Hemlibra 150 mg/ml solucion inyectable
Introduction
Prospecto: information for the user
Hemlibra 150mg/ml injectable solution
emicizumab
Read this prospect carefully before starting to use this medicine, because it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
In addition to this prospect, your doctor will give you a patient information leaflet, which contains important safety information that you need to know. Keep this leaflet with you.
1. What is Hemlibra and what is it used for
What is Hemlibra
Hemlibra contains the active ingredient “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 is Hemlibra used for
Hemlibra is a medicine that can be used to treat patients of all ages with hemophilia A (congenital deficiency of factor VIII):
- who have developed inhibitors of factor VIII
- who have not developed inhibitors of factor VIII with:
- severe disease (factor VIII level in blood is less than 1%)
- moderate disease (factor VIII level in blood is between 1% and 5%) with 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 inhibitors of factor VIII (antibodies against factor VIII) preventing the factor VIII substitution from working.
How Hemlibra works
Hemlibra restores the function of missing activated factor VIII 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 starting to use Hemlibra
No use Hemlibra
- if you are allergic to emicizumab or any of the other components of this medication (listed in section 6). If you are unsure, consult your doctor, pharmacist, or nurse before starting to use Hemlibra.
Warnings and Precautions
Before starting to use Hemlibra, it is very important that you consult your doctor about the use of "bypass agents"(medicines that help blood clotting, but work differently from factor VIII).This is because you may need to change your treatment with bypass agents while receiving Hemlibra. Examples of bypass agents include activated prothrombin complex concentrate (APCC) and recombinant factor VIIa (rFVIIa). Severe and potentially life-threatening adverse effects can occur when APCC is used in patients who are also receiving Hemlibra:Severe adverse effects of using APCC while receiving Hemlibra.
- Red blood cell destruction (microangiopathic hemolytic anemia)
- This is a serious and potentially life-threatening condition.
- When a person has this condition, the lining of blood vessels can be damaged and blood clots can form in 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 developing this condition (you have had it 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 ciclosporin, quinine, and tacrolimus.
- It is essential to know the symptoms of microangiopathic hemolytic anemia in case you develop the condition (see section 4, "Possible side effects" for a list of symptoms).
Stop using Hemlibra and APCC and consult your doctor immediatelyif you or your caregiver notice any symptoms of microangiopathic hemolytic anemia.
- Blood clots (thromboembolism)
- In rare cases, a blood clot can form inside blood vessels and block them, and could be potentially life-threatening.
- It is essential to know the symptoms of internal blood clots in case they form (see section 4, "Possible side effects" for a list of symptoms).
Stop using Hemlibra and APCC and consult your doctor immediatelyif you or your caregiver notice any symptoms of blood clots in the blood vessels.
Other important information about Hemlibra
- Antibody formation (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 against 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 no longer works for you.
Children under 1 year of age
In children under 1 year of age, the blood system is still developing. Ifyour child is under 1 year old, your doctor may prescribe Hemlibra only after carefully weighing the expected benefits and risks of using Hemlibra.
Other medicines and Hemlibra
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.
- Use of a bypass agent while receiving Hemlibra
- Before starting to use Hemlibra, consult your doctor and follow their instructions carefully about when to use a bypass agent and the dose and regimen to follow. Hemlibra increases the blood's clotting ability. Therefore, the dose of the bypass agent needed may be lower than the dose you used before starting Hemlibra.
- Use APCC only if you cannot use another treatment. If you need APCC, consult your doctor if you think you need more than 50units/kg of APCC in total. For more information about the use of APCC while receiving Hemlibra, see section 2: Severe adverse effects of using APCC while receiving Hemlibra.
- Despite the limited experience with the concomitant administration of antifibrinolytics with APCC or rFVIIa in patients treated with Hemlibra, you should know that thrombotic episodes may occur when antifibrinolytics are administered intravenously in combination with APCC or rFVIIa.
Laboratory tests
Consult your doctor if you use Hemlibra before having tests to measure blood clotting ability. This is because the presence of Hemlibra in the blood may interfere with some of these laboratory tests and give inaccurate results.
