SUMMARY CMI

XYNTHA^®

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 XYNTHA?

XYNTHA contains the active ingredient moroctocog alfa, a coagulation factor VIII product. XYNTHA is used to control and treat bleeding and prevent bleeding in people with haemophilia A. People with haemophilia A are deficient in coagulation factor VIII.

For more information, see Section 1. Why am I using XYNTHA? in the full CMI.

2. What should I know before I use XYNTHA?

Do not use XYNTHA if you have had an allergic reaction to moroctocog alfa, hamster proteins 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, are on a low salt diet, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use XYNTHA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with XYNTHA 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 XYNTHA?

• XYNTHA comes in five dosage strengths. Your doctor will decide the dosage strength and dose that you will receive.
• XYNTHA is given by injection directly into your veins. It should be injected using the infusion set provided in the pack.
• 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.
• Your doctor, nurse or pharmacist will show you how to prepare and give an injection of XYNTHA.

More instructions can be found in Section 4. How do I use XYNTHA? in the full CMI.

5. What should I know while using XYNTHA?

For more information, see Section 5. What should I know while using XYNTHA? in the full CMI.

6. Are there any side effects?

Injection of any medicine intravenously may have side effects. Often they are not serious but sometimes they can be and you may need medical treatment. 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.

FULL CMI

XYNTHA^®

Active ingredient(s): moroctocog alfa

Consumer Medicine Information (CMI)

This leaflet provides important information about using XYNTHA. 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 XYNTHA.

Where to find information in this leaflet:

1. Why am I using XYNTHA?
2. What should I know before I use XYNTHA?
3. What if I am taking other medicines?
4. How do I use XYNTHA?
5. What should I know while using XYNTHA?
6. Are there any side effects?
7. Product details

1. Why am I using XYNTHA?

XYNTHA contains the active ingredient moroctocog alfa, human coagulation factor VIII. Moroctocog alfa 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.

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.

2. What should I know before I use XYNTHA?

Warnings

Do not use XYNTHA if:

1. you are allergic to moroctocog alfa, hamster proteins, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

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. If any of these signs occur, stop using XYNTHA and contact your doctor immediately, you may need urgent medical care.

Tell your doctor if:

• you have any other medical conditions
• you take any medicines for any other condition
• 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.

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

Tell your doctor if you are pregnant or intend to become pregnant. It is not known whether XYNTHA can affect your ability to have children or harm your developing baby.

Tell your doctor if you are breastfeeding or intend to breastfeed. It is not known whether XYNTHA passes into breast milk.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you 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.

Some medicines may interfere with XYNTHA and affect how 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect XYNTHA.

4. How do I use XYNTHA?

How much to use

• XYNTHA comes in five dosage strengths. Your doctor will decide the dosage strength and dose of XYNTHA that 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.
• Follow the instructions provided and use XYNTHA until your doctor tells you to stop.

How to use XYNTHA

• 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, nurse or pharmacist 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 provided in the leaflet in the pack.

How to reconstitute and administer XYNTHA

• Always wash your hands before preparing and giving an injection of XYNTHA. Aseptic technique (clean and germ-free) should be used during the make-up (reconstitution) procedure.
• Use only the accessories provided in the pack for dissolving the XYNTHA powder with the sodium chloride solution and then injecting the made-up (reconstituted) XYNTHA solution.
• Inject the XYNTHA solution as soon as possible or within 3 hours after dissolving the powder.
• Only use solutions that are clear and colourless.

If you forget to use XYNTHA

XYNTHA should be used regularly as agreed with your doctor. If you miss your dose at the usual time, you should inject the next dose as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and inject your next dose when you are meant to.

Do not inject a double dose to make up for the dose you missed.

If you use too much XYNTHA

If you think that you have used too much XYNTHA, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should 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.

5. What should I know while using XYNTHA?

Things you should 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, chills, flushing, rapid heartbeat, shortness of breath and/or a swollen face.

Tell all doctors, dentists and pharmacists you visit 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.

Call your doctor straight away if:

• you experience an allergic reaction
• 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.

