What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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


Veklury 100 mg powder for concentrate for solution for infusion

PATIENT INFORMATION LEAFLET

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 effects 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.

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 adolescents (aged 12 to less than 18 years and weighing 40 kg or more) 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 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 liver problems. Some people develop increased liver enzymes when given Veklury. Your doctor will do blood tests before starting treatment to check whether you can be given it safely.
  • if you have kidney problems. Some people with severe kidney problems may not be given this medicine. Your doctor will do blood tests to check whether you can be given it safely.
  • 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 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 kidney or liver show signs of damage during treatment. See section 4 (Possible side effects).

Children and adolescents

Veklury is not to be given to children under 12 years and to children who weigh less than 40 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.

Certain medicines e.g. midazolam or pitavastatin should be taken at least 2 hours after Veklury as Veklury can affect the way they work.

Veklury can affect the way certain medicines (e.g. theophylline or midazolam) work.

Certain medicines (e.g. rifampicin) can affect the way Veklury works.

  • 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 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.

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.

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.

The recommended dose is:

  • a single starting dose of 200 mg on day 1
  • then daily doses of 100 mg starting on day 2.

Treatment duration

Adult and adolescent patients (aged 12 to less than 18 years and weighing 40 kg or more) 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):

  • You will be given Veklury every day for at least 5 days. Your doctor may extend the treatment up to a total of 10 days.

Adult patients who do not need extra oxygen to help them breathe and are at increased risk for progressing to severe COVID-19:

  • You should start taking Veklury within 7 days of the onset of COVID-19 symptoms.
  • You will be given Veklury every day for 3 days.

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 (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 12/2021.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

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