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FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE

AUTHORIZATION (EUA) OF REMDESIVIR

Badan POM, the Indonesia Food and Drug Administration, has issued an Emergency Use

Authorization (EUA) to permit the emergency use of Remdesivir is for treatment or laboratory

confirmed coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and

older with body weight at least 40 kg) patients hospitalized with severe disease. Severe disease is

defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental

oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation

(ECMO).

The Emergency Use Authorization of Remdesivir is for treatment or laboratory confirmed

coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older

with body weight at least 40 kg) patients hospitalized with severe disease. Severe disease

is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring

supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal

membrane oxygenation (ECMO).

ADMINISTRATION :

Remdesivir must be administered by a healthcare professional pursuant to a valid

prescription of a licensed practitioner. Use of Remdesivir is confined to healthcare

facilities in which patients can be monitored closely.

Remdesivir must be administered by intravenous (IV) infusion over 30 to 120 minutes.

The optimal dosing and duration of treatment is unknown.

The suggested dose under this EUA for Remdesivir to treat laboratory confirmed COVID-19

adults and adolescents (aged 12 years and older with body weight at least 40 kg) patients

hospitalized with severe disease, which is : single loading dose of Remdesivir 200 mg given

by intravenous infusion on the first day, continue with 100 mg given once daily by

intravenous infusion on day 2 onwards. The total duration of treatment should be at least

5 days and not more than 10 days.

For patients requiring invasive mechanical ventilation and/or extracorporeal membrane

oxygenation (ECMO), the recommended total treatment duration is 10 days.

For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended

total treatment duration is 5 days. If a patient does not demonstrate clinical improvement,

treatment may be extended for up to 5 additional days for a total treatment duration of up to 10

days.

Remdesivir is available as a lyophilized powder injection.

DISETUJUI OLEH BPOM: 17/09/2020 ID: EREG10042512000056

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See the Full EUA Prescribing Information for complete dosage, administration, and preparation

instructions.

Health care providers must submit a report on all medication errors and ALL SERIOUS

ADVERSE EVENTS related to Remdesivir.

For information on clinical trials that are testing the use of Remdesivir in COVID-19, please see

www.clinicaltrials.gov

INSTRUCTIONS FOR ADMINISTRATION

This section provides essential information on the use of Remdesivir for the treatment of

laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12

years and older with body weight at least 40 kg) patients hospitalized with severe disease. Severe

disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring

supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane

oxygenation (ECMO).

Please refer to this fact sheet for information on use of Remdesivir under the EUA.

COMPOSITION

Each vial contains Remdesivir lyophilized powder injection 100 mg (a sterile, preservative-free

lyophilized solid that is to be reconstituted with 19 mL of sterile water for injection and diluted

into 0.9% saline prior to intravenous (IV) administration).

CONTRAINDICATIONS

Remdesivir is contraindicated in patients with known hypersensitivity to any ingredient of

Remdesivir.

DOSING

Use of Remdesivir is confined to healthcare facilities in which patients can be monitored closely.

The recommended dosage of Remdesivir in patients 12 years of age and older and weighing at

least 40 kg is :

• Day 1 – single loading dose of Remdesivir 200 mg given by intravenous infusion

• Day 2 onwards – 100 mg given once daily by intravenous infusion.

The total duration of treatment should be at least 5 days and not more than 10 days.

Special populations

Elderly

No dose adjustment of Remdesivir is required in patients over the age of 65 years.


http://www.clinicaltrials.gov/

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Renal impairment

The pharmacokinetics of Remdesivir have not been evaluated in patients with renal impairment.

Patients with eGFR ≥30 mL/min have received Remdesivir for treatment of COVID-19 with no

dose adjustment. Remdesivir should not be used in patients with eGFR<30 mL/minute.

Hepatic impairment

The pharmacokinetics of Remdesivir have not been evaluated in patients with hepatic impairment.

It is not known if dosage adjustment is appropriate in patients with hepatic impairment.

Pediatric population

The safety and efficacy of Remdesivir in children under the age of 12 years and weighing < 40 kg

have not yet been established. No data are available.

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.

For instructions on reconstitution and dilution of the medicinal product before administration, see

below.

Table 1 : Recommended rate of infusion – for reconstituted and diluted Remdesivir

lyophilized powder injection

Infusion Bag Volume Infusion Time Rate of Infusion

250 mL 30 min 8.33 mL/min

60 min 4.17 mL/min

120 min 2.08 mL/min

100 mL 30 min 3.33 mL/min

60 min 1.67 mL/min

120 min 0.83 mL/min

Prepare solution for infusion under aseptic conditions and on the same day as administration.

Remdesivir should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit. Should either be observed, the solution

should be discarded and fresh solution prepared.

Remdesivir must be reconstituted with 19 mL sterile water for injections and diluted in sodium

chloride 9 mg/mL (0.9%) solution for injection before being administered via intravenous infusion

over 30 to 120 minutes.

Preparation of Remdesivir solution for infusion

Reconstitution

Remove the required number of single-use vial(s) from storage. For each vial :

• Aseptically reconstitute Remdesivir lyophilized powder injection by addition of 19 mL of

sterile water for injections using a suitably sized syringe and needle per vial.

- Discard the vial if a vacuum does not pull the sterile water for injections into the vial.


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• Immediately shake the vial for 30 seconds.

• Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.

• If the contents of the vial are not completely dissolved, shake the vial again for 30 seconds and

allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the

contents of the vial are completely dissolved.

• Inspect the vial to ensure the container closure is free from defects and the solution is free of

particulate matter.

• Dilute immediately after reconstitution.

Dilution

Care should be taken to prevent inadvertent microbial contamination. As there is no preservative

or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the

final parenteral solution. It is always recommended to administer IV medicines immediately after

preparation when possible.

• Using Table below, determine the volume of sodium chloride 9 mg/mL (0.9%) solution for

injection to withdraw from the infusion bag.

