tecovirimat
Regulatory sources consulted
Approved indications
- Treatment of human smallpox in adults and pediatric patients weighing at least 13 kg who can receive oral capsules. Approval is based on animal efficacy.
Clinical warnings
- Major warning · Clinical efficacy in humans has not been determined and may be reduced in immunocompromised people; use specialist follow-up. — DailyMed, set_id fce826ab-4d6a-4139-a2ee-a304a913a253
Drug interactions
- HighRepaglinide
Mechanism: Tecovirimat inhibits CYP2C8 and may increase repaglinide.
Recommendation: Monitor glucose and adjust as needed.
DailyMed, set_id fce826ab-4d6a-4139-a2ee-a304a913a253
- ModerateMidazolam
Mechanism: Tecovirimat may reduce midazolam exposure.
Recommendation: Monitor midazolam efficacy.
DailyMed, set_id fce826ab-4d6a-4139-a2ee-a304a913a253
- ModeratePhosphate binders
Mechanism: They may increase tecovirimat exposure.
Recommendation: Monitor tolerability and adverse effects during coadministration.
DailyMed, set_id fce826ab-4d6a-4139-a2ee-a304a913a253
Adverse events
Common (≥1%)
Headache, nausea, abdominal pain, and vomiting
Pregnancy and lactation
Use during pregnancy only if the benefit justifies the risk. Do not breastfeed because smallpox may be transmitted to the infant.
Recent literature (PubMed)
A global outbreak of clade IIb Monkeypox virus (MPXV) infections spread rapidly across at least 118 countries resulting in a Public Health Emergency of International Concern (PHEIC) from July 2022 to May 2023. This outbreak affected more than 99 000 persons worldwide and caused more than 33 000 infections and 60 deaths in the US. In 2024, there have been approximately 200 new infections per month in the US. On August 14, 2024, the World Health Organization declared mpox a PHEIC for a second time due to a rapid increase in infections with clade I MPXV in Central Africa. Mpox is primarily acquired through direct skin to skin contact with MPXV. With clade IIb MPXV, infections are most commonly associated with sexual activity among individuals who are gay, bisexual, and other men who have sex with men. After a median incubation period of 7 to 10 days, prodromal symptoms include fever (62%-72%), lymphadenopathy (56%-86%), myalgias (31%-55%), malaise (23%-57%), and headache (25%-55%). Skin lesions progress through 4 well-defined stages (macules, papules, vesicles, and pustules) over 2 to 4 weeks. Clade IIb MPXV is typically a self-limited illness with a low mortality rate (<0.2% in the US); however, severe illness and death may occur in immunocompromised individuals, especially those with advanced HIV (CD4 count <200 cells/μL). Mpox should be suspected in patients with potential exposure to MPXV who have skin lesions, and the diagnosis is confirmed with polymerase chain reaction testing of lesions. Management is supportive and focuses on skin care and symptom relief with analgesics. While no antiviral treatments are currently approved for mpox by the US Food and Drug Administration, several therapeutics, such as tecovirimat, brincidofovir, and vaccinia immune globulin intravenous, are available through expanded access programs or clinical trials. Vaccination with the 2-dose Modified Vaccinia Ankara-Bavarian Nordic vaccine is recommended for high-incidence populations and
Monkeypox is a zoonotic illness caused by the monkeypox virus, an Orthopoxvirus in the same genus as the variola, vaccinia, and cowpox viruses. Since the detection of the first human case in the Democratic Republic of the Congo in 1970, the disease has caused sporadic infections and outbreaks, mainly restricted to some countries in west and central Africa. In July, 2022, WHO declared monkeypox a Public Health Emergency of International Concern, on account of the unprecedented global spread of the disease outside previously endemic countries in Africa and the need for global solidarity to address this previously neglected disease. The 2022 outbreak has been primarily associated with close intimate contact (including sexual activity) and most cases have been diagnosed among men who have sex with men, who often present with novel epidemiological and clinical characteristics. In the 2022 outbreak, the incubation period ranges from 7 days to 10 days and most patients present with a systemic illness that includes fever and myalgia and a characteristic rash, with papules that evolve to vesicles, pustules, and