Description
Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19) in hospitalized patients. It is also used to treat mild to moderate COVID-19 in non-hospitalized patients who are at high risk for progression to severe COVID-19 (eg, hospitalization, death).
Remdesivir is an antiviral medicine that works against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of remdesivir injection in children from birth to less than 18 years of age and weighing at least 1.5 kilograms (kg). Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of remdesivir injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloroquine
- Everolimus
- Hydroxychloroquine
- Tacrolimus
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease—Use with caution. May make this condition worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV will have to stay in place for at least 30 to 120 minutes.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Hospitalized patients: This medicine is usually given once a day for 5 to 10 days. Your doctor will decide how many doses you need.
Non-hospitalized patients: You should receive this medicine within 7 days of the onset of COVID-19 symptoms. This medicine is usually given once a day for 3 days.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine.
Do not receive remdesivir together with chloroquine phosphate or hydroxychloroquine sulfate.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Back pain
- chest tightness
- chills
- cough
- dark-colored urine
- difficulty swallowing
- fast heartbeat
- fever
- flushing
- headache
- hives, itching
- light-colored stools
- nausea and vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain, continuing
- trouble breathing
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Seizures
- skin rash
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
