VEKLURY 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Veklury 100 mg powder for concentrate for solution for infusion

remdesivir

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

If Veklury has been prescribed to your child, note that all the information in this leaflet is intended for your child (in this case, when you read “you” replace it with “your child”).

Contents of the pack

1. What is Veklury and what is it used for
2. What you need to know before you are given Veklury
3. How Veklury is given
4. Possible side effects
5. Storage of Veklury
6. Contents of the pack and other information

1. What is Veklury and what is it used for

The active substance of Veklury is remdesivir. It is an antiviral medicine used to treat COVID-19.

COVID-19 is caused by a virus called coronavirus. Veklury stops the virus from multiplying in the cells, and this stops the virus from multiplying in the body. This can help your body to overcome the viral infection and can help you to recover faster.

Veklury will be given to treat COVID-19 in:

• adults and children from at least 4 weeks of age and who weigh at least 3 kg) who have pneumonia, and who need extra oxygen to help them breathe, but who are not receiving artificial ventilation (in which mechanical means are used to assist or replace spontaneous breathing).
• adults and children (who weigh at least 40 kg) who do not need extra oxygen to help them breathe and who are at higher risk of developing severe COVID-19.

2. What you need to know before you are given Veklury

Veklury will not normally be given to you:

• if you are allergicto remdesivir or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor or nurse as soon as possible,if this applies to you.

Warnings and precautions

Tell your doctor or nurse before starting treatment with Veklury:

• if you have kidney problems.Your doctor may monitor you if you have kidney problems to ensure your safety.
• if you are immunocompromised.Your doctor may monitor you more closely if your immune system is not working properly to ensure that the treatment is working.

Infusion-related reactions

Veklury may cause allergic reactions during or after the infusion, including anaphylactic reactions (sudden, potentially life-threatening allergic reactions). Allergic reactions have been observed rarely. For anaphylactic reactions, the frequency cannot be estimated from the available data. The symptoms may be:

• Changes in blood pressure or heart rate
• Low oxygen level in the blood
• High temperature
• Shortness of breath, wheezing
• Swelling of the face, lips, tongue, or throat (angioedema)
• Rash
• Nausea
• Vomiting
• Sweating
• Chills

Tell your doctor or nurse immediatelyif you notice any of these effects.

Blood tests before and during treatment

If you have been prescribed Veklury, you may have blood tests before starting treatment. Patients who are being treated with Veklury may have blood tests during their treatment as determined by their healthcare professionals. These tests are to detect kidney problems.

Children and adolescents

Veklury must not be given to children under 4 weeks of age or to children who weigh less than 3 kg. Not enough is known for it to be given to these children.

Other medicines and Veklury

Tell your doctor or nurseif you are taking or have recently taken any other medicines.

Do not take chloroquine or hydroxychloroquine at the same time as Veklury.

Tell your doctor if you are taking any of these medicines

Pregnancy and breast-feeding

Tell your doctor or nurse if you are pregnantor if you think you might be pregnant. There is not enough information to confirm that Veklury is safe to use in the first trimester of pregnancy. Veklury should only be given if the potential benefits of treatment outweigh the potential risks to the mother and the fetus. Talk to your doctor about the need to use effective contraceptive methods during treatment with Veklury.

Tell your doctor or nurse if you are breast-feeding.Veklury passes into breast milk in very small amounts. Because experience with use during breast-feeding is limited, you should discuss with your doctor whether you should continue or stop breast-feeding during treatment with Veklury.

Driving and using machines

Veklury is not expected to have any effect on the ability to drive.

Veklury contains a cyclodextrin

This medicine contains 3 g of betadex sulfobutyl ether sodium in each 100 mg dose of Veklury (6 g in the initial dose). This component is a cyclodextrin excipientthat helps the medicine to disperse in the body.

Veklury contains sodium

This medicine contains 212 mg of sodium (the main component of cooking/table salt) in each 100 mg dose. This is equivalent to 10.6% of the maximum recommended daily intake of sodium for an adult.

3. How Veklury is given

A nurse or doctor will give you Veklury through a drip into a vein (intravenous infusion) over 30 to 120 minutes, once a day. You will be closely monitored during treatment.

Recommended dose in adults and children

Duration of treatment

Refer to the Instructions for healthcare professionalswhich provide details on how to administer the Veklury infusion.

If you are given too much or too little Veklury

Because Veklury is given to you by a healthcare professional, it is unlikely that you will be given too much or too little. If you have been given an extra dose or missed a dose, tell your nurse or doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious:

Rare

(may affect up to 1 in 1,000 people)

• Allergic reactions during or after the infusion. The symptoms may be:
• Changes in blood pressure or heart rate
• Low oxygen level in the blood
• High temperature
• Shortness of breath, wheezing
• Swelling of the face, lips, tongue, or throat (angioedema)
• Rash
• Nausea
• Vomiting
• Sweating
• Chills

Frequency not known

(frequency cannot be estimated from the available data)

• Anaphylactic reactions, anaphylactic shock (sudden, potentially life-threatening allergic reactions)

The symptoms are the same as those of allergic reactions, however, the reaction is more severe and requires immediate medical attention.

• Sinus bradycardia (the heart beats more slowly than normal)

Tell your doctor or nurse immediatelyif you notice any of these effects.

Other side effects:

Very common side effects

(may affect more than 1 in 10 people)

• Blood tests may show an increase in liver enzymes, called transaminases
• Blood tests may show that the blood takes longer to clot.

Common side effects

(may affect up to 1 in 10 people)

• Headache
• Nausea
• Rash

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Veklury

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of the month shown.

• Before use,this medicine does not require any special storage precautions.
• After reconstitution,Veklury should be diluted immediately.
• After dilution,Veklury should be used immediately. If necessary, the bags of diluted solution may be stored for up to 24 hours at a temperature below 25°C or up to 48 hours in a refrigerator. Do not exceed 48 hours between dilution and administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Veklury Composition

• The active ingredientis remdesivir. Each vial contains 100 mg.
• The other ingredientsare: betadex sulfobutyl ether sodium, hydrochloric acid, and sodium hydroxide.

Appearance of the Product and Package Contents

Veklury 100 mg powder for concentrate for solution for infusion is a powder of white, off-white, or yellow color that must be reconstituted and then diluted in a sodium chloride solution before administration by intravenous infusion. It is supplied in a single-use transparent glass vial.

Veklury is available in boxes containing 1 vial.

Marketing Authorization Holder and Manufacturer

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: .

Other Sources of Information

Scan the code below with a mobile device to obtain this information in different languages.

QR code to be included www.veklury.eu

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The European Medicines Agency website can be found in all languages of the European Union/European Economic Area.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only.

For more information, consult the Summary of Product Characteristics.

Instructions for Healthcare Professionals

Veklury 100 mg Powder for Concentrate for Solution for Infusion

remdesivir

Each single-use vial contains 100 mg of remdesivir as a white, off-white, or yellow powder for reconstitution and dilution.

Treatment Summary

Veklury is used for the treatment of COVID-19 in:

• adult and pediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia who require supplemental oxygen (high or low flow oxygen or other non-invasive ventilation at the start of treatment).
• adult and pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at higher risk of progressing to severe COVID-19.

Veklury should be administered by intravenous infusion in a total volume of 25 ml, 50 ml, 100 ml, or 250 ml of sodium chloride 0.9% solution over 30 to 120 minutes.

The powder should be reconstituted with sterile water for injection and then diluted in sodium chloride 9 mg/ml (0.9%) solution under aseptic conditions. Administer the diluted solution immediately.

As clinically appropriate, renal function should be determined in patients before starting treatment with remdesivir and while receiving it.

Monitor the patient for adverse effects during and after infusion. See below for details on adverse effect reporting.

Reconstituting the Powder

For each single-use vial, the powder should be reconstituted and then diluted under aseptic conditions.

• Add 19 ml of sterile water for injection to the vial, using a syringe and needle of suitable size for each vial, and insert the needle into the center of the vial stopper.
• This produces a solution of 5 mg/ml of remdesivir.

• Discard the vial if the vacuum does not draw the sterile water into the vial.

• Use only sterile water for injectionto reconstitute remdesivir powder.
• Shake the vial immediately for 30 seconds.
• Allow the vial contents to settle for 2 to 3 minutes. A clear solution should form.
• If the vial contents have not dissolved completely, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the vial contents have dissolved completely.
• Inspect the vial to ensure the container closure is not defective.
• The solution should only be used if it is clear and free of particles.
• Dilute immediately after reconstitution.

Diluting the Concentrate with Sodium Chloride Solution

Reconstituted Veklury should be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection under aseptic conditions.

Dilution Instructions for Adult and Pediatric Patients Weighing at Least 40 kg

Using Table 3, determine the volume of sodium chloride 9 mg/ml (0.9%) solution to withdraw from the infusion bag.

Note: The 100 ml infusion should only be used in patients with severe fluid restrictions.

• Withdraw and discard the required volume of sodium chloride solution from the infusion bag using a syringe and needle of suitable size. See Table 3.
• Withdraw the required volume of reconstituted Veklury from the vial using a syringe of suitable size. See Table 3.
• Transfer the reconstituted Veklury to the infusion bag.
• Gently invert the bag 20 times to mix the solution in the bag. Do not shake.
• Administer the diluted solution immediately or as soon as possible after preparation. The diluted solution is stable for 24 hours at room temperature (between 20°C and 25°C) or for 48 hours in the refrigerator (between 2°C and 8°C).

Dilution Instructions for Pediatric Patients at Least 4 Weeks of Age and Weighing at Least 3 kg but Less Than 40 kg

• Dilute the remdesivir 100 mg/20 ml (5 mg/ml) concentrate further using sodium chloride 0.9% to achieve a fixed concentration of 1.25 mg/ml.
• The total infusion volume of remdesivir 1.25 mg/ml solution for infusion is calculated based on the pediatric dosing guidelines based on weight of 5 mg/kg for the loading dose and 2.5 mg/kg for each maintenance dose.
• Small sodium chloride 0.9% infusion bags (e.g., 25, 50, or 100 ml) or a syringe of suitable size should be used to administer the dose to pediatric patients. The recommended dose is administered by intravenous infusion in a total volume dependent on the dose to achieve the target remdesivir concentration of 1.25 mg/ml.
• A syringe may be used for administration of volumes < 50 ml.

Administering the Infusion

• It is possible to use in cases of severe hypersensitivity reactions, such as anaphylaxis.
• Administer the diluted solution over 30 to 120 minutes at the rate described in Table 4 or Table 5.
• Once the infusion is complete, flush with at least 30 ml of sodium chloride 9 mg/ml (0.9%) solution.
• The diluted solution should not be administered simultaneously with any other medication in the same intravenous line. The compatibility of Veklury with other IV solutions and medications is unknown.

a The infusion rate can be adjusted based on the total volume to be infused.

Monitoring and Reporting of Adverse Effects

• Monitor the patient for adverse effects during and after infusion according to local medical practice.
• Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Safe Storage of Veklury

• Before use,this medicinal product does not require any special storage precautions. Do not use after the expiry date stated on the vials/cartons after the letters EXP.
• Veklury powder is white, off-white, or yellow. The color does not affect the stability of the product.
• After reconstitution,Veklury should be diluted immediately.
• After dilution,Veklury should be administered immediately. If necessary, the diluted solution bags can be stored for up to 24 hours at room temperature (between 20°C and 25°C) or up to 48 hours in the refrigerator (between 2°C and 8°C). Do not exceed 48 hours between dilution and administration.

Do not reuse or store unused Veklury powder, reconstituted solution, or diluted solution.

Information in Other Languages

• Scan the code below with a mobile device to obtain information in different languages.

QR code to be included www.veklury.eu

Date of last revision of this leaflet: .