crusts in the genital, anal, or oral regions and often involve the mucosa. Complications that require medical treatment (eg, antiviral therapy, antibacterials, and pain control) occur in up to 40% of patients and include rectal pain, odynophagia, penile oedema, and skin and anorectal abscesses. Most patients have a self-limited illness; between 1% and 13% require hospital admission (for treatment or isolation), and the case-fatality rate is less than 0·1%. A diagnosis can be made through the presence of Orthopoxvirus DNA in PCRs from lesion swabs or body fluids. Patients with severe manifestations and people at risk of severe disease (eg, immunosuppressed people) could benefit from antiviral treatment (eg, tecovirimat). The current strategy for post-exposure prophylaxis or pre-exposure prophylaxis for people at high risk is vaccination with the non-replicating modifie
Mpox, is a zoonotic disease caused by the monkeypox virus and is primarily endemic to Africa. As countries gradually stop smallpox vaccination, resistance to the smallpox virus is declining, increasing the risk of infection with mpox and other viruses. On 14 August 2024, the World Health Organization announced that the spread of mpox constituted a public health emergency of international concern. Mpox's transmission routes and symptoms are complex and pose new challenges to global health. Several vaccines (such as ACAM2000, JYNNEOS, LC16m8, and genetically engineered vaccines) and antiviral drugs (such as tecovirimat, brincidofovir, cidofovir, and varicella immunoglobulin intravenous injection) have been developed and marketed to prevent and control this disease. This review aims to introduce the epidemic situation, epidemiological characteristics, physiological and pathological characteristics, and preventive measures for mpox in detail, to provide a scientific basis for the prevention and control of mpox viruses worldwide. Information from one patient indicates that milk levels of tecovirimat are low, consistent with relatively high protein binding and low oral absorption. Additionally, tecovirimat is approved for use in pediatric patients weighing as little as 3 kg. Amounts in breastmilk are unlikely to adversely affect the breastfed infant. Tecovirimat is considered to be the drug of choice for treating Mpox during lactation. Individuals with Mpox should feed their infants with pasteurized donor milk or infant formula until all of their lesions are healed. Numerous other safety precautions are advised for mothers with Mpox.[1] Individuals with smallpox are recommended not to breastfeed their infant because of the risk of passing variola virus to the infant through direct contact.
Monkeypox virus (MPXV) is a double-stranded DNA virus belonging to the Poxviridae family of the genus Orthopoxvirus with two different clades known as West African and Congo Basin. Monkeypox (MPX) is a zoonosis that arises from the MPXV and causes a smallpox-like disease. The endemic disease status of MPX was updated to an outbreak worldwide in 2022. Thus, the condition was declared a global health emergency independent of travel issues, accounting for the primary reason for its prevalence outside Africa. In addition to identified transmission mediators through animal-to-human and human-to-human, especially sexual transmission among men who have sex with men came to prominence in the 2022 global outbreak. Although the severity and prevalence of the disease differ depending on age and gender, some symptoms are commonly observed. Clinical signs such as fever, muscle and headache pain, swollen lymph nodes, and skin rashes in defined body regions are standard and an indicator for the first step of diagnosis. By following the clinical signs, laboratory diagnostic tests like conventional polymerase chain reaction (PCR) or real-time PCR (RT-PCR) are the most common and accurate diagnostic methods. Antiviral drugs such as tecovirimat, cidofovir, and brincidofovir are used for symptomatic treatment. There is no MPXV-specific vaccine; however, currently available vaccines against smallpox enhance the immunization rate. This comprehensive review covers the MPX disease history and the current state of knowledge by assessing broad topics and views related to disease origin, transmission, epidemiology, severity, genome organization and evolution, diagnosis, treatment, and prevention.