Pregnancy and breastfeeding
- You should use an effective method of birth control (contraceptive) during treatment with Hemlibra and for the6months after the last injection of Hemlibra.
- If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will weigh the benefit of you taking Hemlibra against the risk to your baby.
Driving and operating machinery
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 in a ready-to-use solution that does not require dilution.
A qualified doctor for treating hemophilia patients will teach you how to use Hemlibra treatment. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.
Keeping a record
Each time you use Hemlibra, note the name and batch number of the medication.
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 the 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 beyond: 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, with your caregiver.
Do notcombine different concentrations of Hemlibra (30 mg/ml and 150 mg/ml) in a single injection to reach the total volume to be administered.
Do not administer more than 2 ml of Hemlibra solution in each injection.
How to administer Hemlibra
If you or your caregiver administer a Hemlibra injection, you must read carefully and follow the instructions given in section 7, “Instructions for use”.
- Hemlibra is administered by subcutaneous injection.
- Your doctor or nurse will teach you how to inject Hemlibra.
- Once you have received training, you will be able to inject the medication at home, alone or with the help of a caregiver.
- To correctly introduce the needle under the skin, form a skin fold in the clean injection site with your free hand. It is essential to form the skin fold to ensure that you inject under the skin (in the adipose tissue) and not deeper (in the muscle). An injection in the muscle could be painful.
- Prepare and administer the injection in clean and germ-free conditions using an aseptic technique. Your doctor or nurse will provide more information on this.
Where to inject Hemlibra
- Your doctor will teach you where to inject Hemlibra.
- The recommended injection sites are: the lower abdominal area, the upper outer arm, or the front of the thighs. Use only recommended injection sites.
- For each injection, use a different area of the body from the one used last time.
- Do not administer injections in areas where the skin is red, purple, sensitive, hardened, or has moles or scars.
- When using Hemlibra, other injectable medications should be administered in a different area.
Use of syringes and needles
- To extract the Hemlibra solution from the vial, introduce it into the syringe, and inject it under the skin, you need a syringe, a 5-micrometer filter transfer needle, or a vial adapter with a 5-micrometer filter, and an injection needle.
- Syringes, transfer needles with filters, or vial adapters with filters and injection needles are not included in the packaging. For more information, see section 6 “What is needed for Hemlibra administration that is not included in the packaging”.
- Make sure to use a new injection needle for each injection and dispose of it after a single use.
- For an injection of up to 1 ml of Hemlibra solution, use a 1-ml syringe.
- For an injection greater 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 can inject the medication themselves, provided the healthcare professional and the child's parent or caregiver agree. Self-injection is not recommended in children under 7 years old.
If you use more Hemlibra than you should
If you use more Hemlibra than you should, inform your doctor immediately. You may be at risk of experiencing adverse effects such as blood clots. Follow exactly the administration instructions of Hemlibra indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.
If you forget to use Hemlibra
- If you forget the scheduled injection, inject the missed dose as soon as possible before the next scheduled dose. Then, continue with the scheduled injections of the medication. Do not inject two doses on the same day to compensate for the missed doses.
- In case of doubt, ask your doctor, pharmacist, or nurse.
If you interrupt the treatment with Hemlibra
Do not interrupt the treatment with Hemlibra without consulting your doctor. If you interrupt the treatment with Hemlibra, you may no longer be protected against bleeding.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects of using CCPa while receiving Hemlibra
Stop using Hemlibra and CCPa and consult your doctor immediatelyif you or your caregiver notice any of the following side effects:
- Red blood cell destruction (microangiopathic thrombosis):
- confusion, weakness, swelling of arms and legs, yellowing of the skin and eyes, diffuse pain (abdominal) or back, feeling of dizziness (nausea), feeling unwell (vomiting) or urinating less than usual: these symptoms may be signs of microangiopathic thrombosis.
- Blood clots (thromboembolism):
- swelling, warmth, pain or redness: these symptoms may 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 vision problems: these symptoms may be signs of a blood clot in a vein behind the eye.
- darkening of the skin: this symptom may be a sign of severe damage to the skin tissue.
Other side effects of using Hemlibra
Very common:can affect more than 1 in 10people
- reaction at the injection site (redness, itching, pain)
- headache
- joint pain
Common:can affect up to 1 in 10people
- fever
- muscle pain
- diarrhea
- pruritic rash or hives (urticaria)
- skin rash
Rare:can affect up to 1 in 100people
- red blood cell destruction (microangiopathic thrombosis)
- blood clot in a vein behind the eye (cavernous sinus thrombosis)
- severe damage to skin tissue (cutaneous necrosis)
- blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
- inflammation 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 of side effects
If you experience any type of side effect, consult your doctor, pharmacist or nurse,even if it is a side effect that does not appear in this leaflet. You can also report them directly through theAppendix Vnational notification system included in thedocument. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Hemlibra
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label of the box and vial after “EXP”. The expiration date is the last day of the month indicated.
Store in the refrigerator (between 2°C-8°C). Do not freeze.
Store in the original packaging to protect it from light.
Once out of 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 storage time of the medication at room temperature must 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 from the vial has been transferred to the syringe, use Hemlibra immediately. Do not refrigerate the solution in the syringe.
Before using the medication, check that the solution does not present particles or color change. The solution must be between colorless and slightly yellow. Do not use this medication if you observe that it is turbid, if it has changed color, or if it contains visible particles.
Dispose of unused solution properly. Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
- The active substance is emicizumab. Each vial of Hemlibra contains 60 mg (0.4 ml at a concentration of 150 mg/ml), 105 mg (0.7 ml at a concentration of 150 mg/ml), 150 mg (1 ml at a concentration of 150 mg/ml) or 300 mg (2 ml at a concentration of 150 mg/ml) of emicizumab.
- The other components are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injection.
Appearance of Hemlibra and contents of the pack
Hemlibra is a solution for injection. It is a colourless or slightly yellowish liquid.
Each pack of Hemlibra contains 1 vial of glass.
Only certain pack sizes may be marketed.
What is not included in the pack and is needed for the administration of Hemlibra
To withdraw the Hemlibra solution from the vial, introduce it into a syringe and inject it under the skin, a syringe, a transfer needle with filter or a vial adapter with filter, and a injection needle (see section 7, “Instructions for use”) are needed.
Syringes
- Syringe of 1 ml:a transparent syringe of polypropylene or polycarbonate with a Luer-lock tip, graduation of 0.01 ml or
- Syringe of 2-3 ml:a transparent syringe of polypropylene or polycarbonate with a Luer-lock tip, graduation of 0.1 ml.
Nota: syringes with Low Dead Space (LDS) should be used when using the vial adapter with filter.
Transfer needles and devices
- Transfer needle with filter:stainless steel with Luer-lock connection, gauge 18, length of 35 mm (1½″), containing a 5 micrometer filter and preferably with a semi-rotating tip
- Vial adapter with filter:polypropylene with Luer-lock connection, with an integrated 5 micrometer filter, and an outer diameter adjustment of the vial neck of 15 mm,
- Injection needle:stainless steel with Luer-lock connection, gauge 26 (acceptable range: gauge 25-27), length preferably of 9 mm (3/8″) or at most 13 mm (½″), preferably with needle safety
Titular of the marketing authorisation
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Responsible for manufacturing
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Further information on this medicinal product can be obtained from the local representative of the marketing authorisation holder:
Czech Republic Roche s. r. o. Phone: +420 - 2 20382111 | Hungary Roche (Magyarország) Kft. Phone: +36 – 1 279 4500 |
Denmark Roche Pharmaceuticals A/S Phone: +45 - 36 39 99 99 | Malta (See Ireland) |
Germany Roche Pharma AG Phone: +49 (0) 7624 140 | Netherlands Roche Nederland B.V. Phone: +31 (0) 348 438050 |
Estonia Roche Eesti OÜ Phone: + 372 - 6 177 380 | Norway Roche Norge AS Tlf: +47 - 22 78 90 00 |
Greece Roche (Hellas) A.E. Phone: +30 210 61 66 100 | Austria Roche Austria GmbH Phone: +43 (0) 1 27739 |
Spain Roche Farma S.A. Phone: +34 - 91 324 81 00 | Poland Roche Polska Sp. z o.o. Phone: +48 - 22 345 18 88 |
France Roche Phone: +33 (0) 1 47 61 40 00 | Portugal Roche Farmacêutica Química, Lda Phone: +351 - 21 425 70 00 |
Croatia Roche d.o.o. Phone: +385 1 4722 333 Ireland Roche Products (Ireland) Ltd. Phone: +353 (0) 1 469 0700 | Romania Roche România S.R.L. Phone: +40 21 206 47 01 Slovenia Roche farmacevtska družba d.o.o. Phone: +386 - 1 360 26 00 |
Iceland Roche Pharmaceuticals A/S c/o Icepharma hf Phone: +354 540 8000 | Slovakia Roche Slovensko, s.r.o. Phone: +421 - 2 52638201 |
Italy Roche S.p.A. Phone: +39 - 039 2471 | Finland Roche Oy Phone/Tel: +358 (0) 10 554 500 |
