SIVEXTRO

TEDIZOLID PHOSPHATE

Manufacturer: Nabriva Therapeutics US, Inc.

Score: 141.0

Quick Summary

SIVEXTRO is an oxazolidinone antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of certain Gram-positive microorganisms. The recommended dosage is 200 mg administered once daily for six days either orally or as an intravenous infusion. Important safety information includes the potential for fetal harm when administered to pregnant women, and the drug is not recommended for use in patients with a history of hypersensitivity to tedizolid or other oxazolidinone-class antibacterial drugs.

Key Clinical Findings and Indications

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients 12 years of age and older
Effective against susceptible isolates of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group, and Enterococcus faecalis

Important Safety Information

Warning

May cause fetal harm when administered to pregnant women

Contraindications

Hypersensitivity to tedizolid or other oxazolidinone-class antibacterial drugs

Adverse Reactions

Nausea
Headache
Diarrhea
Infusion- or injection-related adverse reactions
Vomiting
Dizziness

Dosing Recommendations

General Guidance

No dose adjustment is necessary when changing from intravenous to oral SIVEXTRO

ABSSSI

Adult Dose

200 mg administered once daily for six days either orally or as an intravenous infusion

Pediatric Dose

200 mg administered once daily for six days either orally or as an intravenous infusion in pediatric patients 12 years of age and older

Special Population Considerations

Pregnancy

May cause fetal harm when administered to pregnant women
Use with caution in pregnant women

Nursing Mothers

It is not known whether tedizolid is excreted in human milk

Pediatric Use

Safety and effectiveness have been established in pediatric patients 12 years of age and older
Use in pediatric patients under 12 years of age has not been established

Geriatric Use

No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects
Use with caution in geriatric patients

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