STRENSIQ asfotase alfa rch 28 mg/0.70 ml solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

asfotase alfa, Quantity: 40 mg/mL

Available from:

Alexion Pharmaceuticals Australasia Pty Ltd

INN (International Name):

asfotase alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate

Administration route:

Subcutaneous

Units in package:

28mg per vial, pack of 12

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

STRENSIQ (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

Product summary:

Visual Identification: Clear, colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-01-14

Patient Information leaflet

210906_Strensiq CMI (PI_211012)
1
STRENSIQ®
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 STRENSIQ?
Strensiq contains the active ingredient asfotase alfa _rch_. Strensiq
is an enzyme replacement therapy for patients with paediatric-
onset hypophosphatasia or HPP.
For more information, see Section 1. Why am I using Strensiq? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE STRENSIQ?
Do not use if you have ever had an allergic reaction to Strensiq or
any of the ingredients listed at the end of the CMI.
Patients receiving Strensiq have had allergic reactions including
life-threatening allergic reactions requiring medical treatment.
These may occur within minutes of receiving Strensiq or after a longer
period of time on therapy.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Strensiq? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
The effect of Strensiq with other medicines has not been studied. Ask
your doctor or nurse if you have any questions.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE STRENSIQ?
Your doctor will tell you how much of this medicine (number of
milligrams) you need to inject based on your body weight.
If you are injecting this medicine yourself, you will be shown how to
prepare and give the injection by your doctor, pharmacist, or
nurse. Do not inject this medicine yourself unless you have received
training and you understand the procedure.
Allow unopened Strensiq vial(s) to reach room temperature before
injecting and administer injections within 3 hours. Follow the
instructions in this leaflet carefully regarding the use of sterile
disposable needles to withdraw and inject the medicine.
More instructions on inje

Summary of Product characteristics

210906_Strensiq PI
CCDSv3.0 & 4.0
1
AUSTRALIAN PRODUCT INFORMATION – STRENSIQ
® (ASFOTASE ALFA
_RCH_) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
asfotase alfa _rch_
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Strensiq is supplied as a single-use vial containing 40 or 100 mg/mL
of asfotase alfa _rch_.
Asfotase alfa _rch_ is a human recombinant tissue-nonspecific alkaline
phosphatase
(TNSALP) - Fc-deca-aspartate fusion protein with enzymatic activity,
produced by
recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO)
cell
culture.
For the full list of excipients, see Section 6.1 - List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection. Strensiq is a sterile, preservative-free,
non-pyrogenic, clear,
slightly opalescent or opalescent, colourless to slightly yellow
aqueous solution; few
small translucent or white particles may be present. For subcutaneous
injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Strensiq
(asfotase alfa _rch_) is indicated as enzyme replacement therapy in
patients with
paediatric-onset hypophosphatasia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Strensiq treatment should be initiated by a physician experienced in
the management of
patients with metabolic or bone disorders.
PATIENT MONITORING PROGRAM: Physicians should enrol consenting
patients receiving
Strensiq in a monitoring program.
RECOMMENDED DOSE
The recommended dosage regimen is 2 mg/kg of body weight, administered
subcutaneously 3 times per week, or 1 mg/kg of body weight
administered 6 times per
week. Refer also to the dosing chart below.
THE MAXIMUM VOLUME OF SUBCUTANEOUS INJECTION IS 1 ML PER INJECTION
SITE. IF MORE
THAN 1 ML IS REQUIRED, SPLIT THE VOLUME EQUALLY BETWEEN TWO OR MORE
SYRINGES,
AND ADMINISTER EACH INJECTION USING A SEPARATE SITE.
210906_Strensiq PI
CCDSv3.0 & 4.0
2
BODY
WEIGHT (KG)
DOSE TO BE INJECTED
IF INJECTING 3X PER WEEK
IF INJECTING 6X PER
WEEK
3
6 mg
3mg
4
8 mg
4mg
5
10 mg
5mg
6
12 mg
6 mg
7
14 mg
7 mg
8
16 mg
8 mg
9
18 mg
9 mg
10
20 mg
10 mg
11
22 mg
11 mg
12
24 mg
12 m