Hemgenix 1x10E13 genome copies/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hemgenix 1 x 10¹³ genome copies/ml concentrate for solution for infusion

etranacogene dezaparvovec

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end includes information on how to report these adverse effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient information card. Read it carefully and follow the instructions it contains.

Contents of the leaflet

1. What Hemgenix is and what it is used for
2. What you need to know before receiving Hemgenix
3. How to use Hemgenix
4. Possible side effects
5. How to store Hemgenix
6. Contents of the pack and other information

1. What Hemgenix is and what it is used for

What Hemgenix is and what it is used for

Hemgenix is a gene therapy product containing the active substance etranacogene dezaparvovec. A gene therapy product works by introducing a gene into the body to correct a genetic defect.

Hemgenix is used for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adults who do not have, or have never had, inhibitors (neutralizing antibodies) against factor IX protein.

People with hemophilia B are born with a defective form of the gene required to produce factor IX, a protein essential for blood to clot and stop bleeding. Individuals with hemophilia B have insufficient levels of factor IX and are prone to internal or external bleeding episodes.

How Hemgenix works

The active substance in Hemgenix is based on a virus that does not cause disease in humans. This virus has been modified so that it cannot spread through the body, but can deliver a copy of the factor IX gene to liver cells. This enables the liver to produce factor IX protein and increase factor IX levels in the blood. This helps blood to clot more normally and prevents or reduces bleeding episodes.

2. What you need to know before using Hemgenix

Do not receive Hemgenix

• If you are allergic to etranacogene dezaparvovec or to any of the other ingredients of this medicine (listed in section 6).

• If you have an active infection, either an acute infection (short-term) or a chronic infection (long-term), that cannot be controlled with medication.

• If your liver is not functioning properly due to advanced liver fibrosis (scarring and thickening of tissue), or cirrhosis (scarring caused by prolonged liver damage).

If any of the above situations apply to you, or if you are unsure about any of them, consult your doctor before receiving Hemgenix.

Warnings and precautions

Before receiving Hemgenix treatment

Your doctor will perform several tests before administering Hemgenix.

Blood tests to detect antibodies

Before receiving Hemgenix, your doctor will perform blood tests to check for the presence of certain antibodies (proteins), including:

• Blood test to check for antibodies in the blood directed against human factor IX protein (factor IX inhibitors).

If you test positive for these antibodies, another test will be performed approximately 2 weeks later. If both tests are positive, Hemgenix administration will not be initiated.

• A blood test may also be performed to check the amount of antibodies in your blood directed against the type of virus used to manufacture Hemgenix.

Liver health

When deciding whether this medicine is suitable for you, your doctor will assess your liver health before starting Hemgenix treatment and will carry out the following:

• Blood test to check liver enzyme levels in the blood.
• Blood test to detect active liver infections (hepatitis B and C).
• Liver ultrasound.
• Elastography tests to check for liver scarring or thickening.

During or shortly after Hemgenix infusion

Your doctor will monitor you during or shortly after the Hemgenix infusion.

Infusion-related reactions

During or shortly after receiving the Hemgenix infusion (drip), adverse effects related to the infusion may occur. Your doctor will monitor you during the Hemgenix infusion and for at least 3 hours after administration.

• Symptoms of these adverse effects are listed in section 4 "Possible side effects". Inform your doctor or nurse immediately if you experience these or any other symptoms during or shortly after the infusion.

• Depending on your symptoms, your infusion may be slowed down or interrupted. If the infusion is interrupted, it may be resumed at a slower rate once the infusion reaction resolves. Your doctor may also consider whether you should receive corticosteroids (e.g., prednisolone or prednisone) to help manage the infusion reaction.

After Hemgenix treatment

After Hemgenix treatment, your doctor will continue to monitor your health status. It is important that you discuss the schedule of these blood tests with your doctor so they can be carried out as needed.

Liver enzymes

Hemgenix will trigger a response in your immune system that could lead to an increase in blood levels of certain liver enzymes, known as transaminases (transaminitis). Your doctor will periodically monitor your liver enzyme levels to ensure the medicine is working as expected:

• For at least the first 3 months after receiving Hemgenix, you will have weekly blood tests to monitor your liver enzyme levels.

• If you experience an increase in liver enzymes, you may need more frequent blood tests to monitor your enzyme levels until they return to normal. You may also need to take another medicine (corticosteroids) to manage these adverse effects.

• Your doctor may also perform additional tests to rule out other causes of elevated liver enzymes, if necessary, after consulting with a liver disease specialist.

• Your doctor will repeat liver enzyme tests every 3 months from month 4 up to 1 year after receiving Hemgenix to continue monitoring your liver health. In the second year after receiving Hemgenix, your doctor will check your liver enzyme levels semi-annually. After the second year, your doctor will check your liver enzyme levels once a year for at least 5 years after receiving Hemgenix.

Factor IX levels

Your doctor will periodically check your factor IX levels to determine whether Hemgenix treatment has been effective.

• For at least the first 3 months after receiving Hemgenix, you will have weekly blood tests to check your factor IX levels.

• Your doctor will repeat these tests every 3 months from month 4 up to 1 year after receiving Hemgenix to continue monitoring your factor IX level. In the second year after receiving Hemgenix, your doctor will check your factor IX levels semi-annually. Thereafter, your doctor will check your factor IX levels once a year for at least 5 years after receiving Hemgenix.

• If you experience an increase in liver enzymes or need to take another medicine (e.g., corticosteroids), you will have more frequent blood tests to check your factor IX levels until your liver enzyme levels return to normal or until you stop taking the additional medicine.

Use of other treatments for hemophilia

After using Hemgenix, talk to your doctor about whether you should stop other treatments you are receiving for hemophilia, when to do so, and develop a treatment plan for managing surgery, trauma, bleeding episodes, or any procedure that may increase the risk of bleeding. It is very important to continue regular monitoring and doctor visits to determine whether you need additional treatments for hemophilia.

Abnormal blood clotting (thromboembolic events)

After Hemgenix treatment, your factor IX protein level may increase. In some patients, it may rise to above-normal levels for a period of time.

• Unusually high factor IX levels may cause your blood to clot abnormally, increasing the risk of clot formation, such as in the lung (pulmonary embolism) or in a blood vessel in the leg (venous or arterial thrombosis). This theoretical risk is low due to your congenital deficiency in the coagulation cascade compared to healthy individuals.

• You may be at risk of abnormal blood clotting if you already have cardiovascular problems (e.g., history of heart disease (cardiovascular disease), thickening and hardening of arteries (arteriosclerosis), high blood pressure (hypertension), or if you are diabetic or over 50 years of age).

• Your doctor will periodically test your blood for any possible abnormalities in factor IX levels, especially if you continue receiving your usual factor IX prophylaxis (factor IX replacement therapy) after Hemgenix administration (see also section 3 "How to use Hemgenix").

• Contact your doctor immediately if you notice signs of abnormal clotting, such as sudden chest pain, shortness of breath, sudden onset of muscle weakness, loss of sensation and/or balance, decreased alertness, difficulty speaking, or swelling in one or both legs.

Avoid blood and transplant donations

The active substance in Hemgenix may be temporarily excreted through blood, semen, breast milk, or bodily waste, a process known as excretion (see also section 2 "Pregnancy, breastfeeding, and fertility").

To ensure that other people without hemophilia B are not exposed to Hemgenix DNA through excretion from your body and/or semen, you must not donate blood, semen, or organs, tissues, or cells for transplantation after being treated with Hemgenix.

Immunocompromised patients or patients with HIV or another infection

If you have problems with your immune system (you are immunocompromised), are undergoing or will undergo treatment that suppresses your immune system, or have HIV infection or another new or recent infection, your doctor will decide when you can receive Hemgenix.

