30 mg / 1 ml solution for injection
emicizumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get side effects are, speak with your doctor or pharmacist This includes any possible adverse effects not listed in this leaflet. See section 4.

In this leaflet you will find information about:
1. What Hemlibra is and what it is used for
2. What you need to know before using Hemlibra
3. How to use Hemlibra
4. Possible side effects
5. How to store Hemlibra
6. Contents of the packaging and other information

1. What Hemlibra is and what it is used for

What Hemlibra is

Hemlibra contains the active substance emicizumab. It 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 used to treat patients of all ages with:

  • either hemophilia A which has developed inhibitory antibody to factor VIII
  • or severe haemophilia A that has not developed inhibitory antibodies to factor VIII (blood levels of factor VIII are less than 1%).

Hemophilia A is a hereditary disease caused by a deficiency of factor VIII, which is a necessary substance required for the blood to clot (coagulate) and stop all kinds of bleeding.

The drug prevents bleeding or reduces bleeding episodes in patients with this disease.

Some patients with hemophilia A may develop inhibitors of factor VIII ( antibodies to factor VIII ) that prevent the action of replacement factor VIII.

How Hemlibra works

Hemlibra restores the function of missing activated factor VIII which is needed for efficient coagulation (clotting) of the blood. The structure of Hemlibra differs from factor VIII and therefore Hemlibra is not affected by the factor VIII inhibitors.

2. What you need to know before using 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 cautions

Before you start using Hemlibra, it is very important to talk to your doctor about the use of medicines that have factor VIII inhibitor bypass activity, so-called “bypass preparations” (medicines that help the blood to clot but work in a different way than factor VIII ). This is because treatment with such medicines may need to be changed while you are receiving Hemlibra. Examples of such drugs include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (rFVIIa). Serious and potentially life-threatening adverse reactions may occur when aPCC is used in patients also receiving Hemlibra:

Serious side effects of using aPCC during treatment with Hemlibra.

  • Degradation of red blood cells (thrombotic microangiopathy)
    • This is a serious condition that can be life threatening.
    • When people have this condition, the inside of the blood vessels can be damaged and blood clots can develop in small blood vessels. In some cases, this can cause damage to the kidneys and other organs.
    • Be careful if you have a high risk of developing this condition (have had this condition before or have a relative who has had it), or if you are taking medicines that may increase the risk of developing this condition such as ciclosporin, quinine or tacrolimus.
    • It is important to recognize the symptoms of thrombotic microangiopathy if you develop this 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 healthcare provider notice any symptoms of thrombotic microangiopathy.

  • Blood clots ( thromboembolism )
    • In rare cases, a blood clot can form inside blood vessels and block them, which can be life-threatening.
    • It is important to recognize the symptoms of such blood clots if 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 healthcare provider notice any symptoms of blood clots in your blood vessels.

Children younger than one year

In children younger than one year, the blood system is still developing. If the child is younger than one year, your doctor may only prescribe Hemlibra after carefully weighing the expected benefits against the risks of using this medicine.

Other medicines and Hemlibra

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

  • Use of bypass preparations while receiving Hemlibra
    • Talk to your doctor before using Hemlibra and carefully follow their instructions for when to use bypass preparations and what dose and schedule to use. Hemlibra increases the ability of your blood to clot. Therefore, the dose of one of the bypass preparations required may be lower than the dose you used before starting Hemlibra.
    • Use aPCC only if no other treatment options can be used. If aPCC is still required, talk to your doctor if you feel you need more than a total of 50 units / kg of aPCC. For more information on using aPCC while you are receiving Hemlibra, see section 2: “Serious side effects of using aPCC during treatment with Hemlibra”.
    • Despite limited experience with concomitant use of antifibrinolytics (drugs that cause the blood to coagulate) with aPCC or rFVIIa in patients treated with Hemlibra, you should be aware that there is a risk of thrombotic disease when antifibrinolytics are given intravenously in combination with aPCC or rFVIIa.

Laboratory tests

Tell your doctor if you use Hemlibra before taking samples to measure how well your blood is clotting. This is because Hemlibra in the blood can interfere with some laboratory tests, leading to incorrect results.

Pregnancy and breastfeeding

  • You should use an effective method of 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 taking this medicine. Your doctor will consider the benefits to you of taking Hemlibra against the risks to your child.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use any tools or machines.

3. How to use Hemlibra

Hemlibra is supplied in single-use vials in the form of a ready-to-use solution without first diluting. A doctor qualified to care for patients with hemophilia will start your treatment with Hemlibra. Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.

Take notes

Write down the name and batch number of the medicine each time you use Hemlibra.

How much Hemlibra to use

Dose one of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and the corresponding volume of Hemlibra (in ml) to be injected, as follows:

  • Dosage one of the loading dose: Week 1 to 4: Dose one is 3 milligrams for each kilogram you weigh and is injected once a week.
  • Dosage of maintenance dose: From week 5 onwards: Dose one is either 1.5 milligrams for every kg you weigh, injected once a week, 3 milligrams for every kg you weigh, injected every two weeks, or 6 milligrams for every kg you weigh , injected every four weeks.

The decision to use either 1.5 mg/kg once a week, 3 mg/kg every other week, or 6 mg/kg every four weeks as a maintenance dose should be made in consultation with your doctor and healthcare provider, if available.

Different Hemlibra concentrations (30 mg/ml and 150 mg/ml) should not be combined in the same injection when the total volume is to be injected.

The amount of Hemlibral solution given with each injection should not exceed 2 ml.

How Hemlibra is given

If you are injecting Hemlibra yourself or if your healthcare provider is giving you an injection, you or your healthcare provider must carefully read and follow the instructions in section 7, “User instructions”.

  • Hemlibra is given as an 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 yourself, or with the help of your healthcare provider.
  • To insert the needle correctly under the skin, pinch a fold of loose skin at the cleansed injection site with your free hand. Squeezing the skin is important to ensure that you inject under the skin (into the adipose tissue) but not deeper (into a muscle). Injecting into a muscle can cause discomfort.
  • Prepare and inject one under clean and germ-free conditions using aseptic technique. You will receive more information about this from your doctor or nurse.

Where to inject Hemlibra

  • Your doctor will show you which areas of the body are suitable for injection of Hemlibra.
  • The recommended places to give an injection are: the front of the waist (lower abdomen), the outside of the upper arm or the front of the thighs. Use only the recommended injection sites.
  • For each new injection , use a different area of ​​the body than the one you used before.
  • Do not inject where the skin is red, bruised, tender, hard or in areas where there are birthmarks or scars.
  • When you use Hemlibra, any other medicine that is injected under the skin should be given in a different area.

Use syringes and needles

  • A syringe , a transfer needle with a 5 micrometer filter and an injection needle are used to draw Hemlibral solution from the vial and inject it under the skin.
  • Syringes, transfer needles with filters and injection needles are not included in this package. For further information, see section 6 “What is needed when using Hemlibra and is not included in the package”.
  • Make sure you use a new injection needle for each injection and discard it after use.
  • A 1 ml syringe should be used to inject you with up to 1 ml of Hemlibral solution.
  • A 2 to 3 ml syringe should be used for injections of more than 1 ml and up to 2 ml of Hemlibral solution.

Use for children and adolescents

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

  • A child can inject this medicine themselves, provided that the child’s healthcare provider and parent or caregiver agree. Self-injection for children under 7 years of age is not recommended.

If you use more Hemlibra than you should 

If you take more Hemlibra than you should, tell your doctor immediately. This is because you are 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 to take your scheduled injection , inject the missed dose as soon as possible before the day of your next scheduled dose . Then continue to inject the medicine according to the schedule. Do not inject two doses on the same day to compensate for a missed 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 first. If you stop using Hemlibra, you may no longer be protected against bleeding.

If you have any further questions on the use of this product, ask 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 during treatment with Hemlibra

Stop using Hemlibra and aPCC and contact your doctor immediately if you or your healthcare provider notice any of the following side effects:

  • Degradation of red blood cells (thrombotic microangiopathy):
    • confusion, weakness, swelling of the arms and legs, yellowing of the skin or eyes, diffuse pain in the abdomen or back, nausea, vomiting or a small amount of urine – these symptoms may be signs of thrombotic microangiopathy.
  • Blood clots ( thromboembolism ):
    • swelling, heat, pain or redness – these symptoms may be signs of a blood clot in a vein near the skin.
    • headaches, numbness of the 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 can be a sign of severe damage to the skin tissue.

