Veklury Lyophilised 100 mg Infusion

The active substance in VEKLURY is remdesivir. It is an antiviral medicine used for treating COVID-19 in adults.

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 people with COVID-19. It is suitable for adult patients. It will only be given to patients who have pneumonia, and need extra oxygen to help them breathe.

You will not be given VEKLURY:

• if you are allergic to remdesivir, or any of the other ingredients of VEKLURY (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.

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 health care provider. These tests are to check for kidney problems.

Children and adolescents

VEKLURY is not to be given to children under 18 years. Not enough is known for it to be given to children.

Other medicines and VEKLURY

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary medicines)

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

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

VEKLURY can be used with dexamethasone.

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 is not recommended during pregnancy. 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. Mothers receiving VEKLURY should not breastfeed their babies.

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.

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.

If you are given more or less VEKLURY than you should be

As VEKLURY is only given to you by a healthcare provider, 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 VEKLURY, ask your doctor, pharmacist or nurse.

VEKLURY can have side effects. Not all side effects reported for VEKLURY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VEKLURY, please consult your health care provider for advice.

Tell your doctor if you notice of the following:

• Blood tests may show an increase in liver enzymes, called transaminases.
• Blood tests may show it takes longer for blood to clot
• Headache
• Feeling sick (nausea)
• Rash
• Allergic reactions or reactions following 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

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 right away if you notice any of these effects.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-ucm.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of VEKLURY.

Store all medicines out of reach of children.

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 4 hours below 25 °C, or for up to 24 hours in a refrigerator. Do not allow more than 24 hours between dilution and administration.

Keep this medicine out of the sight and reach of children.