Things you should not do

• Do not stop using this medicine or lower the dosage without first checking with your doctor, unless you have an allergic reaction.
• 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.

Driving or using machines

XYNTHA is not expected to affect your ability to drive a car or operate machinery.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

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.
• Avoid exposure of XYNTHA to light.
• XYNTHA can be stored at room temperature (below 25°C) 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.

After Reconstitution:

• Use the reconstituted (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.

Do not use this medicine after the expiry date.

Keep XYNTHA (and pack contents) where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Dispose of all unused sodium chloride solution, empty vials, used syringes and needles into a sharps container.

6. Are there any side effects?

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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

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.

7. Product details

This medicine is only available with a doctor's prescription.

What XYNTHA contains

Do not use this medicine if you are allergic to any of these ingredients.

What XYNTHA 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.

Each prefilled dual chamber syringe of XYNTHA is provided with a plunger rod for assembly, a vented sterile cap, a sterile infusion set, two alcohol swabs, a sticking plaster and a sterile gauze pad.

XYNTHA 250 IU: AUST R 174837

XYNTHA 500 IU: AUST R 174838

XYNTHA 1000 IU: AUST R 174839

XYNTHA 2000 IU: AUST R 174840

XYNTHA 3000 IU: AUST R 174841

Vial and Diluent Syringe

XYNTHA is provided as a white powder in a glass vial. There are 4 strengths of XYNTHA in vials - 250 IU, 500 IU, 1000 IU and 2000 IU

Each vial of XYNTHA is provided with a pre-filled diluent syringe containing 4 mL sterile sodium chloride 9 mg/mL (0.9%) solution and accessories required for making up the solution and injection. These include a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a sticking plaster and a sterile gauze pad.

XYNTHA 250 IU: AUST R 161714

XYNTHA 500 IU: AUST R 161715

XYNTHA 1000 IU: AUST R 161716

XYNTHA 2000 IU: AUST R 161717

Who distributes XYNTHA

XYNTHA is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au

XYNTHA is supplied in New Zealand by:

Pfizer New Zealand Limited
PO Box 3998
Auckland
Toll Free Number: 0800 736 363
www.pfizermedinfo.co.nz

The XYNTHA administration kit is manufactured by Wyeth Farma, Algete, San Sebastian de los Reyes, Madrid, Spain.

This leaflet was prepared in June 2022.

® Registered Trademark

Published by MIMS July 2022

1 Name of Medicine

Moroctocog alfa.

2 Qualitative and Quantitative Composition

Xyntha is formulated as a sterile, non-pyrogenic, lyophilised powder for intravenous (IV) injection. It is available in single use vials and in single use prefilled dual chamber syringes containing the labelled amount of factor VIII activity, expressed in IUs.
Each vial contains nominally 250, 500, 1000 or 2000 IU of Xyntha per vial.
Each prefilled dual chamber syringe contains nominally 250, 500, 1000, 2000 or 3000 IU of Xyntha per syringe.
Each vial/prefilled dual chamber syringe of Xyntha contains 1.23 mmol (or 29 mg) sodium, to be taken into consideration by patients on a controlled sodium diet.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
The product reconstituted with 4 mL sodium chloride diluent (9 mg/mL (0.9%)), is a clear colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Xyntha is indicated for 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.

4.2 Dose and Method of Administration

Treatment with Xyntha should be initiated under the supervision of a physician experienced in the treatment of haemophilia A.
Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Individual patients may vary in their response to factor VIII, achieving different levels of recovery and demonstrating different half-lives. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses or appropriate specific treatment may be required. Dosage adjustment for patients with renal or hepatic impairment has not been studied in clinical trials.
Xyntha is appropriate for use in both adults and children.
The number of units of factor VIII administered is expressed in IU, which is related to the current WHO international standard for factor VIII activity. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to an International Standard for factor VIII in plasma).
One IU of factor VIII activity corresponds approximately to the quantity of factor VIII activity in one mL of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that on average 1 IU of factor VIII per kg bodyweight raises the plasma factor VIII activity by approximately 2 IU/dL. The required dosage is determined using the following formula:
Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5 IU/kg.
The example for a 20 kg child requiring 100 IU (or 100%) replacement would be:
20 (kg) x 100 (%) x 0.5 (IU/kg) = 1000 IU required units.

