Zinbryta - patient leaflet, side effects, dosage

What Zinbryta is and what it is used for

The active substance in Zinbryta is daclizumab beta. This is a type of medicine called a monoclonal antibody.

What Zinbryta is used for

Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments.

In MS, the body’s immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord). This loss of myelin is called demyelination. This stops nerves from working properly.

People with relapsing MS have repeated attacks (relapses) of symptoms caused by their nerves not working properly. These symptoms vary from patient to patient but usually involve problems such as difficulty with walking, vision and balance.

Symptoms may disappear completely after the relapse is over but, over time, some problems may remain between relapses and interfere with daily activities.

How Zinbryta works

Zinbryta works by stopping the body’s immune system from damaging your brain and spinal cord. This can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Treatment with Zinbryta can help to prevent you from getting worse, although it will not cure MS. Your doctor will decide whether Zinbryta is the right medicine for you.

2. What you need to know before you use Zinbryta

Do not use Zinbryta

if you have previously had a serious allergic reaction to any form of daclizumab, or any of the other ingredients of this medicine listed in section 6.

if you have liver problems.

Warnings and precautions

Talk to your doctor before using Zinbryta:

• - if you have any other autoimmune disorders in addition to MS

• – if you are taking, have recently taken or might take any other medicines and herbal

supplements. Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while taking Zinbryta

• – if you have depression or have had it in the past.

• – if you have a serious infection , such as pneumonia.

• – if you have ever had tuberculosis (also called TB) or live in a region where TB infections are

common, you may be at greater risk of TB. You may be tested for TB before starting Zinbryta and monitored during treatment.

x<y

Possible liver problems

Zinbryta may cause serious liver problems that may be life-threatening or result in death. Serious liver problems can occur both early after starting treatment with Zinbryta, any time during treatment and several months after discontinuing treatment. Even if you have had no previous liver problems, your doctor will carry out blood tests to test yout liver function. You will need:

• - a blood test before starting treatment to check your liver function and if you have hepatitis B and C. If your blood test shows that you have some liver problems, your doctor will decide whether to start Zinbryta

at least monthly blood tests during treatment, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary

tests for up to 6 months after stopping treatment. Side effects may occur even after stopping treatment (see serious side effects in section 4).

It is very important that you have these regular blood tests. If you do not not undergo your scheduled blood tests your doctor may decide to stop treatment with Zinbryta.

You will be given a Patient Card with further information about the things to watch out for while taking Zinbryta. Keep this Card with you during treatment and for 6 months afterwards. When you have any medical treatment, even if it is not for your MS, show the Patient Card to the doctor, pharmacist or nurse.

If you experience any of the following, contact your doctor immediately:

• unexplained nausea (feeling sick)
• vomiting (being sick)
• stomach pain
• increased tiredness
• loss of appetite
• your skin or the whites of your eyes turn yellow
• dark (tea-coloured) urine

These symptoms may suggest problems with your liver. If you do develop liver problems your MS doctor may stop your treatment with Zinbryta and refer you to a liver specialist (see section 4, Possible side effects).

Children and adolescents

Zinbryta is not to be used in children and adolescents younger than 18 years old. The safety and effectiveness of Zinbryta in this age group are not known.

Elderly

Zinbryta has had very little testing in people older than 55 years old. If you are over 55 your doctor may still prescribe Zinbryta.

Other medicines and Zinbryta

Tell your doctor if you are taking, have recently taken or might take any other medicines and herbal supplements. Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while receiving Zinbryta.

Vaccinations

If you need a vaccination, ask your doctor first because Zinbryta may affect how well vaccines work. Seasonal flu vaccines (inactive vaccine) have been shown to be effective when given to patients taking Zinbryta. However, Zinbryta’s effect on other vaccines (live vaccines) is not known.

Pregnancy and breast-feeding

As data on use of Zinbryta during pregnancy are limited, the risk to the baby and benefit to the mother should be taken into consideration. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

It is not known whether Zinbryta passes into breast milk. Your doctor will help you decide whether you should stop breast-feeding, or stop using Zinbryta.

