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Kanuma (sebelipase alfa) – Package leaflet - A16

Updated on site: 08-Oct-2017

Medication nameKanuma
ATC CodeA16
Substancesebelipase alfa
ManufacturerAlexion Europe SAS

Package leaflet: Information for the user

KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you or your child may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor.

-If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What KANUMA is and what it is used for

2.What you need to know before you are given KANUMA

3.How KANUMA is given

4.Possible side effects

5.How to store KANUMA

6.Contents of the pack and other information

1.What KANUMA is and what it is used for

KANUMA contains the active substance sebelipase alfa. Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats. It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).

LAL deficiency is a genetic disease that leads to liver damage, high blood cholesterol, and other complications due to a build-up of certain types of fats (cholesteryl esters and triglycerides).

How KANUMA works

This medicine is an enzyme replacement therapy. This means that it replaces the missing or defective LAL enzyme in patients with LAL deficiency. This medicine works by lowering the build-up of fat that causes medical complications, including impaired growth, liver damage and heart complications. It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.

2. What you need to know before KANUMA is given

You must not be given KANUMA:

-if you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

-If treated with KANUMA, you or your child may experience a side effect while you or your child is being given the medicine or during the hours following the infusion (see section 4). This is known as an infusion reaction which can sometimes be severe, and may include an

allergic reaction. If you or your child experiences a severe infusion reaction like this, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of anti- inflammatory medicines).

If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.

-This medicine may contain egg proteins. If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).

Other medicines and KANUMA

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

Pregnancy and breast-feeding

You should not be given KANUMA if you are pregnant unless clearly necessary. It is not known whether sebelipase alfa passes into breast milk; therefore it is recommended that you stop breast-feeding or using KANUMA treatment while breast-feeding.

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.

Driving and using machines

KANUMA has no or negligible influence on the ability to drive and use machines.

KANUMA contains sodium

Each 10 ml vial contains 33 mg sodium. Tell your doctor if you or your child is on a controlled sodium diet.

3.How KANUMA is given

The dose you or your child receives is based on your or your child’s body weight. The recommended dose is 1 mg per kg body weight once every other week through a drip into a vein. For patients who have signs and symptoms of the disease when they are infants, the recommended starting dose is

1 mg/kg once weekly. Each infusion will take approximately 1 to 2 hours. You or your child may be monitored by your doctor or nurse for an additional hour after the infusion. Dose adjustments may be considered based on how well you or your child responds to treatment. KANUMA should be started at as young an age as possible and is intended for long-term use.

Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein. The medicine will be diluted before being given to you or your child.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects were seen while patients were being given the medicine or shortly after (infusion reactions). The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, swelling of the throat, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, and hives. If you or your child experiences symptoms like these, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given

additional medicines to treat or help prevent future reactions. If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.

Very common side effects reported in infants (1 to 6 months old) are:

eyelid swelling

agitation

high blood pressure

decreased muscle tone

difficulty breathing

wheezing

paleness

stuffy or swollen nose

sneezing

cough

heartburn (reflux diseases)

dry heaving

diarrhoea

hives

rash

vomiting

itching

raised rash

red swollen skin

fever

swelling

chills

rapid breathing

not enough oxygen in the blood

fast heartbeat

irritability

 

Common side effects reported in children and adolescents (4 to 18 years old) and adults are:

severe allergic reaction

infection of the urinary system

swelling of the eyelids

(anaphylactic reaction)

 

 

temporary increased cholesterol

fast heartbeat

anxiety

or triglyceride (fats) levels in

 

 

the blood

 

 

sleeplessness

dizziness

low blood pressure

redness in face

shortness of breath

swelling of the throat

diarrhoea

stomach ache

stomach bloating

nausea

hives

rash

itching

red swollen skin

increased menstrual bleeding

shivers

chest discomfort

swelling

tiredness

hardened area around the

fever

 

infusion site

 

Frequency, type and severity of adverse reactions in children are the same as in adults.

Reporting of side effects

If you or your child gets any side effects, talk to your doctor. 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.

5.How to store KANUMA

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

Store in a refrigerator (2°C to 8°C). Do not freeze. Do not shake. Store in the original package in order to protect from light.

For diluted solutions, immediate use is recommended. If not used immediately, the diluted solution may be stored up to 24 hours at 2°C to 8°C or up to 12 hours below 25°C.

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 KANUMA contains

-The active substance is sebelipase alfa. Each ml of concentrate contains 2 mg sebelipase alfa. Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).

-The other ingredients are trisodium citrate dihydrate (see section 2 under ‘KANUMA contains sodium’), citric acid monohydrate, human serum albumin, and water for injections.

What KANUMA looks like and contents of the pack

KANUMA is supplied as a concentrate for solution for infusion. It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.

Pack sizes: 1 vial containing 10 ml of concentrate.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Alexion Europe SAS

1-15, avenue Edouard Belin

92500 Rueil-Malmaison France

Manufacturer:

Almac Pharma Services

Seagoe Industrial Estate

Craigavon BT63 5UA

United Kingdom

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

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The following information is intended for healthcare professionals only:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Each vial of KANUMA is intended for single use only. KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.

The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2 as available in order to avoid filter occlusion.

Preparation of the sebelipase alfa infusion

KANUMA should be prepared and used according to the following steps. Aseptic technique should be used.

a.The number of vials to be diluted for infusion should be determined based on the patient’s weight and prescribed dose.

b.It is recommended to allow KANUMA vials to reach a temperature between 15°C and 25°C prior to reconstitution to minimize the potential for the formation of sebelipase alfa protein particles in solution. The vials should not be left outside the refrigerator longer than 24 hours prior to dilution for infusion. The vials should not be frozen, heated or microwaved and should be protected from light.

c.The vials should not be shaken. Prior to dilution, the solution in the vials should be inspected visually; the solution should be clear to slightly opalescent, colourless to slightly coloured (yellow). Due to the proteinaceous nature of the product, slight flocculation (e.g., thin translucent fibres) may be present in the vialed solution and is acceptable for use.

d.Do not use if the solution is cloudy, or if foreign particulate matter is present.

e.Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion. See Table 1 for recommended total infusion volumes by weight range. The solution should be mixed gently, and not be shaken.

Table 1: Recommended infusion volumes (1 mg/kg dose)*

Weight range (kg)

Total infusion volume (ml)

 

 

1-10

 

 

11-24

 

 

25-49

 

 

50-99

 

 

100-120

* The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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