Plasma factor VIII activity monitoring.

Dosing for bleeding and surgery.

Dosage for prophylaxis.

Inhibitors.

Instructions for use.

Reconstitution.

Note.

Method of administration (intravenous injection).

4.3 Contraindications

Xyntha has not been studied in patients with a known history of hypersensitivity to hamster proteins. Xyntha is contraindicated in patients with a known history of hypersensitivity to any of the constituents of the preparation and in patients with a known history of hypersensitivity to hamster proteins.

4.4 Special Warnings and Precautions for Use

Use with caution in the following circumstances:

Activity-neutralising antibodies (inhibitors).

Less than expected therapeutic effect.

Hypersensitivity.

Interchangeability with other factor VIII products.

Usage while travelling.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No formal drug interaction studies have been conducted with Xyntha. No interactions of recombinant coagulation factor VIII products with other medicinal products are known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and to use machines have been performed. However, there are no indications that Xyntha may impair the ability to drive or operate machines.

4.8 Adverse Effects (Undesirable Effects)

Safety data for Xyntha are derived from the all-causality treatment-emergent adverse events (TEAEs) observed in the pooled dataset of 8 completed clinical studies with Xyntha and 2 completed clinical studies with its predecessor product, ReFacto. The pooled dataset comprised a total of 765 patients, including 124 previously untreated patients (PUPs) and 641 previously treated patients (PTPs).
Adverse effects are presented in Table 2 by system organ class (SOC) and frequency of occurrence per patient. These frequencies have been estimated on a per-patient basis across the completed studies based on a denominator of 765 patients. The incidence of the AE Factor VIII inhibition is presented separately for PTPs and PUPs.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, hives, generalised urticaria, headache, tightness of the chest, tingling, vomiting, wheezing, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed infrequently, and may in some cases progress to severe anaphylaxis (including shock) (see Section 4.4 Special Warnings and Precautions for Use). Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate counter measures and supportive therapy should be administered.

Factor VIII inhibitors.

Reporting suspected adverse effects.

4.9 Overdose

No symptoms of overdose have been reported with recombinant coagulation factor VIII products.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

In a pivotal cross-over clinical study, the pharmacokinetics of Xyntha was compared to another recombinant factor VIII product (rFVIII, Advate) in 30 previously treated patients (≥ 12 years) following a single infusion of 50 IU/kg. The 90% confidence intervals for the mean AUC_0-∞ ratio of Xyntha to Advate was shown to be within the bioequivalence range of 80-125% using the one stage assay to measure factor VIII levels.
In a 6-month follow-up assessment in 25 patients, the pharmacokinetic profile of Xyntha was comparable between baseline and month 6 (see Table 3). The 90% confidence intervals for the 6 month-to-baseline ratios of mean recovery and AUC_0-∞ were both within the equivalence range of 80-125%, suggesting negligible time dependent changes in the pharmacokinetic properties of Xyntha.
In a pivotal phase 3 study for surgical prophylaxis, Xyntha pharmacokinetics were evaluated during the perioperative management of patients with haemophilia A who were undergoing major surgery. At the baseline visit, all patients received a single dose of Xyntha of approximately 50 IU/kg. Plasma samples were analyzed for FVIII activity using a validated one-stage (OS) clotting method. Recovery data are available for a total of 30 patients; the mean (± standard deviation [SD]) was 2.11 (± 0.43) IU/dL per IU/kg.
In previously untreated patients (PUPs), pharmacokinetic parameters of Xyntha manufactured by a previous process were evaluated using the chromogenic assay. These patients (n=59; median age 10 ± 8.3 months) had a mean recovery at Week 0 of 1.5 ± 0.6 IU/dL per IU/kg (range 0.2 to 2.8 IU/dL per IU/kg) which was lower than that obtained in PTPs at Week 0 with a mean value of 2.4 ± 0.4 IU/dL per IU/kg (range 1.1 to 3.8 IU/dL per IU/kg). In the PUPs, the mean recovery was stable over time (5 visits during a 2 year period) and ranged from 1.5 to 1.8 IU/dL per IU/kg. Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, sucrose, histidine, calcium chloride dihydrate, and polysorbate 80.