Table 2 : Recommended dilution instructions – Reconstituted Remdesivir lyophilized

powder injection

Remdesivir dose Sodium chloride 9

mg/mL (0.9%)

infusion bag volume

to be used

Volume to be

withdrawn and

discarded from

sodium chloride 9

mg/mL (0.9%)

infusion bag

Required volume of

reconstituted

Remdesivir

200 mg (2 vials) 250 mL 40 mL 2x20 mL

100 mL 40 mL 2x20 mL

100 mg (1 vial) 250 mL 20 mL 20 mL

100 mL 20 mL 20 mL

Note : 100 mL should be reserved for patients with severe fluid restriction, e.g. with ARDS or

renal failure

• Withdraw and discard the required volume of sodium chloride 9 mg/mL from the bag using

an appropriately sized syringe and needle per Table 2.

• Withdraw the required volume of reconstituted Remdesivir lyophilized powder injection using

an appropriately sized syringe per Table 2. Discard any unused portion remaining in the

Remdesivir vial.

• Transfer the required volume of reconstituted Remdesivir lyophilized powder injection to the

selected infusion bag.

• Gently invert the bag 20 times to mix the solution in the bag. Do not shake.


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• The prepared solution is stable for 4 hours at room temperature (20°C to 25°C) or 24 hours in

the refrigerator (2°C to 8°C) (including any time before dilution into intravenous infusion

fluid).

After infusion is complete, flush with at least 30 mL of sodium chloride 9 mg/mL.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

IMPORTANT :

This product contains no preservative. Any unused portion of a single-dose Remdesivir vial should

be discarded after a diluted solution is prepared.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior

to administration, whenever solution and container permit.

Should either be observed, the solution should be discarded and fresh solution prepared.

The prepared diluted solution should not be administered simultaneously with any other

medication. The compatibility of Remdesivir injection with IV solutions and medications other

than 0.9% saline is not known.

WARNINGS

There are limited clinical data available for Remdesivir. Serious and unexpected adverse events

may occur that have not been previously reported with Remdesivir use.

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, dyspnea, 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. If signs and symptoms of a clinically significant hypersensitivity reaction occur,

immediately discontinue administration of Remdesivir and initiate appropriate treatment.

Increased Risk of Transaminase Elevations

Transaminase elevations have been observed in the Remdesivir clinical trials, including in healthy

volunteers and patients with COVID-19. Liver function should be determined in all patients prior

to starting Remdesivir and should be monitored while receiving it as clinically appropriate. No

clinical studies with Remdesivir have been conducted in patients with hepatic impairment.

Remdesivir should only be used in patients with hepatic impairment if the potential benefit

outweighs the potential risk.

• Remdesivir should not be initiated in patients with Alanine Aminotransferase (ALT) ≥5 times

the upper limit of normal at baseline


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• Remdesivir should be discontinued in patients who develop :

- ALT ≥5 times the upper limit of normal during treatment with Remdesivir. It may be

restarted when ALT is <5 times the upper limit of normal. OR

- ALT elevation accompanied by signs or symptoms of liver inflammation or increasing

conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).

Renal impairment

In animal studies on rats and monkeys, severe renal toxicity was observed. The mechanism of this

renal toxicity is not fully understood. A relevance for humans cannot be excluded. All patients

should have eGFR determined prior to starting Remdesivir and while receiving it as clinically

appropriate. Remdesivir should not be used in patients with eGFR <30 mL/min.

Excipients

Remdesivir contains betadex sulfobutyl ether sodium, which is renally cleared and accumulates in

patients with decreased renal function, which may potentially adversely affect renal function.

Therefore Remdesivir should not be used in patients with eGFR <30 mL/min.

Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine

Coadministration of Remdesivir and chloroquine phosphate or hydroxychloroquine sulphate is not

recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the

intracellular metabolic activation and antiviral activity of Remdesivir.

DRUG INTERACTIONS

No clinical interaction studies have been performed with Remdesivir. The overall potential for

interactions is currently unknown; patients should remain under close observation during the days

of Remdesivir administration. Due to antagonism observed in vitro, concomitant use of

Remdesivir with chloroquine phosphate or hydroxychloroquine sulphate is not recommended.

Effects of other medicinal products on Remdesivir

In vitro, Remdesivir is a substrate for esterases in plasma and tissue, drug metabolizing enzymes

CYP2C8, CYP2D6, and CYP3A4, and is a substrate for Organic Anion Transporting Polypeptides

1B1 (OATP1B1) and P-glycoprotein (P-gp) transporters.

The potential of interaction of Remdesivir with inhibitors/inducers of the hydrolytic pathway

(esterase) or CYP2C8, 2D6 or 3A4 has not been studied. The risk of clinically relevant interaction

is unknown. Strong inhibitors may result in increased Remdesivir exposure. The use of strong

inducers (e.g. rifampicin) may decrease plasma concentrations of Remdesivir and is not

recommended.

Dexamethasone is reported to be a moderate inducer of CYP3A and P-gp. Induction is dose-

dependent and occurs after multiple doses. Dexamethasone is unlikely to have a clinically

significant effect on Remdesivir as Remdesivir has a moderate-high hepatic extraction ratio, and

is used for a short duration in the treatment of COVID-19.


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Effects of Remdesivir on other medicinal products

In vitro, Remdesivir is an inhibitor of CYP3A4, OATP1B1 and OATP1B3. The clinical relevance

of these in vitro drug interactions has not been established. Remdesivir may transiently increase

plasma concentrations of medicinal products that are substrates of CYP3A or OATP 1B1/1B3. No

data is available, however it can be suggested that medicinal products that are substrates of

CYP3A4 or substrates of OATP1B1/1B3 should be administered at least 2 hours after Remdesivir.

Remdesivir induced CYP1A2 and potentially CYP3A in vitro. Co-administration of Remdesivir

with CYP1A2 or CYP3A4 substrates with narrow therapeutic index may lead to loss of their

efficacy.

Dexamethasone is a substrate of CYP3A4 and although Remdesivir inhibits CYP3A4, due to

Remdesivir's rapid clearance after I.V administration, Remdesivir is unlikely to have a significant

effect on dexamethasone exposure.

FERTILITY, PREGNANCY AND LACTATION

Pregnancy

There are no or limited amount of data from the use of Remdesivir in pregnant women. Animal

studies are insufficient with respect to reproductive toxicity (see section Preclinical Studies).

Remdesivir should not be used during pregnancy unless the clinical condition of the women

requires treatment with it.

Women of child-bearing potential have to use effective contraception during treatment.

