Chemical formula: C₁₉H₁₅F₃N₂O₃ Molecular mass: 376.335 g/mol PubChem compound: 16124688
Tecovirimat interacts in the following cases:
Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19. Co-administration with tecovirimat may lead to increased plasma exposures of sensitive substrates of CYP2C8 or CYP2C19, potentially leading to increased adverse effects. Monitoring is advised during co-administration of tecovirimat with CYP2C8 and CYP2C19 substrates that have narrow therapeutic windows.
Tecovirimat is a substrate of UGT1A1, 1A3 and 1A4. Co-administration of tecovirimat with strong inhibitors or inducers of these UGTs is not expected to have a clinically important effect on tecovirimat exposures.
Tecovirimat and its M4 metabolite are inducers of cytochrome P450 (CYP)3A and CYP2B6. Co-administration with tecovirimat may lead to reduced plasma exposures of sensitive substrates of CYP3A4 or CYP2B6, potentially leading to reduced effects. Monitoring is advised during co-administration of tecovirimat with CYP3A4 and CYP2B6 substrates that have narrow therapeutic windows.
Tecovirimat should be used with caution in patients with severe renal impairment as there is limited clinical data in this population and higher unbound drug and metabolites levels may be observed.
Tecovirimat should be used with caution in patients with severe hepatic impairment as there is limited clinical data in this population and higher unbound drug and metabolite levels may be observed.
No vaccine-drug interaction studies have been performed in human subjects. Some animal studies have indicated that co-administration of tecovirimat at the same time as live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine.
The safety and efficacy of tecovirimat has not been evaluated in immunocompromised individuals. Nonclinical studies using animal models indicate that tecovirimat may have reduced efficacy in immunocompromised individuals.
The effects of tecovirimat on fertility in humans have not been studied.
Tecovirimat caused decreased fertility due to testicular toxicity in male mice.
Co-administration of midazolam and tecovirimat may reduce the effectiveness of midazolam. Effectiveness of midazolam should be monitored when administering tecovirimat with midazolam.
Co-administration of repaglinide and tecovirimat may cause mild to moderate hypoglycaemia. Blood glucose and hypoglycaemic symptoms should be monitored when administering tecovirimat with repaglinide.
There are no data from the use of tecovirimat in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity.
Tecovirimat is not recommended during pregnancy.
It is unknown whether tecovirimat/metabolites are excreted in human milk.
Available toxicological/safety data in animals have shown excretion of tecovirimat in milk.
A risk to the newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment with tecovirimat.
The effects of tecovirimat on fertility in humans have not been studied.
Tecovirimat caused decreased fertility due to testicular toxicity in male mice.
Tecovirimat has minor influence on the ability to drive and use machines. Patients should be informed about the possible occurrence of dizziness and should be cautoned about driving or operating machines until they know how tecovirimat will affect them.
The most frequently reported adverse drug reactions were headache (12.3%) and nausea (4.5%).
Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Frequency of Adverse Reactions by System Organ Class from Clinical Trials:
| System organ class | Very common | Common | Uncommon |
|---|---|---|---|
| Blood and lyphatic system disorders | Haematocrit Decreased HaemoglobinDecreased Leucopoenia Thrombocytopenia | ||
| Metabolism and nutrician disorders | Decreased appetite | ||
| Hepatobiliary disorders | Elevated LFT | ||
| Psychiatric disorders | Anxiety Depression Dysphoria Irritability Panic attack | ||
| Nervous system disorders | Headache | Dizziness | Disturbance in attention Dysgeusia Electroencephalogram abnormal Insomnia Migraine Somnolence Paraesthesia |
| Cardiac disorders | Heart Rate Increased Palpitations | ||
| Respiratory, thoracic and mediastinal disorders | Oropharyngeal pain | ||
| Gastrointestinal disorders | Abdominal pain upper Abdominal discomfort Diarrhoea Nausea Vomiting | Abdominal distention Aphthous ulcer Chapped lips Constipation Dry mouth Dyspepsia Eructation Flatulence Gastrooesophageal reflux disease Infrequent bowel movements Paraesthesia oral | |
| Skin and subcutaneous tissue disorders | Palpable purpura Pruritus generalised Rash Rash pruritic | ||
| Musculoskeletal and connective tissue disorders | Arthralgia Osteoarthritis | ||
| General disorders and administration site conditions | Chills Fatigue Feeling jittery Malaise Pain Pyrexia Thirst |
Tecovirimat has not been studied in the paediatric population.
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