Veklury

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. This will allow for rapid identification of new
safety information. You can help by reporting any side effects you experience while taking this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before this medicine is administered to you because it contains
important information for you.

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

If Veklury has been prescribed for your child, please note that all the information in this leaflet
relates to your child (in this case, read “your child” instead of “you”).
Contents of this leaflet

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

1. What Veklury is and what it is used for

The active substance of Veklury is remdesivir. It is an antiviral medicine used for the treatment of
coronavirus disease 2019 (COVID-19).
COVID-19 is caused by a type of virus called coronavirus. Veklury blocks the virus from multiplying in cells,
preventing it from replicating in the body. This may help the body overcome the viral infection and recover more quickly.
Veklury is administered for the treatment of COVID-19 in adults and children (at least 4 weeks of age weighing at least 3 kg):

• with pneumonia who require supplemental oxygen to breathe, but who are not on mechanical ventilation (which involves the use of mechanical means to assist or replace spontaneous respiration at the start of treatment);
• who do not require supplemental oxygen to breathe and who are at increased risk of progressing to severe COVID-19.

2. What you should know before being given Veklury

Veklury will generally not be administered to you:

• if you are allergic to remdesivir or to any of the other ingredients of this medicine (listed in section 6). Contact your doctor or nurse as soon as possible if this applies to you.

Warnings and precautions
Contact 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 properly, to ensure the treatment is effective.

Infusion-related reactions
Veklury may cause allergic reactions during or after infusion, including anaphylactic reactions (sudden, life-threatening allergic reactions). Allergic reactions have been observed rarely. The frequency of anaphylactic reactions cannot be determined from the available data. Symptoms may include:

• changes in blood pressure or heart rate
• low blood oxygen levels
• high fever
• shortness of breath, wheezing
• swelling of the face, lips, tongue, or throat (angioedema)
• rash
• nausea
• vomiting
• sweating
• chills.

Inform your doctor or nurse immediately if you experience any of these symptoms.
Blood tests before and during treatment
If you have been prescribed Veklury, you may undergo blood tests before starting treatment. Patients treated with Veklury may also undergo blood tests during treatment, as determined by the healthcare provider. These tests are performed to monitor for possible kidney problems.
Children and adolescents
Veklury must not be administered to children under 4 weeks of age or to children weighing less than 3 kg. Sufficient data are not available on the use of this medicine in these children.
Other medicines and Veklury
Tell your doctor or nurse if you are taking or have recently taken any other medicines.
Do not take chloroquine or hydroxychloroquine at the same time as Veklury.
Inform your doctor if you are taking any of these medicines.
Pregnancy and breastfeeding
Inform your doctor or nurse if you are pregnant or suspect you may be pregnant. There is insufficient information to confirm that the use of Veklury is safe during the first trimester of pregnancy. Veklury should only be administered if the potential benefits of treatment outweigh the potential risks to the mother and fetus. Discuss with your doctor the need to use an effective method of contraception during treatment with Veklury.
Inform your doctor or nurse if you are breastfeeding. Veklury is excreted in very small amounts into human breast milk. Because experience with the use of Veklury during breastfeeding is limited, you should discuss carefully with your doctor whether to discontinue or continue breastfeeding during treatment with this medicine.
Driving and using machines
Veklury is considered not to have any effect on the ability to drive.
Veklury contains a cyclodextrin
This medicine contains 3 g of sulfobutylether beta-cyclodextrin sodium salt in each 100 mg dose of Veklury (6 g in the initial dose). This component is a cyclodextrin emulsifier that helps disperse the medicine in the body.
Veklury contains sodium
This medicine contains 212 mg of sodium (the main component of table salt) per 100 mg dose. This corresponds to 10.6% of the maximum daily sodium intake recommended in an adult's diet.

