Alario-TL (Capsules) Instructions for Use

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Manufactured By

R-Pharm JSC (Russia)

ATC Code

J05AB18 (Molnupiravir)

Active Substance

Molnupiravir (Rec.INN registered by WHO)

Dosage Form

Alario-TL

Capsules 200 mg: 40 pcs.

Dosage Form, Packaging, and Composition

Capsules oblong size No. 0 with an almost white body and cap. The capsule contents are a powder or a mixture of powder and granules, white or almost white in color.

Excipients: microcrystalline cellulose type 101, croscarmellose sodium, magnesium stearate.

Hypromellose capsule No. 0 (body: titanium dioxide, hypromellose; cap: titanium dioxide, hypromellose)

10 pcs. – blister pack (4) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; nucleosides and nucleotides, excluding reverse transcriptase inhibitors

Pharmacological Action

An antiviral agent, it is a prodrug that is metabolized to the ribonucleoside analogue N-hydroxycytidine (NHC). NHC is distributed into cells and phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP).

NHC-TP acts via a mechanism known as viral error catastrophe during the virus replication process. The incorporation of NHC-TP into viral RNA by the RNA polymerase enzyme leads to an accumulation of errors in the viral genome, resulting in the suppression of replication.

Molnupiravir helps prevent the risks of complicated COVID-19, including in patients with risk factors for progression to severe disease. Therapy with molnupiravir leads to a reduction in the time to virus elimination and a decrease in the duration of disease symptoms.

Pharmacokinetics

Molnupiravir is a prodrug of 5′-isobutyrate which is hydrolyzed to NHC before entering the systemic circulation. The pharmacokinetics of NHC are similar in healthy individuals and patients with COVID-19.

Steady-state pharmacokinetics of NHC after administration of 800 mg molnupiravir every 12 hours: C_max is 2970 (%CV 16.8) ng/mL, C_{12 h} is 31.1 (%CV 124) ng/mL, AUC_{0-12 h} is 8260 (%CV 41.0) ng×h/mL.

After twice-daily oral administration of 800 mg molnupiravir, the T_max of NHC averages 1.5 hours.

The NHC metabolite does not bind to plasma proteins.

The T_1/2 of NHC is approximately 3.3 hours. The fraction of the dose excreted as NHC in urine was ≤3% in healthy volunteers.

Indications

Treatment of mild to moderate COVID-19 in adults, including those at increased risk of progression to severe disease and who do not require supplemental oxygen.

ICD codes

Dosage Regimen

Take the capsules orally.

Administer 800 mg (four 200 mg capsules) twice daily for 5 days.

The total daily dose is 1600 mg.

Initiate treatment as soon as possible after a positive COVID-19 diagnosis and within 5 days of symptom onset.

Swallow the capsules whole with a sufficient amount of water.

Take doses approximately 12 hours apart to maintain consistent drug levels.

Complete the full 5-day course of treatment, even if symptoms improve.

If a dose is missed and it is less than 10 hours until the next scheduled dose, take it immediately.

If it is more than 10 hours until the next dose, skip the missed dose and resume the normal schedule.

Do not take a double dose to make up for a missed one.

No dose adjustment is required for elderly patients or those with mild to moderate renal or hepatic impairment.

Use with caution in patients with severe renal impairment (GFR less than 30 mL/min/1.73 m²); monitor biochemical parameters.

Adverse Reactions

Nervous system disorders: common – dizziness, headache.

Gastrointestinal disorders: common – diarrhea, nausea; uncommon – vomiting.

Skin and subcutaneous tissue disorders: uncommon – rash, urticaria.

Contraindications

Hypersensitivity to molnupiravir; pregnancy or planning pregnancy, breastfeeding period; children under 18 years of age.

With caution

In patients with severe renal impairment (GFR less than 30 mL/min/1.73 m²) and in patients with impaired liver function, monitoring of blood biochemical parameters is necessary.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Dose adjustment in patients with hepatic impairment is not required.

Use in Renal Impairment

Dose adjustment in patients with renal impairment is not required.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Dose adjustment is not required.

Special Precautions

A number of comorbidities increase the risk of progression of COVID-19 to a severe course: age ≥ 60 years, obesity (BMI > 30 kg/m²), diabetes mellitus, chronic kidney disease, severe cardiovascular diseases, chronic obstructive pulmonary disease, active malignant neoplasms.

The use of molnupiravir is possible only under medical supervision.

If use in women of reproductive age (including those with postmenopause for less than 2 years) is necessary, a negative pregnancy test result must be confirmed before starting treatment. A repeat pregnancy test should be performed after the end of administration.

Women of childbearing potential should use effective methods of contraception during treatment and for 4 days after its completion. In case of a suspected pregnancy, molnupiravir should be discontinued immediately.

Due to the fact that animal studies have shown reproductive toxicity of molnupiravir, the use of effective contraception is recommended in men during molnupiravir administration and for 3 months after its completion.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.