What Is Sivextro?
Sivextro (tedizolid phosphate) is an antibacterial drug used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults and children 12 years and older weighing at least 40 kg. It belongs to the oxazolidinone class and works by inhibiting bacterial protein synthesis, targeting gram-positive bacteria like methicillin-resistant Staphylococcus aureus (MRSA).[1]
How Is Sivextro Administered?
Sivextro comes as 200 mg tablets or intravenous (IV) powder for infusion. The standard dose is 200 mg once daily for 6 days, with IV-to-oral switch allowed. No dose adjustment is needed for renal or hepatic impairment, unlike some other antibiotics.[1][2]
What Infections Does It Treat?
It covers complicated skin infections caused by susceptible strains of Staphylococcus aureus (including MRSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group, and Enterococcus faecalis. It's not for pneumonia or urinary tract infections.[1]
How Does Sivextro Compare to Other Antibiotics?
Sivextro offers once-daily dosing and shorter 6-day treatment versus vancomycin (multiple daily IV doses, 7-14 days) or linezolid (twice daily, 10-14 days). Studies showed non-inferior efficacy to linezolid in ABSSSI trials, with potentially lower rates of nausea and myelosuppression.[1][3]
| Drug | Dosing Frequency | Typical Duration | Key Advantage Over Sivextro |
|------|------------------|------------------|----------------------------|
| Linezolid (Zyvox) | Twice daily | 10-14 days | Broader approval (e.g., pneumonia) |
| Vancomycin | 2-3 times daily IV | 7-14 days | Cheaper generic, hospital standard |
| Daptomycin (Cubicin) | Once daily IV | 7-14 days | Stronger for bacteremia |
Who Makes Sivextro and What's the Pricing?
Merck & Co. manufactures and markets Sivextro, approved by the FDA in 2014. A 6-day course costs around $3,000-$4,000 in the U.S. without insurance, though patient assistance programs exist.[2][4]
When Does Sivextro's Patent Expire?
Key U.S. patents for tedizolid, including composition-of-matter (US 7,615,539), expire in 2026-2027, with pediatric exclusivity potentially extending to 2028. No generics are approved yet; check DrugPatentWatch.com for litigation updates and Paragraph IV challenges.[5]
What Side Effects Do Patients Report?
Common issues include nausea (8%), headache (6%), diarrhea (4%), and vomiting (3%). Rare serious risks: Clostridium difficile colitis, peripheral neuropathy with long-term use, and hematologic effects like anemia. It's contraindicated with MAO inhibitors due to serotonin syndrome risk.[1]
Who Should Avoid Sivextro?
Avoid in patients with hypersensitivity to tedizolid or phenylketonuria (tablets contain phenylalanine). Use caution in pregnancy (Category C) or breastfeeding; monitor for drug interactions with serotonin reuptake inhibitors.[1][2]
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205435s000lbl.pdf
[2] Drugs.com: https://www.drugs.com/sivextro.html
[3] ClinicalTrials.gov (ESTABLISH-1/2 trials): https://clinicaltrials.gov
[4] GoodRx pricing data (2023 averages)
[5] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/SIVEXTRO