Driving and using machines

Zinbryta is not expected to affect whether your illness allows you to drive vehicles and use machines safely.

Zinbryta contains a small amount of sodium

Each dose of Zinbryta contains 0.14 mmol sodium. It is essentially ‘sodiu people on a sodium-restricted diet.

3. How to use ZinbrytaZin

ill be prescribed to you by a doctor experienced in the treatment of MS.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Recommended dose

The dose of Zinbryta is 150 mg every month.

Try to do your injection on the same day each month, to help you remember it. For example, inject on the first day of each month.

You will also have a blood test to check your liver every month, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary. It is very important that you do not miss this blood test. Try to keep to a set day for it each month. Contact your doctor if you think you may have missed a blood test.

Injecting yourself

Zinbryta is injected under the skin (subcutaneously) into your thigh, stomach or back of your upper arm. Detailed instructions for injecting Zinbryta are given in section 7, Instructions for injecting Zinbryta.

Your doctor or nurse should train you to give yourself the injections. Read and follow the advice given in section 7.

If you have trouble handling the syringe/pen, tell your doctor or nurse who may be able to help.

Q>

How long to use Zinbryta

Your doctor will tell you how long you need to keep using Zinbryta. Do not make changes unless your doctor tells you to.

If your doctor has told you to stop using your medicine, do not restart unless your doctor tells you to. If your MS does not respond to Zinbryta, your doctor may decide to stop your treatment with Zinbryta.

If you use more Zinbryta than you should

If you have injected more than your usual dose, and you notice any side effects, or are concerned, speak with your doctor or nurse. Patients have received double the recommended dose of Zinbryta with no serious extra side effects.

If you forget to take Zinbryta

Zinbryta is injected monthly. Try to keep to a particular day of the month to help remember your injection.

• If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can. Then carry on as normal, sticking to your usual injection day.
• However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your next dose on your usual day.

In either case, do not use two injections to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not try to treat any side effects yourself , but contact your doctor or nurse. Some side effects may require your doctor to interrupt your treatment and refer you to a specialist.

Serious side effects:

Liver problems:

(Common – may affect up to 1 in 10 people)

• unexplained nausea (feeling sick)
• vomiting (being sick)
• stomach pain
• increased tiredness
• loss of appetite (anorexia)
• your skin or the whites of your eyes turn yellow
• dark (tea-coloured) urine

(Uncommon – may affect up to 1 in 100 people)

• Severe inflammation of the liver which might be life-threatening or result in death

Contact your doctor immediately. These may be signs of a serious liver problem. Your

Patient Card has more information about these side effects.

Skin reactions:

(Common – may affect up to 1 in 10 people)

• severe wide-spread rash.

Depression:

(Uncommon – may affect up to 1 in 100 people)

• feeling unusually sad, hopeless or bad about yourself
• irritability, getting upset easily
• nervousness, anxiety
• thoughts of hurting yourself or suicide

Lung infections:

(Common – may affect up to 1 in 10 people)

• lung infection (e.g. pneumonia, bronchitis)

Low red blood cell counts (autoimmune haemolytic anaemia

(Uncommon – may affect up to 1 in 100 people)

• paleness
• increased tiredness
• dark urine
• shortness of breath
• your skin or the whites of the eyes turn yello

Increased tiredness, dark urine and skin or whites of the eyes turning yellow also may be symptoms of liver problems, see section above on liver problems.

Inflammation of the bowel (Common – may affect up to

• diarrhoea that does not go away
• stomach pain
• fever
• blood in your

Stomach pain may also be a symptom of liver problems, see section above on liver problems.

