Patient Leaflet Updated 25-Mar-2024 | Gilead Sciences Ltd
Veklury 100 mg powder for concentrate for solution for infusion
Veklury 100 mg powder for concentrate for solution for infusion
remdesivir
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects you may get. See the end of section 4 for how to report side effects.
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
The active substance in Veklury is remdesivir. It is an antiviral medicine used for treating COVID-19.
COVID-19 is caused by a virus called a coronavirus. Veklury stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.
Veklury will be given to treat COVID-19 in:
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:
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:
Tell your doctor or nurse straight away if you notice any of these effects.
If you are prescribed Veklury, you will be given blood tests before treatment starts. Patients being treated with Veklury will have blood tests during their treatment as determined by their healthcare professional. These tests are to check for kidney or liver problems, and how quickly your blood clots. Veklury will be stopped if your liver shows signs of damage during treatment. See section 4 (Possible side effects).
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 pregnancy. Veklury will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child. You must use effective contraception while having Veklury treatment.
Tell your doctor or nurse if you are breast-feeding. It is not yet known whether Veklury or the COVID-19 virus pass into human breast milk, or what the effects might be on the baby or milk production. Your doctor will help you decide whether to continue breast-feeding or to start treatment with Veklury. You will need to consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby.
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.
Veklury will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 30 to 120 minutes, once a day. You will be closely monitored during your treatment.
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be or could become serious:
Rare
(these may affect up to 1 in 1000 patients)
Not known
(frequency cannot be estimated from the available data)
Symptoms are the same as for allergic reactions however the reaction is more severe and requires immediate medical care.
Tell your doctor or nurse straight away if you notice any of these effects.
Very common side effects
(these may affect more than 1 in 10 patients)
Common side effects
(these may affect up to 1 in 10 patients)
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.
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 that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 02/2024.
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