Other side effects are with the use of Hemlibra

Very common: may affect more than 1 user in 10

  • reaction in the area where the injection is given ( redness , itching , pain)
  • headache
  • joint pain

Common: may affect up to 1 in 10 users

  • fever
  • muscle aches
  • diarrhea

Uncommon: may affect up to 1 in 100 people

  • degradation of red blood cells (thrombotic microangiopathy)
  • blood clot in a vein behind your eye (cavernous sinus thrombosis)
  • severe damage to the skin tissue (skin necrosis)
  • blood clot in a vein near the skin surface (superficial thrombophlebitis )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hemlibra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”. or “EXP”. The expiration date is the last day of the specified month.

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

Store in the original package. Sensitive to light.

Unopened vials that have been removed from the refrigerator can be stored at room temperature (at a maximum of 30 ° C) for up to 7 days. After storage at room temperature, unopened vials can be returned to the refrigerator. The total storage time at room temperature should not exceed 7 days.

Disposable vials that have been stored at room temperature for more than 7 days or that have been exposed to temperatures above 30 ° C should be discarded.

Once Hemlibra has been transferred from the vial to the syringe, it should be used immediately. Do not store the syringe with the solution in the refrigerator.

Before using this medicine, make sure that the solution does not contain any particles or discolorations. The solution should be colorless to pale yellow. Do not use this medicine if you notice that it is cloudy, discolored, or contains visible particles.

Dispose of any unused solution appropriately. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and contents of the pack

Hemlibra is a solution for injection. It has a colorless to pale yellow liquid.

Each pack of Hemlibra contains 1 glass vial.

What is needed when using Hemlibra and is not included in the package.

A syringe, transfer needle, and injection needle are needed to draw Hemlibral solution from the vial to the 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, 0.01 ml graduation or
  • 2 to 3 ml syringe: clear polypropylene or polycarbonate syringe with Luer-lock tip, 0.1 ml graduation.

Needles

  • Transfer needle with filter : Stainless steel with Luer-lock connection, gauge 18 G, length 35 mm (1½ ″), with a filter of 5 micrometers and preferably with a semi-blunt 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 maximum 13 mm (½ ″), preferably with needle safety device.

Marketing Authorisation Holder

Roche Registration GmbH 

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen 

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Wyhlen

Germany

Roche Austria GmbH

Engelhorngasse 3

A-1211 Vienna

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNV Roche SATel: +32 (0) 2 525 82 11 LithuaniaUAB “Roche Lietuva”Tel: +370 5 2546799
BulgariaRosh BULGARIA LOODETel: +359 2 818 44 44 Luxembourg / Luxemburg(See / See Belgium / Belgium)
Czech RepublicRoche sroTel: +420 – 2 20382111 HungaryRoche (Hungary) Kft.Tel: +36 – 23 446 800
DenmarkRoche a / sTel: +45 – 36 39 99 99 Malta(See Ireland)
GermanyRoche Pharma AGTel: +49 (0) 7624 140 The NetherlandsRoche Nederland BVTel: +31 (0) 348 438050
EestiRoche Eesti OÜTel: + 372 – 6 177 380 NorwayRoche Norge ASTel: +47 – 22 78 90 00
GreeceRoche (Hellas) AE:Ηλ: +30 210 61 66 100 AustriaRoche Austria GmbHTel: +43 (0) 1 27739
SpainRoche Farma SATel: +34 – 91 324 81 00 PolandRoche Polska Sp.z ooTel: +48 – 22 345 18 88
FranceRocheTel: +33 (0) 1 47 61 40 00 PortugalRoche Pharmacêutica Chemica, LdaTel: +351 – 21 425 70 00
CroatiaRoche dooTel: + 385 1 47 22 333 RomaniaRoche România SRLTel: +40 21 206 47 01
IrelandRoche Products (Ireland) Ltd.Tel: +353 (0) 1 469 0700 SloveniaRoche pharmacevtska družba dooTel: +386 – 1 360 26 00
IcelandRoche a / sc / o Icepharma hfPhone: +354 540 8000 Slovak RepublicRoche Slovensko, sroTel: +421 – 2 52638201
ItalyRoche SpATel: +39 – 039 2471 Finland / FinlandRoche Oy Puh / Tel: +358 (0) 10 554 500
ύπρος Γ.Α.Σταμάτης & Σια Λτδ.:Ηλ: +357 – 22 76 62 76 SwedenRoche ABTel: +46 (0) 8 726 1200
LatviaRoche Latvija SIATel: +371 – 6 7039831 United KingdomRoche Products Ltd.Tel: +44 (0) 1707 366000

Muhammad Nadeem

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