Remidia Patient Counseling Information

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.
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 Healthcare 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.
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 a 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 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.