6.2 Incompatibilities

Because the use of Xyntha by continuous infusion has not been evaluated, Xyntha should not be mixed with infusion solutions. In the absence of incompatibility studies, reconstituted Xyntha should not be administered in the same tubing or container with other medicinal products. Treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment. Infusion kit components supplied in the carton are compatible with Xyntha for administration.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store and transport refrigerated at 2°C to 8°C. Do not freeze, in order to prevent damage to the vial/prefilled dual chamber syringe.
Xyntha does not contain a preservative. To reduce the possibility of microbiological hazard from environmental contamination, the reconstituted solution should be used as soon as possible after reconstitution. If storage after reconstitution is necessary, hold at 2°C to 8°C and use within 3 hours.
Xyntha may be removed from refrigerated storage and stored at room temperature (below 25°C) for one single period of maximum 3 months. After room temperature storage, Xyntha may be returned to refrigerated storage until the expiration date. Do not store Xyntha at room temperature and return it to refrigerated storage more than once.
During storage, avoid prolonged exposure of Xyntha to light. Do not use Xyntha after the expiry date on the label.

6.5 Nature and Contents of Container

Xyntha lyophilised powder for reconstitution is supplied in strengths of 250 IU, 500 IU, 1000 IU and 2000 IU in a glass vial, with a butyl rubber stopper and flip off seal. The glass pre-filled diluent syringe containing 4 mL sodium chloride solution (9 mg/mL) has a butyl rubber plunger stopper and butyl rubber tip-cap.
The administration set provided with each vial of Xyntha comprises: 1 vial adapter, 2 alcohol swabs, 1 sterile infusion set, sticking plaster and gauze.
Xyntha is also supplied in a prefilled dual chamber syringe containing 250 IU, 500 IU, 1000 IU, 2000 IU or 3000 IU of Xyntha lyophilised powder for reconstitution in one chamber and 4 mL sodium chloride solution (9 mg/mL) in the second chamber.
Each prefilled dual chamber syringe is supplied with a vented cap that is attached to the tip of the syringe prior to reconstitution, a plunger rod, 2 alcohol swabs, a sterile infusion set, sticking plaster and gauze.
Not all presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Xyntha contains moroctocog alfa (rch) (cho), also known as recombinant coagulation factor VIII. Moroctocog alfa (rch) is a purified protein produced by recombinant DNA technology for use in therapy of factor VIII deficiency (haemophilia A or classic haemophilia). Xyntha is a purified glycoprotein with an approximate molecular mass of 170 kDa, consisting of 1438 amino acids, which does not contain the non-functional B-domain. The amino acid sequence of moroctocog alfa is comparable to the 90 + 80 kDa form of factor VIII. (The post-translational modifications and in vitro functional characteristics of moroctocog alfa are comparable to those of endogenous factor VIII).
Morocotocog alfa is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line has been extensively studied and found to be free of detectable viruses. The cell line is grown in a chemically defined cell culture medium that does not contain any materials derived from human or animal sources. The purification process has been refined to affinity purify moroctocog alfa using a column chromatography method that employs chemically synthesised affinity ligand, replacing the murine monoclonal antibody Sepharose resin and eliminating a potential risk of viral contamination associated with murine monoclonal antibody and its manufacture.
Because Xyntha is not purified from human blood and is manufactured from a well-characterised cell line in the absence of human- or animal-derived materials, it minimises the risk of transmission of human blood-borne pathogens, such as human immunodeficiency virus (HIV), hepatitis viruses and parvovirus. The viral safety profile is further enhanced by the inclusion of a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step during purification.
The protein is purified by a chromatography purification process that yields a high purity, active product. The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organisation (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of Xyntha is 5500 to 9900 IU per mg protein.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes