KANUMA sebelipase alfa rce 2 mg/mL injection intravenous infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sebelipase alfa, Quantity: 2 mg/mL

Available from:

Alexion Pharmaceuticals Australasia Pty Ltd

INN (International Name):

sebelipase alfa

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; Albumin

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).

Product summary:

Visual Identification: Clear to slightly opalescent, colourless to slightly coloured (yellow) liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-18

Patient Information leaflet

KANUMA
®
K
a
n
u
m
a
®
2
1
1
0
1
5
_
C
M
I
(
P
I
2
1
1
0
1
4
)
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.
1.
WHY AM I USING KANUMA?
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.
2.
WHAT SHOULD I KNOW BEFORE I USE KANUMA?
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.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
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.
4.
HOW DO I USE KANUMA?
•
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.
5.
WHAT SHOULD I KNOW WHILE USING KANUMA?
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 yo

Summary of Product characteristics

210903_Kanuma PI
CCDS v3.0 & 4.0
1
AUSTRALIAN PRODUCT INFORMATION – KANUMA
® (SEBELIPASE
ALFA _RCE_) CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sebelipase alfa _rce_
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kanuma is supplied as a single-use vial containing 20 mg of sebelipase
alfa _rce_ (2
mg/mL).
For the full list of excipients, see Section 6.1 - List of Excipients.
3
PHARMACEUTICAL FORM
Concentrated solution for intravenous infusion. Kanuma is a clear to
slightly opalescent,
colourless to slightly coloured solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Kanuma (sebelipase alfa_ rce_) is indicated for long-term enzyme
replacement therapy
(ERT) in patients of all ages with lysosomal acid lipase deficiency
(LAL-D).
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is important to initiate treatment as early as possible.
Kanuma is for intravenous use only. The total volume of the infusion
should be
administered over approximately 2 hours. Infusion over 1 hour may be
considered after
patient tolerability is established. The infusion period may be
extended in the event of
dose escalation.
For instructions on the preventive measures and monitoring of
hypersensitivity
reactions, _see section 4.4 – Special Warnings and Precautions for
Use; Hypersensitivity _
_reactions, including anaphylaxis_.
RECOMMENDED DOSE
INFANTS (< 6 MONTHS OF AGE) PRESENTING WITH LAL-D
The recommended starting dose in infants < 6 months of age presenting
with rapidly
progressive LAL-D is 1 mg/kg administered as an IV infusion once
weekly.
Dose escalations maybe considered based on suboptimal response to
clinical and
biochemical criteria, including, poor growth, deteriorating
biochemical markers (e.g.
liver transaminases, ferritin, C-reactive protein, and coagulation
parameters),persistent
or worsening organomegaly, increased frequency of intercurrent
infections, and
persistent or worsening of other symptoms (e.g. gastrointestinal
symptoms).
A dose escalation to 3 mg/kg should be considered in case of
subop