Blujepa (gepotidacin) is an oral antibiotic for treating two common infections: uncomplicated urinary tract infections (UTIs) in females and uncomplicated urogenital gonorrhea. Its recent FDA approval makes it the first medicine in a new class of antibiotics to be approved for gonorrhea in more than 30 years. It is meant to be used in adults and teenagers (12 years or older and weighing at least 45 kilograms) who cannot use standard treatments due to allergies, side effects, or other reasons.
Gonorrhea is a sexually transmitted infection caused by a type of bacteria called Neisseria gonorrhoeae. If left untreated, it can lead to serious health problems, including infertility. More than 600,000 cases were reported in the U.S. in 2023. The CDC and the World Health Organization consider it a serious and urgent public health threat because it is becoming harder to treat due to the bacteria’s growing resistance to current antibiotics, including the standard injectable treatment ceftriaxone.
Blujepa works differently than older antibiotics. It blocks two enzymes that the bacteria need to copy their DNA. Without these enzymes, the bacteria can’t grow or spread. This approval comes after the approval of this medicine as an oral treatment for uncomplicated UTIs in females ages 12 or older by the FDA earlier this year.
Why Was It Approved?
The FDA approved Blujepa based on a study that showed that it works well and is generally safe for treating gonorrhea.
The study enrolled about 600 people with uncomplicated gonorrhea. Blujepa was tested against the standard treatment — an injection of ceftriaxone and an oral dose of azithromycin. Blujepa cleared the infection in about 92.6% of people, which was similar to the 91.2% success rate achieved with the standard treatment. This showed that this medicine was just as effective as the standard treatment.
Common side effects of this medicine for uncomplicated gonorrhea include diarrhea, nausea, stomach pain, vomiting, gas, dizziness, soft stools, headache, tiredness, and excessive sweating.
What Do I Need to Know?
Blujepa is taken by mouth and should be taken after eating to help reduce the risk of stomach upset. For gonorrhea, you’ll take four tablets, followed by four more tablets after 12 hours.
It’s important to finish the full course of treatment, even if you start to feel better. Stopping the treatment early can make the infection come back and may lead to antibiotic resistance, which means the medicine might not work as well in the future.
Blujepa can affect your heart rhythm and may cause a condition called QTc prolongation, which can lead to serious heart problems in some people. Tell your health care provider if you have a history of heart rhythm issues, have had a recent heart attack, or have low potassium levels or liver or kidney problems (including if you have kidney failure or are on dialysis), or take medicines that affect your heart. Be sure to mention all medications, including prescription medicines, over-the-counter products, herbal remedies, and supplements.
Blujepa may interact with certain medicines, such as digoxin, some antifungals, and certain antibiotics, especially those that affect liver enzymes.
Let your health care provider know if you are planning surgery with general anesthesia using intravenous muscle relaxants. Also inform your health care provider if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed, as it is not known whether this medicine can harm a fetus or pass into breast milk.
Call your health care provider right away if you notice signs of a serious reaction, such as an irregular heartbeat, fainting, or symptoms of an allergic reaction like trouble breathing or swelling. These may be signs of a rare but serious side effect.