Low level of a type of white blood cells (called lymphocytes):

duce your level of these white blood cells so you will have a blood test every 3 months.

ur doctor immediately if you get any serious side effects.

side effects:

Very common side effects

(These may affect more than 1 in 10 people)

• infections of the airways, such as coughs and colds (nasopharyngitis, upper respiratory tract

infection)

• increases in liver enzymes in the blood (these will show up in blood tests)

Common side effects

(These may affect up to 1 in 10 people)

• flu (influenza)
• sore throat, tonsillitis (pharyngitis, laryngitis)
• runny nose (rhinitis)
• skin rashes, including inflamed, irritated, itchy, dry or peeling skin (dermatitis, eczema,

psoriasis)

• skin infection (folliculitis, acne)
• decreases in the amount of white blood cells (these will show up in blood tests)
• increases in body temperature (fever)
• inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis)
• diarrhoea
• changes in your blood (anaemia) which may make you feel weak

Uncommon side effects

(These may affect up to 1 in 100 people)

• Immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis)

Reporting of side effects

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

5. How to store Zinbryta

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

Keep the Zinbryta pre-filled syringe/pen in its original package to protect from light. Keep the pack closed until you need to use a new syringe/pen.

Store in a refrigerator (2oC to 8oC).

o Do not freeze. Throw away any Zinbryta that is accidentally frozen.

If a refrigerator is not available, Zinbryta syringes/pens can be stored at room temperature (up to 30oC) in the original pack for up to 30 days.

o Make sure Zinbryta is out of the refrigerator for no longer than 30 days.

o If Zinbryt a has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, throw the syringe/pen away (see section 7, Instructions for injecting Zinbryta).

Do not place Zinbryta back into the refrigerator after warming to room temperature.

Additional information

Do not use this medicine if you notice that:

• the syringe/pen is cracked or broken.
• the solution is cloudy or you can see particles floating in it.
• the solution is any other colour than colourless to slightly yellow.
• the pen has been dropped or is visibly damaged.

Disposal

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.

6. Contents of the pack and other information

What Zinbryta contains

The active substance is daclizumab beta.

Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.

Each pre-filled pen contains 150 mg of daclizumab beta in 1 mL solution for injection.

The other ingredients are sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections (see section 2 ‘Zinbryta contains a small amount of sodium’).

PT

What Zinbryta looks like and contents of the pack

Zinbryta is a colourless to slightly yellow, clear to opalescent liquid contained within a synnge,pen.

Pack sizes: Each pack contains one pre-filled glass syringe/pre-filled pen with an at ready to inject. A multipack of three packs of one syringe/pen is also available.

Not all pack sizes may be marketed. PC

Biogen Allé 1

is medicine, please contact the local representative of the Marketing

Lietuva

UAB "JOHNSON & JOHNSON © +370 5 278 68 88

Luxembourg/Lu­xemburg

Biogen Belgium N.V./S.A. © +32 2 219 12 18

Česká republika

Biogen (Czech Republic) s.r.o.

© +420 255 706 200

Danmark

Biogen (Denmark) A/S g +45 77 41 57 57

Malta

Pharma MT limited © +356 213 37008/9

Deutschland

Biogen GmbH

S +49 (O) 89 99 6170

Nederland

Biogen Netherlands B.V.

S +31 20 542 2000

• 7. Instructions for injecting Zinbryta

How to inject Zinbryta

Read the instructions before you start using Zinbryta and each time you get a refill of your prescription. There may be new information. This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.

Note:

Before you use the Zinbryta pre-filled syringe for the first time,

your doctor or nurse should show you or your carer how to prepare and inject the Zinbryta pre-filled syringe.

Do not use more than one pre-filled syringe per month.

Zinbryta pre-filled syringe is for injecting the medicine under the skin only (subcutaneous).

Each Zinbryta pre-filled syringe can be used once only. Do not share Zinbryta pre-filled syringe with anyone else.

Supplies needed for your Zinbryta injection

• Zinbryta pre-filled syringe

150 mg Prefilled Syringe Figure A

Additional supplies which are not included in the pack (See Figure B):

• alcohol wipe
• gauze pad
• adhesive bandage or plaster

Ask your doctor, pharmacist, or nurse for instructions on throwing away used syringes.

