Favivir Patient Counseling Information

FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF FAVIPIRAVIR FOR TREATMENT OF COVID-19 PATIENTS: Badan POM, The Indonesian Food and Drug Administration, has issued an Emergency Use Authorization (EUA) to permit the emergency use of Favipiravir for the management of adult patients (aged 18 years and older) with mild to moderate COVID-19, combined with standard supportive care.
The Emergency Use Authorization of Favipiravir is for the management of adult patients (aged 18 years and older) with mild to moderate COVID-19, combined with standard supportive care.
ADMINISTRATION: Favipiravir must be administered by a healthcare professional pursuant to a valid prescription of a licensed practitioner.
Favipiravir must be administered orally.
The Optimal dosing and duration of treatment is unknown.
The suggested dose under this EUA for Favipiravir to treat adults patients with mild to moderate COVID-19 is in accordance with the available clinical trials and current available guideline on the procedure for the treatment of COVID-19, which is: 1600 mg orally twice daily for first day followed by 600 mg orally twice daily on subsequent days until 7 to 14 days, based on clinical consideration by prescriber. The total administration period should not be more than 14 days. The suggested dose and duration may be updated as data from clinical trials becomes available.
Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to Favipiravir, See specific reporting instructions as follows.
For information on clinical trials that are testing the use of Favipiravir in COVID-19, see www.crinicaltrials.go.id.
Instructions for Health Care Providers: As the health care provider administering Favipiravir, you should, provide your patients with the Fact Sheet titled "Emergency Use Authorization (EUA) of Favipiravir Informasi Produk untuk Pasien (Fact Sheet for Patients and Parent/Caregivers)" and communicate the following information to the patient: 1. That the Badan POM has authorized emergency use Favipiravir.
2. That the patient has the option to accept or refuse administration of Favipiravir.
3. The potential consequences of refusing Favipiravir.
4. The significant known and potential risks and benefits of Favipiravir, 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 Favipiravir to a degree that would endanger the lives of patients, the information must be provided to the patients as soon as practicable after Favipiravir is administered.
If the drug is dispensed separate from the pack for inpatient use, the dispensing container should clearly identify the drug and dosage strength.
Mandatory Requirements for Favipiravir Administration under Emergency Use Authorization: In order to mitigate the risks of using this approved product for an unapproved use under EUA and to optimize the potential benefit of Favipiravir, the following items are required.
Use of Favipiravir under this EUA is limited to the following (all requirements must be met): 1. Adult patients with COVID-19.
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 Favipiravir. 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: Given the "lnformasi Produk untuk Pasien"; Informed of alternatives to receiving authorized Favipiravir and; Informed that Favipiravir is authorized for the use of treatment of adult patients with COVID-19 under this Emergency Use Authorization.
3. The prescribing health care provider and/or the provider's designee are/is to provide responses to requests from Badan POM for information about adverse events and medication errors following receipt of Favipiravir.
4. The prescribing health care provider and/or the provider's designee are/is responsible for reporting medication errors and adverse events (death, serious adverse events^*) occurring during Favipiravir treatment within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words "Favipiravir Treatment 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 lmpor 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 "Favipiravir 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.
Additional Requirement for Use Under this UEA: 5. Additional requirements for reporting of patient outcomes, in addition to safety, may be required as a condition of use under this EUA.
APPROVED AVAILABLE ALTERNATIVES: There are no approved available alternative products. There is an EUA for treatment of the same population with Favipiravir. The health care provider should visit https://clinicaltrials.qov/ to determine whether enrollment of the patient(s) in a clinical trial is more appropriate than product use under this EUA.
AUTHORITY FOR ISSUANCE OF THE EUA: Indonesia Government has declared an emergency situation as a result of pandemic outbreak of COVID-19 that justifies the emergency need of using Favipiravir 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 Favipiravir for treatment of adult patients with COVID-19. As a health care provider, you must comply with the mandatory requirements of the EUA listed previously.
Although limited scientific information is available, it is reasonable to believe that Favipiravir may be effective for treatment of adult patients with COVID-19, 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 Favipiravir must be reported to Badan POM through Pusat Farmakovigilans/MESO Nasional, Badan Pengawas Obat dan Makanan online http://e-meso.pom.go.id/ADR. Include in the field name, "Describe Event, Problem, or Product Use/Medication Error" the following statement: Favipiravir Treatment under Emergency Use Authorization (EUA).
This EUA for Favipiravir 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.