There’s a Monkeypox Treatment Drug Approved by the FDA—Here’s What We Know

There’s a Monkeypox Treatment Drug Approved by the FDA—Here’s What We Know

Before this summer, monkeypox was practically unheard of in the U.S. But, now that the country has confirmed more than 7,500 cases, there are a lot of questions about monkeypox treatment.

Here’s the thing: As of now, there’s just one medication that can treat monkeypox—tecovirimat, also known as Tpoxx. With reports circulating about regular increases in monkeypox cases, monkeypox spreading, and concerns about access to treatment, it’s understandable to have questions. Here’s what you need to know.

What is tecovirimat, also known as Tpoxx?

Tpoxx is a medication approved by the Food and Drug Administration for the treatment of smallpox. But, while it’s not approved by the FDA for monkeypox (or other orthopoxvirus infections), it’s currently being used as a treatment for monkeypox as a non-research expanded access investigation new drug (EA-IND), according to the Centers for Disease Control and Prevention (CDC).

This designation allows for the use of tecovirimat for monkeypox in adults and children, the CDC explains. Tecovirimat is available as an oral capsule and IV injection.

How does tecovirimat work?

Tecovirimat is an anti-viral medication. “It interacts with a specific viral protein,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.

If you want to get more specific, tecovirimat is “an inhibitor of a protein in monkeypox called VP37,” says Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University. “The VP37 protein interacts with machinery that packages the virus for dissemination in the body,” she adds.

“Typically, when a virus infects a cell, it replicates and bursts out of the cell to infect other cells,” Dr. Russo explains. “But tecovirimat blocks the virus from leaving the cell.” Taking tecovirimat should lower the risk of developing serious complications of monkeypox, including death, the CDC says.

What are the potential side effects of tecovirimat?

There are some potential side effects of taking tecovirimat, and they’re slightly different depending on whether you have the oral medication or IV infusion. Here’s a breakdown from the CDC, along with how common these side effects were in clinical research:

Oral medication:

  • headache (12%)

  • nausea (5%)

  • abdominal pain (2%)

  • vomiting (2%)

IV:

  • infusion site pain (73%)

  • infusion site swelling (39%)

  • infusion site redness (23%)

  • infusion site extravasation (leakage into surrounding tissue) (19%)

  • headache (15%)

How can you get tecovirimat?

It’s actually not that easy. “There’s a lot of paperwork involved to get you the drug,” says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine. “For the average doctor, it’s difficult to get Tpoxx for patients.” Dr. Russo agrees. “It’s not as simple as getting a prescription from your doctor and popping down to Walgreens,” he says.

If you have a confirmed case of monkeypox, Dr. Schaffner recommends contacting your local health department. “They may not be able to help directly, but they should be able to direct you to a clinic where you could get Tpoxx,” he says.

The medication isn’t recommended for everyone—the CDC says it should be reserved for people with a high risk of severe disease, including those who are immunocompromised, under the age of eight, and have a history of certain skin conditions. In other people, “the illness should resolve on its own,” Dr. Schaffner says.

Now that the U.S. has declared monkeypox a public health emergency, it should become easier for people to get tecovirimat, Dr. Russo says. But, he points out, there’s still a lot of paperwork involved and restricted access to the drug right now.

If you suspect you have monkeypox, contact your doctor. They should be able to guide you on next steps but, if they can’t, your local health department can.

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