KANUMA®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
Kanuma contains the active ingredient sebelipase alfa rce. Sebelipase alfa rce is
similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body
uses to breakdown fats. Kanuma is used to treat patients of all ages with lysosomal
acid lipase deficiency (LAL-D).
For more information, see Section 1. Why am I using Kanuma? in the full CMI.
For more information, see Section 1. Why am I using Kanuma? in the full CMI.
Do not use if you or your child has had a life-threatening allergic reaction to Kanuma,
or to egg, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Kanuma? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Kanuma? in the full CMI.
Some medicines may interfere with Kanuma and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor or nurse will give Kanuma to you or your child by an infusion (drip) into
a vein.
More instructions can be found in Section 4. How do I use Kanuma? in the full CMI.
More instructions can be found in Section 4. How do I use Kanuma? in the full CMI.
|
Things you should do
|
Ask your doctor if you have any questions about why this medicine has been prescribed
for you or your child.
Remind any doctor, dentist, nurse or pharmacist you visit that you or your child are
using Kanuma.
Keep appointments with your doctor or clinic. It is important to have you or your
child's Kanuma infusion at the appointed time each time to make sure Kanuma has the
best chance of providing effective treatment for the condition.
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. You must not be given Kanuma.
|
|---|---|
|
Things you should not do
|
Do not stop taking your medicine without checking with your doctor.
|
|
Driving or using machines
|
Kanuma has not been shown to impair the ability to drive or operate machinery. However,
if you experience dizziness, a reported side effect, then you should not drive or
operate machinery until it has resolved.
|
|
Looking after your medicine
|
Store under refrigeration (2°C to 8°C) and protected from light in the hospital or
pharmacy.
|
For more information, see Section 5. What should I know while using Kanuma? in the full CMI.
Kanuma contains a protein and proteins can cause allergic reactions in some people
including serious, potentially life-threatening allergic reaction. If you or your
child experiences a severe infusion reaction like this, seek immediate medical attention.
The development of blood proteins against Kanuma, also called anti-drug antibodies, may occur during the treatment. Talk to your doctor if you experience decreased efficacy with Kanuma.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
The development of blood proteins against Kanuma, also called anti-drug antibodies, may occur during the treatment. Talk to your doctor if you experience decreased efficacy with Kanuma.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
KANUMA®
(ka-nu-ma)
Active ingredient(s):
[sebelipase alfa,rce]
Consumer Medicine Information (CMI)
This leaflet provides important information about using Kanuma.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Kanuma.
Where to find information in this leaflet:
Kanuma contains the active ingredient sebelipase alfa rce.
Sebelipase alfa rce is similar to the naturally occurring enzyme lysosomal acid lipase
(LAL), which the body uses to breakdown fats.
Kanuma is an enzyme replacement therapy. This means that it replaces the missing or
defective LAL enzyme in patients with LAL-D.
Kanuma is used to treat patients of all ages with lysosomal acid lipase deficiency
(LAL-D).
Kanuma works by lowering the buildup of fat that causes medical complications, including
impaired growth, digestive problems, liver damage, including liver failure and heart
complications. It also improves blood levels of fats, including reducing elevated
low-density lipoprotein cholesterol (LDL; also known as bad cholesterol) and triglycerides.
Warnings
Do not use Kanuma if you or your child has had a life-threatening allergic reaction:
to sebelipase alfa rce,
to any of the ingredients listed at the end of this leaflet, or
to egg
that cannot be managed when you or your child receives Kanuma again.
Some symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing,
swelling of the face, lips, tongue, or other parts of the body,
rash, itching or hives on the skin.
If you are not sure whether you or your child should be treated with Kanuma, talk
to your doctor.
You or your child may experience side effects while being given Kanuma, or during
the hours following the infusion. This is known as an infusion reaction. It can sometimes
be severe and may include an allergic reaction (see above "Some symptoms of an allergic
reaction may include"). If you or your child experiences a severe infusion reaction,
seek immediate medical attention.
If you or your child has an infusion reaction you may be given additional medicines
to treat or prevent future reactions. These medicines may include antihistamines,
fever-reducing medicines or corticosteroids (a type of anti-inflammatory medicines).