Breast-feeding

It is unknown whether Remdesivir is excreted in human milk or the effects on the breast-fed infant,

or the effects on milk production.

In animal studies, the nucleoside analog metabolite GS-441524 has been detected in the blood of

nursing rat pups of mothers given Remdesivir. Therefore, excretion of Remdesivir and/or

metabolites into the milk of lactating animals can be assumed.

Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse

reactions from the drug in breast-feeding infants, a decision must be made whether to discontinue

breast-feeding or to discontinue/abstain from Remdesivir therapy taking into account the benefit

of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No human data on the effect of Remdesivir on fertility are available. In male rats, there was no

effect on mating or fertility with Remdesivir treatment. In female rats, however, an impairment of

fertility was observed. The relevance for humans is unknown.

ADVERSE REACTIONS

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%).


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The adverse reactions in Table 3 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).

Table 3 : Tabulated list of adverse reactions

Frequency Adverse reaction

Immune system disorders

Rare Hypersensitivity

Nervous system disorders

Common Headache

Gastrointestinal disorders

Common Nausea

Hepatobiliary disorders

Very common Transaminases increased

Skin and subcutaneous tissue disorders

Common Rash

Injury, poisoning and procedural complications

Rare Infusion-related reaction

PHARMACOLOGY PROPERTIES

Pharmacodynamic properties

Mechanism of action

Remdesivir is an adenosine nucleotide prodrug that is metabolized within host cells to form the

pharmacologically active nucleoside triphosphate metabolite. Remdesivir triphosphate acts as an

analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for

incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase,

which results in delayed chain termination during replication of the viral RNA.

Antiviral activity

Remdesivir exhibited in vitro activity against a clinical isolate of SARS-CoV-2 in primary human

airway epithelial cells with a 50% effective concentration (EC50) of 9.9 nM after 48 hours of

treatment. The EC50 values of Remdesivir against SARS-CoV-2 in Vero cells were 137 nM at 24

hours and 750 nM at 48 hours post-treatment. The antiviral activity of Remdesivir was antagonised

by chloroquine phosphate in a dose-dependent manner when the two drugs were co-incubated at

clinically relevant concentrations in HEp-2 cells infected with respiratory syncytial virus (RSV).

Higher Remdesivir EC50 values were observed with increasing concentrations of chloroquine

phosphate. Increasing concentrations of chloroquine phosphate reduced formation of Remdesivir

triphosphate in normal human bronchial epithelial cells.

Resistance

Cell culture resistance profiling of Remdesivir using the rodent CoV murine hepatitis virus

identified 2 substitutions (F476L and V553L) in the viral RNA-dependent RNA polymerase at


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residues conserved across CoVs that conferred 5.6-fold reduced susceptibility to Remdesivir.

Introduction of the corresponding substitutions (F480L and V557L) into SARS-CoV resulted in

6-fold reduced susceptibility to Remdesivir cell culture and attenuated SARS-CoV pathogenesis

in a mouse model.

The cell culture development of SARS-CoV-2 resistance to Remdesivir has not been assessed to

date. No clinical data are available on the development of SARS-CoV-2 resistance to Remdesivir.

PRECLINICAL STUDIES

Toxicology

Following intravenous administration (slow bolus) of Remdesivir to rhesus monkeys and rats,

severe renal toxicity occurred after short treatment durations. In male rhesus monkeys at dosage

levels of 5, 10, and 20 mg/kg/day for 7 days resulted, at all dose levels, in increased mean urea

nitrogen and increased mean creatinine, renal tubular atrophy, and basophilia and casts, and an

unscheduled death of one animal at the 20 mg/kg/day dose level. In rats, dosage levels of >3

mg/kg/day for up to 4 weeks resulted in findings indicative of kidney injury and/or dysfunction.

Systemic exposures (AUC) of the predominant circulating metabolite of Remdesivir (GS-441524)

were 0.1 times (monkeys at 5 mg/kg/day) and 0.3 times (rat at 3 mg/kg/day) the exposure in

humans at the RHD. An unidentified major metabolite (M27) was shown to be present in human

plasma. The exposure of M27 in rhesus monkeys and rats is unknown. Animal studies may

therefore not be informative of potential risks associated with this metabolite.

Carcinogenesis

Long-term animal studies to evaluate the carcinogenic potential of Remdesivir have not been

performed.

Mutagenesis

Remdesivir was not genotoxic in a battery of assays, including bacterial mutagenicity,

chromosome aberration using human peripheral blood lymphocytes, and in vivo rat micronucleus

assays.

Reproductive toxicity

In female rats, decreases in corpora lutea, numbers of implantation sites, and viable embryos, were

seen when Remdesivir was administered intravenously daily at a systemically toxic dose (10

mg/kg/day) 14 days prior to mating and during conception; exposures of the predominant

circulating metabolite (GS-441524) were 1.3 times the exposure in humans at the RHD. There

were no effects on female reproductive performance (mating, fertility, and conception) at this dose

level.

In rats and rabbits, Remdesivir demonstrated no adverse effect on embryofoetal development

when administered to pregnant animals at systemic exposures (AUC) of the predominant

circulating metabolite of Remdesivir (GS-441524) that were up to 4 times the exposure in humans

at the recommended human dose (RHD).


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In rats, there were no adverse effects on pre- and post-natal development at systemic exposures

(AUC) of the predominant circulating metabolite of Remdesivir (GS-441524) that were similar to

the exposure in humans at the recommended human dose (RHD).

It is unknown if the active nucleoside analog triphosphate GS-443902 and the unidentified major

human metabolite M27 are formed in rats and rabbits. The reproductive toxicity studies may

therefore not be informative of potential risks associated with these metabolites.

CLINICAL STUDIES

NIAID ACTT-1 Trial in Subjects with Mild/Moderate and Severe COVID-19

A randomized, double-blind, placebo-controlled clinical trial evaluated Remdesivir 200 mg once

daily for 1 day followed by Remdesivir 100 mg once daily for 9 days (for a total of up to 10 days

of intravenously administered therapy) in hospitalized adult subjects with COVID-19 with

evidence of lower respiratory tract involvement. Treatment with Remdesivir was stopped in

subjects who were discharged from the hospital prior to the completion of 10 days of treatment.