3. How Veklury will be administered to you

Veklury will be administered to you by a nurse or doctor, as an intravenous infusion (i.e. via an intravenous infusion) lasting between 30 and 120 minutes, once daily. You will be closely monitored during treatment.
Recommended dose for adults and children

Duration of treatment

For information on the administration of Veklury infusion, see the Instructions for Healthcare Providers.
If you are given more or less Veklury than you should
Since Veklury is administered only by a healthcare provider, it is unlikely that you will receive too much or too little of the medicine. If you have been given an overdose, or if a dose has been missed, inform your doctor or nurse immediately.
If you have any doubts about the use of this medicine, consult 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 could be or become serious.

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

• Allergic reactions during or after infusion. Symptoms may include:
  • changes in blood pressure or heart rate
  • low oxygen levels in the blood
  • high fever
  • shortness of breath, wheezing
  • swelling of the face, lips, tongue or throat (angioedema)
  • skin rash
  • nausea
  • vomiting
  • sweating
  • chills

Not known
(frequency cannot be estimated from the available data)

• Anaphylactic reactions, anaphylactic shock (sudden, life-threatening allergic reactions). Symptoms are the same as for allergic reactions, but the reaction is more severe and requires immediate medical attention.
• Sinus bradycardia (slower than normal heart rate).

Immediately inform your doctor or nurse if you experience any of these effects.

Other side effects

Very common side effects
(may affect more than 1 in 10 patients)

• Blood tests may show increased levels of liver enzymes called transaminases
• Blood tests may show prolonged blood clotting time

Common side effects
(may affect up to 1 in 10 patients)

• headache (cephalalgia)
• nausea
• skin rash

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

5. How to store 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 the carton after Exp.
The expiry date refers to the last day of that month.

• Before use, this medicine does not require special storage conditions.
• After reconstitution, Veklury must be diluted immediately.
• After dilution, Veklury must be used immediately. If necessary, bags of diluted solution may be stored for up to 24 hours at a temperature below 25 °C or for up to 48 hours under refrigeration (2 °C to 8 °C). The time between dilution and administration must not exceed 48 hours.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Veklury contains

• The active substance is remdesivir. Each vial contains 100 mg.
• The other components are: sulfobutylether beta-cyclodextrin sodium salt, hydrochloric acid and sodium hydroxide.

Description of the appearance of Veklury and contents of the pack
Veklury 100 mg powder for concentrate for solution for infusion is a white to off-white to yellow powder which must be reconstituted and then diluted in sodium chloride solution prior to administration by intravenous infusion. The product is supplied in a single-use clear glass vial.
Veklury is available in cartons containing 1 vial.

Marketing Authorisation Holder and Manufacturer
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50

Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel.: + 353 (0) 1 686 1888

Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf.: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1686 1 888

Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98

Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830

España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel.: + 48 22 262 8702

France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél : + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1686 1 888 Tel: + 40 31 631 18 00

Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999 Tel: + 353 (0) 1686 1 888

Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210

Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended for healthcare professionals only.

Refer to the product characteristics summary for further information.
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 to off-white to yellow powder to be reconstituted and diluted.
Treatment Summary
Veklury is used for the treatment of coronavirus disease 2019 (COVID-19) in adult and pediatric patients (at least 4 weeks of age and weighing at least 3 kg):

• with pneumonia requiring supplemental oxygen (low-flow or high-flow oxygen or other forms of non-invasive ventilation at initiation of treatment)
• who do not require supplemental oxygen but are at increased risk of progression to severe COVID-19

Veklury must be administered in a total volume of 25 mL, 50 mL, 100 mL or 250 mL of 0.9% sodium chloride solution by intravenous infusion over 30 to 120 minutes.
Table 1. Recommended dosage in adult and pediatric patients

Table 2. Duration of treatment

The powder must be reconstituted with sterile water for injectable preparations and then diluted with sodium chloride 9 mg/mL (0.9%) solution under aseptic conditions. Administer the diluted solution immediately.
Renal function must be assessed in all patients prior to initiating therapy and during treatment with remdesivir, as clinically appropriate.
Monitor the patient during and after infusion for potential adverse reactions. See below for details on reporting adverse reactions.

Reconstitution of the powder
For each single-dose vial, the powder must be reconstituted and then diluted under aseptic conditions.