If the infusion reaction is severe, your doctor may stop the infusion.
Check with your doctor if you:
or your child has allergies to any other medicines, foods, preservatives, or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant, your doctor
can discuss with you the risks and benefits involved. There is insufficient data from
the use of Kanuma in pregnant women to determine if sebelipase alfa rce exposure during
pregnancy poses any risk to the mother or fetus.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
whether Kanuma passes into breast milk. You should not breast feed while using Kanuma
unless you have discussed it with your doctor.
Your doctor will discuss the benefits and risks of continuing treatment with Kanuma
whilst breastfeeding.
Tell your doctor or pharmacist if you or your child are taking any other medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
It is not known if Kanuma interferes with other medicines or other medicines affects
Kanuma and how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Kanuma.
Follow all directions given to you by your doctor, nurse or pharmacist carefully.
They may differ from the information contained in this leaflet.
The dose you or your child receives is based on body weight.
Infants (less than 6 months of age)
For patients who have signs and symptoms of the disease when they are infants, the
recommended starting dose is 1 mg per kg or 3 mg per kg of body weight once weekly.
Children and adults
The recommended dose is 1 mg per kg body weight once every two weeks.
Dose adjustments may be considered based on how well 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. Kanuma will be diluted before being administered.
Each infusion will take approximately 1 to 2 hours. You or your child will be monitored
by your doctor or nurse after infusion.
If you forget to use Kanuma
If you forget or miss you or your child's appointment for a Kanuma infusion, contact
your doctor immediately.
If you use too much Kanuma
As Kanuma is given to you or your child under the supervision of your doctor, it is
unlikely that you will receive too much.
Things you should do
Tell any other doctors, dentists, and pharmacists who treat you that you or your child
is taking this medicine.
Keep appointments with your doctor or clinic. It is important to have your or your
child's Kanuma infusion at the appointed time each time to make sure Kanuma has the
best chance of providing effective treatment for the condition.
Call your doctor straight away if you:
If you or your child experiences a severe infusion reaction.
You or your child may experience a side effect while you or your child is being given
Kanuma or during the hours following the infusion.
This is known as an infusion reaction which can sometimes be severe and may include
an allergic reaction that could be life-threatening and require medical treatment.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Kanuma
affects you.
It is not known if Kanuma impairs the ability to drive or operate machinery. However,
if you experience dizziness, a reported side effect it could affect your ability to
drive or operate machinery until it has resolved.
Looking after your medicine
Kanuma will be stored under refrigeration (2°C to 8°C, do not freeze) in the original
packaging in order to protect from light in the hospital or pharmacy.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|---|---|
|
Side effects reported in infants (1 to 6 months old) are:
Eyelid swelling
Fast heartbeat
Diarrhoea
Vomiting
Rash, raised rash
Fever
Low red blood cell count
Running nose, cold, cough
Development of blood proteins against the drug
Catheter related infection
Reaction at the site of infusion
Side effects reported in children and adults are:
Headache
Dizziness
Stomach-ache, diarrhoea, constipation, nausea
Tiredness
Fever
Cold, throat pain
Rash, raised rash
Stomach bloating
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|---|---|
|
Severe allergic reaction (anaphylactic reaction), hypersensitivity (chills, eczema,
laryngeal oedema, nausea, itching and hives, decreased oxygen in the blood, blood
pressure increased, rapid breathing.
Allergy may also present as: Fast heartbeat, low blood pressure, shortness of breath,
difficulty breathing, rapid breathing, chest discomfort, mild swelling of eyelids,
red eyes, runny nose, flushing, hives, itching, diarrhoea, paleness, wheezing, low
blood oxygen, skin redness, irritability.
In infants, allergic reaction may present as irritability, agitation, vomiting, hives,
eczema, itching, paleness.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What Kanuma contains
|
Active ingredient
(main ingredient)
|
Sebelipase alfa rce
|
|---|---|
|
Other ingredients
(inactive ingredients)
|
Sodium citrate
Citric acid monohydrate
Albumin
Water for Injection
|
|
Potential allergens
|
Egg
|
Do not take this medicine if you are allergic to any of these ingredients.
