Remdesivir | Covid-19 Treatment

EMA recommends authorisation for remdesivir to combat COVID-19

Generic name: remdesivir (rem DES i veer)
Brand name: Veklury
Dosage forms: intravenous powder for injection (100 mg); intravenous solution (5 mg/mL)
Drug class: Investigational drugs, Purine nucleosides

Remdesivir is used to treat people with coronavirus disease 2019 (COVID-19) who are in a hospital.

Remdesivir is approved for use in adults and children at least 12 years old who weigh at least 88 pounds (40 kilograms).

The US Food and Drug Administration (FDA) has authorized emergency use of remdesivir in children younger than 12 years old who weigh at least 8 pounds (3.5 kg) and are hospitalized with COVID-19. Remdesivir has not been FDA-approved to treat COVID-19 in these younger patients, especially outside of a hospital.

Remdesivir may also be used for purposes not listed in this medication guide.

Warnings

Remdesivir is for use only in people with COVID-19 who are in a hospital. You must remain under the care of a doctor while receiving remdesivir.

Before taking this medicine

You should not be treated with remdesivir if you are allergic to it.

Tell your doctor if you have ever had:

  • liver disease; or
  • kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

How is remdesivir given?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using remdesivir.

Remdesivir is given as an infusion into a vein. A healthcare provider will give you this injection.

remdesivir must be given slowly, and the infusion can take 30 to 120 minutes to complete.

Remdesivir is usually given once per day for 5 to 10 days.

You will need frequent blood tests to check your liver function.

You must remain under the care of a doctor while you are being treated with remdesivir for COVID-19.

What happens if I miss a dose?

Because you will receive remdesivir in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Since remdesivir is given by a healthcare professional in a medical setting, you will be treated quickly if an overdose occurs.

What should I avoid while receiving remdesivir?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Remdesivir side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your caregiver right away if you have:

  • severe headache, pounding in your neck or ears;
  • fast, slow, or pounding heartbeats;
  • wheezing, trouble breathing;
  • swelling in your face;
  • nausea;
  • fever, chills, or shivering;
  • itching, sweating; or
  • a light-headed feeling, like you might pass out;

Common side effects may include:

  • nausea; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects requiring immediate medical attention

Along with its needed effects, remdesivir 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 while taking remdesivir:

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

Side effects not requiring immediate medical attention

Some side effects of remdesivir 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

For Healthcare Professionals

Applies to remdesivir: intravenous powder for injection, intravenous solution

General

The most common side effect in healthy subjects was increased transaminases. The most common side effects in patients with coronavirus disease 2019 (COVID-19) were nausea, increased AST, and increased ALT.

Hepatic

In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). In a clinical study of patients with COVID-19, the incidence of at least grade 3 nonserious side effects of increased aminotransferase levels (including ALT, AST, or both) was 4% with this drug compared to 6% with placebo. In a clinical trial in hospitalized patients with severe COVID-19 receiving this drug for 5 or 10 days, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 40% and 42% of patients, respectively; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were both reported in 7% of patients. In a clinical trial in hospitalized patients with moderate COVID-19 receiving this drug for 5 or 10 days compared to standard of care, any grade laboratory abnormalities of increased AST and increased ALT occurred in 32% and 33% of patients, respectively, receiving this drug and 33% and 39% of patients, respectively, receiving standard of care; at least grade 3 laboratory abnormalities of increased AST and increased ALT occurred in 2% and 3% of patients, respectively, receiving this drug and 6% and 7%, respectively, receiving standard of care.

Very common (10% or more): Increased transaminases, increased ALT, increased AST

Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin

Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests

Renal

Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%)

Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 15%), decreased lymphocytes (up to 11%)

Common (1% to 10%): Increased prothrombin time

Metabolic

Very common (10% or more): Increased glucose (up to 12%)

Gastrointestinal

Common (1% to 10%): Nausea

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Generalized seizure

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Angioedema

Other

Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase

Cardiovascular

Uncommon (0.1% to 1%): Decreased heart rate

Local

Uncommon (0.1% to 1%): Injection site erythema

Frequency not reported: Administration site extravasation

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Anaphylaxis

What other drugs will affect remdesivir?

Tell your doctor if you also take chloroquine or hydroxychloroquine. Either of these other medicines could make remdesivir less effective.

Other drugs may affect remdesivir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Considerations in Pregnancy

  • Pregnant patients were excluded from the clinical trials that evaluated the safety and efficacy of remdesivir for the treatment of COVID-19, but preliminary reports of remdesivir use in pregnant patients from the remdesivir compassionate use program are reassuring.
  • Among 86 pregnant and postpartum hospitalized patients with severe COVID-19 who received compassionate use remdesivir, the therapy was well tolerated, with a low rate of serious adverse events.8
  • Remdesivir should not be withheld from pregnant patients if it is otherwise indicated.

Considerations in Children

  • The safety and effectiveness of using remdesivir to treat COVID-19 have not been evaluated in pediatric patients aged <12 years or weighing <40 kg.
  • Remdesivir is available through an FDA EUA for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg.
  • A clinical trial is currently evaluating the pharmacokinetics of remdesivir in children (ClinicalTrials.gov Identifier NCT04431453).

Clinical Trials

Several clinical trials that are evaluating the use of remdesivir for the treatment of COVID-19 are currently underway or in development.