Tedizolid
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Tedizolid is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- Dosing Information
- Dosage
Condition2
- Dosing Information
- Dosage
Condition3
- Dosing Information
- Dosage
Condition4
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Tedizolid in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tedizolid in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Tedizolid in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Tedizolid in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tedizolid in pediatric patients.
Contraindications
- Condition1
Warnings
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Title
See full prescribing information for complete Boxed Warning.
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- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Tedizolid in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tedizolid in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tedizolid in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tedizolid during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tedizolid with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tedizolid with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tedizolid with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tedizolid with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tedizolid with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tedizolid in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tedizolid in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tedizolid in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tedizolid in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Tedizolid in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Tedizolid in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Tedizolid in the drug label.
Pharmacology
There is limited information regarding Tedizolid Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tedizolid in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tedizolid in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tedizolid in the drug label.
Clinical Studies
Acute Bacterial Skin and Skin Structure Infections
- A total of 1315 adults with acute bacterial skin and skin structure infections (ABSSSI) were randomized in two multicenter, multinational, double-blind, non-inferiority trials. Both trials compared SIVEXTRO 200 mg once daily for 6 days versus linezolid 600 mg every 12 hours for 10 days. In Trial 1, patients were treated with oral therapy, while in Trial 2, patients could receive oral therapy after a minimum of one day of intravenous therapy. Patients with cellulitis/erysipelas, major cutaneous abscess, or wound infection were enrolled in the trials. Patients with wound infections could have received aztreonam and/or metronidazole as adjunctive therapy for gram-negative bacterial coverage, if needed. The intent-to-treat (ITT) patient population included all randomized patients.
- In Trial 1, 332 patients with ABSSSI were randomized to SIVEXTRO and 335 patients were randomized to linezolid. The majority (91%) of patients treated with SIVEXTRO in Trial 1 were less than 65 years old with a median age of 43 years (range: 18 to 86 years). Patients treated with SIVEXTRO were predominantly male (61%) and White (84%); 13% had BMI ≥35 kg/m2, 8% had diabetes mellitus, 35% were current or recent intravenous drug users, and 2% had moderate to severe renal impairment. The overall median surface area of infection was 188 cm2. The types of ABSSSI included were cellulitis/erysipelas (41%), wound infection (29%), and major cutaneous abscess (30%). In addition to local signs and symptoms of infection, patients were also required to have at least one regional or systemic sign of infection at baseline, defined as lymphadenopathy (87% of patients), temperature 38°C or higher (16% of patients), white blood cell count greater than 10,000 cells/mm3 or less than 4000 cells/mm3 (42%), or 10% or more band forms on white blood cell differential (4%).
- The primary endpoint in Trial 1 was early clinical response defined as no increase from baseline lesion area at 48-72 hours after the first dose and oral temperature of ≤37.6°C, confirmed by a second temperature measurement within 24 hours in the ITT population.
- In Trial 2, 332 patients with ABSSSI were randomized to SIVEXTRO and 334 patients were randomized to linezolid. The majority (87%) of patients treated with SIVEXTRO in Trial 2 were less than 65 years old with a median age of 46 years (range: 17 to 86 years). Patients treated with SIVEXTRO were predominantly male (68%) and White (86%); 16% had BMI ≥35 kg/m2, 10% had diabetes mellitus, 20% were current or recent intravenous drug users, and 4% had moderate to severe renal impairment. The overall median surface area of infection was 231 cm2. The types of ABSSSI included were cellulitis/erysipelas (50%), wound infection (30%), and major cutaneous abscess (20%). In addition to local signs and symptoms of infection, patients were also required to have at least one regional or systemic sign of infection at baseline, defined as lymphadenopathy (71% of patients), temperature 38°C or higher (31% of patients), white blood cell count greater than 10,000 cells/mm3 or less than 4000 cells/mm3 (53%), or 10% or more band forms on white blood cell differential (16%). The primary endpoint in Trial 2 was early clinical response defined as at least a 20% decrease from baseline lesion area at 48-72 hours after the first dose in the ITT population (TABLE 7).
table03
- An investigator assessment of clinical response was made at the post-therapy evaluation (PTE) (7 - 14 days after the end of therapy) in the ITT and CE (Clinically Evaluable) populations. Clinical success was defined as resolution or near resolution of most disease-specific signs and symptoms, absence or near resolution of systemic signs of infection if present at baseline (lymphadenopathy, fever, >10% immature neutrophils, abnormal WBC count), and no new signs, symptoms, or complications attributable to the ABSSSI requiring further treatment of the primary lesion
table04
How Supplied
Tablets
- SIVEXTRO tablets are yellow film-coated oval tablets containing 200 mg of tedizolid phosphate; each tablet is debossed with "TZD" on one side and "200" on the other side.
- They are supplied as follows:
- HDPE bottles of 30 tablets with child-resistant closure (NDC 67919-041-01)
- Unit dose blister packs of 6 tablets (NDC 67919-041-02)
For Injection
- SIVEXTRO is supplied as a sterile, lyophilized powder for injection in single-use vials of 200 mg. Each 200 mg vial must be reconstituted with Sterile Water for Injection and subsequently diluted only with 0.9% Sodium Chloride Injection, USP.
- They are supplied as follows:
- Package of ten 200 mg single-dose vials (NDC 67919-040-01)
Storage and Handling
- SIVEXTRO tablets and SIVEXTRO for injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage
There is limited information regarding Tedizolid Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Administration with Food
- Patients should be informed that SIVEXTRO tablets may be taken with or without food and without any dietary restrictions [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL PHARMACOLOGY (12.3)].
Usage Safeguards
- Patients should be advised that antibacterial drugs including SIVEXTRO should only be used to treat bacterial infections. SIVEXTRO does not treat viral infections (e.g., the common cold). When SIVEXTRO is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by SIVEXTRO or other antibacterial drugs in the future [seeINDICATIONS AND USAGE (1.2)].
- Patients should be informed that if they miss a dose, they should take the dose as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remains before the next dose, then they should wait until their next scheduled dose. Patients should take the prescribed number of doses [see DOSAGE AND ADMINISTRATION (2.1)].
- Keep SIVEXTRO and all medications out of reach of children.
Potentially Serious Adverse Reactions
- Patients should be advised that diarrhea is a common problem caused by antibacterial drugs including SIVEXTRO and usually resolves when the drug is discontinued. Sometimes after starting treatment with antibiotics, patients can develop frequent watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic and may be a sign of a more serious intestinal infection [see WARNINGS AND PRECAUTIONS (5.2) andADVERSE REACTIONS (6.1)]. If this occurs, patients should contact their healthcare provider as soon as possible.
Precautions with Alcohol
- Alcohol-Tedizolid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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