Eravacycline

Eravacycline is a tetracycline antibiotic that treats serious stomach infections in adults.

Eravacycline may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Eravacycline is given as an infusion into a vein. A healthcare provider will give you your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use eravacycline if you do not understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Eravacycline must be given slowly, and the infusion can take at least 1 hour to complete.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Use eravacycline for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Eravacycline will not treat a viral infection such as the flu or a common cold.

Store unmixed eravacycline powder in the refrigerator, do not freeze.

Mixed eravacycline must be used within 6 hours if you keep it at room temperature, or 24 hours if kept in a refrigerator. Do not freeze.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.

You should not use eravacycline if you are allergic to any Tetracycline antibiotic.

Using eravacycline during pregnancy may affect tooth and bone development in the unborn baby.

Eravacycline is not approved for use by anyone younger than 18 years old. Eravacycline can cause permanent yellowing or graying of the teeth in children.

You should not use this medicine if you are allergic to eravacycline or other tetracycline antibiotics such as demeclocycline, doxycycline, minocycline, tetracycline, or tigecycline.

Tell your doctor if you have ever had:

• liver disease.

Using eravacycline during the second or third trimester of pregnancy may affect tooth and bone development in the unborn baby. This could cause permanent tooth discoloration later in the baby's life.

Eravacycline can pass into breast milk and may affect bone and tooth development in a nursing infant. Do not breastfeed while you are using eravacycline, and for at least 4 days after your last dose.

Eravacycline is not approved for use by anyone younger than 18 years old. Eravacycline can cause permanent yellowing or graying of the teeth in children.

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

Eravacycline may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain, diarrhea that is watery or bloody (may happen up to 2 months after your last dose of eravacycline);
• severe headaches, dizziness, ringing in your ears, vision problems;
• severe pain in your upper stomach that spreads to your back, nausea, and vomiting; or
• signs of a fungal infection--skin itching or crusting, white patches in your mouth, vaginal itching or discharge, issues with your fingernails or toenails.

Common side effects of eravacycline may include:

• nausea, vomiting; or
• pain, bruising, redness, swelling, burning, or irritation around the IV needle.

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Intraabdominal Infection:

1 mg/kg IV every 12 hours for 4 to 14 daysUse: For the treatment of complicated intraabdominal infections due to susceptible Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, K oxytoca, Enterococcus faecalis, E faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, Parabacteroides distasonis

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may indicate a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Eravacycline could make you more sensitive to the sun. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Tell your doctor about all your other medicines, especially:

• enzalutamide;
• mitotane;
• rifampin;
• St. John's wort; or
• a blood thinner--warfarin, Coumadin, Jantoven; or
• seizure medicine--carbamazepine, phenytoin.

This list is not complete. Other drugs may affect eravacycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.