XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe

Main information

  • Trade name:
  • XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 174840
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

174840

XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

4/10/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. XYNTHA moroctocog alfa (rch) 2000IU powder for injection and diluent dual-chamber syringe

Product Type

Composite Pack

Effective date

1/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings.

XYNTHA does not contain von Willebrand factor and should not be used by patients with von Willebrand's disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

3 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1. Active chamber

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

White cake or powder

Active Ingredients

Moroctocog alfa

2000 IU

2. Diluent chamber

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colourless liquid.

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:40:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

XYNTHA

®

moroctocog alfa rch, also known as recombinant coagulation factor VIII

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common questions about XYNTHA.

It does not contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

If you have any concerns about

using XYNTHA, ask your doctor

or pharmacist.

Your doctor and pharmacist have

more information.

Keep this leaflet with your

XYNTHA. You may need to read it

again.

What XYNTHA is

XYNTHA is a protein called

coagulation factor VIII protein

product that is important for helping

your blood clot. XYNTHA is

produced by recombinant DNA

technology and is made in a

laboratory, rather than isolated from

human blood donors, which is where

plasma derived factor VIII comes

from. Mammalian cells, which have

the DNA for human coagulation

factor VIII put in them, are grown in

large amounts in cell culture

laboratories. These cells make

recombinant human factor VIII,

which is released into cell culture

media and then very highly purified.

XYNTHA does not contain any

human blood or preservatives and no

animal or human-derived materials

have been used in the cell culture

process, purification or final

formulation of XYNTHA.

What XYNTHA is used

for

People with haemophilia A

(congenital factor VIII deficiency or

classic haemophilia) do not have

enough coagulation factor VIII.

XYNTHA works by replacing factor

VIII to enable blood to clot.

XYNTHA is used for the control and

treatment of bleeding and the routine

and surgical prevention of bleeding

in people with haemophilia A.

XYNTHA does not contain von

Willebrand factor and so is not used

to treat von Willebrand's disease

XYNTHA has been approved for use

in haemophilia A. Ask your doctor if

you have any questions about why

XYNTHA has been prescribed for

you.

There is no evidence that XYNTHA

is addictive.

XYNTHA is not expected to affect

your ability to drive a car or operate

machinery.

Before you use

XYNTHA

When you must not use it

Do not use XYNTHA if you know

you are allergic to moroctocog alfa,

hamster proteins or any of the

ingredients of XYNTHA.

Signs of allergy include a skin rash,

itching, chest tightness, wheezing,

dizziness, hives, faintness, rapid

heartbeat, difficulty breathing,

shortness of breath and/or a swollen

face.

Your doctor will not prescribe

XYNTHA if you have von

Willebrand's disease. XYNTHA does

not contain von Willebrand's factor.

Do not use XYNTHA after the

expiry date (Exp) printed on the

pack.

Do not use XYNTHA if the

packaging is torn or shows signs of

tampering.

Before you start to use it

Certain people must use XYNTHA

with caution. Ask your doctor for

advice.

You must tell your doctor if:

You are pregnant or planning to

become pregnant.

It is not known whether

XYNTHA can affect your ability

to have children or harm your

developing baby.

You are breast feeding.

It is not known whether

XYNTHA passes into breast

milk.

You are on a low salt diet.

XYNTHA contains 29 mg

sodium per vial/ dual chamber

syringe of reconstituted powder

and this should be taken into

account in a controlled sodium

diet.

Your doctor will advise you whether

or not to use XYNTHA or if you

need to adjust the dose, or adapt your

treatment.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

XYNTHA

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may be affected by

XYNTHA, or may affect how well it

works. You may need to use different

amounts of your medicine or you

may need to take different medicines.

Your doctor will advise you.

Using XYNTHA

How XYNTHA is given

XYNTHA is given as an injection

directly into your veins, usually by

either yourself, a doctor, nurse, or

other trained person.

XYNTHA is supplied as a freeze-

dried powder. Before it can be

injected into your vein it must be

mixed with 0.9% Sodium Chloride

solution. XYNTHA should be

injected using the infusion set

provided in the kit.

