Lagevrio (Eua)

Drug overview for LAGEVRIO (EUA) (molnupiravir):

Generic name: molnupiravir
Drug class: COVID-19 (SARS-CoV-2) Antiviral Agents-Nucleotide Analog
Therapeutic class: Anti-Infective Agents

Molnupiravir is a prodrug of N4-hydroxycytidine (NHC), which is a cytidine nucleoside analog that has antiviral activity against SARS-CoV-2.

No enhanced Uses information available for this drug.

DRUG IMAGES

LAGEVRIO 200 MG CAP (EUA)

The following indications for LAGEVRIO (EUA) (molnupiravir) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

Dosing information for LAGEVRIO (EUA)
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
LAGEVRIO 200 MG CAP (EUA)	Maintenance	Adults take 4 capsules (800 mg) by oral route every 12 hours for 5 days

The following drug interaction information is available for LAGEVRIO (EUA) (molnupiravir):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Deoxycytidine Kinase Substrates/Cladribine SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine and zalcitabine may inhibit the intracellular phosphorylation of cladribine by deoxycytidine kinase (dCK). CLINICAL EFFECTS: Concurrent administration of clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine, or zalcitabine with cladribine may result in decreased clinical efficacy of cladribine. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of lamivudine states that the concurrent use of lamivudine and cladribine is not recommended.(1) The manufacturer of cladribine states that concurrent use of compounds that require activation by intracellular phosphorylation should be avoided.(2) DISCUSSION: Cladribine undergoes a series of phosphorylations to its active metabolites. In a case report, a patient on lamivudine who received cladribine concurrently did not experience a decrease in his lymphocyte count. After discontinuation of lamivudine and readministration of cladribine, his lymphocytes dropped as expected.(3) It is expected that other compounds phosphorylated by dCK would also decrease cladribine's efficacy.(4) Compounds phosphorylated by dCK include: clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine and zalcitabine.	CLADRIBINE, MAVENCLAD

Drug Interaction

Drug Names

Deoxycytidine Kinase Substrates/Cladribine

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine and zalcitabine may inhibit the intracellular phosphorylation of cladribine by deoxycytidine kinase (dCK).

CLINICAL EFFECTS: Concurrent administration of clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine, or zalcitabine with cladribine may result in decreased clinical efficacy of cladribine.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of lamivudine states that the concurrent use of lamivudine and cladribine is not recommended.(1) The manufacturer of cladribine states that concurrent use of compounds that require activation by intracellular phosphorylation should be avoided.(2)

DISCUSSION: Cladribine undergoes a series of phosphorylations to its active metabolites. In a case report, a patient on lamivudine who received cladribine concurrently did not experience a decrease in his lymphocyte count. After discontinuation of lamivudine and readministration of cladribine, his lymphocytes dropped as expected.(3)

It is expected that other compounds phosphorylated by dCK would also decrease cladribine's efficacy.(4) Compounds phosphorylated by dCK include: clofarabine, cytarabine, emtricitabine, fludarabine, gemcitabine, lamivudine, molnupiravir, nelarabine and zalcitabine.

CLADRIBINE, MAVENCLAD

There are 0 moderate interactions.

Contraindication List
Lactation

Severe List
Pregnancy

The following adverse reaction information is available for LAGEVRIO (EUA) (molnupiravir):

Overview
Severe
Less Severe

Adverse reaction overview.

Most common adverse reactions occurring in 1% or more of patients receiving molnupiravir include diarrhea, nausea, and dizziness. Post-authorization experience has identified additional adverse effects, including erythema, rash, urticaria, and hypersensitivity reactions through voluntary reporting.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Hypersensitivity drug reaction

There are 6 less severe adverse reactions.

More Frequent	Less Frequent
None.	Diarrhea Dizziness Nausea

Rare/Very Rare
Erythema Skin rash Urticaria

The following precautions are available for LAGEVRIO (EUA) (molnupiravir):

Pediatric
Pregnant
Lactation
Geriatric

Molnupiravir is not authorized for use in pediatric patients younger than 18 years of age because of possible effect on bone and cartilage growth. Safety and efficacy of the drug have not been assessed in pediatric patients. In a repeat-dose toxicity study in rats, impaired transformation of growth cartilage into new bone was observed in the femur and tibia.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Molnupiravir may cause fetal harm if administered to pregnant women based on animal findings. Pregnant females or females who become pregnant while receiving molnupiravir are encouraged to enroll in the manufacturer's pregnancy surveillance program. Patients or their clinicians should call 1-877-888-4231 to enroll.

It is not known whether molnupiravir or its metabolites are distributed into human milk; however, NHC was detected in plasma of nursing pups when molnupiravir was administered to lactating rats. The effects of the drug on the breast-fed infant or on the production of milk are unknown. Because of the potential for adverse reactions to molnupiravir in breast-fed infants, females should be advised not to breast-feed while receiving the drug and for 4 days after the final dose. Lactating females may consider pumping and discarding breast milk during molnupiravir therapy and for 4 days after the final dose.

In the MOVe-OUT clinical trial, no difference in safety and tolerability was observed between ambulatory geriatric patients and younger adults receiving molnupiravir for the treatment of COVID-19; therefore, no dosage adjustment is necessary based on age. The pharmacokinetics of NHC are similar in geriatric patients and younger adults.