Molcovir 200 Special Precautions

Clinical data on the use of molnupiravir are limited. Serious adverse events or previously unknown adverse events that have not been reported with the use of molnupiravir may occur.
The occurrence of hypersensitivity, including severe acute intolerance to the drug (anaphylaxis), hypersensitivity, including severe acute intolerance, has been reported. Anaphylaxis from molnupiravir if the patient experience signs or symptoms of hypersensitivity or acute severe allergic reaction to the drug. If there is clinically significant anaphylaxis, discontinue molnupiravir immediately and institute drug and/or supportive therapy.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed
Use in Pregnancy: Embryo-fetal toxicity: Based on data found in animal fertility studies, molnupiravir can cause fetal harm when administered to pregnant women. There are no data on the use of molnupiravir in pregnant women to assess the risk of congenital malformations, miscarriage or problems that are unfavorable to the mother and the fetus. Therefore, molnupiravir is not recommended for use during pregnancy. If molnupiravir is considered to be administered to pregnant women, the prescribing physician must communicate the benefits and risks of using molnupiravir during pregnancy. Molnupiravir is approved for use in pregnant women only if the benefit is determined by the physician to outweigh the risks for a specific patient outcome. If it is decided to use molnupiravir during pregnancy, the prescribing physician must have documentation that explains the benefits and risks of using molnupiravir during pregnancy to the pregnant woman.
Advise those of childbearing age to the risks to the baby and to use effective methods of contraception (use properly and regularly) during treatment up to 4 days after the last dose of molnupiravir.
Prior to initiating molnupiravir therapy, assess whether individuals of childbearing age are individualized if clinically indicated. It is not necessary to confirm pregnancy status in patients undergoing permanent vasectomy. People who are using an IUD or using contraceptives implanted under the skin including those who are unable to become pregnant. Other patients with normal menstrual cycles, assess whether the patient is pregnant or not from the first day of the last menstruation. People who use effective methods of contraception (use correctly and regularly) or have a negative pregnancy test, patients with irregular menstrual cycles or unsure of when the first day of their last menstruation was or did not use effective methods of contraception (use properly and consistently). Pregnancy test kits are recommended.
Use in Children: Bones and cartilage toxicity: Molnupiravir is not approved for use in pediatric patients under 18 years of age because the drug may affect bone and cartilage growth. Bone and cartilage toxicity was found in rats after repeated dosing [see Pharmacology: Toxicology: Preclinical safety data: Toxicology and/or Pharmacology in Laboratory Animals under Actions]. The safety and efficacy of molnupiravir in pediatric patients have not been studied.