Your doctor will show you how to

prepare and give an injection of

XYNTHA. Once you have learned

how to self-inject, you can follow the

instructions for preparing and giving

an injection of XYNTHA at the end

of this leaflet.

Dosage

Your doctor will decide the dose of

XYNTHA you will receive. The dose

and duration will depend upon your

individual needs for replacement

factor VIII therapy.

Your doctor may decide to change

the dose of XYNTHA you receive

during your treatment. In the

presence of an inhibitor, you may

need higher doses or specific

treatment. Dosage adjustment for

people with kidney or liver

impairment has not been studied in

clinical trials.

Disposal

Dispose of all unused solution,

empty vials and syringes, and used

needles into a sharps container.

Medicines must not be disposed of

down the toilet or via household

waste. These measures help protect

the environment.

Overdose

Immediately telephone your doctor

or the Poisons Information Centre

(in Australia; tel 13 11 26, or in

New Zealand; tel 0800 POISON or

0800 764 766), or go to Accident

and Emergency at your nearest

hospital, if you think that you or

anyone else may have used too

much XYNTHA. Do this even if

there are no signs of discomfort or

poisoning. Always take the labelled

medicine carton with you, even if it

is empty.

While you are using

XYNTHA

Things you must do

Contact your doctor immediately

or seek emergency care if your

bleeding does not stop as expected

If bleeding is not adequately

controlled with the usual dose, you

should be monitored in order to find

out whether a factor VIII inhibitor is

present. Some people receiving

factor VIII products may sometimes

develop antibodies or inhibitors to

factor VIII, which may prevent the

factor VIII product from working

properly.

Stop the infusion immediately and

contact your doctor, if you

experience reactions such as:

Headache, fever, chills, flushing,

nausea, vomiting or allergic reactions

such as skin rash, itching, chest

tightness, wheezing, dizziness, hives,

faintness, rapid heartbeat, difficulty

breathing, shortness of breath and/or

a swollen face.

Always follow your doctor's

instructions carefully

Tell all the doctors, dentists and

pharmacists who are treating you

that you are using XYNTHA.

If you are about to be started on

any new medicine, including

medicines obtained without a

prescription, tell your doctor and

pharmacist that you are using

XYNTHA.

If you become pregnant while you

are using XYNTHA, tell your

doctor.

Things you must not do

Do not give XYNTHA to anyone

else, even if they have the same

condition as you.

Do not use XYNTHA to treat any

other complaints unless your

doctor tells you to.

Do not stop using XYNTHA or

lower the dosage, without checking

with your doctor, unless you have

an allergic reaction.

Side Effects

Tell your doctor immediately if

you are using increasing amounts

of XYNTHA in order to control a

bleeding episode.

During your treatment with

XYNTHA, your blood will be

checked for inhibitors to factor VIII

activity. Inhibitors are antibodies

against factor VIII, which are made

by your immune system. The

inhibitors stop the factor VIII from

working as well as it used to.

Tell your doctor as soon as possible

if you do not feel well while you are

using XYNTHA.

Injection of any medicine

intravenously may have side effects.

Often they are not serious but

sometimes they can be. You may

need medical treatment if you

experience some side effects.

Tell your doctor if you notice any

of the following:

Stomach or bowel problems such

as:

nausea

vomiting

XYNTHA

loss of appetite

stomach pain or cramps

diarrhoea.

Difficulty thinking or working

because of:

headache

dizziness

drowsiness

numbness

muscle weakness or pain

joint pain

excessive sweating

flushing

fever

feeling faint

chest pain

rapid or irregular heartbeat

chills or feeling cold.

Respiratory problems such as:

shortness of breath

coughing.

Changes in your sight, taste or

touch such as:

blurred vision

altered taste

Skin problems such as:

itching

rash

bruising or bleeding

swelling of a vein from a blood

clot.

Other problems such as:

difficulties in catheter access to a

vein

injection site reaction, including

pain and swelling.

These are all uncommon to very rare

side effects of XYNTHA injection.

If any of the following signs of an

allergic reaction happen suddenly,

STOP using XYNTHA and tell

your doctor immediately:

a swollen face, lips, tongue or

throat

difficulty breathing

shortness of breath

chest tightness

wheezing

chills or feeling cold

flushing

dizziness

feeling tired

feeling restless

nausea

vomiting

faintness

rapid heartbeat

hives

a skin rash

headache

tingling

burning and stinging at the

injection site.

