Hemlibra.
Other medicines and Hemlibra
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Use of a bypassing agent while receiving Hemlibra
Before you start using Hemlibra, talk to your doctor and follow their instructions carefully about when to use a bypassing agent and the dose and schedule to follow. Hemlibra increases the blood's ability to clot. Therefore, the dose of the bypassing agent needed may be lower than the dose you used before starting Hemlibra.
Use aPCC only if you cannot use another treatment. If aPCC is needed, talk to your doctor if you think you need more than 50 units/kg of aPCC in total. For more information on the use of aPCC while receiving Hemlibra, see section 2: Potentially serious side effects of using aPCC while receiving Hemlibra.
Despite limited experience with the concomitant administration of antifibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that thrombotic events may occur when antifibrinolytics are administered intravenously in combination with aPCC or rFVIIa.
Lab tests
Talk to your doctor if you use Hemlibra before having lab tests to measure your blood's ability to clot. This is because the presence of Hemlibra in your blood may interfere with some of these lab tests and give inaccurate results.
Pregnancy and breastfeeding
You must use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after the last injection of Hemlibra.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medicine. Your doctor will weigh the benefits of you taking Hemlibra against the risks to your baby.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.
3. How to use Hemlibra
Hemlibra is supplied in single-use vials as a ready-to-use solution that does not need to be diluted.
A qualified doctor who is experienced in treating patients with hemophilia will teach you how to use Hemlibra. Follow your doctor's instructions for administering this medicine exactly. If you are unsure, talk to your doctor again.
Keep a record
Each time you use Hemlibra, write down the name and batch number of the medicine.
How much Hemlibra to use
The dose of Hemlibra depends on your weight, and your doctor will calculate the amount (in mg) and the corresponding amount of Hemlibra solution (in ml) to be injected:
Loading dose regimen, weeks 1-4: the dose is 3 milligrams per kilogram of body weight, injected once a week.
Maintenance dose regimen, week 5 and onwards: the dose is either 1.5 milligrams per kilogram of body weight, injected once a week; 3 milligrams per kilogram of body weight, injected every 2 weeks; or 6 milligrams per kilogram of body weight, injected every 4 weeks.
The decision to use the maintenance dose of 1.5 mg/kg once a week, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks should be discussed with your doctor and, when applicable, your caregiver.
Do notmix different concentrations of Hemlibra (30 mg/ml and 150 mg/ml) in a single injection to achieve the total volume to be administered.
Do not administer more than 2 ml of Hemlibra solution in a single injection.
How Hemlibra is administered
If you or your caregiver administer an injection of Hemlibra, you must read and follow the instructions in section 7, “Instructions for use” carefully.
Hemlibra is administered by injection under the skin (subcutaneously).
Your doctor or nurse will teach you how to inject Hemlibra.
Once you have received training, you can inject the medicine yourself at home, either alone or with the help of a caregiver.
To correctly insert the needle under the skin, make a skin fold at the injection site with your free hand. It is important to make a skin fold to ensure that you inject under the skin (into the fatty tissue) and not deeper (into the muscle). An injection into the muscle can be painful.
Prepare and administer the injection in a clean and germ-free environment using an aseptic technique. Your doctor or nurse will give you more information about this.
Where to inject Hemlibra
Your doctor will teach you which areas of the body are suitable for injecting Hemlibra.
Recommended injection sites are: the front of the waist (lower abdomen), the upper outer arm, or the front of the thighs. Only use recommended injection sites.
For each injection, use a different area of the body than you used last time.
Do not administer injections in areas where the skin is red, bruised, tender, hardened, or has moles or scars.
When using Hemlibra, other medicines injected under the skin should be administered in a different area.
Use of syringes and needles
To withdraw the Hemlibra solution from the vial, transfer it to the syringe, and inject it under the skin, you need a syringe, a transfer needle with a 5-micron filter, or a vial adapter with a 5-micron filter and an injection needle.
Syringes, transfer needles with filters, or vial adapters with filters and injection needles are not included in the pack. For more information, see section 6, “What you need to administer Hemlibra that is not included in the pack”.
Make sure to use a new injection needle for each injection and discard it after a single use.
For an injection of up to 1 ml of Hemlibra solution, use a 1-ml syringe.
