JAKARTA - The Food and Drug Supervisory Agency (BPOM) has issued a license for Paxlovid tablets for the treatment of COVID-19 patients in Indonesia. The drug was developed and manufactured by Pfizer.
Head of BPOM Penny K Lukito said the permit for emergency use of the film-coated tablet Paxlovid, an antiviral therapy drug for the SARS-CoV-2 protease inhibitor, was released Sunday, July 17.
"Paxlovid in a kombipak form consisting of Nirmatrelvir 150 mg and Ritonavir 100 mg with indications for treating COVID-19 in adults who do not require supplemental oxygen and who are at high risk of progression to severe COVID-19," said Penny in her written statement, Monday, July 18.
The recommended use, according to BPOM, is Nirmatrelvir 300 mg (two 150 mg tablets) and Ritonavir 100 mg (one 100 mg tablet) taken together twice a day for five days.
Based on a safety review, Penny said, administration of Paxlovid was generally safe and tolerable.
According to him, the side effects of using the drug were in the mild to moderate range in the form of dysgeusia or impaired sense of taste (5.6 percent), diarrhea (3.1 percent), headache (1.4 percent), and vomiting (1.1 percent). ).
He said that the results of phase 2 and 3 clinical trials showed Paxlovid could reduce the risk of hospitalization or death by up to 89 percent in adult COVID-19 patients with comorbidities or comorbidities who were not hospitalized.
"Comorbidities associated with this increased risk include elderly, obesity, active smoking, history of heart disease, diabetes, or kidney disorders," he said.
Based on the Antara report, Paxlovid added to the list of types of antivirals that can be used in treating COVID-19 patients in Indonesia.
In addition to Paxlovid, BPOM has issued permits for emergency use of the antiviral drugs Favipiravir and Remdesivir (2020), the monoclonal antibody Regdanvimab (2021), and Molnupiravir (2022).
BPOM and the Ministry of Health supervise the use of Paxlovid and COVID-19 therapeutic drugs that have been permitted to be used in Indonesia.
Penny said BPOM carried out surveillance from upstream to downstream to prevent illegal drug trafficking. Supervision is carried out starting from the entry of drug raw materials, drug production, drug distribution, to drug products circulating in the market.
"We urge the public to be more vigilant before buying or consuming medicinal products. People must be smart consumers, avoid taking illegal drugs," he said.
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