The trial enrolled 1,062 subjects : 105 (9.9%) subjects with mild/moderate disease and 957

(90.1%) subjects with severe disease. A total of 285 subjects (26.8%) (n=131 received

Remdesivir) were on invasive mechanical ventilation/ECMO. Subjects were randomized in a 1:1

manner, stratified by disease severity at enrollment, to receive Remdesivir (n=541) or placebo

(n=521), plus standard of care.

The primary clinical endpoint was time to recovery within 29 days after randomization, defined

as either discharged from the hospital or hospitalized but not requiring supplemental oxygen and

no longer requiring ongoing medical care. The median time to recovery was 10 days in the

Remdesivir group compared to 15 days in the placebo group recovery rate ratio, 1.29; [95% CI

1.12 to 1.49]; p<0.001). Overall, the odds of improvement in the ordinal scale were higher in the

Remdesivir group at Day 15 when compared to the placebo group (odds ratio, 1.6; [95% CI, 1.3

to 1.9]; p<0.001). In a preliminary analysis conducted after 607 recoveries, 14-day mortality was

7.1% for the Remdesivir group versus 11.9% for the placebo group (hazard ratio, 0.70 [95% CI

0.47, 1.04]; p=0.07).

Among subjects with mild/moderate disease at enrollment (n=105), the median time to recovery

was 5 days in both the Remdesivir and placebo groups (recovery rate ratio, 1.22; [95% CI 0.82 to

1.81]); the odds of improvement in the ordinal scale in the Remdesivir group at Day 15 when

compared to the placebo group wereas follows : odds ratio, 1.46; [95% CI, 0.71 to 2.97].

Among subjects with severe disease at enrollment (n=957), the median time to recovery was 11

days in the Remdesivir group compared to 18 days in the placebo group (recovery rate ratio, 1.31;

[95% CI, 1.12 to 1.52]; p<0.001); the odds of improvement in the ordinal scale in the Remdesivir

group at Day 15 when compared to the placebo group were as follows : odds ratio, 1.56; [95% CI,

1.24 to 1.95].

Study GS-US-540-5773 in Subjects with Severe COVID-19

A randomized, open-label multi-center clinical trial (Study GS-US-540-5773) of hospitalized

subjects at least 12 years of age with confirmed SARS-CoV-2 infection, oxygen saturation of


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≤94% on room air, and radiological evidence of pneumonia compared 200 subjects who received

IV Remdesivir for 5 days with 197 subjects who received IV Remdesivir for 10 days. Patients on

mechanical ventilation at screening were excluded. All subjects received 200 mg of Remdesivir

on Day 1 and 100 mg once daily on subsequent days, plus standard of care. Treatment with

Remdesivir was stopped in subjects who were discharged from the hospital prior to completion of

their protocol-defined duration of treatment.

The primary endpoint was clinical status on Day 14 assessed on a 7-point ordinal scale consisting

of the following categories : 1, death; 2, hospitalized, receiving invasive mechanical ventilation

or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4,

hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental

oxygen but receiving ongoing medical care (related or not related to COVID-19); 6, hospitalized,

requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the

protocol for Remdesivir administration); and 7, not hospitalized. After adjusting for between-

group differences at baseline, patients receiving a 10-day course of Remdesivir had similar clinical

status at Day 14 as those receiving a 5-day course (odds ratio for improvement, 0.75; [95% CI

0.51 to 1.12]). 28-day mortality was 11.5% and 14.2% in the 5- and 10-day treatment groups,

respectively.

Study GS-US-540-5774 in Subjects with Moderate COVID-19

A randomized, open-label multi-center clinical trial (Study GS-US-540-5774) of hospitalized

subjects at least 12 years of age with confirmed SARS-CoV-2 infection and radiological evidence

of pneumonia without an oxygen requirement during screening compared treatment with

Remdesivir for 5 days (n=191) and treatment with Remdesivir for 10 days (n=193) with standard

of care (SOC) (n=200). Subjects treated with Remdesivir received 200 mg on Day 1 and 100 mg

once daily on subsequent days. Treatment with Remdesivir was stopped in subjects who were

discharged from the hospital prior to completion of their protocol-defined duration of treatment.

The primary endpoint was clinical status on Day 11 assessed on a 7-point ordinal scale consisting

of the following categories : 1, death; 2, hospitalized, receiving invasive mechanical ventilation

or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4,

hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental

oxygen but receiving ongoing medical care (related or not related to COVID-19); 6, hospitalized,

requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the

protocol for Remdesivir administration); and 7, not hospitalized. Baseline clinical status, oxygen

support status, and median duration of symptoms and hospitalization prior to first dose of

Remdesivir were similar across treatment groups. Overall, the odds of improvement in clinical

status were higher in the 5-day Remdesivir group at Day 11 when compared to those receiving

only SOC (odds ratio, 1.65; [95% CI, 1.09 to 2.48]; p=0.017). The odds of improvement in clinical

status with the 10-day treatment group when compared to those receiving only SOC were not

statistically significantly different (odds ratio, 1.31; [95% CI 0.88 to 1.95]; p=0.183). At Day 28,

mortality was ≤ 2% in all treatment groups.


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Study GS-US-540-5758 in Hospitalized China Subjects with Severe COVID-19

A randomized, double-blind, placebo control, and multi center clinical trial in China (Study GS-

US-540-5758) of hospitalized adult subjects who confirmed SARS-CoV-2 infection with

Pneumonia confirmed by chest imaging or had oxygen saturation of 94% or lower on room air,

OR, ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mmHg or less.

One hundred and fifty-eight subjects received Remdesivir for 10 days (200 mg on the first day

and continued with 100 mg Day 10) compared with seventy eight subject received placebo.

The primary endpoint was time to clinical improvement within 28 days after randomization, which

defined as a two-point reduction in patients’ admission status on a six-point ordinal scale (1,

Discharged or having reached discharge criteria (defined as clinical recovery–ie, normalization of

pyrexia, respiratory rate<24 breaths per minute, saturation of peripheral oxygen>94% on room air,

and relief of cough, all maintained for at least 72 h); 2, Hospital admission but no requiring oxygen

therapy; 3, Hospital admission for oxygen therapy (but not requiring high-flow oxygen therapy);

4, Hospital admission for noninvasive ventilation or high-flow oxygen therapy; 5, Hospital

admission for extracorporeal membrane oxygenation or mechanical ventilation; and 6, Death), or

live discharge from the hospital, whichever came first. The secondary endpoint was 28-day all-

cause mortality. The time to clinical improvement in Remdesivir group were not statistically

significant different (21 vs 23 days; 95% CI: 0.87 to 1.75). The mortality were also not statistically

significant different between Remdesivir and placebo group (14% vs 13%; 95% CI: -8.1 to 10.3).

The main outcomes of this trial are presented in the table below.

Table 4 : Main outcomes (ITT-analysis)

Remdesivir group

(n=158)

Placebo group

(n=78)

Difference*

Time to clinical

improvement

21.0 (13.0 to 28.0) 23.0 (15.0 to 28.0) 1.23 (0.87 to 1.75)†

Day 28 mortality 22 (14%) 10 (13%) 1.1% (-8.1 to 10.3)

Early (≤ 10 days of

symptoms onset)

8/71 (11%) 7/47 (15%) -3.6% (-16.2 to 8.9)

Late (> 10 days of

symptoms onset)

12/84 (14%) 3/31 (10%) 4.6% (-8.2 to 17.4)

Clinical improvement

rates

Day 7 4 (3%) 2 (3%) 0.0% (-4.3 to 4.2)

Day 14 42 (27%) 18 (23%) 3.5% (-8.1 to 15.1)

Day 28 103 (65%) 45 (58%) 7.5% (-5.7 to 20.7)

Duration of invasive

mechanical ventilation,

days

7.0 (4.0 to 16.0) 15.5 (6.0 to 21.0) -4.0 (-14.0 to 2.0)


mechanical ventilation

in survivors, days ‡

19.0 (5.0 to 42.0) 42.0 (17.0 to 46.0) -12.0 (-41.0 to 25.0)


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mechanical ventilation

in non-survivors, days ‡

7.0 (2.0 to 11.0) 8.0 (5.0 to 16.0) -2.5 (-11.0 to 3.0)

Duration of oxygen

support, days

19.0 (11.0 to 30.0) 21.0 (14.0 to 30.5) -2.0 (-6.0 to 1.0)

Duration of hospital stay,

days

25.0 (16.0 to 38.0) 24.0 (18.0 to 36.0) 0.0 (-4.0 to 4.0)

Time from random group

assignment to discharge,

days

21.0 (12.0 to 31.0) 21.0 (13.5 to 28.5) 0.0 (-3.0 to 3.0)

Time from random group

assignment to death, days

9.5 (6.0 to 18.5) 11.0 (7.0 to 18.0) -1.0 (-7.0 to 5.0)

Pharmacokinetic Properties

The pharmacokinetic properties of Remdesivir has been investigated in healthy volunteers.

No pharmacokinetic data is available from patients with COVID-19.

Absorption

The pharmacokinetic properties of Remdesivir and the predominant circulating metabolite GS-

441524 have been evaluated in healthy adult subjects. Following intravenous administration of

Remdesivir adult dosage regimen, peak plasma concentration was observed at end of infusion,

regardless of dose level, and declined rapidly thereafter with a half-life of approximately 1 hour.

Peak plasma concentrations of GS-441524 were observed at 1.5 to 2.0 hours post start of a 30

minutes infusion.

Distribution

Remdesivir is approximately 88% bound to human plasma proteins. Protein binding of GS-441524

was low (2% bound) in human plasma. After a single 150 mg dose of [14C]-Remdesivir in healthy

subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.68 at 15 minutes from

start of infusion, increased over time reaching ratio of 1.0 at 5 hours, indicating differential

distribution of Remdesivir and its metabolites to plasma or cellular components of blood.

Biotransformation

Remdesivir is extensively metabolized to the pharmacologically active nucleoside analog

triphosphate GS-443902 (formed intracellularly). The metabolic activation pathway involves

hydrolysis by esterases, which leads to the formation of the intermediate metabolite, GS-704277.

Phosphoramidate cleavage followed by phosphorylation forms the active triphosphate, GS-

443902. Dephosphorylation of all phosphorylated metabolites can result in the formation of

nucleoside metabolite GS-441524 that itself is not efficiently re-phosphorylated. The human mass

balance study also indicates presence of a currently unidentified major metabolite (M27) in

plasma.


14

Elimination

Following a single 150 mg IV dose of [14C]-Remdesivir, mean total recovery of the dose was 92%,

consisting of approximately 74% and 18% recovered in urine and feces, respectively. The majority

of the Remdesivir dose recovered in urine was GS-441524 (49%), while 10% was recovered as

Remdesivir. These data indicate that renal clearance is the major elimination pathway for GS-

441524. The median terminal half-lives of Remdesivir and GS-441524 were approximately 1 and

27 hours, respectively.

Other special populations

Gender, race and age

Pharmacokinetic differences for gender, race, and age have not been evaluated.

Paediatric patients

The pharmacokinetics in paediatric patients have not been evaluated.

Renal impairment

The pharmacokinetics of Remdesivir and GS-441524 in renal impairment has not been evaluated.

Remdesivir is not cleared unchanged in urine to any substantial extent, but its main metabolite

GS-441524 is renally cleared and the metabolite levels in plasma may theoretically increase in

patients with impaired renal function. The excipient betadex sulfobutyl ether sodium is renally

cleared and accumulates in patients with decreased renal function. Remdesivir should not be used

in patients with eGFR <30 mL/min.

Hepatic impairment

The pharmacokinetics of Remdesivir and GS-441524 in hepatic impairment has not been

evaluated. The role of the liver in the metabolism of Remdesivir is unknown.

OVERDOSE

Treatment of overdose with Remdesivir should consist of general supportive measures including

monitoring of vital signs and observation of the clinical status of the patient. There is no specific

antidote for overdose with Remdesivir.

STORAGE CONDITIONS

Do not reuse or save unused Remdesivir lyophilized powder, injection solution, or diluted solution

for infusion for future use. This product contains no preservative.

Lyophilized powder

Store Remdesivir for injection, 100 mg, vials below 30°C until required for use. Do not use after

expiration date.

After reconstitution with sterile water, the solution is stable for 4 hours at room temperature (20°C

to 25°C) or 24 hours at refrigerated temperature (2°C to 8°C).

