Byfavo is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to help you relax before having a minor surgery, dental work, or other medical procedure.

Byfavo may also be used for purposes not listed in this medication guide.

Byfavo can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

Midazolam is injected into a vein by a healthcare provider.

Byfavo is usually given as a single dose just before a surgery or medical procedure.

Byfavo can make you very drowsy, dizzy, or light-headed. These effects may last longer in older adults. Use caution to avoid falling or accidental injury after you have received this medicine. You may need help getting out of bed for several hours.

You will be watched to make sure the medication is working and does not cause harmful side effects.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

You should not be treated with Byfavo if you are allergic to Byfavo or dextran 40.

Byfavo may harm an unborn baby, and generally should not be used during pregnancy. Tell your doctor if you are pregnant.

If you use Byfavo during pregnancy, your baby could be born with life-threatening sedation or withdrawal symptoms, and may need medical treatment for several weeks.

Anesthesia may affect brain development in a young child or unborn baby (when used in the mother), which may lead to learning or behavior problems later in life. Long surgeries or repeated procedures pose the highest risks.

Anesthesia may still be necessary for a life-threatening condition, medical emergency, or surgery to correct a birth defect. Your doctor can inform you about all medicines given during a surgery or procedure.

If you are breastfeeding, tell your doctor if you notice sedation, poor feeding, and poor weight gain in the nursing baby.

Do not breastfeed within 5 hours after using Byfavo. If you use a breast pump during this time, throw out the milk and do not feed it to your baby. Tell your doctor if you are breastfeeding or plan to breastfeed.

In a medical setting you are not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

Do not drink alcohol shortly after receiving Byfavo.

Byfavo can cause extreme drowsiness that may last for several hours after you have received the medication. Older adults may feel sleepy for even longer.

Avoid driving or doing anything that requires you to be awake and alert until the effects of Byfavo have worn off completely.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Byfavo can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. Your caregivers will watch you for symptoms such as weak or shallow breathing.

Tell your medical caregivers right away if you have:

• weak or shallow breathing;

• confusion;

• slow heartbeats; or

• a light-headed feeling, like you might pass out.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of Byfavo may include:

• feeling light-headed;

• shallow breathing; or

• changes in blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Shortly after you are treated with Byfavo, using other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medicine, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect Byfavo, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.