Drugs List

Therapeutic Indications

Uses

Complicated intra-abdominal infections: treatment

Administration

For intravenous infusion only over approximately 1 hour.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Severe hepatic impairment

Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Suspend treatment or reduce rate until infusion reactions resolve
Exclude pregnancy prior to initiation of treatment
Consider pseudomembranous colitis if patient presents with diarrhoea
May cause tooth discolouration during tooth development
Prolonged use may result in superinfection with non-susceptible organisms
Advise patient to seek advice at first indications of pregnancy
Discontinue at once if pseudomembranous colitis occurs
Discontinue if pancreatitis is suspected
Discontinue if severe hypersensitivity reactions occur
Advise patient not to take St John's wort concurrently

Patients with severe hepatic impairment should be monitored for adverse reactions, particularly if the patient is obese and/or being treated with strong CYP3A inhibitors where the exposure may further increased.

Pregnancy and Lactation

Pregnancy

Eravacycline is contraindicated during pregnancy.

The manufacturer advises that eravacycline should not be used during pregnancy unless the clinical condition of the women requires treatment with eravacycline.

At the time of writing there are limited data on the use of eravacycline in pregnant women. Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in fetuses exposed in utero during 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes.

Lactation

Eravacycline is contraindicated during breastfeeding.

The manufacturer advises that a decision on whether to discontinue breastfeeding or to discontinue therapy with eravacycline should be made, taking into account the benefit of breastfeeding for the child, and the benefit of therapy for the woman.

It is unknown whether eravacycline and its metabolites are excreted in human breast milk. Animal studies have shown excretion of eravacycline and its metabolites in breast milk. Long term use of other tetracyclines during breastfeeding may result in significant absorption by the breastfed infant and is not recommended because of the risk of dental discolouration and delay ossification.

Side Effects

Acidosis
Alanine aminotransferase increased
Antibiotic-associated colitis
Aspartate aminotransferase increased
Azotaemia
Dental discolouration
Diarrhoea
Dizziness
Erythema at injection site
Fungal superinfection
Headache
Hyperbilirubinaemia
Hyperhidrosis
Hyperphosphataemia
Hypersensitivity reactions
Hypoaesthesia
Hypoaesthesia (injection site)
Increase in blood urea nitrogen
Inflammation (injection site)
Infusion site pain
Infusion site reaction
Nausea
Pain / soreness (injection site)
Pancreatitis
Phlebitis
Photosensitivity
Pseudomembranous colitis
Pseudotumor cerebri
Rash
Swelling (injection site)
Thrombophlebitis
Thrombosis (injection site)
Vomiting

Presentation

Infusions of eravacycline.

Drugs List

Therapeutic Indications

Uses

Complicated intra-abdominal infections: treatment

Dosage

Adults

Additional Dosage Information

Administration

For intravenous infusion only over approximately 1 hour.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Severe hepatic impairment

Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Suspend treatment or reduce rate until infusion reactions resolve
Exclude pregnancy prior to initiation of treatment
Consider pseudomembranous colitis if patient presents with diarrhoea
May cause tooth discolouration during tooth development
Prolonged use may result in superinfection with non-susceptible organisms
Advise patient to seek advice at first indications of pregnancy
Discontinue at once if pseudomembranous colitis occurs
Discontinue if pancreatitis is suspected
Discontinue if severe hypersensitivity reactions occur
Advise patient not to take St John's wort concurrently

Patients with severe hepatic impairment should be monitored for adverse reactions, particularly if the patient is obese and/or being treated with strong CYP3A inhibitors where the exposure may further increased.

Pregnancy and Lactation

Pregnancy

Eravacycline is contraindicated during pregnancy.

The manufacturer advises that eravacycline should not be used during pregnancy unless the clinical condition of the women requires treatment with eravacycline.

At the time of writing there are limited data on the use of eravacycline in pregnant women. Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in fetuses exposed in utero during 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes.

Lactation

Eravacycline is contraindicated during breastfeeding.

The manufacturer advises that a decision on whether to discontinue breastfeeding or to discontinue therapy with eravacycline should be made, taking into account the benefit of breastfeeding for the child, and the benefit of therapy for the woman.

It is unknown whether eravacycline and its metabolites are excreted in human breast milk. Animal studies have shown excretion of eravacycline and its metabolites in breast milk. Long term use of other tetracyclines during breastfeeding may result in significant absorption by the breastfed infant and is not recommended because of the risk of dental discolouration and delay ossification.

Side Effects

Acidosis
Alanine aminotransferase increased
Antibiotic-associated colitis
Aspartate aminotransferase increased
Azotaemia
Dental discolouration
Diarrhoea
Dizziness
Erythema at injection site
Fungal superinfection
Headache
Hyperbilirubinaemia
Hyperhidrosis
Hyperphosphataemia
Hypersensitivity reactions
Hypoaesthesia
Hypoaesthesia (injection site)
Increase in blood urea nitrogen
Inflammation (injection site)
Infusion site pain
Infusion site reaction
Nausea
Pain / soreness (injection site)
Pancreatitis
Phlebitis
Photosensitivity
Pseudomembranous colitis
Pseudotumor cerebri
Rash
Swelling (injection site)
Thrombophlebitis
Thrombosis (injection site)
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2022

Reference Sources

Summary of Product Characteristics: Xerava 100mg powder for concentrate for solution for infusion. PAION UK Ltd. Revised August 2021.