Neutralizing antibodies against factor IX proteins (factor IX inhibitors)

Neutralizing antibodies against factor IX proteins may prevent Hemgenix from working properly. Your doctor may test your blood for these antibodies if bleeding episodes are not controlled or recur after receiving Hemgenix (see also section 3 "How to use Hemgenix").

Receiving gene therapy again in the future

After receiving Hemgenix, your immune system will produce antibodies against the AAV vector capsid. It is currently unknown whether Hemgenix treatment can be repeated, or under what conditions. It is also unknown whether another gene therapy can be used later, or under what conditions.

Potential risk of malignancy associated with Hemgenix

• Hemgenix will integrate into liver cells and could integrate into the DNA of liver cells or other body cells. Therefore, Hemgenix could potentially increase the risk of cancer, such as liver cancer (hepatocellular carcinoma). Although there is currently no evidence of this in clinical studies, it remains possible due to the nature of the medicine. Therefore, you should discuss this with your doctor.

• If you are a patient with pre-existing risk factors for hepatocellular carcinoma (e.g., liver fibrosis [liver scarring and thickening], hepatitis B, hepatitis C, fatty liver [non-alcoholic fatty liver disease (NAFLD)], or excessive alcohol consumption), your doctor will periodically (e.g., once a year) assess your long-term liver health for at least 5 years after Hemgenix administration and perform the following tests:

• Annual liver ultrasound and

• Annual blood test to check for elevated levels of alpha-fetoprotein.

• After Hemgenix treatment, you are expected to be included in a long-term follow-up study to help evaluate the long-term safety (15 years), efficacy, and any adverse effects potentially related to the treatment. In the event of cancer, your doctor may take a sample of the tumor (biopsy) to check whether Hemgenix has integrated into the cellular DNA.

Children and adolescents

Hemgenix has not been studied in children or adolescents under 18 years of age.

Other medicines and Hemgenix

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

If you are taking medicines known to damage the liver (hepatotoxic medicines), your doctor may decide that you need to stop taking them before receiving Hemgenix.

Pregnancy, breastfeeding, and fertility

There are no data on the use of Hemgenix in women with hemophilia B.

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using Hemgenix.

• Hemgenix treatment is not recommended in women of childbearing potential.

It is currently unknown whether Hemgenix can be safely used in these patients, as the effects on pregnancy and the fetus are unknown.

• Hemgenix must not be used during pregnancy. It is unknown whether this medicine may have harmful effects on the fetus when administered during pregnancy.

• Hemgenix must not be used during breastfeeding. It is unknown whether this medicine is excreted in breast milk. Risk to newborns/infants cannot be excluded.

Use of contraception to prevent pregnancy in a partner for a period of time

After a male patient has been treated with Hemgenix, the patient and his female partner must avoid pregnancy for 12 months. Effective contraceptive methods (e.g., double-barrier contraception such as condoms and diaphragm) must be used. This is to avoid the theoretical risk that the factor IX gene from Hemgenix treatment in the father could be transmitted to the child with unknown consequences. For the same reason, male patients must not donate semen. Consult your doctor on which contraceptive methods are appropriate.

Driving and using machines

The influence of Hemgenix on the ability to drive and use machines is minor. Dizziness, fatigue, and temporary headaches have occurred shortly after Hemgenix infusion. If you experience these, you should exercise caution until you are certain that Hemgenix does not negatively affect your ability to drive or use machines. Discuss this with your doctor.

Hemgenix contains sodium and potassium

• The medicine contains 35.2 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 1.8% of the maximum daily intake recommended for an adult.

• This medicine contains less than 39 mg (1 mmol) of potassium per vial and is therefore considered essentially “potassium-free”.

3. How to use Hemgenix

Hemgenix will be administered to you in a hospital setting under the supervision of a physician experienced and trained in the treatment of your condition, hemophilia B.

Hemgenix will be given to you only once, as a single slow intravenous infusion (drip). The infusion will normally take between 1 and 2 hours to complete.

Your doctor will determine the correct dose for you based on your body weight.