• Add 19 mL of sterile water for injectable preparations to the vial, using a syringe and needle of appropriate size for each vial, inserting the needle into the center of the vial stopper.
• This will yield a solution containing 5 mg/mL of remdesivir.
• Discard the vial if the vacuum inside does not draw in the sterile water.
• Only use sterile water for injectable preparations to reconstitute remdesivir powder.
• Immediately shake the vial for 30 seconds.
• Wait 2–3 minutes for the contents of the vial to become stable. A clear solution should be obtained.
• If the contents of the vial are not completely dissolved, shake the vial again for 30 seconds, then wait 2–3 minutes for the contents to become stable. If necessary, repeat this procedure until the contents of the vial are completely dissolved.
• Visually inspect the vial to ensure the container closure is free from defects.
• The solution should only be used if clear and free from particles.
• Dilute immediately after reconstitution.

Dilution of the concentrate with sodium chloride solution
Reconstituted Veklury must be diluted with 9 mg/mL (0.9%) sodium chloride injectable solution under aseptic conditions.

Dilution instructions for adult and pediatric patients weighing at least 40 kg
Refer to Table 3 to determine the volume of 9 mg/mL (0.9%) sodium chloride solution to be withdrawn from the infusion bag.

Table 3. Dilution instructions

• Withdraw from the infusion bag and discard the volume of sodium chloride solution required, using a syringe and needle of appropriate size. See Table 3.
• Withdraw the required volume of reconstituted Veklury from the vial using a syringe of appropriate size. See Table 3.
• Transfer the reconstituted Veklury into the infusion bag.
• Gently invert the bag 20 times to mix the solution. 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 – 25 °C) or 48 hours under refrigeration (2 °C – 8 °C).

Dilution instructions for pediatric patients at least 4 weeks of age weighing at least 3 kg but less than 40 kg

• Further dilute the remdesivir concentrate 100 mg/20 mL (5 mg/mL) to a fixed concentration of 1.25 mg/mL with 0.9% sodium chloride.
• The total volume of 1.25 mg/mL remdesivir solution required for infusion is calculated based on pediatric dosing regimens of 5 mg/kg for the loading dose and 2.5 mg/kg for the maintenance dose.
• For pediatric administration, small 0.9% sodium chloride infusion bags (e.g., 25, 50, or 100 mL) or an appropriately sized syringe should be used. The recommended dose is administered as an intravenous infusion with a total volume adjusted according to the dose to achieve the target remdesivir concentration of 1.25 mg/mL.
• A syringe may be used to administer volumes < 50 mL.

Infusion administration

• Use in settings where severe hypersensitivity reactions, including anaphylaxis, can be managed.
• Administer the diluted solution over a period of 30 to 120 minutes at the rate specified in Table 4 or 5.
• After completion of the infusion, flush the line with at least 30 mL of 9 mg/mL (0.9%) sodium chloride solution.
• The diluted solution must not be administered simultaneously with other medicinal products through the same intravenous infusion line. Compatibility of Veklury with other drugs and intravenous solutions, apart from sodium chloride solution, is unknown.

Table 4. Infusion rates for adult and pediatric patients weighing at least 40 kg

Table 5. Infusion rate in pediatric patients at least 4 weeks of age weighing at least 3 kg but less than 40 kg

Monitoring and Reporting of Adverse Reactions

• Monitor the patient during and after infusion for any adverse reactions, according to local practice.
• Healthcare professionals are required to report any suspected adverse reactions through the national reporting system listed in Annex V.

Safely Store Veklury

• Prior to use, this medicinal product requires no special storage conditions. Do not use after the expiry date stated on the vials/packaging after “Exp.”.
• Veklury powder is white to off-white or yellow in colour. The colour does not affect the product's stability.
• After reconstitution, Veklury must be diluted immediately.
• After dilution, Veklury must be administered immediately. If necessary, diluted solution bags may be stored for up to 24 hours at room temperature (20 °C - 25 °C) or for up to 48 hours under refrigeration (2 °C - 8 °C). Do not exceed 48 hours between dilution and administration.

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