What is Tecovirimat (Tpoxx)? When will it be available for MonkeyPox? Side effects explained

Multiple clusters of monkeypox have been reported as of May 2022 in several countries that do not normally report monkeypox, including US cases. Tecovirimat is an antiviral medicine used to treat monkeypox. Let’s see in detail the drug Tecovirimat (Tpoxx) MonkeyPox, its availability and side effects.

Tecovirimat (Tpoxx) Medicine MonkeyPox

Tecovirimat

On July 13, 2018, the FDA approved the smallpox treatment for Tecovirimat (ST-246, TPOXX), an antiviral with in vitro activity against variola virus (smallpox).

Although smallpox was declared extinct in 1980, it is still possible that there are hidden reservoirs of smallpox or that the virus is produced from available genomic sequences.

It is therefore very interesting that effective antiviral chemotherapy is available.

Tecovirimat is an orally accessible low molecular weight substance.

It is effective against all known orthopoxviruses in vitro, including smallpox,60,61 but not against other recognized viruses.

Additionally, it was found after looking at over 350,000 different chemicals from a chemically diverse library.

The FDA has given approval for Tecovirimat (also known as TPOXX or ST-246) to treat adults and children.
People have human smallpox induced by the smallpox virus.

However, the FDA has not approved its use for diseases caused by other orthopoxviruses, such as monkeypox.

For this reason, the CDC has established a process for improving access to investigational new drugs (EA-IND).

This allows tecovirimat to be used as the main or sole treatment for diseases caused by non-variola orthopoxviruses, such as monkeypox, in adults and children of all ages.

Pharmacist Jonathan Parducho holds a box of capsules of the antiviral drug Tecovimat, a drug to treat smallpox, at Zuckerberg General Hospital in San Francisco Friday, July 29, 2022 in San Francisco.  (Lea Suzuki/San Francisco Chronicle via AP)

Jonathan Parducho, pharmacist, holds a box of capsules of the antiviral drug Tecovimat, a drug to treat smallpox, in ZuckerbergSan Francisco General Hospital Friday, July 29, 2022 in San Francisco. (Lea Suzuki/San Francisco Chronicle via AP)

What is Tecovirimat (TPOXX)?

Under a Centers for Disease Control and Prevention Expanded Access Investigational New Drug (IND) protocol.

Tecovirimat, an antiviral drug once used to treat smallpox infection, is now used to treat monkeypox infection.

Oral capsules and an IV formulation are available to children and adults.

Tecovirimat was successful in treating the disease and reducing the risk of death from orthopoxvirus in animal trials, despite a lack of data on its usefulness in treating monkeypox infections in humans.

This drug is safe in human clinical studies, with relatively modest side effects.

When will Tecovirimat (TPOXX) be available?

Tecovirimat (TPOXX) is an antiviral medication available from the Centers for Disease Control and Prevention (CDC).

It is used to treat monkeypox infection under the CDC’s Expanded Access Investigational New Drug (IND) protocol.

To date, tecovirimat has been prescribed to more than 400 patients in New York.

Recently, the FDA and CDC have facilitated this protocol so that treatment with tecovirimat can begin after obtaining informed permission from the patient.

No prior registration is required and assessments can be done via telemedicine.

Providers are advised to take essential steps to prescribe tecovirimat when involved for patients who test positive.

NYC providers who want to prescribe tecovirimat and can meet the IND protocol can email [email protected] for information about free patient delivery or to request supplies for a pharmacy at their facility.

For more information about monkeypox, visit the New York City Department of Health and Mental Hygiene’s Monkeypox Information for Providers web page.

Monkeypox infection outbreak in the United States

The number of monkeypox cases is rising in US states and three governors declared states of emergency last week due to the continued global spread of the outbreak.

According to data released by the Centers for Disease Control and Prevention on Monday, the number of confirmed cases of monkeypox has now exceeded 23,600 worldwide.

The outbreak, which was first identified in Europe in late April, has spread to 80 countries, the majority of which had not previously seen significant numbers of cases of the rare viral infection.

Late last month, the World Health Organization declared monkeypox a global health emergency.

According to the CDC, the United States had recorded more than 5,800 confirmed cases as of Monday.

States with large populations lead the way in terms of instances, with 1,390 cases in New York and 827 cases in California.

How well does the drug work to prevent monkeypox?

An antiviral with activity against orthopoxviruses, including smallpox and monkeypox, tecovirimat is marketed under the trade names Tpoxx and others.