Discontinuation of exogenous factor IX treatment

• It may take several weeks before improvement in bleeding control becomes apparent after Hemgenix infusion, and you may need to continue your replacement therapy with exogenous factor IX during the first few weeks following Hemgenix infusion.

• Your doctor will periodically monitor the levels of factor IX activity in your blood—once a week for at least the first 3 months, and at regular intervals thereafter—and will decide whether you should receive, reduce, or discontinue your exogenous factor IX treatment and when (see section 2).

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

The following adverse effects were observed in clinical studies with Hemgenix.

Very common (may affect more than 1 in 10 people)

• Headache
• Increased levels of liver enzymes in the blood (increased alanine aminotransferase)
• Increased levels of liver enzymes in the blood (increased aspartate aminotransferase)
• Pseudo-flu syndrome
• Increased levels of C-reactive protein, a marker of inflammation
• Infusion-related reaction (allergic reactions [hypersensitivity], reaction at the infusion site, dizziness, eye itching [pruritus], skin redness [flushing], upper abdominal pain, itchy rash [urticaria], chest discomfort, and fever)

Common (may affect up to 1 in 10 people)

• Dizziness
• Feeling unwell (nausea)
• Tiredness (fatigue)
• General feeling of discomfort
• Increased levels of bilirubin in the blood, a yellowish substance formed during the breakdown of red blood cells
• Increased blood levels of creatine phosphokinase, an enzyme (protein) found mainly in the heart, brain, and skeletal muscle

Reporting of adverse effects

If you experience any type of adverse effect, please consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hemgenix

This information is intended for healthcare professionals only.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial label and the outer carton after EXP.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep vials in the original packaging to protect from light.

Dilute before use.

After dilution with 9 mg/ml (0.9%) sodium chloride solution for injection, Hemgenix may be stored in an infusion bag at a temperature between 15 °C and 25 °C, protected from light, for up to 24 hours after dose preparation.

Do not use this medicine if particles, cloudiness, or discoloration are observed.

6. Contents of the package and other information

Composition of Hemgenix

• The active substance is etranacogene dezaparvovec. Each ml of etranacogene dezaparvovec contains 1 x 10^13 vector genomes (vg)/ml.

• The other components (excipients) are sucrose, polysorbate 20, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sodium hydrogen phosphate, hydrochloric acid (for pH adjustment), and water for injections (see also section 2, "Hemgenix contains sodium and potassium").

This medicinal product contains genetically modified organisms.

Appearance of Hemgenix and contents of the pack

Hemgenix is a concentrate for solution for infusion (sterile concentrate).

Hemgenix is a clear, colourless solution.

Hemgenix is supplied in a vial containing 10 ml of etranacogene dezaparvovec.

The total number of vials in a pack corresponds to the dose required for each patient, based on body weight, and is indicated on the packaging.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium CSL Behring NV Tel/Tel: +32 15 28 89 20	Luxembourg/Luxembourg CSL Behring NV Tel/Tel: +32 15 28 89 20
	Hungary CSL Behring Kft. Tel: +36 1 213 4290
Czech Republic CSL Behring s.r.o. Tel: +420 702 137 233	Malta AM Mangion Ltd. Tel: +356 2397 6333
Denmark CSL Behring AB Tlf: +46 8 544 966 70	Netherlands CSL Behring BV Tel: +31 85 111 96 00
Germany CSL Behring GmbH Tel: +49 6190 75 84810	Norway CSL Behring AB Tlf: +46 8 544 966 70
Estonia CentralPharma Communications OÜ Tel: +3726015540	Austria CSL Behring GmbH Tel: +43 1 80101 1040
Greece CSL Behring ΕΠΕ Tel: +30 210 7255 660	Poland CSL Behring Sp. z o.o. Tel.: +48 22 213 22 65
Spain CSL Behring S.A. Tel: +34 933 67 1870	Portugal CSL Behring Lda Tel: +351 21 782 62 30
France CSL Behring SA Tél: +33 1 53 58 54 00	Romania Prisum Healthcare S.R.L. Tel: +40 21 322 01 71
Croatia Marti Farm d.o.o. Tel: +385 1 5588297	Slovenia Emmes Biopharma Global s.r.o. - branch office in Slovenia Tel: +386 41 42 0002
Ireland CSL Behring GmbH Tel: +49 6190 75 8470	Slovakia CSL Behring Slovakia s.r.o. Tel: +421 911 653 862
Iceland CSL Behring AB Sími: +46 8 544 966 70	Finland/Sweden CSL Behring AB Puh/Tel: +46 8 544 966 70
Italy CSL Behring S.p.A. Tel: +39 02 34964 200	Sweden CSL Behring AB Tel: +46 8 544 966 70
Cyprus CSL Behring ΕΠΕ Tel: +30 210 7255 660
Latvia CentralPharma Communications SIA Tel: +371 6 7450497
Lithuania CentralPharma Communications UAB Tel: +370 5 243 0444