For an injection of more than 1 ml and up to 2 ml of Hemlibra solution, use a 2-3 ml syringe.
Use in children and adolescents
Hemlibra can be used in children and adolescents of all ages.
A child may inject the medicine themselves, provided that the healthcare professional and the child's parent or caregiver agree. Self-injection is not recommended in children under 7 years of age.
If you use more Hemlibra than you should
If you use more Hemlibra than you should, talk to your doctor immediately. This is because you may be at risk of experiencing side effects such as blood clots. Follow your doctor's instructions for administering Hemlibra exactly. If you are unsure, talk to your doctor, pharmacist, or nurse again.
If you forget to use Hemlibra
If you miss a scheduled injection, inject the missed dose as soon as possible before the next scheduled dose. Then, continue with the scheduled injections of the medicine. Do not inject two doses on the same day to make up for missed doses.
If you are unsure, talk to your doctor, pharmacist, or nurse.
If you stop using Hemlibra
Do not stop using Hemlibra without talking to your doctor. If you stop using Hemlibra, you may no longer be protected against bleeding.
If you have any other questions about using this medicine, talk to 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 of using aPCC while receiving Hemlibra
Stop using Hemlibra and aPCC and talk to your doctor immediatelyif you or your caregiver notice any of the following side effects:
Destruction of red blood cells (thrombotic microangiopathy):
confusion, weakness, swelling of arms and legs, yellowing of the skin and eyes, abdominal pain or back pain, feeling sick (nausea), being sick (vomiting), or urinating less than usual: these symptoms could be signs of thrombotic microangiopathy.
Blood clots (thromboembolism):
swelling, warmth, pain, or redness: these symptoms could be signs of a blood clot in a vein near the surface of the skin.
headache, numbness of the face, pain or swelling in the eyes, or problems with your vision: these symptoms could be signs of a blood clot in a vein behind the eye.
discoloration of the skin: this symptom could be a sign of serious damage to the skin tissue.
Other side effects of using 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
diarrhea
itchy rash or hives (urticaria)
skin rash
Uncommon:may affect up to 1 in 100 people
destruction of red blood cells (thrombotic microangiopathy)
blood clot in a vein behind the eye (cavernous sinus thrombosis)
serious damage to the skin tissue (necrotic skin lesion)
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, along with difficulty breathing, which are indicative of angioedema
lack of effect or reduced response to treatment
Reporting side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Hemlibra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. The expiry date is the last day of the month shown.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the pack in the outer carton in order to protect from light.
Once removed from the refrigerator, unopened vials can be stored at room temperature (below 30°C) for a maximum of 7 days. After storage at room temperature, unopened vials can be returned to the refrigerator. The total time of storage of the medicine 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 exposed to temperatures above 30°C.
Once the solution is transferred from the vial to the syringe, use Hemlibra immediately. Do not refrigerate the solution in the syringe.
Before using the medicine, check that the solution does not contain particles or has changed color. The solution should be colorless to slightly yellow. Do not use this medicine if it is cloudy, has changed color, or contains visible particles.
Dispose of unused solution properly. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Container Contents and Additional Information
Hemlibra Composition
The active ingredient is emicizumab. Each vial of Hemlibra 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 injectable preparations.
Appearance of Hemlibra and Container Contents
Hemlibra is an injectable solution. It is a colorless or slightly yellowish liquid.
Each Hemlibra container contains 1 glass vial.
Only some package sizes may be marketed.
What is Needed for Hemlibra Administration Not Included in the Container
To extract the Hemlibra solution from the vial, insert it into a syringe, and inject it under the skin, a syringe, a transfer needle with a filter or a vial adapter with a filter, and an injection needle are needed (see section 7, "Instructions for Use").
Syringes
1 ml Syringe:transparent polypropylene or polycarbonate syringe with Luer-lock tip, 0.01 ml graduation or
2-3 ml Syringe:transparent polypropylene or polycarbonate syringe with Luer-lock tip, 0.1 ml graduation.
Note: Low Dead Space (LDS) syringes should be used when using the vial adapter with a filter.
