Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hemlibra

Document Subject

Generated Narrative: MedicinalProductDefinition mp46ce8c3bfb2b68d2cb00bd6f9c79816f

identifier: http://ema.europa.eu/identifier/EU/1/18/1271/006 (12 mg/0.4 mL)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Hemlibra 30 mg/mL solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-46ce8c3bfb2b68d2cb00bd6f9c79816f

identifier: http://ema.europa.eu/identifier/EU/1/18/1271/006 (12 mg/0.4 mL)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hemlibra

Attesters

7. Instructions for use

What is in this leaflet

1. What Hemlibra is and what it is used for
2. What you need to know before you use Hemlibra
3. How to use Hemlibra
4. Possible side effects
5. How to store Hemlibra
6. Contents of the pack and other information

What Hemlibra is

Hemlibra contains the active substance emicizumab . This belongs to a group of medicines called monoclonal antibodies . Monoclonal antibodies are a type of protein that recognise and bind to a target in the body.

What Hemlibra is used for

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

who have developed factor VIII inhibitors

who have not developed factor VIII inhibitors with:

• severe disease (the factor VIII blood level is less than 1%)
• moderate disease (the factor VIII blood level is from 1% to 5%) with severe bleeding phenotype.

Haemophilia A is an inherited condition caused by a lack of factor VIII, an essential substance required for blood to clot and stop any bleeding.

The medicine prevents bleeding or reduces bleeding episodes in people with this condition.

Some patients with haemophilia A can develop factor VIII inhibitors (antibodies against factor VIII) which stop the replacement factor VIII from working. How Hemlibra works

Hemlibra restores the function of missing activated factor VIII that is needed for effective blood clotting. Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors.

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 to talk to your doctor about using bypassing agents (medicines that help blood clot but which work in a different way from factor VIII). This is because treatment with bypassing agents may need to change while receiving Hemlibra. Examples of bypassing agents include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (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 people have this condition, the lining of the blood vessels can be damaged and blood clots may develop in small blood vessels. In some cases, this can cause damage to the kidneys and other organs.
• Be cautious if you are at high risk for this condition (have had this condition in the past, or a member of your family have suffered from it), or if you are taking medicines that can increase the risk of developing this condition, such as ciclosporin, quinine or 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 a doctor immediately if you or your caregiver notices any symptoms of thrombotic microangiopathy.

Blood clots (thromboembolism)

• In rare cases, a blood clot can form inside blood vessels and block them, which may be life-threatening.
• It is important to know the symptoms of such internal blood clots, in case they develop (see section 4, Possible side effects for a list of symptoms).

Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of blood clots in blood vessels.

Other important information about Hemlibra

Antibody formation (immunogenicity)

• You may notice that bleeding is not being controlled with your prescribed dose of this medicine. This could be due to the development of antibodies to this medicine.

Talk to a doctor immediately if you or your caregiver notices an increase in bleeds. Your doctor may decide to change your treatment if this medicine stops working for you.

Children below the age of 1 year

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

Other medicines and Hemlibra

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Using a bypassing agent while receiving Hemlibra

• Before you start using Hemlibra, talk to your doctor and carefully follow their instructions on when to use a bypassing agent and the dose and schedule you should use. Hemlibra increases the ability of your blood to clot. Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.
• Use aPCC only if no other treatment can be used. If aPCC is required, talk to your doctor in case you feel you need a total of more than 50 units/kg of aPCC. For more information on using aPCC while receiving Hemlibra, see in section 2: Potentially serious side effects of using aPCC while receiving Hemlibra .
• Despite limited experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that there may be a possibility of thrombotic events using anti-fibrinolytics administered intravenously in combination with aPCC or rFVIIa.

Laboratory tests

Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting. This is because Hemlibra in the blood may interfere with some laboratory tests, leading to inaccurate results.

Pregnancy and breast-feeding

You should use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after your last injection of Hemlibra.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will consider the benefit of you taking Hemlibra against the risk to your baby.

Driving and using machines

This medicine is not likely to affect your ability to drive or use machines.

Hemlibra is provided in single-use vials as ready to use solution which does not need to be diluted. A doctor qualified to care for patients with haemophilia will start you on treatment with Hemlibra. Always use this medicine exactly as your doctor has told you. Check with your healthcare provider if you are not sure.

Keeping a record

Each time you use Hemlibra, record the name and batch number of the medicine.

How much Hemlibra to use

The dose of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and corresponding amount of Hemlibra solution (in mL) to be injected:

Loading dose regimen: Weeks 1 to 4: The dose is 3 milligrams for every 1 kilogram you weigh, injected once a week.

Maintenance dose regimen: Week 5 and onwards: The dose is either 1.5 milligrams for every 1 kilogram you weigh, injected once a week, 3 milligrams for every 1 kilogram you weigh, injected every 2 weeks, or 6 milligrams for every 1 kilogram you weigh, injected every 4 weeks.

