Eravacycline

What is Eravacycline?

• Eravacycline (brand name: XERAVA) is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

Eravacycline structure

What are the uses of this medicine?

• XERAVA is indicated for the treatment of complicated intra‑abdominal infections (cIAI) caused by susceptible microorganisms in patients 18 years or older.
• XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

How does this medicine work?

• Eravacycline is an antibacterial drug that disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.

Who should not use this medicine?

This medicine cannot be used if you have a known hypersensitivity to:

• eravacycline
• tetracycline-class antibacterial drugs

Is this medicine FDA approved?

• Eravacycline was approved for use in the United States in 2018 under the brand name XERAVA.

How should this medicine be administered?

For adults:

• Administer XERAVA for injection 1 mg/kg by intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days.
• The duration of therapy should be guided by the severity and location of infection and the patient’s clinical response.

For patients with severe hepatic impairment:

• Administer 1 mg/kg of XERAVA every 12 hours on Day 1, followed by 1 mg/kg every 24 hours starting on Day 2 for a total duration of 4 to 14 days.
• No dosage adjustment is warranted in patients with mild to moderate hepatic impairment.

For patients with a concomitant use of a strong cytochrome P450 isoenzymes (CYP) 3A inducer:

• Administer 1.5 mg/kg of XERAVA every 12 hours for a total duration of 4 to 14 days.
• No dosage adjustment is warranted in patients with concomitant use of a weak or moderate CYP3A inducer.

XERAVA may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of XERAVA with 0.9% Sodium Chloride Injection, USP.

What are the dosage forms and brand names of this medicine?

XERAVA for injection is a yellow to orange, sterile, preservative-free, lyophilized powder in single-dose vials for reconstitution and further dilution. XERAVA is available in two strengths:

• 50 mg of eravacycline (equivalent to 63.5 mg eravacycline dihydrochloride)
• 100 mg of eravacycline (equivalent to 127 mg eravacycline dihydrochloride)

What side effects can this medication cause?

Common possible side effects of this medicine include:

• infusion site reactions
• nausea
• vomiting
• diarrhea
• hypotension

More serious possible side effects of this medicine include:

• hypersensitivity reactions
• tooth discoloration and enamel hypoplasia
• inhibition of bone growth
• clostridium difficile-associated diarrhea (CDAD)
• tetracycline class adverse reactions

What special precautions should I follow?

• Life threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA. Avoid use in patients with known hypersensitivity to tetracyclines.
• Breastfeeding is not recommended during treatment with XERAVA.

What to do in case of emergency/overdose?

• No reports of overdosage with XERAVA have been reported.
• In case of suspected overdose, XERAVA should be discontinued and the patient should be monitored for adverse reactions.
• Hemodialysis is not expected to remove significant quantities of XERAVA.

Can this medicine be used in pregnancy?

• XERAVA, like other tetracycline-class antibacterial drugs, may cause discoloration of teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of XERAVA in pediatric patients have not been established.

What should I know about storage of this medication?

• Prior to reconstitution, XERAVA should be stored at 2°C to 8°C (36°F to 46°F).
• Keep vial in carton until use.

What are the active and inactive ingredients in this medicine?

• Active ingredient: eravacycline dihydrochloride

• Inactive ingredients: mannitol, sodium hydroxide, and hydrochloric acid.

Who manufactures and distributes this medicine?

• XERAVA is a registered trademark of Tetraphase Pharmaceuticals, Inc.
• Distributed by: Tetraphase Pharmaceuticals, Inc., Watertown, Massachusetts 02472.

• Dailymed label info on Eravacycline
• FDA Eravacycline