Brexafemme

Brexafemme carries a Boxed Warning for the risk of toxicity to an unborn baby.

Brexafemme may cause serious side effects, including:

• Harm to your unborn baby. Treatment with Brexafemme during pregnancy may cause harm to your unborn baby. Women who can become pregnant may be asked by their healthcare provider to take a pregnancy test before each treatment with Brexafemme. Women who can become pregnant should use effective birth control throughout the duration of treatment with Brexafemme and for 4 days after the last dose of Brexafemme. Talk to your healthcare provider about birth control methods that may be right for you.
• See " Before taking", below.

• Take Brexafemme exactly as your healthcare provider tells you to take it.
• Take Brexafemme tablets by mouth with or without food.

Do not take Brexafemme if you:

• are pregnant or plan to become pregnant. Brexafemme may harm your unborn baby. Tell your healthcare provider if you are pregnant, think you might be pregnant, or plan to become pregnant.
• are allergic to ibrexafungerp.

Before you take Brexafemme, tell your healthcare provider about all of your medical conditions, including if you:

• are breastfeeding or plan to breastfeed. Brexafemme passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby while taking Brexafemme.

Brexafemme may affect the way other medicines work, and other medicines may affect how Brexafemme works.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• See "What is the most important information I should know about Brexafemme?"

Common side effects

The most common side effects of Brexafemme when used to treat vaginal yeast infection include:

• loose stools
• nausea
• stomach pain
• dizziness
• vomiting

The most common side effects of Brexafemme when used to reduce the number of recurrent vaginal yeast infections include:

• headache
• stomach pain
• loose stools
• nausea
• urinary tract infection
• tiredness (fatigue)

These are not all the possible side effects of Brexafemme.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store Brexafemme at room temperature between 68°F and 77°F (20°C and 25°C).
• Brexafemme is supplied in child-resistant packaging.

Keep Brexafemme and all medicines out of reach of children.

Active ingredient: ibrexafungerp

Inactive ingredients: Tablet core: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose. Tablet film coating: FD&C Blue #2, FD&C Red #40, hydroxypropyl cellulose, hydroxypropylmethyl cellulose 2910, talc, and titanium dioxide.

Brexafemme is manufactured for GlaxoSmithKline, Durham, NC 27701. For more information about Brexafemme, call 1-888-825-5249 or visit our website at www.brexafemme.com.