After dilution for infusion : The prepared diluted solution is stable for 4 hours at room temperature

(20°C to 25°C) or 24 hours at refrigerated temperature (2°C to 8°C).


15

INSTRUCTIONS FOR HEALTH CARE PROVIDERS

As the health care provider, you must communicate to your patient or parent/caregiver information

consistent with the “Informasi Produk untuk Pasien (Fact Sheet for Patients and

Parents/Caregivers)” (and provide a copy of the Fact Sheet) prior to the patient receiving

Remdesivir, including :

1. That the Badan POM has authorized emergency use of Remdesivir

2. That the patient has the option to accept or refuse administration of Remdesivir

3. The potential consequences of refusing Remdesivir

4. The significant known and potential risks and benefits of Remdesivir, as supplied under this

EUA.

5. The alternative products that are available and their benefits and risks, including clinical trials.

If providing this information will delay the administration of Remdesivir to a degree that would

endanger the lives of patients, the information must be provided to the patients as soon as

practicable after Remdesivir is administered.

MANDATORY REQUIREMENTS FOR REMDESIVIR ADMINISTRATION UNDER

EMERGENCY USE AUTHORIZATION :

In order to mitigate the risks of using this unapproved product under EUA and to optimize the

potential benefit of Remdesivir, the following items are required. Use of unapproved Remdesivir

under this EUA is limited to the following (all requirements must be met) :

1. Treatment of laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and

adolescents (aged 12 years and older with body weight at least 40 kg) patients hospitalized with

severe disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94%

on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring

extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is authorized only

for the following patients who are admitted to a hospital and under the care or consultation of

a licensed clinician (skilled in the diagnosis and management of patients with potentially life-

threatening illness and the ability to recognize and manage medication-related adverse events):

a. Adult patients for whom use of an IV agent is clinically appropriate.

b. Adolescent patients for whom use of an IV agent is clinically appropriate.

2. As the health care provider, communicate to your patient or parent/caregiver information

consistent with the “Informasi Produk untuk Pasien” prior to the patient receiving

Remdesivir. Health care providers (to the extent practicable given the circumstances of the

emergency) must document in the patient’s medical record that the patient/caregiver has been :

a. Given the “Informasi Produk untuk Pasien”,

b. Informed of alternatives to receiving Remdesivir, and

c. Informed that Remdesivir is an unapproved drug that is authorized for use under Emergency

Use Authorization.

3. Adult and adolescents patients (> 12 years old) must have an eGFR determined prior to

Remdesivir first administration.


16

4. Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and

daily while receiving Remdesivir.

5. Patients with known hypersensitivity to any ingredient of Remdesivir must not receive

Remdesivir.

6. The prescribing health care provider and/or the provider’s designee are/is responsible for

mandatory responses to requests from Badan POM for information about adverse events and

medication errors following receipt of Remdesivir.

7. The prescribing health care provider and/or the provider’s designee are/is responsible for

mandatory reporting of all medication errors and adverse events (death, serious adverse

events*) considered to be potentially related to Remdesivir occurring during Remdesivir

treatment within 7 calendar days from the onset of the event. The reports should include unique

identifiers and the words “Remdesivir under Emergency Use Authorization (EUA)” in the

description section of the report.

• Submit adverse event reports to :

Pusat Farmakovigilans/MESO Nasional

Direktorat Pengawasan Keamanan, Mutu, dan Ekspor Impor Obat, Narkotika, Psikotropika,

Prekursor dan Zat Adiktif

Badan Pengawas Obat dan Makanan https://e-meso.pom.go.id/ADR

• Submitted reports should include in the field name, “Describe Event, Problem, or Product

Use/Medication Error” the statement “Remdesivir Treatment under EUA”

*Serious Adverse Events are defined as:

• death;

• a life-threatening adverse event;

• inpatient hospitalization or prolongation of existing hospitalization;

• a persistent or significant incapacity or substantial disruption of the ability to conduct

normal life functions;

• a congenital anomaly/birth defect.

• a medical or surgical intervention to prevent death, a life-threatening event, hospitalization,

disability, or congenital anomaly.

APPROVED AVAILABLE ALTERNATIVES

There is no approved available alternative product. There are EUAs for other COVID-19

treatments. The health care provider should visit https://clinicaltrials.gov/ to determine whether

the patient may be eligible for enrollment in a clinical trial.

AUTHORITY FOR ISSUANCE OF THE EUA

Indonesian Government has declared an emergency situation as a result of pandemic outbreak of

COVID-19 that justifies the emergency need of using Remdesivir as an treatment option in this

situation. In response to that situation, the Badan POM has issued an Emergency Use

Authorization (EUA) for the use of the Badan POM-approved product Remdesivir for treatment


https://e-meso.pom.go.id/ADR

https://clinicaltrials.gov/

17

of laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12

years and older with body weight at least 40 kg) patients hospitalized with severe disease. As a

health care provider, you must comply with the mandatory requirements of the EUA listed above.

Although limited scientific information is available, it is reasonable to believe that Remdesivir

may be effective for treatment of suspected or laboratory confirmed coronavirus disease 2019

(COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg)

patients hospitalized with severe disease, as specified in this Fact Sheet. You may be contacted

and asked to provide information to help with the assessment of the use of the product during this

emergency. Serious adverse events related to the use of Remdesivir must be reported to Badan

POM through Pusat Farmakovigilans/MESO Nasional, Badan Pengawas Obat dan Makanan

online http://e-meso.pom.go.id/ADR. Please include in the field name, “Describe Event, Problem,

or Product Use/Medication Error” the following statement : Remdesivir Treatment under

Emergency Use Authorization (EUA).

This EUA for Remdesivir will end when the Badan POM determines that the circumstances

justifying the EUA no longer exist or when there is a change in the approval status of the product

such that an EUA is no longer needed.

