Molnupiravir Investigational

Molnupiravir is an investigational medication used for the treatment of COVID-19 disease.

• Molnupiravir is available under the following different brand names: Lagevrio

Common side effects of Molnupiravir include:

• diarrhea, 
• nausea, and
• dizziness

Serious side effects of Molnupiravir include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• dizziness

Rare side effects of Molnupiravir include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 200 mg

COVID-19 Disease Treatment (Emergency use authorization)

Adult dosage

• 800 mg orally every 12 hours  for 5 days
• Initiate as soon as possible after COVID-19 diagnosis and within 5 days of symptom onset
• Completing the full 5-day treatment course and continuing to isolate in accordance with public health recommendations are important to maximize viral clearance and minimize viral transmission

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Molnupiravir has no noted severe interactions with any other drugs.
• Molnupiravir has no noted serious interactions with any other drugs.
• Molnupiravir has no noted moderate interactions with any other drugs.
• Molnupiravir has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None have been identified based on the limited available data on the emergency use authorized under this EUA

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Molnupiravir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Molnupiravir?”

Cautions

• There are limited clinical data available; serious and unexpected adverse events may occur that have yet to be reported
• May cause fetal harm when administered to pregnant females
• Bone and cartilage toxicity
  • Not authorized for use in patients aged below 18 years owing to possible effects on bone and cartilage growth
  • Bone and cartilage toxicity was observed in rats after repeated dosing
• Safety and efficacy have not been established in pediatric patients

Pregnancy and Lactation

• Not recommended during pregnancy
• Based on animal data, fetal harm may occur when administered to pregnant females
• No available human data are available on use in pregnant females to evaluate the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Verify pregnancy status in females of childbearing potential
• Prescribing healthcare providers must communicate the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual
• May only be prescribed to pregnant individuals after the prescribing healthcare provider has determined that the benefits would outweigh the risks for that individual patient
• If used during pregnancy, the prescribing healthcare provider must document potential risks and benefits were communicated
• Clinical considerations
  • There are maternal and fetal risks (eg, preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, fetal death) associated with untreated COVID-19 in pregnancy
  • Pregnancy surveillance program
  • The program monitors pregnancy outcomes in individuals exposed to molnupiravir during pregnancy
  • A prescribing healthcare provider must document that pregnant individuals were made aware of Merck Sharp & Dohme’s pregnancy surveillance program at 1-877-888-4231 or pregnancyreporting.msd.com
  • Those who agree to participate in the program and allow the healthcare provider to disclose patient-specific information to Merck Sharp & Dohme must provide a full name and contact information
  • Pregnant individuals exposed to molnupiravir can also report the exposure by contacting the phone number or website listed above
• Contraception
  • Females of childbearing potential: Use a reliable method of contraception correctly and consistently, as applicable during treatment and for 4 days after the final dose
  • Males with partners of childbearing potential: Use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the final dose; risk beyond 3 months after the last dose is unknown; studies on the risks below 3 months are ongoing
• Lactation
  • There are no data on the presence of molnupiravir or its metabolites in human milk
  • NHC was detected in the plasma of nursing pups from lactating rats administered molnupiravir
  • It is unknown whether molnupiravir affects breastfed infants or has effects on milk production
  • Not recommended during treatment and for 4 days after the final dose
  • Consider interrupting breastfeeding, and consider pumping and discarding breast milk during treatment and for 4 days after the final dose