These can be very serious side

effects. If you have them, you may

have a serious allergic reaction to

XYNTHA and you may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Storage

Before Reconstitution:

Keep XYNTHA in the refrigerator

(2°C to 8°C). XYNTHA must be

used by the expiry date on the

label.

DO NOT freeze.

XYNTHA can be stored at room

temperature for a single period of up

to 3 months. Do not store XYNTHA

above 25°C. After room temperature

storage, XYNTHA can be returned to

the refrigerator until the expiration

date.

Do not store XYNTHA at room

temperature and return it to

refrigerated storage more than

once.

Write the date on the package

when you first store XYNTHA at

room temperature.

Avoid exposure of XYNTHA to

light.

Keep XYNTHA (and kit contents)

where young children cannot reach

it.

Do not use XYNTHA beyond the

date (month and year) printed on

the label after the letters 'Exp',

even if it has been stored properly.

Medicines cannot be stored

indefinitely.

After Reconstitution:

Use the made-up product as soon

as possible after dissolving the

powder.

If the made-up solution is not used

right away, it should be stored at

2°C to 8°C and used within 3

hours.

Only use solutions that are clear

and colourless.

Use only the accessories provided

in the box for reconstitution and

administration.

Product Description

What it looks like

Prefilled Dual Chamber Syringe

XYNTHA is provided in a prefilled

dual chamber syringe. The top

chamber contains XYNTHA powder

for injection. The bottom chamber

contains Sodium Chloride Solution

for injection.

There are 5 strengths of XYNTHA

available in the prefilled dual

chamber syringe - 250 IU, 500 IU,

1000 IU, 2000 IU and 3000 IU.

The contents of the XYNTHA kit

are:

one prefilled dual chamber

syringe

XYNTHA

one plunger rod for assembly

one vented sterile cap

one sterile infusion set

two alcohol swabs

one sticking plaster

one sterile gauze pad

Vial and Diluent Syringe

XYNTHA is provided as a white

powder for injection in a glass vial

and a diluent is provided in a pre-

filled syringe.

There are 4 strengths of XYNTHA -

250 IU, 500 IU, 1000 IU and 2000

The contents of the XYNTHA kit

are:

one vial of moroctocog alfa

powder

one pre-filled syringe of diluent,

containing 4mL sterile sodium

chloride 9mg/mL (0.9%) solution

for injection for reconstitution

one sterile vial adapter

reconstitution device

one sterile infusion set

two alcohol swabs

one sticking plaster

one sterile gauze pad.

Ingredients

Active ingredients: Coagulation

factor VIII (moroctocog alfa (rch))

Inactive ingredients: Sucrose,

calcium chloride dihydrate, L-

histidine, sodium chloride and

polysorbate 80.

Australian Registration Numbers

XYNTHA 250 IU prefilled dual

chamber syringe: AUST R 174837

XYNTHA 500 IU prefilled dual

chamber syringe: AUST R 174838

XYNTHA 1000 IU prefilled dual

chamber syringe: AUST R 174839

XYNTHA 2000 IU prefilled dual

chamber syringe: AUST R 174840

XYNTHA 3000 IU prefilled dual

chamber syringe: AUST R 174841

XYNTHA 250 IU vial and diluent:

AUST R 161714

XYNTHA 500 IU vial and diluent:

AUST R 161715

XYNTHA 1000 IU vial and diluent:

AUST R 161716

XYNTHA 2000 IU vial and diluent:

AUST R 161717

Supplier

XYNTHA is supplied in Australia

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

WEST RYDE NSW 2114

Toll Free Number: 1800 675 229

XYNTHA is supplied in New

Zealand by:

Pfizer New Zealand Limited

PO Box 3998

Auckland

Toll Free Number: 0800 736 363

The XYNTHA administration kit is

manufactured by Wyeth Farma,

Algete, San Sebastian de los Reyes,

Madrid, Spain.

Date of preparation

This leaflet was prepared in January

2017.

® Registered Trademark

© Pfizer Australia Pty Ltd

XYNTHA