The protocol for the administration of the medicinal product Molnupiravir 200mg hard capsules for the treatment of COVID-19 is implemented from Monday.
Specifically, Molnupiravir will be available the day after tomorrow for prescribing, via the GHS IT system, to patients with laboratory-confirmed (PCR or Rapid Ag Test) mild or moderate COVID-19 disease, not requiring hospitalisation, within 5 days of the date of onset of symptoms or the date of test (whichever occurs first) and with at least one risk factor.
According to the Health Insurance Agency, before prescribing, attending physicians will be asked to answer a questionnaire, which will be posted on the GHS IT system, in order to ensure that prescribing is done only for patients who meet the criteria set by the ad-hoc committee of the Ministry of Health for the creation and implementation of the relevant protocols regarding COVID-19 medication.
It also notes that when prescribing, treating physicians will have to complete in the IT system both the diagnosis of COVID-19 and the underlying disease (ICD-10) that is a risk factor.
According to the protocol, high-risk factors are considered - based on the updated list of the Ministry of Health - pre-existing Chronic Respiratory Disease (e.g. severe bronchial asthma, patient on chronic oxygen therapy or non-invasive ventilation [CPAP OR BIPAP] at home, 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 defibrillator or cardiomyopathy with permanent defibrillator and biventricular pacemaker, heart failure of any etiology (ischemic or non-ischemic) of NYHA stage III or IV, cardiovascular disease and recent acute coronary syndrome or revascularisation surgery, angioplasty or stent implantation in the last 12 months, CABG bypass in the last 12 months and recent stroke in the last 12 months or with established neurological features.
Also considered high risk factors are cardiomyopathy (History of documented cardiomyopathy, hypertrophic, dilated, infiltrative (amyloidosis), congenital heart disease after surgical correction with significant residual damage or uncorrected congenital heart disease with significant residual damage, active use of biologic agents (e.g. TNF inhibitors, interleukin inhibitors) or other immunosuppressive drugs, active chronic corticosteroid use (≥20 mg of prednisone or its equivalent for ≥1 month), patients with a history of solid organ or hematopoietic stem cell transplantation, patients with solid organ or haematological malignancy, receiving chemotherapy or radiotherapy or immunotherapy l, patients with HIV or patients with a CD4 lymphocyte count < 200/mm3. m, Hereditary or acquired immunodeficiencies, patients with haemoglobinopathies, falling into Category C, patients at very high risk according to the recommendations of the International Thalassaemia Federation.
In addition, treating physicians are invited to prescribe the medicinal product Molnupiravir on a separate prescription, and it is noted that Molnupiravir may be prescribed by Adult Personal Physicians, general practitioners, physicians specialising in Infectious Diseases, pulmonologists, haematologists, medical oncologists, cardiologists, nephrologists, neurologists, rheumatologists, endocrinologists and geriatricians.
OAI notes that the medicinal product Molnupiravir will be available only from the hospital pharmacies of OCYPY, namely from the General Hospitals of Nicosia, Limassol, Larnaca, Famagusta, Famagusta, Paphos and Troodos and Polos Chrysochous Hospitals.
It also notes that no supplement (1€) will be collected for the medicinal product Molnupiravir.
Important information about Molnupiravir
The medicinal product Molnupiravir is at this stage not authorised in the EU.
It is administered on the basis of a recommendation issued by the European Medicines Agency (EMA) evaluating the interim study data available at the time of the review of the medicinal product.
These data from 775 subjects showed that molnupiravir reduced the risk of hospitalisation or death in people with COVID-19 who were at higher risk of serious disease from 14.1% in the placebo group to 7.3% in the molnupiravir group.[BR]
The study did not include people who had been vaccinated.
The application for marketing authorisation in the EU is currently under review by the EMA 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 hospitalisation or death in people with COVID-19 disease who were at higher risk of severe disease from 9.7% in the placebo group to 6.8% in the molnupiravir group.
Please note that molnupiravir is not recommended during pregnancy and in women who may become pregnant and who are not using effective contraception.
Women who may 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 animal studies which have shown that high doses of molnupiravir may affect fetal development.
Molnupiravir is also not indicated for use in pediatric patients.
Source: CNA
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