Hemlibra 30 mg/ml solucion inyectable
Introduction
Prospecto: information for the user
Hemlibra 30mg/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 a 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"(medications 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:
Potentially 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 medications that may increase the risk of developing this condition, such as cyclosporine, quinine, and tacrolimus.
- It is essential to know the symptoms of microangiopathic hemolytic anemia in case you develop the condition (see section 4, "Possible adverse 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 adverse 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 medication. This may be due to the development of antibodies to this medication.
Talk to your doctor immediatelyif you or your caregiver notice an increase in bleeding. Your doctor may decide to change your treatment if this medication 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 medications and Hemlibra
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
- 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 you should follow. Hemlibra increases blood 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 on the use of APCC while receiving Hemlibra, see section 2: Potentially severe adverse 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 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 medication. Your doctor will weigh the benefits of you taking Hemlibra against the risk to your baby.
Driving and operating machinery
It is unlikely that this medication will affect your ability to drive or operate machinery.
3. How to use Hemlibra
Hemlibra is supplied in non-reusable vials in the form of a ready-to-use solution that does not need to be diluted.
A qualified doctor for treating patients with hemophilia 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.
Maintaining 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) that should be injected:
- Load 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 consulted 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 a clean and germ-free condition 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 sites for injection 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 medications injected under the skin 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 will need a syringe, a transfer needle with a 5-micrometer filter, 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 that the healthcare professional and the child's parent or caregiver agree. Auto-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 Hemlibra treatment
Do not interrupt Hemlibra treatment without consulting your doctor. If you interrupt Hemlibra treatment, 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 the. 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 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
Composition of Hemlibra
- The active ingredient is emicizumab. Each vial of Hemlibra contains12 mg (0.4 ml at a concentration of 30 mg/ml) or 30mg (1ml at a concentration of30mg/ml) of emicizumab.
- The other components are L-arginine, L-histidine, L-aspartic acid, poloxamer 188and water for injection.
Appearance of Hemlibra and contents of the pack
Hemlibra is an injectable solution. It is a colourless or slightly yellowish liquid.
Each pack of Hemlibra contains1vial of glass.
Only certain pack sizes may be marketed.
What is not included in the pack
For the administration of Hemlibra, the following items are not included in the pack:
• Needle for injection
• Syringe
• Transfer needle with filter
• Adapter for vial with filter
What is needed for the administration of Hemlibra that is not included in the pack
To withdraw the Hemlibra solution from the vial, introduce it into a syringe and inject it under the skin, the following items are needed:
• Syringe
• Transfer needle with filter or adapter for vial with filter and needle for injection
Syringes
- Syringe of1ml:Syringe made of transparent polypropylene or polycarbonate with Luer-lock tip, graduation of0.01mlor
- Syringe of2-3ml:Syringe made of transparent polypropylene or polycarbonate with Luer-lock tip, graduation of0.1ml.
Nota: syringes with Low Dead Space (LDS) should be used when using the adapter for vial with filter.
Devices and transfer needles
- Transfer needle with filter:Stainless steel with Luer-lock connection, gauge18G, length of35mm (1½″), containing a filter of5micrometers and preferably with a semi- blunt tipor
- Adapter for vial with filter:Polypolypropylene with Luer-lock connection, with an integrated filter of 5 micrometers and adjustable outer diameter of the vial neck of 15 mmand
- Needle for injection:Stainless steel with Luer-lock connection, gauge26G (acceptable range: gauge25-27), length preferably of 9mm (3/8″) or maximum of 13mm (½″), preferably with safety needle
Marketing authorisation holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Responsible for manufacturing
Roche Pharma AG
Emil-Barell-Strasse1
79639GrenzachWyhlen
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 RochePharmaceuticals 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 Phone: +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 RochePharmaceuticals 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.A.Σταμ?της&ΣιαΛτδ. 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 this leaflet
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
Vial(s) of single dose(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 with filter to transfer Hemlibra from the vial. These instructions are only used with the Adapter for vial. |
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Storage of Hemlibra vials
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Storage of adapters for vial, needles and syringes
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Inspection of the medicinal product and materials
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The pack contains: | |
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The pack does not contain: | |
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Do not insert the needle for injection into the adapter for vial. | |
Important:
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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: Keep the sharp object container out of the reach of children.
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1. PREPARATION | |
Step 1. Remove the cap from the vial and clean the top | |
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Step 2. Insert the adapter for vial into the vial | |
Do not removethe adapter for vial from the transparent plastic blister. | |
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Step 3. Connect the syringe to the adapter for vial | |
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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 adapter for vial | |
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Step 8. Place the needle for injection in the syringe | |
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Step 9. Remove the safety device | |
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Step 10. Remove the cap from the needle for injection | |
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Step 11. Adjust the plunger to the prescribed dose | |
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