Cyprus Γ. Α. Στáμης Phone: +357 - 22 76 62 76 | Sweden Roche AB Phone: +46 (0) 8 726 1200 |
Lithuania Roche Latvija SIA Phone: +371 - 6 7039831 | United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Phone: +44 (0) 1707 366000 |
Last update of the summary of product characteristics
Other sources of information
The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/
7. Instructions for use
Transfer needle with filter Option (for transferring the medicinal product from the vial to the syringe) |
Instructions for use
Hemlibra
Injection
Single-dose vial(s)
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 in doubt, 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 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 label on the vial. ?Before opening the vial, read the label on the vial to check that it has the correct concentration of the medicinal product for the prescribed dose for you. You may need to use more than 1 vial to administer the total correct dose. ?Check the expiry date that appears on the box and the label on the vial.Do not useit after the expiry date. ?Only use the vial once.Once the dose has been injected, discard the remaining solution of Hemlibra in the vial.Do not store the unused medicinal product 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 the caps, vials, syringes and needles used. ?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 the appropriate 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 not freeze.
?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 the 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.
Storage of vial adapters, needles and syringes: ?Store the vial adapter, injection needle and syringe dry.
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Inspection of the medicinal product and materials:
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The pack includes: |
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The pack does not include: | ?Alcohol wipes Nota:if you need to use more than 1 vial to inject the prescribed dose, you must use a new alcohol wipe for each vial. ?Gas ?Cotton wool | |
?Syringe For injecting up to 1 ml, use asyringe of 1 ml.
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?Transfer needle with filter of 5 micrometers of 18 G Nota:if you need to use more than 1 vial to inject the prescribed dose, you must use a new transfer needle for each vial. | ||
?Injection needle with safety device (used to inject the medicinal product)
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Prepare: | |
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Selection and preparation of the injection site:
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For the injection, you can use:
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Preparation of the syringe for the injection:
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Important information after the injection:
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Disposal of the medicinal product and materials: Important: Always keep the container for sharp objects out of the reach of children.
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1. PREPARATION | |
Step 1. Remove the stopper from the vial and clean the top | |
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Step 2. Insert the vial adapter into the vial | |
Do not removethe vial adapter from the transparent plastic blister. | |
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Step 3. Connect the syringe to the vial adapter | |
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Step 4. Transfer the medicinal product to the syringe | |
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Important:if the prescribed dose is greater than the amount of Hemlibra in the vial,withdraw all the medicinal productand consult now the section“Combination of vials”. | |
Step 5. Remove air bubbles | |
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Nota:check that you have enough medicinal product in the syringe to complete the dose before proceeding to the next step. |
2. INJECTION | |
Step 6. Clean the injection site | |
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Step 7. Remove the syringe from the vial adapter | |
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Step 8. Attach the injection needle to the syringe | |
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Step 9. Remove the safety device from the injection needle | |
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Step 10. Remove the cap from the injection needle | |
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Step 11. Adjust the plunger to the prescribed dose | |
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Step 12. Subcutaneous injection (under the skin) | |
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Step 13. Inject the medicinal product | |
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3. DISPOSAL | |
Step 14. Cover the injection needle with the safety device | |
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?Maintain your fingers behind the safety device and away from the injection needle at all times. ?Do not separate the injection needle. | |
Step 15. Discard the syringe and injection needle | |
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