Prospect: information for the patient

Veklury 100 mg powder for concentrate for solution for infusion

remdesivir

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before this medicine is administered to you, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

If you have been prescribed Veklury for your child, note that all the information in this prospect is directed at your child (in this case, when you read “you” substitute it with “your child”).

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

Covid-19 is caused by a virus called coronavirus. Veklury stops the virus multiplication in cells, and this stops the virus multiplication in the body. This may help your body overcome the viral infection and may help you recover faster.

Veklury will be administered to treat COVID-19 in:

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

Generalmente, Veklury no se le administrará:

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

Consult your doctor or nurse as soon as possible,if this is your case.

Warnings and precautions

Consult 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 functioning correctly to ensure that the treatment is working.

Reactions after infusion

Veklury may cause allergic reactions after and during infusion, including anaphylactic reactions (potentially fatal allergic reactions). Allergic reactions have been observed in rare cases. For anaphylactic reactions, the frequency cannot be estimated from available data. Symptoms may include:

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

Inform your doctor or nurse immediatelyif you observe 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 undergoing treatment with Veklury may have blood tests during treatment as determined by their healthcare professionals. These tests are to detect kidney problems.

Children and adolescents

Veklury should not be administered to children under 4 weeks of age or to children weighing less than 3 kg. There is not enough information for its administration in these children.

Other medications and Veklury

Inform your doctor or nurseif you are taking or have recently taken any other medication.

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

Inform your doctor if you are taking any of these medications

Pregnancy and breastfeeding

Inform your doctor or nurse if you are pregnantor if you think you may be pregnant. There is not enough information to ensure that Veklury is safe for use in the first trimester of pregnancy. Veklury should only be administered if the potential benefits of treatment outweigh the potential risks for the mother and fetus.Discuss with your doctor the need to use effective contraceptive methods during treatment with Veklury.

Inform your doctor or nurse if you are breastfeeding.Veklury passes into breast milk in very small amounts. Due to limited experience with use during breastfeeding, you should discuss in detail with your doctor whether you should continue or interrupt breastfeeding during treatment with Veklury.

Driving and operating machinery

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

Veklury contains a cyclodextrin

This medication contains 3 g of sodium sulfobutylether of beta-cyclodextrin in each 100 mg dose of Veklury (6 g in the initial dose). This component is acyclodextrin emulsifierthat helps the medication disperse in the body.

Veklury contains sodium

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

A healthcare professional, such as a nurse or doctor, will administer Veklury to you through an intravenous infusion (intravenous perfusion) in a vein using a drip, once a day, for 30 to 120 minutes. You will be closely monitored during treatment.

Recommended dose in adults and children

Treatment duration

See theInstructions for healthcare professionalsfor details on how to administer the Veklury infusion.

If you are given more or less Veklury than you should

Since Veklury is only administered by a healthcare professional, it is unlikely that you will be given too much or too little. If you have been given an additional dose or missed a dose, inform your nurse or doctor immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Some adverse effects may be or may become severe:

Rare

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

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

Unknown frequency

(frequency cannot be estimated from available data)

• Anaphylactic reactions, anaphylactic shock (potentially fatal allergic reactions)

Symptoms are the same as allergic reactions, however, the reaction is more severe and requires immediate medical assistance.

• Bradycardia (heart beats slower than normal)

Inform your doctor or nurse immediatelyif you observe any of these effects.

Other adverse effects:

Very frequent adverse effects

(may affect more than 1 in 10 patients)

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

Frequent adverse effects

(may affect up to 1 in 10 patients)

• Headache
• Nausea
• Rash

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and the packaging after CAD. The expiration date is the last day of the month indicated.

• Before its use,this medication does not require any special precautions for conservation.
• Once reconstituted,Veklury must be diluted immediately.
• Once diluted,Veklury must be used immediately. If necessary, the bags of diluted solution can be stored for up to 24 hours at a temperature below 25 °C or up to 48 hours in the refrigerator. Do not let more than 48 hours pass between dilution and administration.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This way, you will help protect the environment.

Composition of Veklury

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

Appearance of the product and contents of the pack

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

Veklury is available in boxes containing 1 vial.

Marketing authorization holder and responsible manufacturer

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics: .

Other sources of information

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

QR code that will be included on www.veklury.eu

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

This summary of product characteristics is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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The following information is intended for healthcare professionals only.

For more information, please refer to the SmPC.

Instructions for healthcare professionals

Veklury 100 mg powder for concentrate for solution for infusion

remdesivir

Each single-use vial contains 100 mg of remdesivir in the form of a powder of white, off-white or yellowish color for reconstitution and dilution.

Treatment summary

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

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

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

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

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

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

Reconstitute the powder

For each single-use vial, the powder must be reconstituted and then diluted in 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 introduce the needle into the center of the stopper of the vial.
• 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.

• Onlysterile waterfor injection should be used to reconstitute remdesivir powder.
• Immediately agitate the vial for 30 seconds.
• Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should form.
• If the contents of the vial have not completely dissolved, agitate the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial have completely dissolved.
• Inspect the vial to ensure that the closure of the container is not defective.
• The solution should only be used if it is clear and free of particles.
• The solution should be diluted immediately after reconstitution.

Dilute the concentrate with sodium chloride solution

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

Instructions for dilution for adult and pediatric patients weighing at least 40 kg

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

Nota: 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 Veklury reconstituted from the vial using a syringe of suitable size. See Table 3.
• Transfer the Veklury reconstituted to the infusion bag.
• Invert the infusion bag gently 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 (20°C to 25°C) or for 48 hours in the refrigerator (2°C to 8°C).

Instructions for dilution 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 solution to achieve a fixed concentration of 1.25 mg/ml.
• The total infusion volume required of remdesivir 1.25 mg/ml solution for infusion is calculated according to pediatric dosing guidelines based on weight of 5 mg/kg for the loading dose and 2.5 mg/kg for each maintenance dose.
• Small infusion bags of sodium chloride solution 0.9% (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 volume-dependent total infusion volume to achieve the target concentration of remdesivir 1.25 mg/ml.
• A syringe may be used for administration of volumes <50>

Administer the infusion

• It may be used in conditions 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 solution 9 mg/ml (0.9%).
• The diluted solution should not be administered simultaneously with any other medicinal product in the same intravenous route. The compatibility of Veklury with different IV solutions and medicinal products other than sodium chloride is unknown.

a The infusion rate may be adjusted according to 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 practices.
• Healthcare professionals are invited to report suspected adverse reactions through the national reporting system included in Appendix V.

Store Veklury safely

• Before use,this medicinal product does not require any special precautions for storage. Do not use after the expiry date that appears on the vials/boxes after the letters CAD.
• Veklury powder is white, off-white or yellowish in color. The color does not affect the stability of the product.
• Once reconstituted,Veklury should be diluted immediately.
• Once diluted,Veklury should be administered immediately. If necessary, the infusion bags of diluted solution may be stored for up to 24 hours at room temperature (20°C to 25°C) or up to 48 hours in the refrigerator (2°C to 8°C). Do not allow more than 48 hours to pass between dilution and administration.

Do not reuse or store Veklury powder, reconstituted solution or diluted solution without using.

Information in other languages

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

QR code that will be included on www.veklury.eu

Last update of this summary of product characteristics: .