Transfer Devices and Needles
Transfer Needle with Filter:stainless steel with Luer-lock connection, 18 G gauge, 35 mm (1½″) length, containing a 5-micron filter and preferably with a semi-blunt tip or
Vial Adapter with Filter:polypropylene with Luer-lock connection, with an integrated 5-micron filter and an outer diameter adjustment of the vial neck of 15 mm and
Injection Needle:stainless steel with Luer-lock connection, 26 G gauge (acceptable range: 25-27 gauge), preferred length of 9 mm (3/8″) or up to 13 mm (½″), preferably with needle safety.
Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Ceská republika
Roche s. r. O.
Tel.: +420 - 2 20382111
Magyarország
Roche (Magyarország) Kft.
Tel: +36 – 1 279 4500
Danmark
Roche Pharmaceuticals A/S
Tel.: +45 - 36 39 99 99
Malta
(See Ireland)
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140
Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050
Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00
Ελλάδα
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739
España
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
France
Roche
Tél: +33 (0) 1 47 61 40 00
Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
Hrvatska
Roche d.o.o.
Tel: +385 1 4722 333
Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0700
România
Roche România S.R.L.
Tel: +40 21 206 47 01
Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00
Ísland
Roche Pharmaceuticals A/S
c/o Icepharma hf
Sími: +354 540 8000
Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201
Italia
Roche S.p.A.
Tel: +39 - 039 2471
Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Κύπρος
Γ.Α.Σταμ?της & Σια Λτδ.
Τηλ: +357 - 22 76 62 76
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000
Date of Last Revision of this Leaflet
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
Instructions for Use
Transfer Needle with Filter
Option
(for transferring the 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 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 not useit after the expiration date.
? Only use 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.
? Only use the syringes, transfer needles, and injection needles prescribed by your healthcare professional.
? Only use the 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 °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 up to 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 temperatures 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 °C) 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, the 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 covering the stopper is missing.
? Inspect the materials for damage. Do not usethem if they appear damaged or have fallen to the ground.
? Place the materials on a flat, clean, and well-lit work surface.
The Box Includes:
Vial with the medication
Hemlibra Instructions for Use
The Box Does Not Include:
? Alcohol swabs
Note:If you need to use more than 1 vial to inject the prescribed dose, you should use a new alcohol swab for each vial.
? Gauze
? Cotton
? Syringe
To inject up to 1 ml, use a 1 ml syringe.
For an injection of 1 ml to 2 ml, use a 2 ml or 3 ml syringe.
Note: Do notuse a 2 ml or 3 ml syringe for doses up to 1 ml.
? Transfer Needle
with 5-micron filter
18 G
Note:If you need to use more than 1 vial to inject the prescribed dose, you should use a new transfer needle for each vial. Do notuse the transfer needle to inject the medication.
? Injection Needle with safety shield (used to inject the medication).
Do notuse the injection needle to withdraw the medication from the vial.
Sharps Container
for sharp objects
Prepare:
? Before using it/them, leave the vial(s) for 15 minutes on a flat, clean, and light-protected surface to reach room temperature.
? Do notattempt to heat the vial in any other way.
? Wash your handswell with water and soap.
Selection and Preparation of the Injection Site:
? Clean the chosen injection site area with an alcohol swab.
? 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 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 the exposed needles or leave them on any surface once the cap is removed.
? 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 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 sharps container out of the reach of children.
? Discard any used cap(s), vial(s), needles, and syringes in a sharps container.
? Dispose of used needles and syringes in a sharps container immediately after use. Do notdispose of caps, vials, needles, or syringes loosely 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 sharp objects to escape.
is kept upright and stable during use.
is leak-proof.
is properly labeled to indicate that it contains hazardous waste.
? When the sharps container is almost full, you should follow local guidelines for proper disposal.
? Do not dispose of any used sharps container in household trash unless local guidelines permit it. Do not recycle your sharps container.
PREPARATION
Step 1. Remove the Vial Cap and Clean
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 swab.
Step 2. Attach the Transfer Needle with Filter to the Syringe
Push and turn the transfer needle with filter clockwiseonto the syringe until it is securely attached.
Slowly pull the plunger back and draw into the syringe the same amount of air as the prescribed dose.
Step 3. Remove the Transfer Needle Cap
Hold the syringe body with the transfer needle pointing upwards.
Carefully remove the transfer needle cap, keeping it away from you. Do notdiscard the cap.
