XEMBIFY normal immunoglobulin 10 g/50 mL (20%) solution for subcutaneous injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human immunoglobulin G, Quantity: 9000 mg

Available from:

Grifols Australia Pty Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: glycine; polysorbate 80; water for injections

Administration route:

Subcutaneous

Units in package:

50 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indications for subcutaneous administration (SCIg),Xembify? is indicated as replacement therapy in adult and paediatric patients for:,- Primary immunodeficiency diseases (PID),- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Product summary:

Visual Identification: SCIg; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-06-30

Patient Information leaflet

Xembify®
1
XEMBIFY®
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING XEMBIFY®?
Xembify® contains the active ingredient normal immunoglobulin .
Xembify® is used to help your body fight infections.
For more information, see Section 1. Why am I using Xembify®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XEMBIFY®?
Do not use if you have ever had an allergic reaction to normal
immunoglobulin 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
Xembify®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Xembify® 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 XEMBIFY®?
•
The recommended dose and dosing schedule are established by your
doctor.
•
Xembify® has to be infused under the skin (subcutaneous or SC
administration).
More instructions can be found in Section 4. How do I use Xembify®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XEMBIFY®?
THINGS YOU
SHOULD DO
• Remind any doctor, dentist or pharmacist you visit that you are
using Xembify®
• Have routine blood tests to measure the level of immunoglobulin in
your blood.
THINGS YOU
SHOULD NOT DO
• Do not change the dose or the time interval to the next dose
without talking to your doctor first.
• Do not use this medicine after the expiry date which is stated on
the label and carton
• Do not use this medicine if you notice it is cloudy, discoloured,
turbid, or if it has been frozen.
DRIVING OR USING
MACHINES
• Your ability t

Summary of Product characteristics

Xembify
®
Product Information
1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
XEMBIFY
®
NORMAL IMMUNOGLOBULIN (HUMAN) 20% SOLUTION FOR
SUBCUTANEOUS INJECTION
1.
NAME OF THE MEDICINE
Normal Immunoglobulin (Human) 20% solution for subcutaneous injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Normal immunoglobulin
One ml contains:
Normal immunoglobulin
200 mg
(purity of at least 98% human immunoglobulin G (IgG))
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dosage form: Injection
Solution for injection, for subcutaneous use.
The solution is clear to slightly opalescent, and colourless or pale
yellow or light brown.
Xembify
®
has an approximate osmolality range of 280 to 404 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indications for subcutaneous administration (SCIg)
Xembify
®
is indicated as replacement therapy in adult and paediatric patients
for:

Primary immunodeficiency diseases (PID)

Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under the
supervision of a physician
experienced in the treatment of immunodeficiency.
Dosage
The dose and dose regimen are dependent on the indication.
▼
2
_Replacement therapy_
The product should be administered via the subcutaneous route.
In replacement therapy the dose may need to be individualised for each
patient dependent on the
pharmacokinetic and clinical response. The following dose regimens are
given as a guideline.
The dose regimen should achieve a trough level of IgG (measured before
the next infusion) of at least
5 to 6 g/l and aim to be within the reference interval of serum IgG
for age. A loading dose of at leas