Veklury

4). Patients receiving remdesivir in an outpatient setting should be monitored according to local medical practice. Use under conditions where treatment of severe hypersensitivity reactions, including anaphylaxis, is possible. 5 mg/kg Table 2: Treatment duration Adults Paediatric patients (weighing at least 40 kg) Paediatric patients at least 4 weeks old (weighing at least 3 kg but less than 40 kg) Patients with pneumonia and requiring supplemental oxygen Daily for at least 5 days and not more than 10 days.

Daily for at least 5 days and not more than 10 days. Daily for up to a total of 10 days Patients who do not require supplemental oxygen and are at increased risk for progressing to severe COVID-19 Daily for 3 days, starting as soon as possible after diagnosis of COVID-19 and within 7 days of the onset of symptoms.

Daily for 3 days, starting as soon as possible after diagnosis of COVID-19 and within 7 days of the onset of symptoms. Daily for 3 days, starting as soon as possible after diagnosis of COVID-19 and within 7 days of the onset of symptoms.

2). Renal impairment No dose adjustment of remdesivir is required in patients with renal impairment, including those on dialysis. 4) and based on a 5-day treatment duration. 2). 2). However, safety data in patients with severe hepatic impairment are limited and only based on a single 100 mg dose administration.

1). Immunocompromised population The safety and efficacy of remdesivir in immunocompromised patients have not yet been established. 4). 4 Method of administration For intravenous use. Remdesivir is for administration by intravenous infusion after reconstitution and further dilution.

It must not be given as an intramuscular (IM) injection. 6. 21 mL/min a Rate of infusion may be adjusted based on total volume to be infused.

Summary of the safety profile The most common adverse reaction in healthy volunteers is increased transaminases (14%). The most common adverse reaction in patients with COVID-19 is nausea (4%). Tabulated summary of adverse reactions The adverse reactions in Table 7 are listed below by system organ class and frequency.

Frequencies are defined as follows:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data). 5 to 5 times ULN (4%). In clinical studies of patients with COVID-19, the incidence of increased transaminases was similar in patients treated with remdesivir compared to placebo or standard of care.

Prothrombin time prolonged In a clinical study (NIAID ACTT-1) of patients with COVID-19, the incidence of prolonged prothrombin time or INR (predominantly less than 2 times ULN) was higher in subjects who received remdesivir compared to placebo, with no difference observed in the incidence of bleeding events between the two groups.

In Study GS-US-540-9012, the incidence of increased prothrombin time or INR was similar in patients treated with remdesivir compared to placebo. 2). Safety data from these patients were comparable to the known safety profile of remdesivir.

1). 1). The adverse reactions observed were consistent with those observed in clinical trials of remdesivir in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Hypersensitivity including infusion-related and anaphylactic reactions Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration of remdesivir. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnoea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering.

Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. Monitor patients for hypersensitivity reactions during and following administration of remdesivir as clinically 5 appropriate.

Patients receiving remdesivir in an outpatient setting should be monitored after administration according to local medical practice. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment.

Renal impairment As clinically appropriate, patients should have eGFR determined prior to starting remdesivir and while receiving it. Safety data from patients with severe renal impairment and ESRD reported during Study GS-US-540-5912 were comparable to the known safety profile of remdesivir.

However, there are limited safety data in this patient population. 2). 1) Immunocompromised patients: It is unclear if the treatment duration of three days is sufficient to clear the virus in immunocompromised patients, in whom prolonged viral shedding occurs.

There is a potential risk of resistance development. Only limited data are available. 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.