The document is an informed consent form from Hospital Sumber Waras Cirebon certifying that they are ordering 2 vials of Actemra to treat a COVID-19 patient named Tn A under the care of Dr. H.Edy Kurniawan Sp.P for an unlicensed indication in Indonesia. The hospital acknowledges they are aware Actemra is not approved for treating COVID-19 patients but they are proceeding with off-label use after evaluating the risks and benefits.
The document is an informed consent form from Hospital Sumber Waras Cirebon certifying that they are ordering 2 vials of Actemra to treat a COVID-19 patient named Tn A under the care of Dr. H.Edy Kurniawan Sp.P for an unlicensed indication in Indonesia. The hospital acknowledges they are aware Actemra is not approved for treating COVID-19 patients but they are proceeding with off-label use after evaluating the risks and benefits.
The document is an informed consent form from Hospital Sumber Waras Cirebon certifying that they are ordering 2 vials of Actemra to treat a COVID-19 patient named Tn A under the care of Dr. H.Edy Kurniawan Sp.P for an unlicensed indication in Indonesia. The hospital acknowledges they are aware Actemra is not approved for treating COVID-19 patients but they are proceeding with off-label use after evaluating the risks and benefits.
INFORMED CONSENT for ACTEMRA UN-LICENSED INDICATION
Hospital Sumber Waras Cirebon hereby certify that:
order to PT Tempo for product ACTEMRA, 2 vials (as per
Purchase Order number two as per-attached) is intended for the treatment of hospitalized COVID-19 patients.
Patient Initial(s): Tn A
Treating Physician(s): dr. H.Edy Kurniawan Sp.P
Hospital Sumber Waras Cirebon is fully aware that the usage of drugs as mentioned above is for an unlicensed indication in Indonesia.
Hospital Authorized Person,
dr. H.Edy Kurniawan Sp.P
Pulmonologist March 03 2021
[ In Indonesia, Actemra (tocilizumab) is approve by BPOM for Rheumatoid Arthritis
(RA), Polyarticular Juvenile Idiopathic Arthritis (pJIA), and Systemic Juvenile Idiopathic Arthritis (sJIA). It is not approved for the treatment of hospitalized COVID-19 patients. As evaluating the risk-benefit profile of Actemra use is important for Patient Safety Risk Management, Roche encourage HCP to report the use of Actemra in COVID-19 patients and its adverse event through online form: https://cprt.roche.com/ or contact Roche Patient Safety at indonesia.safety@roche.com].