The protocol for the administration of the medicinal product Molnupiravir 200mg hard capsules, for the treatment of COVID-19 disease, will be implemented from Monday.
Specifically, Molnupiravir will be available the next day for prescription, through the GESS system in patients with laboratory-confirmed (PCR or Rapid Ag Test) mild or moderate COVID-19 disease, who do not need hospitalization, within 5 days from the date of onset of symptoms or the date of the test (whichever occurs first) and with at least one risk factor.
According to the Health Insurance Organization, the treating physicians, before the prescription, will be asked to answer a questionnaire, which will be posted in the Information System of GESS, in order to ensure that the prescription will be made only to those patients who will meet the criteria set by the ad-hoc Committee of the Ministry of Health, for the creation and implementation of the relevant protocols, concerning the medication against COVID-19.
He also notes that the treating physicians should, when prescribing, complete in the Information System both the diagnosis of COVID-19 disease and the underlying disease (ICD-10) which is a risk factor.
According to the protocol, high risk factors are considered – based on the updated list of the Ministry of Health – the pre-existing Chronic Respiratory Disease (eg severe bronchial asthma, patient in chronic oxygen therapy or in non-invasive ventilation [CPAP] B [CPAP] severe pulmonary hypertension (NYHA III and IV), severe pulmonary fibrosis, pneumonectomy / lobectomy, severe chronic renal failure (creatinine clearance below 15 ml / min and dialysis), cardiac arrhythmia with permanent or permanent cardiac defibrillator and ventricular pacemaker, heart failure of any etiology (ischemic or non-etiologic) stage according to NYHA III or IV, cardiovascular disease and recent acute coronary syndrome or revascularization, angioplasty or stent implantation -coronary bypass (CABG – bypass) in the last 12 months and the recent GNI in the last 12 months or with an established neurologist 's semiology.
Also, high risk factors are considered to be cardiomyopathies (History of documented myocarditis, hypertrophic, dilated, invasive (amyloidosis), congenital heart diseases after surgical correction with significant residual damage or eg TNF inhibitors, interleukin inhibitors) or other immunosuppressive drugs, active chronic corticosteroids (≥20 mg prednisone or its equivalent for ≥ 1 month), patients with a history of solid organ transplantation or primary hematopoietic organ or hematological, receiving chemotherapy or radiation or immunotherapy l, patients with HIV or patients with CD4 lymphocyte count <200 / mm3. m, Hereditary or acquired immunodeficiencies, patients with with a very high risk, according to the recommendations of the International Om Thalassemia federation.
In addition, treating physicians are invited to prescribe the drug Molnupiravir in a separate prescription, while it is noted that the prescription of Molnupiravir can be done by Personal Adult Physicians, physicians, physicians specializing in infectious diseases, pathologists, cardiologists, psychologists, psychologists nephrologists, neurologists, rheumatologists, endocrinologists and geriatricians.
OAY notes that the medicinal product Molnupiravir will be available only from the hospital pharmacies of OKYPY and specifically from the General Hospitals of Nicosia, Limassol, Larnaca, Famagusta, Paphos and Troodos and Polis Chrysochous Hospitals.
He also points out that no supplement (€ 1) should be charged for the Molnupiravir medicinal product.
Important information about Molnupiravir
Molnupiravir is not currently licensed in the EU.
It is administered on the basis of a recommendation issued by the European Medicines Agency (Coreper) evaluating the intermediate data of the drug study available at the time of the examination.
These data from 775 people showed that molnupiravir reduced the risk of hospitalization or death in people with COVID-19 who had a higher risk of serious illness from 14.1% in the placebo group to 7.3% in the group receiving the placebo. molnupiravir.
The study did not include people who had been vaccinated.
The application for marketing authorization of the drug in the EU is currently under consideration by Coreper, which is evaluating new data on the efficacy of molnupiravir as updated results, based on 1,408 subjects, show that molnupiravir reduced the risk of hospitalization or death in people with COVID-19 who were at higher risk of serious illness from 9.7% in the placebo group to 6.8% in the molnupiravir group.
It should be noted that molnupiravir is not recommended during pregnancy and in women who may become pregnant and who are not using effective contraception.
Women who can become pregnant should use effective contraception during treatment and for 4 days after the last dose of molnupiravir.
Breastfeeding should be discontinued during treatment and for 4 days after treatment.
These recommendations are based on laboratory studies in animals which have shown that high doses of molnupiravir may affect fetal development.
Molnupiravir is also not indicated for use in pediatric patients.