100 mg powder for concentrate for infusion solution,
remdesivir solution
What Veklury is and what it is used for
The active substance in Veklury is remdesivir. It is an antiviral drug used to treat COVID‑19.
COVID‑19 is caused by a virus called coronavirus. Veklury stops the virus et from multiplying in cells and this prevents the virus et from multiplying in the body. It can help the body overcome the viral infection and can help you recover faster.
Very will be given to treat COVID-19 in:
- adults and children, who are at least 4 weeks old and weigh at least 3 kg, who has pneumonia and need extra oxygen to help them breathe, but who are not being treated with artificial ventilation (where mechanical aids are used to supplement or replace spontaneous breathing at the start of treatment).
- adults and children (weighing at least 40 kg), who do not need supplemental oxygen to help them breathe and who are at increased risk of developing severe COVID-19.
What you need to know before you receive Veklury
Do not use Veklury
- if you are allergic to remdesivir or any of the other ingredients of this medicine (listed in section 6).
→ Talk to a doctor or nurse as soon as possible, if this applies to you.
Warnings and precautions
Talk to your doctor or nurse before you receive Veklury:
- if you have liver problems. Some people get elevated liver enzymes after taking Veklury. Your doctor will take blood samples before starting the treatment to check that you can receive them safely.
- if you have kidney problems. Some people with severe kidney problems cannot receive this medicine. Your doctor will do blood tests to check if you can get it safely.
- if you have a weakened immune system. The doctor may monitor you more closely if your immune system is weakened to make sure the treatment is working.
Reactions after infusion a
Very can cause allergic reactions after and during infusion, including anaphylactic reactions (sudden life-threatening allergic reactions). Allergic reactions have been observed in rare cases. The frequency of anaphylactic reactions cannot be calculated from the available data.
Symptoms may include:
- Changes in blood pressure or heart rate.
- Low oxygen content in the blood
- High body temperature
- Shortness of breath, wheezing
- Swelling of the face, lips, tongue, or throat ( angioedema )
- Rash
- Nausea
- Vomiting
- Sweating
- Overindulge.
→ Tell your doctor or nurse immediately if you notice any of these symptoms.
Blood samples before and during treatment
If you are prescribed Veklury, blood samples will be taken from you before treatment begins. Patients treated with Veklury will have blood samples taken during their treatment as instructed by their healthcare professional. These samples are taken to check if you have kidney or liver problems and how quickly your blood clots. Very treatment will be stopped if your kidneys or liver show signs of damage during treatment. See section 4 ( Possible side effects ).
Children and young people
Very should not be given to children younger than 4 weeks of age or children weighing less than 3 kg. Not enough is known about the drug for it to be given to 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.
Certain medicines such as midazolam or pitavastatin should be taken at least 2 hours after Veklury as Veklury may affect how they work.
Very can affect the way some medicines (eg theophylline or midazolam) work.
Some medicines (eg rifampicin) can affect how Veklury works.
→ Tell your doctor if you are taking any of these medicines
Pregnancy and breastfeeding
Tell your doctor or nurse if you are pregnant or might be pregnant. There is not enough information to determine whether Veklury is safe to use during pregnancy. Very is given only if the possible benefits of the treatment outweigh the possible risks to the mother and the unborn child. You must use effective contraception while being treated with Veklury.
Tell your doctor or nurse if you are breastfeeding. It is not yet known whether Veklury or the COVID-19 virus is transmitted to human breast milk or what effects it may have on the baby or milk production. The doctor will help you decide whether to continue breastfeeding or start treatment with Veklury. You must consider the possible benefits of treatment against the health benefits and risks of breastfeeding for your baby.
Driving ability and use of machinery
Very is not expected to have any effect on your ability to drive.
Veklury contains cyclodextrin
This medicine contains 3 g of sulfobutylbetadex sodium in each 100 mg dose of Veklury (6 g starting dose). This ingredient is a cyclodextrin emulsifier that helps the medicine spread in the body.
How Veklury is given to you
Very 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 | Children (weighing at least 40 kg) | Children who are at least 4 weeks old (weighing at least 3 kg but less than 40 kg) | |
|---|---|---|---|
| Day 1(single starting dose) | 200 mg | 200 mg | 5 mg per kg of body weight |
| Day 2 onwards(Once a day) | 100 mg | 100 mg | 2.5 mg per kg of body weight |
How long the treatment lasts:
| Adults | Children (weighing at least 40 kg) | Children who are at least 4 weeks old (weighing at least 3 kg but less than 40 kg) | |
|---|---|---|---|
| Patients with pneumonia who need extra oxygen | Daily for at least 5 days. Can be extended up to a total of 10 days. | Daily for at least 5 days. Can be extended up to a total of 10 days. | Daily for up to a total of 10 days. |
| Patients who do not need supplemental oxygen and who are at increased risk of developing severe COVID-19 | Daily for 3 days, starting within 7 days of the onset of COVID-19 symptoms. | Daily for 3 days, starting within 7 days of the onset of COVID-19 symptoms. | not applicable |
See Instructions for Healthcare Professionals for detailed information on how to administer a Veklury infusion.
If you get more or less Veklury then you should
Because 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 had an extra dose or missed one, tell the nurse or doctor immediately.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be or may become serious.
Rare
(these may occur in up to 1 in 1,000 patients)
- Allergic or post-infusion reactions a. Symptoms may include:
- Changes in blood pressure or heart rate
- Low oxygen level in the blood
- High body temperature
- Shortness of breath, wheezing
- Swelling of the face, lips, tongue, or throat ( angioedema )
- Rash
- Nausea
- Vomiting
- Sweating
- Overindulge
Not known
(frequency cannot be calculated from available data)
- Anaphylactic reactions, anaphylactic shock (sudden life-threatening allergic reactions)
The symptoms are the same as for allergic reactions, however, the reaction is more severe and requires immediate medical attention.
- Sinus bradycardia (heart beats more slowly than normal)
→ Tell your doctor or nurse immediately if you experience any of these symptoms.
Other side effects:
Very common side effects are
(these may affect more than 1 in 10 patients)
- Blood tests can show elevated values of certain liver enzymes, so-called transaminases
- Blood tests may show that it takes longer for the blood to clot.
Common side effects are
(these may occur in up to 1 in 10 patients)
- Headache
- Nausea
- Rash
How to store Veklury
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
- Before use, this medicine does not need to be stored specially.
- Once Veklury has been reconstituted, it should be diluted immediately.
- After dilution, Veklury should be used immediately. If necessary, bags of diluted solution can be stored for up to 24 hours at room temperatures up to 25 °C, or for up to 48 hours in a refrigerator. The time between dilution and administration must not be longer than 48 hours.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacy staff how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is remdesivir. Each vial contains 100 mg.
- Other ingredients are: sulfobutylbetadex sodium, hydrochloric acid, and sodium hydroxide
Appearance and package sizes of the medicine
Very 100 mg powder for concentrate for solution for infusion is a white, off-white to yellow powder, which must be reconstituted and then diluted in saline (sodium chloride) before administration by intravenous infusion. It is supplied in a clear glass vial for single use.
Very is supplied in cartons containing 1 vial.
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland