The protocol for the administration of the medicinal product Molnupiravir 200mg hard capsules, for the treatment of the disease, comes into force from Monday COVID-19.
Specifically, Molnupiravir will be available tomorrow for prescription, through the GESS system in patients with laboratory-confirmed (PCR or Rapid Ag Test) mild or moderate disease COVID-19, who do not require hospitalization, within 5 days of the 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 establishment 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 the disease COVID-19 as well as 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 cardiomyopathies (History of documented myocarditis, hypertrophic, dilated, infiltrative (amyloidosis), congenital heart diseases after surgical correction with significant residual damage or uncorrected congenital heart diseases with significant residual damage, the active use of biological agents ( eg TNF blockers, interleukin blockers) or other immunosuppressive drugs, active chronic corticosteroids (≥20mg prednisone or its equivalent for ≥ 1 month), patients with a history of solid organ or hematopoietic stem cell transplantation, patients with solid malignancy organ or hematological, receiving chemotherapy or radiation or immunotherapy l, patients with HIV or patients with a CD4 lymphocyte count < 200/mm3. m, Hereditary or acquired immunodeficiencies, patients with hemoglobinopathies, falling into Category C, patients with a very high risk, according to the recommendations of the International Om Thalassemia Federation. In addition, the attending physicians are called to prescribe the medicinal product Molnupiravir in a separate prescription, while it is noted that the prescription of Molnupiravir can be made by adult Personal Physicians, pathologists, physicians specializing in Infectious Diseases, pulmonologists, hematologists, pathologists-oncologists, cardiologists, nephrologists, neurologists, rheumatologists, endocrinologists and geriatricians. The OAU notes that the pharmaceutical product Molnupiravir will only be available from OKYpY hospital pharmacies, specifically from the General Hospitals of Nicosia, Limassol, Larnaca, Famagusta, Paphos and Troodos and Polios Chrysochous Hospitals. He also points out that no co-payment (€1) should be collected for the medicinal product Molnupiravir. 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 at a higher risk of serious illness from 14% in the placebo group to 1% in the molnupiravir group.
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 the disease COVID-19 who were at higher risk of serious disease 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.