Date of the most recent review of this leaflet:

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

The European Medicines Agency will review new information on this medicinal product at least once a year, and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This leaflet can be found on the European Medicines Agency's website in all languages of the European Union/European Economic Area.

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This information is intended for healthcare professionals only:

Important: consult the complete summary of product characteristics before use.

Precautions to be taken before handling or administering the medicinal product

This medicinal product contains genetically modified organisms (GMOs).

Personal protective equipment, such as gloves, safety goggles, protective clothing, and masks, must be used during the preparation and administration of etranacogene dezaparvovec.

Preparation of etranacogene dezaparvovec prior to administration

1. Use aseptic techniques during the preparation and administration of etranacogene dezaparvovec.
2. Do not expose etranacogene dezaparvovec to ultraviolet radiation from a germicidal lamp.
3. Use the vial(s) of etranacogene dezaparvovec only once (single-use vials).
4. Verify the required dose of etranacogene dezaparvovec based on the patient's body weight. The total number of vials in each finished container corresponds to the required dose for each patient according to body weight.

Example calculation for a 72 kg patient:

Patient body weight	Etranacogene dezaparvovec dose (ml) = body weight × 2	Number of vials* required = etranacogene dezaparvovec dose (ml) divided by 10, rounded to the nearest whole vial number.
72 kg	144 ml	15

*The total volume of the patient's dose of etranacogene dezaparvovec to be diluted may be less than the total volume of vials required.

The patient's body weight used for dose calculation must be rounded to the nearest kilogram.

Example:

For a patient weighing between 72.1 kg and 72.4 kg, use 72 kg.

For a patient weighing between 72.5 kg and 72.9 kg, use 73 kg.

1. Etranacogene dezaparvovec must be diluted with an injection solution of 9 mg/ml (0.9%) sodium chloride prior to administration.

• Before dilution, inspect each vial of etranacogene dezaparvovec.
  • If particles, turbidity, or discoloration are observed, do not use the vial or vials.
• Gently mix the vials by rotating them 3 times (for approximately 10 seconds) to homogenize the etranacogene dezaparvovec suspension.
  • To avoid foam formation, do not shake the etranacogene dezaparvovec vials.
• Withdraw the calculated dose volume of Hemgenix (in ml) from the 500 ml infusion bag(s) containing an injection solution of 9 mg/ml (0.9%) sodium chloride.

The volume to be withdrawn will vary depending on the patient's body weight.

• For patients < 120 kg body weight, withdraw the volume of injection solution of 9 mg/ml (0.9%) sodium chloride corresponding to the total dose of Hemgenix (in ml) from one 500 ml infusion bag.

• For patients ≥ 120 kg body weight, withdraw the volume of injection solution of 9 mg/ml (0.9%) sodium chloride corresponding to the total dose of Hemgenix (in ml) from two 500 ml infusion bags, withdrawing half of the volume from each of the two 500 ml infusion bags.

• Withdraw etranacogene dezaparvovec from each vial using a 20 G needle and syringe.

• Subsequently, add the required dose of Hemgenix to the infusion bag(s) so that the total volume of each infusion bag is 500 ml.