PRESENTATION :

COVIFOR Lyophilized powder injection 100 mg

Box, 1 vial @ 100 mg

HARUS DENGAN RESEP DOKTER

ON MEDICAL PRESCRIPTION ONLY

Manufactured by :

ASPIRO PHARMA LIMITED

Telangana – India

Manufactured for :

HETERO LABS LIMITED

Telangana – India

Imported and marketed by :

PT. AMAROX PHARMA GLOBAL

Bekasi – Indonesia

COVIFOR is manufactured under a license from Gilead Sciences, Inc., USA


http://e-meso.pom.go.id/ADR

1

INFORMASI PRODUK UNTUK PASIEN DAN ORANG

TUA/PENGASUH PENGGUNAAN REMDESIVIR UNTUK

PENGOBATAN COVID-19 PADA PASIEN YANG DIRAWAT DI

RUMAH SAKIT

Anda diberikan obat Remdesivir untuk pengobatan COVID-19. Informasi Produk (PIL) ini

mengandung informasi yang dapat membantu Anda untuk mengetahui manfaat dan risiko

penggunaan Remdesivir yang sudah atau akan anda terima.

Belum ada obat yang disetujui izin edarnya oleh Badan Pengawas Obat dan Makanan (Badan

POM) untuk mengobati COVID-19. Penggunaan Remdesivir dapat bermanfaat bagi pasien

COVID-19 yang dirawat di rumah sakit. Baca Informasi Produk ini untuk mengetahui

informasi mengenai Remdesivir. Bicarakan kepada tenaga kesehatan yang merawat Anda

apabila ada pertanyaan lebih lanjut. Hal ini merupakan pilihan Anda untuk menggunakan

Remdesivir atau menghentikannya.

APAKAH COVID-19 ?

COVID-19 merupakan penyakit yang disebabkan oleh virus yang disebut coronavirus. Jenis

coronavirus ini belum diketahui sebelumnya. Virus baru ini pertama kali ditemukan di Wuhan,

Provinsi Hubei, China pada Desember 2019. Penyebaran dari orang ke orang telah dilaporkan

di luar Hubei dan di negara selain China, termasuk di Indonesia. Anda dapat menderita

COVID-19 melalui kontak dengan orang yang memiliki virus tersebut.

APA GEJALA DARI COVID-19 ?

Gejalanya adalah demam, batuk dan sesak nafas yang dapat timbul 2-14 hari setelah terpapar

virus. Jika Anda mengalami kesulitan bernafas, nyeri atau sesak yang terus-menerus di

dada, kebingungan atau kesulitan berdiri atau bibir atau wajah pucat kebiruan segera

hubungi petugas kesehatan.

Penyakit COVID-19 memiliki rentang keparahan dari sangat ringan (termasuk beberapa

laporan kasus tanpa gejala hingga parah, termasuk penyakit yang mengakibatkan kematian.

Informasi yang ada sejauh ini menunjukkan sebagian besar penyakit COVID-19 bersifat

ringan, namun penyakit serius dapat terjadi dan dapat menyebabkan beberapa kondisi medis

Anda lainnya menjadi lebih buruk. Orang yang lebih tua dan orang dari segala usia dengan

kondisi medis kronis yang parah, seperti penyakit jantung, penyakit paru-paru dan diabetes,

berisiko lebih tinggi dirawat di rumah sakit apabila terjangkit COVID-19

APA ITU REMDESIVIR ?

Remdesivir merupakan obat antivirus untuk pengobatan COVID-19 bagi pasien yang dirawat

di rumah sakit. Saat ini Remdesivir sedang diteliti untuk mengatasi infeksi virus COVID-19.

Obat Remdesivir sebelumnya tidak pernah beredar di Indonesia.

Remdesivir belum disetujui untuk pengobatan COVID-19. Obat ini sudah digunakan dalam

penelitian untuk mengobati beberapa pasien COVID-19, termasuk pasien yang dirawat di

rumah sakit. Remdesivir digunakan untuk menghentikan virus COVID-19 agar tidak menyebar

di dalam tubuh Anda, sehingga dapat membantu Anda merasa lebih baik.

Remdesivir merupakan obat yang masih dalam pengujian karena belum diketahui pasti


2

khasiatnya untuk mengobati COVID-19. Badan POM memberikan izin penggunaan

emergency (darurat) Remdesivir untuk mengobati COVID-19, tetapi penggunaan darurat ini

diperbolehkan hanya untuk pasien dewasa dan remaja (usia 12 tahun atau lebih yang memiliki

berat badan 40 kg atau lebih) dan merupakan pasien COVID-19 berat yang dirawat inap di

rumah sakit.

APA YANG HARUS SAYA BERITAHUKAN KEPADA TENAGA KESEHATAN

SEBELUM SAYA MEMINUM REMDESIVIR :

Beritahukan petugas kesehatan jika Anda :

• Memiki alergi, termasuk alergi terhadap Remdesivir atau bahan dalam obat ini obat lainnya

yang mengandung obat-obat ini.

• Memiliki penyakit ginjal atau sedang menjalani cuci darah

• Memiliki penyakit hati

• Sedang hamil atau merencanakan kehamilan

• Sedang menyusui

• Memiliki penyakit yang serius

• Sedang mengkonsumsi obat lain (obat resep dokter, obat bebas, vitamin, atau produk

herbal). Remdesivir dapat mempengaruhi cara kerja obat lain, dan demikian sebaliknya.

Khususnya infokan ke dokter jika sedang menggunakan obat klorokuin fosfat atau

hidroksiklorokuin sulfat.

SIAPA YANG TIDAK BOLEH MENGGUNAKAN REMDESIVIR

Jangan menggunakan Remdesivir jika sebelumnya Anda memiliki riwayat reaksi alergi

terhadap Remdesivir. Beritahukan dokter Anda atau petugas kesehatan bila ini terjadi pada

Anda.

BAGAIMANA SAYA MENGKONSUMSI REMDESIVIR ?

Remdesivir tersedia dalam bentuk serbuk. Obat ini akan dilarutkan dan hanya boleh diberikan

melalui infus oleh dokter atau oleh petugas medis di bawah pengawasan. Remdesivir diberikan

dalam bentuk infus melalui vena (intravena atau IV) selama 30 menit hingga 2 jam, sekali

sehari hingga maksimum 10 hari berdasarkan pertimbangan dokter.

Dosis Remdesivir yang direkomendasikan adalah 200 mg pada hari pertama dan dilanjutkan

dengan 100 mg per hari mulai hari ke-2 dan seterusnya. Anda akan mendapatkan Remdesivir

setiap hari sekurang-kurangnya selama 5 hari. Dokter Anda dapat memperpanjang

pengobatan hingga maksimum 10 hari.

