Morlipar 200 Mg Capsules

MORLIPAR (molnupiravir) capsules are indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test, who do not require supplemental oxygen due to COVID-19 and who have at least one risk factor for developing severe illness.

Posology

Adults

The recommended dose of MORLIPAR in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food.

Should a patient require hospitalisation after starting treatment with MOLIPAR, the patient may complete the full 5 day treatment course per the healthcare provideru2019s discretion. The safety and efficacy of MORLIPAR when administered for periods longer than 5 days have not been established. MORLIPAR should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset in adults who are at risk for progression to severe COVID-19, including hospitalisation or death. Certain medical conditions or other factors may place individual patients at increased risk for progression to severe COVID-19.

Missed dose

If the patient misses a dose of MORLIPAR within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.

Special populations

Elderly Use

No dose adjustment of MORLIPAR is recommended for elderly patients (see section 5.2).

Renal Impairment

The pharmacokinetics of molnupiravir and NHC has not been evaluated in patients with eGFR less than 30 mL/min or on dialysis (see section 5.2).

Hepatic Impairment

No dose adjustment of molnupiravir is recommended for patients with hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of MORLIPAR have not been established in patients less than 18 years of age.

Pregnancy

Based on animal data, molnupiravir may cause foetal harm. Human pregnancy data are not available. The use of molnupiravir is not recommended during pregnancy.

Method of administration

For oral use. MORLIPAR 200 mg capsules can be taken with or without food. The capsules should be swallowed whole with enough fluid (e.g., a glass of water). The capsules should not be opened, crushed, or chewed.

Hypersensitivity to the active ingredient, molnupiravir, or to any of the excipients of MORLIPAR listed in section 6.1

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially u2018sodium-freeu2019.

No medicine interactions have been identified based on the limited available data. Clinical drug-drug interaction studies of molnupiravir with concomitant medications have not been conducted. Molnupiravir is hydrolysed to N-hydroxycytidine (NHC) prior to reaching systemic circulation. Uptake and metabolism of NHC are mediated by the same pathways involved in endogenous pyrimidine metabolism. NHC is not a substrate of major medicine metabolising enzymes or transporters. Neither molnupiravir nor NHC are inhibitors or inducers of major medicine metabolising enzymes or inhibitors of major medicine transporters. Therefore, the potential for molnupiravir or NHC to interact with concomitant medications is considered unlikely.

Women of childbearing potential

Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of molnupiravir.

Pregnancy

Risk Summary

Based on animal data, molnupiravir may cause foetal harm when administered to pregnant women. There are no available data on the use of molnupiravir in pregnant women to evaluate the risk of major birth defects, miscarriage or adverse maternal or foetal outcomes. The use of molnupiravir is not recommended during pregnancy.

Breast-feeding

It is unknown whether molnupiravir or any of the components of molnupiravir are present in human milk, affect human milk production, or have effect on the breastfed infant. NHC was detected in the plasma of nursing pups from lactating rats administered molnupiravir during animal lactation studies. Based on the potential for adverse reactions on the infant from molnupiravir, breast-feeding is not recommended during treatment and for 4 days after the last dose of Molnupiravir.

Fertility

Animal studies showed no effects on female or male fertility in rats at NHC exposures approximately 2 and 6 times respectively, the exposure in humans at the recommended human dose (RHD).

Molnupiravir has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequent adverse reactions reported in patients treated with 800 mg molnupiravir every 12 hours for 5 days in clinical trials were diarrhoea, nausea, dizziness, and headache all of which were Grade 1 (mild) or Grade 2 (moderate).

Tabulated summary of adverse reactions

The adverse events are listed below by MedRA system organ class and frequency. Frequencies are defined as follows: Frequent, Less Frequent and Frequency unknown.

Table 1: Tabulated list of adverse reactions

SOC category Frequency Side effect

Immune system disorders Less frequent hypersensitivity

Nervous system disorders Frequent dizziness, headache

Gastrointestinal disorders Frequent diarrhoea, nausea

Less frequent vomiting

Skin and subcutaneous tissue disorders Less frequent angioedema, erythema, rash, urticaria

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6 . 04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/wp-content/uploads/2021/11/6.04_ARF1_v6.0_28Oct2021.docx.pdf, or via the SAHPRA portal: https://primaryreporting.who-umc.org/ZA or via the Med Safety App: https://medsafety.sahpra.org.za/.

There is no human experience of overdosage with molnupiravir. Treatment of overdose with molnupiravir should consist of general supportive measures including the monitoring of the clinical status of the patient. Haemodialysis is not expected to result in effective elimination of NHC.