Veklury 100 mg powder for concentrate for solution for infusion

• 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 for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).

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

• if you are allergic to remdesivir, or any of the other ingredients of this medicine (listed in section 6)

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

Talk to your doctor or nurse before starting on 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 the treatment is working.

Veklury can cause allergic reactions following and during the infusion, including anaphylactic reactions (sudden life-threatening allergic reactions). Allergic reactions have been seen rarely. For anaphylactic reactions frequency cannot be estimated from the available data. Symptoms can include:

• Changes to blood pressure or heart rate
• Low oxygen level in blood
• High temperature
• Shortness of breath, wheezing
• Swelling of the face, lips, tongue or throat (angioedema)
• Rash
• Feeling sick (nausea)
• Being sick (vomiting)
• Sweating
• Shivering

• Tell your doctor or nurse straight away if you notice any of these effects.

If you are prescribed Veklury, you may be given blood tests before treatment starts. Patients being treated with Veklury may have blood tests during their treatment as determined by their healthcare professional. These tests are to check for kidney problems.

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

Tell your doctor or nurse about any other medicines you are taking, or have recently taken.

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

• Tell your doctor if you are taking any of these medicines

Tell your doctor or nurse if you are pregnant, or if you might be. There is not enough information to be sure that Veklury is safe for use in first trimester of pregnancy. Veklury will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child. Discuss with your doctor the need to use effective contraception during treatment with Veklury.

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

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

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

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

Adults:

Day 1 (single starting dose) 200 mg

Day 2 and onwards (once daily) 100 mg

Children (weighing at least 40 kg):

Day 1 (single starting dose) 200 mg

Day 2 and onwards (once daily) 100 mg

Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg):

Day 1 (single starting dose) 5 mg per kg of body weight

Day 2 and onwards (once daily) 2.5 mg per kg of body weight

Adults:

Patients who have pneumonia and need extra oxygen - Daily for at least 5 days. May be extended up to a total of 10 days.

Patients who do not need extra oxygen and are at increased risk for progressing to severe COVID-19 - Daily for 3 days, starting within 7 days of the onset of COVID-19 symptoms.

Children (weighing at least 40 kg):

Patients who have pneumonia and need extra oxygen - Daily for at least 5 days. May be extended up to a total of 10 days.

Patients who do not need extra oxygen and are at increased risk for progressing to severe COVID-19 - Daily for 3 days, starting within 7 days of the onset of COVID-19 symptoms.

Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg):

Patients who have pneumonia and need extra oxygen - Daily for up to a total of 10 days.

Patients who do not need extra oxygen and are at increased risk for progressing to severe COVID-19 - Not applicable.

See the Instructions for healthcare professionals which gives details on how the Veklury infusion is given.

As Veklury is only 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 one, tell your nurse or doctor straight away.

Very common side effects

(these may affect more than 1 in 10 patients)

• Blood tests may show an increase in liver enzymes, called transaminases
• Blood tests may show it takes longer for blood to clot

Common side effects

(these may affect up to 1 in 10 patients)

• Headache
• Feeling sick (nausea)
• Rash

If you get 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 dedicated COVID-19 Yellow Card reporting site at coronavirus-yellowcard.mhra.gov.uk.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is remdesivir. Each vial contains 100 mg.
• The other ingredients are: betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide.

Veklury 100 mg powder for concentrate for solution for infusion is a white, off-white to yellow powder, to be reconstituted and then diluted into sodium chloride solution prior to administration by intravenous infusion. It is supplied in a single-use clear glass vial.

Veklury is available in cartons containing 1 vial.