Patient Medication Information: uses, side effects, how to take - Veklury (Gilead Sciences Canada, Solution)
What is VEKLURY used for?
The active substance of VEKLURY is remdesivir. It is an antiviral medicine for treating coronavirus 2019 (COVID-19). VEKLURY will be given to people with COVID-19. It is suitable for:
- hospitalized adults and children (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia, and need extra oxygen to help them breathe;
- non-hospitalized adults and children (weighing at least 40 kg) with positive SARS-CoV-2 test results, and who are at high risk for progression to severe COVID-19, including being hospitalized and dying.
How does VEKLURY work?
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.
What are the ingredients in VEKLURY?
Medicinal ingredients: remdesivir.
Non-medicinal ingredients: betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide.
VEKLURY comes in the following dosage form:
Powder for solution for infusion; 100 mg/vial (5 mg/mL when reconstituted)
Do not use VEKLURY if:
- You are allergic to remdesivir or any of the other ingredients in VEKLURY.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive VEKLURY. Talk about any health conditions or problems you may have, including if you:
- Have severe liver problems. Your healthcare professional may monitor the health of your liver during treatment.
- Have kidney problems. Your healthcare professional may monitor the health of your kidneys during treatment.
Have any reactions following the infusion. VEKLURY can cause 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)
- Sweating
- Shivering.
Your healthcare professional will monitor you for allergic reactions or reactions during and after treatment with VEKLURY.
Other warnings you should know about:
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 provider. These tests are to check for kidney or liver problems.
If you are pregnant or plan to become pregnant:
Tell your healthcare professional 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.
If you are breast-feeding or plan to breast-feed:
Tell your healthcare professional 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 healthcare professional 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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VEKLURY:
- Chloroquine (used to treat malaria)
- Hydroxychloroquine (used to treat inflammatory autoimmune diseases)
- Rifampicin (used to treat bacterial infections, including tuberculosis)
- Medicines that reduce kidney function
It is not yet known if VEKLURY affects other medicines or is affected by them. Your healthcare team will monitor you for signs of medicines affecting each other.
How to take VEKLURY:
VEKLURY will be given to you by a healthcare professional, 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.
Usual dose:
The recommended dose for adults and children:
| Adults and Children (weighing at least 40 kg) | Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg) | |
Day 1 (single starting dose) | 200 mg | 5 mg per kg of body weight |
Day 2 and onwards (once daily) | 100 mg | 2.5 mg per kg of body weight |
How long treatment lasts:
| Adults and Children (weighing at least 40 kg) | Children at least 4 weeks old (weighing at least 3 kg but less than 40 kg) | |
| Patients admitted to the hospital who have pneumonia and need extra oxygen | Daily for at least 5 days. May be extended up to a total of 10 days. | Daily for up to a total of 10 days. |
Patients who are not hospitalized 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. | Not applicable. |
Overdose:
If you think you, or a person you are caring for, have received too much VEKLURY, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you have missed a dose, tell your healthcare professional straight away. If you have any further questions on the use of this medicine, ask your healthcare professional.
What are possible side effects from using VEKLURY?
These are not all the possible side effects you may feel during your treatment with VEKLURY. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Headache
- Feeling sick (nausea)
- Rash
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
| Hypersensitivity (allergic reactions or reactions following the infusion): 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), sweating, shivering | |||
| UNKNOWN FREQUENCY | |||
| Sinus bradycardia (slower than normal heartbeat): fainting or near-fainting, dizziness or lightheadedness, not feeling well, feeling weak or very tired, shortness of breath, chest pains, confusion or memory problems | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
VEKLURY will be stored by your healthcare professional as follows:
- Before use, VEKLURY should be stored below 30°C.
- 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. Your healthcare professional should not allow more than 24 hours between dilution and administration.
Your healthcare professional should not use this medicine if they see particles in the vial, or if the solution does not appear colourless to yellow.
Keep out of reach and sight of children.
If you want more information about VEKLURY:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.
Last revised: MAY 06, 2024
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 7K2
VEKLURY® is a trademark of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
- 2024 Gilead Sciences, Inc. All rights reserved.
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