Step 4. Inject air into the vial
Hold 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 upwards, 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.
Step 5. Transfer the medication to the syringe
Slide the tip of the needle downwards so that it is inside the medication.
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.
Avoid pulling the plunger out of the syringe.
Important:If the prescribed dose is greater than the amount of Hemlibra in the vial, extract all the medicationand refer to the section “Combining vials”now.
Step 6. Remove air bubbles
Keep the needle in the vial and check that there are no large air bubbles in the syringe. Large bubbles can reduce the dose received.
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 upwards 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 moreof the medication needed for the prescribed dose.
Avoid pulling the plunger out of the syringe.
Repeat the previous steps until the larger air bubbles have been removed.
Note:Make sure you have enough medication in the syringe to complete the dose before proceeding to the next step. If you cannot extract all the medication, turn the vial upside down to reach the remaining amount.
Do notuse the transfer needle to inject the medication, as it may cause pain and bleeding.
INJECTION
Step 7. Replace the transfer needle cap
Remove the syringe and transfer needle from the vial.
Using one hand, insertthe transfer needle into the cap and push upwardsto cover the needle.
Once the needle is covered, push the transfer needle cap towards the syringe to secure it completely with one handto avoid accidental needlestick injury.
Step 8. Clean the injection site
Select and cleanthe injection site with an alcohol swab.
Step 9. Remove the used transfer needle from the syringe
Remove the used transfer needle from the syringe by rotating it counterclockwise and pulling it gently.
Discard the used transfer needle in a sharps container.
Step 10. Attach the injection needle to the syringe
Push and rotate the injection needle clockwise over the syringe until it is securely attached.
Step 11. Remove the safety protector
Remove the safety protector from the needle by sliding it towardsthe syringe body.
Step 12. Remove the injection needle cap
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.
Step 13. Adjust the plunger according to the prescribed dose
Hold the syringe with the needle pointing upwards and slowly push the plunger until the prescribed dose is reached.
Check your dose, ensure that the top edge of the plunger is aligned with the syringe mark corresponding to the prescribed dose.
Step 14. Subcutaneous injection (under the skin)
Pinch the selected injection site and insert the needle completely at an angle of between 45º and 90ºwith a quick and firm motion. Do nothold or push the plunger while inserting the needle.
Maintain the position of the syringe and release the selected injection site.
Step 15. Inject the medication
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 they were inserted.
SYRINGE AND NEEDLE DISPOSAL
Step 16. Cover the needle with the safety protector
Slide the safety protector forward 90º, away from the syringe body.
Holding the syringe with one hand, press the safety protectordownwardsagainst 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 17. Discard the syringe and needle.
Discard 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 extracting the medication from the first vial as described in step 5. You must use a new transfer needle for each vial.
Step A. Replace the transfer needle cap
Remove the syringe and transfer needle from the first vial.
Using one hand, insertthe transfer needle into the cap and push upwardsto cover the needle.
Once the needle is covered, push the transfer needle cap towards the syringe to secure it completely with one handto avoid accidental needlestick injury.
Step B. Remove the used transfer needle from the syringe
Remove the used transfer needle from the syringe by rotating it counterclockwise and pulling it gently.
Discard the used transfer needle in a sharps container.
Step C. Attach a new transfer needle with a filter to the syringe
Push and rotate a newtransfer needle clockwise over the syringe until it is securely attached.
Slowly, pull back the plunger and introduce a little air into the syringe.
Step D. Remove the transfer needle cap
Hold the syringe body with the transfer needle cap pointing upwards.
Carefully, remove the transfer needle cap while keeping it away from you. Do not discard the cap.You will need to replace the transfer needle cap after transferring the medication.
Do nottouch the tip of the needle.
Step E. Inject air into the vial
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 upwards, 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.
Step F. Transfer the medication to the syringe
Slide the tip of the needle downwards so that it is inside the medication.
With the syringe facing upwards, slowly pull back the plunger to fill the syringe body with moreof the medicationneeded for the prescribed dose.
Hold the plunger firmlyto ensure it does not retract.
Avoid pulling 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 extract all the medication, turn the vial upside down to reach the remaining amount.
Do notuse the transfer needle to inject the medication, as it may cause damage such as pain and bleeding.