The decision, to use either the 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks maintenance dose, should be made in consultation with your doctor and, where applicable, with your caregiver.

Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection when making up the total volume to be injected.

The amount of Hemlibra solution given in each injection must not be more than 2 mL.

How Hemlibra is given

If you inject Hemlibra yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, Instructions for use .

Hemlibra is given by injection under the skin (subcutaneously).

Your doctor or nurse will show you how to inject Hemlibra.

Once you have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver.

To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand. Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injecting into a muscle could cause discomfort.

Prepare and give the injection in clean and germ-free conditions using aseptic technique. Your doctor or nurse will give more information about this.

Where to inject Hemlibra

Your doctor will show you which areas of the body are suitable for injecting Hemlibra.

The recommended places to give an injection are: the front of the waist (lower abdomen), upper outer arms, or the front of the thighs. Use only recommended places for injection.

For each injection, use a different area of the body to the one you used last time.

Do not give injections where the skin is red, bruised, tender, hard, or areas where there are moles or scars.

When using Hemlibra, any other medicine injected under the skin should be given in a different area.

Using syringes and needles

A syringe, a transfer needle with 5 micrometre filter, and an injection needle are used to draw up the Hemlibra solution from the vial into the syringe and to inject it under the skin.

Syringes, transfer needles with filter and injection needles are not provided in this pack. For more information, see in section 6 What is needed for Hemlibra administration and is not contained in this pack .

Make sure that you use a new injection needle for each injection and dispose of it after a single use.

A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution.

A 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL of Hemlibra solution.

Use in children and adolescents

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

A child can self-inject the medicine provided the child s healthcare provider and the parent or caregiver agree. Self-injection for children below the age of 7 years is not recommended.

If you use more Hemlibra than you should

If you use more Hemlibra than you are supposed to, tell your doctor immediately. This is because you may be at risk of developing side effects such as blood clots. Always use Hemlibra exactly as your doctor has told you, and check with your doctor, pharmacist or nurse if you are not sure.

If you forget to use Hemlibra

If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose. Then, continue to inject the medicine as scheduled. Do not inject two doses on the same day to make up for a forgotten dose.

If you are not sure what to do, ask 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 further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 a doctor immediately if you or your caregiver notices any of the following side effects:

Destruction of red blood cells (thrombotic microangiopathy):

• confusion, weakness, swelling of arms and legs, yellowing of skin and eyes, vague belly (abdominal) or back pain, feeling sick (nausea), being sick (vomiting) or urinating less
  these symptoms may be signs of thrombotic microangiopathy.

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 in your face, eye pain or swelling or problems with your vision
  these symptoms may be signs of a blood clot in a vein behind your eye.
• blackening of the skin this symptom may be a sign of severe damage to the skin tissue.

Other side effects when using Hemlibra

Very common: may affect more than 1 in 10 people

a reaction in the area where the injection is given (redness, itching, pain)

headache

joint pain

Common: may affect up to 1 in 10 people

fever

muscle aches

diarrhoea

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 your eye (cavernous sinus thrombosis)

severe damage of the skin tissue (skin necrosis)

blood clot in a vein near the surface of the skin (superficial thrombophlebitis)

swollen face, tongue and/or throat and/or difficulty in swallowing, or hives, together with difficulty in breathing which are suggestive of an angioedema

lack of effect or decreased response to treatment

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 the vial label after EXP . The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze.

Store in the original pack in order to protect from light.

Once removed from the refrigerator, unopened vials may be kept at room temperature (below 30 C) for up to 7 days. After storage at room temperature, unopened vials may be returned back to the refrigerator. The total time the medicine is stored at room temperature should not be more than 7 days.

Discard vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30 C.

Once transferred from the vial to the syringe, use Hemlibra straight away. Do not refrigerate the solution in the syringe.

Before using the medicine, check the solution for particles or discoloration. The solution should be colourless to slightly yellow. Do not use this medicine if it is cloudy, discoloured, or contains visible particles.

Throw away any unused solution appropriately. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Hemlibra contains

The active substance 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 ingredients are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injections.

What Hemlibra looks like and contents of the pack

Hemlibra is a solution for injection. It is a colourless to slightly yellow liquid.

Each pack of Hemlibra contains 1 glass vial.

Not all pack sizes may be marketed.

What is needed for Hemlibra administration and is not contained in this pack

A syringe, a transfer needle and an injection needle are needed to withdraw the Hemlibra solution from the vial to a syringe and inject it under the skin (see section 7, Instructions for use ).

Syringes

1 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL or

2 to 3 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.

Needles

Transfer needle with filter: Stainless steel with Luer-lock connection, gauge 18 G, length 35 mm (1 ), containing a 5 micrometre filter and preferably with semi-blunted tip, and

Injection needle: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8 ) or maximally 13 mm ( ), preferably including needle safety feature.

Marketing Authorisation Holder

Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
Germany
Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. O. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 - 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E. : +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0) 1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: +385 1 4722 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: