Eravacycline

Eravacycline is a prescription medication indicated for the treatment of complicated intraabdominal infections (cIAIs).

• Eravacycline is available under the following different brand names: Xerava

Common side effects of Eravacycline include:

• infusion site reactions (pain, fluid leaking, numbness, swelling, blood clot, and redness),
• nausea
• vomiting

Serious side effects of Eravacycline include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• severe stomach pain, diarrhea that is watery or bloody (may occur up to 2 months after your last dose of eravacycline)
• severe headaches, dizziness, ringing in your ears, vision problems
• severe pain in the upper stomach spreading to your back, nausea, and vomiting
• signs of a fungal infection--skin itching or crusting, white patches in the mouth, vaginal itching or discharge, problems with the fingernails or toenails

Rare side effects of Eravacycline include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 50 mg/single-dose vial

Intraabdominal infections

Adult dosage

• 1 mg/kg IV every 12 hours × 4-14 days; infuse IV over approximately 60 minutes

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Eravacycline has severe interactions with no other drugs
• Eravacycline has serious interactions with the following drugs:
  • amoxicillin
  • ampicillin
  • microbiota oral
  • palovarotene
• sodium sulfate/magnesium sulfate/potassium chloride
• sodium sulfate/potassium sulfate/magnesium sulfate
• Eravacycline has moderate interactions with the following drugs:
  • warfarin
  • zinc
• Eravacycline has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to eravacycline, tetracycline antibacterials, or any of the excipients

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Eravacycline?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Eravacycline?"

Cautions

• Life-threatening hypersensitivity (anaphylaxis) reported; avoid with history of tetracycline allergy; discontinue if allergic reaction occurs
• Clostridium difficile–associated diarrhea (CDAD) is reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures
• Structurally like tetracyclines and may have similar adverse reactions, including photosensitivity, pseudotumor cerebri, and antianabolic action, which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests
• May cause overgrowth of nonsusceptible organisms, including fungi
• Prescribing without proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk for the development of drug-resistant bacteria
• Use during tooth and bone development
  • Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow–grey–brown); enamel hypoplasia reported with tetracyclines; advise the patient of potential risk
  • May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
  • All tetracyclines form a stable calcium complex in any bone-forming tissue
  • Decreased fibula growth rate observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours; reversible when drug discontinued
• Drug interaction overview
  • Coadministration with strong CYP3A inducers decreases eravacycline exposure, which may reduce efficacy; increased eravacycline dose is recommended
  • Tetracyclines may depress plasma prothrombin activity; patients taking an anticoagulant therapy may require a lower anticoagulant dose

Pregnancy and Lactation

• Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy
• Infertility
  • Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
• Lactation
  • Unknown if the drug is excreted in human breast milk
  • Eravacycline (and its metabolites) is excreted in the milk of lactating rats
  • Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including eravacycline, by the breastfed infant is not known
  • Because other antibacterial drug options are available to treat cIAIs in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment and for 4 days (based on half-life) after the last dose