Remdesivir dapat membantu menurunkan jumlah virus corona dalam tubuh Anda, sehingga

Anda dapat merasa lebih baik.

APA EFEK SAMPING PENTING YANG MUNGKIN TERJADI DARI KONSUMSI

REMDESIVIR ?

Efek samping Remdesivir yang mungkin terjadi adalah:

• Reaksi alergi. Remdesivir dapat menyebabkan reaksi alergi, termasuk reaksi alergi yang

serius selama atau setelah pemberian infus. Beritahukan kepada dokter atau perawat, segera

mencari pertolongan medis apabila Anda mengalami tanda dan gejala reaksi alergi : tekanan

darah rendah, perubahan detak jantung, nafas pendek, mengi (nafas bunyi), pembengkakan

pada bibir, wajah, atau tenggorokan, kemerahan, mual, muntah, berkeringat, atau menggigil.


3

• Peningkatan kadar enzim hati. Peningkatan kadar enzim hari telah dilaporkan pada orang

yang mendapatkan Remdesivir, yang merupakan tanda peradangan atau kerusakan sel pada

organ hati. Dokter Anda atau petugas kesehatan akan melakukan tes darah untuk

mengetahui kondisi hati Anda sebelum dan setiap hari pada saat Anda menggunakan

Remdesivir.

Efek samping Remdesivir tidak hanya efek samping yang disebutkan di atas. Remdesivir masih

dipelajari, sehingga tidak semua risiko efek samping diketahui pada saat ini.

Tidak banyak orang yang menggunakan Remdesivir. Efek samping serius atau yang tidak

terduga dapat terjadi. Efek samping obat yang dimasukkan melalui pembuluh vena yang

mungkin terjadi dapat berupa nyeri, perdarahan, memar pada kulit, pembengkakan, sakit dan

kemungkinan infeksi pada tempat injeksi.

APA PILIHAN PENGOBATAN LAINNYA ?

Seperti Remdesivir Badan POM telah mengizinkan penggunaan darurat klorokuin fosfat,

hidroksiklorokuin sulfat, dan favipiravir untuk mengobati pasien yang dirawat di rumah sakit

dengan COVID-19. Lihat www.pom.go.id untuk informasi tentang penggunaan darurat

klorokuin fosfat, hidroksiklorokuin sulfat, dan favipiravir. Sebagai tambahan, dokter dapat

menjelaskan kepada Anda tentang uji klinis yang sedang dilakukan untuk obat-obat untuk

pengobatan COVID-19.

Ini merupakan pilihan Anda untuk diobati atau tidak dengan Remdesivir. Anda dapat

memutuskan untuk tidak mendapatkannya atau menghentikannya kapan saja. Itu tidak akan

mengubah pemberian terapi standar untuk Anda, jika Anda memutuskan untuk tidak

mengkonsumsinya.

APA YANG HARUS SAYA HINDARI SAAT MENGKONSUMSI REMDESIVIR ?

Beberapa obat lain dapat berinteraksi dengan Remdesivir dan menyebabkan masalah bagi

Anda.

Beri tahu dokter Anda apa obat lain yang Anda pakai, termasuk obat-obatan bebas dan

suplemen makanan.

Jangan menggunakan klorokuin atau hidroksiklorokuin pada saat bersamaan dengan

Remdesivir.

Obat tertentu, seperti midazolam atau pitavastatin harus digunakan sekurang-kurangnya 2 jam

setelah penggunaan Remdesivir karena Remdesivir dapat mempengaruhi kerja obat-obat

tersebut. Remdesivir dapat berefek pada kerja obat-obat tertentu, seperti: teofilin atau

midazolam.

BAGAIMANA JIKA SAYA HAMIL ATAU MENYUSUI ?

Pengalaman penggunaan Remdesivir pada wanita hamil atau menyusui masih terbatas. Untuk

Ibu atau bayi dalam kandungan, keuntungan penggunaan Remdesivir mungkin lebih besar dari

pada risikonya. Jika Anda hamil atau menyusui, diskusikan pilihan Anda dan kondisi spesifik

Anda dengan dokter Anda.


4

BAGAIMANA SAYA MELAPORKAN EFEK SAMPING REMDESIVIR ?

Hubungi dokter Anda jika Anda mengalami efek samping apapun yang dirasakan setelah

penggunaan Remdesivir, laporkan efek samping ke :

Pusat Farmakovigilans

Direktorat Pengawasan Keamanan, Mutu dan Ekspor Impor Obat Narkotika, Psikotropika,

Prekursor, dan Zat Adiktif

Badan Pengawas Obat dan Makanan Republik Indonesia

Melalui pos : Jl. Percetakan Negara No. 23, Jakarta Pusat, 10560

Email : [email protected]

Tel: +62-21-4244755 Ext. 111; 4244691 Ext. 1072

Fax: +62-21-42883485

Website: http://e-meso.pom.go.id/

BAGAIMANA SAYA MENYIMPAN REMDESIVIR ?

Remdesivir disimpan pada tempat yang aman jauh dari jangkauan bayi dan anak- anak.

Simpan di tempat yang sejuk, kering, suhu ruang (di bawah 30°C), jauh dari panas dan cahaya

matahari.

Setelah dilarutkan atau direkonstitusi, larutan Remdesivir harus segera digunakan. Jika

diperlukan, larutan Remdesivir dapat disimpan hingga maksimum 4 jam pada suhu di bawah

25 oC atau 24 jam dalam lemari pendingin/kulkas (2 – 8oC).

BAGAIMANA SAYA MEMPEROLEH INFORMASI LEBIH LANJUT ?

• Tanyakan pada dokter atau petugas layanan kesehatan

• Kunjungi website pom.go.id

KEMASAN :

COVIFOR Lyophilized powder injection 100 mg

Dus, 1 vial @ 100 mg

HARUS DENGAN RESEP DOKTER

Diproduksi oleh :

ASPIRO PHARMA LIMITED

Telangana – India

Diproduksi untuk :

HETERO LABS LIMITED

Telangana – India


http://e-meso.pom.go.id/

5

Diimpor dan dipasarkan oleh :

PT. AMAROX PHARMA GLOBAL

Bekasi – Indonesia

COVIFOR diproduksi di bawah lisensi dari Gilead sciences, Inc, USA


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