Advanced search

Report side effect

Report a suspected side effect or falsified product to the MHRA Yellow Card scheme.
Go to {yellow_card_logo} site
{arrow_up} Back to top

Veklury 100 mg powder for concentrate for solution for infusion {equilateral_black_triangle}

Active Ingredient:
remdesivir
Company:  
Gilead Sciences Ltd See contact details
ATC code: 
J05AB16
{info_black}
About Medicine
{medical_services}
Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
{arrow_left}
{arrow_right}
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 15 May 2024

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 11972/0036.

{printer} Print patient leaflet as text only

Veklury 100 mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

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.

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 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”).

What is in 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 is 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 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:

  • adults and children (at least 4 weeks old and weighing at least 3 kg) who have pneumonia, and need extra oxygen to help them breathe, but who are not on artificial ventilation (where mechanical means are used to assist or replace spontaneous breathing at start of treatment).
  • adults and children (weighing at least 40 kg) who do not need extra oxygen to help them breathe and are at increased risk for progressing to severe COVID-19.

2. What you need to know before you are given Veklury
You will not usually be given Veklury:
  • 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.

Warnings and precautions

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.

Reactions following the infusion

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.

Blood tests before and during treatment

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.

Children and adolescents

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.

Other medicines and Veklury

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

Pregnancy and breast-feeding

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.

Driving and using machines

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

Veklury contains a cyclodextrin

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.

Veklury contains sodium

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.

3. How Veklury is given to you

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.

Recommended dose for adults and children

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

How long treatment lasts

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.

If you are given more or less Veklury than you should

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.

4. Possible side effects

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)

  • Allergic reactions following and during the infusion. 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

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 however the reaction is more severe and requires immediate medical care.
  • Sinus bradycardia (heart beats more slowly than normal).

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

Other side effects:

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

Reporting of side effects

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.

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 carton after EXP. The expiry date refers to the last day of that month.

  • Before use, this medicinal product does not require any special storage conditions.
  • Once reconstituted, Veklury should be diluted immediately.
  • Once diluted, Veklury should be used immediately. If necessary, bags of diluted solution can be stored for up to 24 hours below 25°C, or for up to 48 hours in a refrigerator. Do not allow more than 48 hours between dilution and administration.

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.

6. Contents of the pack and other information
What Veklury contains
  • The active substance is remdesivir. Each vial contains 100 mg.
  • The other ingredients are: betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide.

What Veklury looks like and contents of the pack

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.

Marketing Authorisation Holder
Gilead Sciences Ltd
280 High Holborn
London
WC1V 7EE
United Kingdom

Manufacturer
Gilead Sciences Ireland UC
Carrigtohill
County Cork
T45 DP77
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Gilead Sciences Ltd
Tel: + 44 (0) 8000 113 700

This leaflet was last revised in 03/2024.

Other sources of information

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

QR code to be included www.veklury.eu

Gilead Sciences Ltd
Company image
Address
280 High Holborn, London, WC1V 7EE, UK
Telephone
+44 (0)203 681 4500
E-mail
[email protected]
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)203 681 4681
Customer Care direct line
+353 1 291 3580 (Ireland)
Medical Information Direct Line
08000 113 700 (UK)
Medical Information Direct Line
+353 214 825 999 (Ireland)