Parts of the Zinbryta pre-filled syringe (See Figure C)

Step 5: Gently pinch your injection site

Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge. (See Figure H.)

Hold the Zinbryta pre-filled syringe at a 45°-90° angle to the injection site (see Figure I). Quickly insert the needle straight into the skin fold until the needle is fully under the skin. (See Figure I.)

After the needle is in, let go of your skin

A Do not pull back on the plunger.

until the syringe is empty. (See Figure J.)

A Do not take the Zinbryta pre-filled syringe out of the injection site until you have pushed the plunger all the way down.

Step 7: Remove the pre-filled syringe from your injection site

Pull the needle straight out. (See Figure K.)

Caution – do not recap the Zinbryta pre-filled syringe. You could get a needle injury.

Do not reuse the Zinbryta pre-filled syringe.

Step 8: Disposing of the used Zinbryta Pre-filled Syringe

• Check with your doctor, pharmacist or nurse about the right way to throw away the used syringe.

Step 9: Care for your injection site

If needed, apply the gauze pad, adhesive bandage or plaster to the injection site.

General Warnings V

A Do not reuse Zinbryta pre-filled syringe.

A Do not share Zinbryta pre-filled syringe.

• Keep Zinbryta pre-filled syringe and all medicines out of reach and sight of children.

Storage

• Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
• If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.

A Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room

temperature.

Do not freeze or expose to high temperatures.

0°

• 7. Instructions for injecting Zinbryta

A Caution! Do not remove the cap until you are ready to inject.

Read the instructions before you start using Zinbryta and each time you get a refill of your prescription. There may be new information. This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.

Note:

• Before you use the pen for the first time,your doctor or nurse should show you or your carer how to prepare and inject the pen.
• The pen is for use under the skin only (subcutaneous).
• Each pen can be used once only.

A Do not share the pen with anyone else to avoid giving an infection to them or getting infection from them.

A Do not use more than 1 pen per month.

A Do not use the pen if it has been dropped or is visibly damaged.

Additional supplies which are not included in the pack (See Figure B):

Note : You might see air bubbles in the medicine window. This is normal and will not affect your dose.

A Do not use the pen if it has be en dropped or is visibly damaged.

Step 4: Choose and clean your injection site

a. Choose an injection site in your thigh, abdomen, or the back of your upper arm (See highlighted areas in Figure D).

• if some areas are too difficult for you to ieach, ask a carer who has been trained to help you.

A Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.

A Do not inject directly into your belly button.

b.	Wipe your skin with an alcohol wipe.
À	Note: Do not touch or blow on this area
before giving your injection.
c.	Let your injection site dry on its own before
injecting your dose.

Giving your injection

Step 5: Remove the Zinbryta Pen cap __________

• a. Pull the pen cap straight off and set it aside (See Figure E). Your pen is now ready to inject.

A Warning! Do not touch, clean or manipulate the needle cover. You could get a needle injury or the pen may lock.

A Do not re-cap the pen. This could lock the pen.

Note : Do not rest the pen on the injection site until you are ready to inject. This may cause the pen to accidentally lock.

• b. Firmly press and hold down the pen on your injection site. You will hear the clicking sounds start.

This tells you that the injection is happening (see Figure G).

c Continue to hold the pen firmly down on your injection site until the clicking sounds have stopped (see Figure H).

Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.

Warning! If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection. You should then contact your doctor, nurse or pharmacist.

Step 7: Remove the Zinbryta Pen from your injection site

a. After the clicking sound has stopped, lift the pen from your injection site. The needle cover will extend to cover the needle and will lock (See Figure I).

• If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster.

After your injection

Note : After the pen has been removed from the injection site, the needle cover will lock to protect against needle injury. Do not re-cap the pen.

Step 9: Disposing of used Zinbryta Pens

Check with your doctor, pharmacist or nurse about the right way to throw away the used pen.

Do not re-cap the pen.

Step 10: Care for your injection site

If needed, apply a gauze pad, adhesive bandage or plaster to the injection site.

Storage

• Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
• If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.