Repeat steps A to F with each additional vial until you have more than the amount of medication needed for your prescribed dose. When 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 the 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 carton and 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 carton and 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 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 temperatures 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 °C) before preparing an injection.
Do notshake the vial.
Storage of vial adapters, needles, and syringes:
Keep the vial adapter, injection needle, and syringe dry.
Keep the vial adapter, injection needle, and syringe out of sight and reach of children.
Inspection of the 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, blurry, or has changed color
the medication contains particles.
the cap covering the stopper is missing.
Inspect the materials for damage. Do not usethem if they appear damaged or have fallen to the floor.
Place the materials on a flat, clean, and well-lit work surface.
The box includes:
Vial with the medication
Hemlibra instructions for use
The box does not include:
Alcohol wipesNote:if you need to use more than 1 vial to inject the prescribed dose, you must use a new alcohol wipe for each vial.
Gauze
Cotton
Vial adapter with filter(to be inserted into the top of the vial).Note:use it to transfer the medicine from the vial to the syringe. If you need more than 1 vial to inject the prescribed dose, you must use a new vial adapter for each vial.
Do not insertthe injection needle into the vial adapter.
Low Dead Space (LDS) syringe with plunger
Important:
To inject up to 1 ml, use a 1 ml LDS syringe.
To inject more than 1 ml, use a 2 or 3 ml LDS syringe.
Note: do notuse a 2 or 3 ml LDS syringe for doses up to 1 ml.
Injection needle with safety protector (used to inject the medication)
Do not insertthe injection needle into the vial adapter or use the injection needle to withdraw the medication from the vial.
Sharps container
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 handswell 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.
Preparation of the syringe for injection:
When you have filled the syringe with the medication, the injection should be administered 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 any 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 ball or gauze for at least 10 seconds until the bleeding stops.
If you have a hematoma (a small bleeding 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 sharps container out of the reach of children.
Discard any cap(s), vial(s), vial adapters, needles, and syringes used 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 sharp objects to escape.
is kept upright and stable during use.
is leak-proof.
is properly labeled to indicate that it contains hazardous waste.
When the sharps container is almost full, you must follow local guidelines for proper disposal.
Do not discardany used sharps container in household trash unless local guidelines permit it. Do not recycleyour sharps container.
PREPARATION
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 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 necessary).
Push and turn the syringe clockwiseonto the vial adapter until it is fully secured.
Step 4. Transfer the medication to the syringe
Hold the vial adapter in place 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 required amount of medicationfor the prescribed dose.
Hold the plunger firmlyto 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 medicationand consult the “Combining vials”section now.
Step 5. Remove air bubbles
Hold the vial attached to the syringe and check for air bubbles. Large air bubbles can reduce the dose received.
Remove large air bubblesby gently tapping the 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 medication 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 medication for the prescribed dose.
Try not to pull the plunger out of the syringe.
Repeat the above steps until you have removed the large air bubbles.
Note:make sure you have enough medication in the syringe to complete the dose before proceeding to the next step.
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 and 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 withdraw the medication from the vial.
Step 9. Remove the safety protector
Remove the safety protector from the needle by sliding it towardthe syringe body.
Step 10. Remove the needle cap
Carefully, pull the needle cap straight off awayfrom 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 medication 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 upwards 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 nothold or push the plunger while inserting the needle.
Maintain the position of the syringe and release the pinched injection site.
Step 13. Inject the medication
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.
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 needle from the syringe.
Step 15. Dispose of the syringe and needle
Discard used needles and syringes in a puncture-resistant container immediately after use. For more information, see the "Disposal of Medication and Materials" section.
Do notattempt to remove the used injection needle from the syringe.
Do notrecap the injection needle with the cap.
Important:always keep the puncture-resistant container out of the reach of children.
Discard any cap(s), vial(s), vial adapter(s), needles, and syringes in the puncture-resistant container.
Vial Combination
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 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 notremove the 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 B. Withdraw 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 puncture-resistant container.
Step C. Attach the syringe to the new vial adapter
Push and turn the same syringe clockwiseinto the new vial adapter until it is fully secured.
Step D. Transfer the medication to the syringe
Hold the vial adapter secure 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 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 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 "Withdraw air bubbles". Continue with the remaining steps.
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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