It is one of only two drugs – the other is brincidofovir – approved for the treatment of monkeypox in the US and EU, and it is the first antipoxviral drug to receive FDA approval. and Drug Administration of the United States.

The drug, created by Siga Technologies, has two million doses available in the United States as part of the strategic national stockpile in the event of a bioterrorist attack.

Side effects of Tecovirimat (TPOXX)?

Serious side effects of TPOXX include:

  • Urticaria
  • Respiratory problems
  • Swelling of the face, lips, tongue or throat

Seek immediate medical attention if you experience any of the above symptoms.

The most common side effects of TPOXX include:

Nausea, vomiting, stomach pain and headache.

Consult the doctor immediately if you experience any side effects that bother you or do not go away.

Not all potential negative effects of TPOXX are included here. Ask your doctor or pharmacist for more details. For medical advice on side effects, contact your doctor.

Call 1-800-FDA-1088 to report side effects to the FDA.

What dose of TPOXX is safe?

TPOXX should be taken by adults at doses of 600 mg twice daily for 14 days. The dosage of TPOXX for children is determined by body weight.

What ingredients or supplements respond with TPOXX?

The drugs repaglinide and midazolam can interact with TPOXX. Give your doctor a complete list of all medications and supplements you take.

Is using TPOXX during pregnancy safe?

Before using TPOXX, tell your doctor if you are pregnant or want to become pregnant because it is not known how the medicine will affect the unborn child.

The ability of TPOXX to pass into breast milk is uncertain. Before breastfeeding, talk to your doctor.

Will India demand the drugs?

A small amount of medicine may be needed, according to Dr Sushil Jain, consultant pulmonologist at Masina Hospital in Mumbai.

Unlike COVID-19, monkeypox spreads very slowly, but there is a chance it will, he added.

Therefore, in certain circumstances, it may be necessary to administer this drug to immunocompromised patients who contract the virus to reduce the risk of consequences, according to Jain.

“Not everyone may need a certain amount of stock. It will be necessary, but not in excess.

He underscored the need for India to keep stock available so that it is accessible to people who need it when the time is right.

Jain added, however, that because prevention is more important than therapy, proactive measures should also be considered, such as early detection, rapid isolation and vaccination.

Moreover, Dr. Laxman Jessani, Infectious Disease Expert at Apollo Hospitals, Navi Mumbai, said that Tecovimat is the preferred drug to treat monkeypox and will help treat cases of the disease that have been positively identified.

However, he added, “it is more crucial to focus on vaccination against monkeypox as it may be more beneficial.”

What is monkey pox?

A rare disease known as monkeypox, which can infect anyone.

The virus can cause flu-like symptoms, swollen lymph nodes, and a rash that frequently starts on the face and spreads to other areas of the body.

Without close contact, monkeypox cannot easily be transmitted to humans. In the United States, cases of monkeypox are currently quite rare.

Symptoms of Monkey Pox

A new, unexplained rash that progresses to a hard, rounded, pus- or fluid-filled skin lesion is how monkeypox is commonly recognized. Other early indications include:

  • Swollen lymph nodes and fever
  • Body aches Colds
  • One to three days after a fever.
  • The rash appears normally.
  • However, in some people, a rash or sores may appear before other symptoms.
  • Some people may also just have a rash.

Monkey pox treatment

Monkeypox usually goes away without requiring treatment in two to four weeks.

Antiviral drugs that have been used to treat smallpox can be used even though there is no specific treatment for monkeypox.

Those who have come into contact with someone with monkeypox may be eligible to receive a vaccine to prevent the disease from developing or lessen the severity of symptoms.

DHS will work with medical professionals to procure necessary vaccines and treatments.

How to prevent monkeypox infection?

  • If you have had monkeypox, watch for symptoms for 21 days after the last exposure.
  • It is crucial to take your temperature twice a day while you are being monitored.
  • If symptoms appear, consult a doctor once and stay alone.
  • If you have no symptoms, you can continue with your normal activities, such as going to work or school.
  • Avoid intimacy or sex if your spouse has monkeypox until all lesions have healed and a new layer of skin has developed.
  • Avoid handling or touching anyone who has monkeypox bedding, towels, or clothing.
  • All surfaces and materials handled by a person with monkeypox should be cleaned.
  • with common household cleaners and disinfectants before hand washing.
  • Since monkeypox is most commonly transmitted from person to person, contact tracing is a crucial tool that can be used to prevent the spread of disease.

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