1. Add the Hemgenix dose directly to the injection solution of 9 mg/ml (0.9%) sodium chloride. Do not add the Hemgenix dose into the air space in the infusion bag during dilution.
2. Gently rotate the infusion bag(s) at least 3 times (for 10 seconds) to mix the solution and ensure uniform distribution of the diluted product.
3. To avoid foam formation:

• Do not shake the prepared infusion bag(s).
• Do not use filter needles during the preparation of etranacogene dezaparvovec.

1. To reduce the risk of spillage and/or aerosol formation, the infusion bag(s) should be connected to a pre-filled infusion line containing sterile 9 mg/ml (0.9%) sodium chloride injection solution.
2. The pre-filled infusion line with sterile 9 mg/ml (0.9%) sodium chloride solution must be connected to the main intravenous infusion line, which is also primed with sterile 9 mg/ml (0.9%) sodium chloride injection solution, prior to use.
3. Use only the 9 mg/ml (0.9%) sodium chloride injection solution, as the stability of etranacogene dezaparvovec has not been established with other solutions and diluents.
4. Do not co-infuse the diluted etranacogene dezaparvovec solution through the same intravenous line with any other product.
5. Do not use a central line or port.

Administration

1. The diluted etranacogene dezaparvovec solution must be visually inspected before administration. The diluted etranacogene dezaparvovec solution should be clear and colorless. If particles, cloudiness, or discoloration are observed in the infusion bag, do not use etranacogene dezaparvovec.
2. After dilution, use the product as soon as possible. The storage time of the diluted product must not exceed the time specified in section 6.3 of the Summary of Product Characteristics.
3. Use an in-line integrated filter of 0.2 µm made of polyethersulfone (PES).
4. The diluted etranacogene dezaparvovec solution must be administered into a peripheral vein via an independent intravenous infusion line through a peripheral venous catheter.
5. The etranacogene dezaparvovec solution must be infused strictly according to the infusion rate(s) provided in section 4.2 of the Summary of Product Characteristics. Administration must be completed within ≤ 24 hours after dose preparation (see section 4.2 of the Summary of Product Characteristics).
6. After infusing the entire content of the infusion bag(s), flush the infusion line at the same infusion rate with 9 mg/ml (0.9%) sodium chloride injection solution to ensure complete administration of the etranacogene dezaparvovec content.

Measures to be taken in case of accidental exposure

In case of accidental exposure, follow local guidelines for pharmaceutical waste.

• In case of accidental eye exposure, immediately rinse eyes with water for at least 15 minutes. Do not use an alcohol-based solution.
• In case of accidental needlestick injury, encourage bleeding from the wound and thoroughly wash the injection site with water and soap.
• In case of accidental skin exposure, thoroughly clean the affected area with water and soap for at least 15 minutes. Do not use an alcohol-based solution.
• In case of accidental inhalation, move the person to fresh air.
• In case of accidental oral exposure, rinse the mouth thoroughly with water.
• In all cases, seek medical attention afterward.

Work surfaces and materials that may have come into contact with etranacogene dezaparvovec must be decontaminated with an appropriate disinfectant with viricidal activity (e.g., a chlorine-releasing disinfectant such as hypochlorite containing 0.1% available chlorine [1000 ppm]) after use.

Precautions for disposal of the medicinal product

Unused medicine and disposable materials that may have come into contact with Hemgenix (solid and liquid waste) must be disposed of in accordance with local pharmaceutical waste guidelines. However, the risk of an adverse effect on human health following accidental exposure to Hemgenix and environmental risks are considered negligible. Caregivers should be advised on the proper handling of waste materials generated by medical components contaminated during the use of Hemgenix.

Work surfaces and materials that may have come into contact with etranacogene dezaparvovec must be decontaminated with an appropriate disinfectant with viricidal activity (e.g., a chlorine-releasing disinfectant such as hypochlorite containing 0.1% available chlorine [1000 ppm]) after use and autoclaved if possible.