Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

SIVEXTRO (NDA-205436)

(TEDIZOLID PHOSPHATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/27/2026 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serotonin Syndrome

Newly added section:

Spontaneous reports of serotonin syndrome have been observed with the co-administration of oxazolidinones, including SIVEXTRO, and serotonergic agents. Commonly used serotonergic agents include serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, buspirone, serotonin 5-HT1 receptor agonists (triptans), and opioids, including meperidine. Symptoms associated with serotonin syndrome may include hyperthermia, diaphoresis, agitation, hyperreflexia, clonus, pyrexia, opsoclonus, muscle rigidity, tremor, and hypertonia. Monitor patients for the emergence of serotonin syndrome with the concomitant use of SIVEXTRO and serotonergic agents. If signs or symptoms of serotonin syndrome occur, consider discontinuing SIVEXTRO and/or concomitant serotonergic agents as clinically appropriate and initiate supportive treatment. Inform patients of the increased risk of serotonin syndrome when SIVEXTRO is used concomitantly with serotonergic agents.

6 Adverse Reactions

Additions and/or revisions undelined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Serotonin Syndrome [see Warnings and Precautions (5.1)]

Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.3)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Nervous system disorders: serotonin syndrome

7 Drug Interactions

7.1 Membrane Transporters

Newly added subsection title

Orally administered SIVEXTRO inhibits Breast Cancer Resistance Protein (BCRP) in the intestine, which can increase the plasma concentrations of orally administered BCRP substrates, and the potential for adverse reactions. If possible, an interruption in the treatment of the co-administered BCRP substrate medicinal product should be considered during treatment with SIVEXTRO, especially for BCRP substrates with a narrow therapeutic index (e.g., methotrexate or topotecan). If coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates, including rosuvastatin [see Clinical Pharmacology (12.3)].

7.2 Serotonergic Agents

Newly added subsection

In post marketing experience, there have been reports of serotonin syndrome in patients taking SIVEXTRO with serotonergic agents [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Serotonin Syndrome

Advise patients to inform their healthcare provider if they are taking serotonergic agents and of the increased risk of serotonin syndrome when SIVEXTRO is used concomitantly with serotonergic agents [see Warnings and Precautions (5.1)].

PATIENT INFORMATION

Additions and/or revisions underlined:

…

SIVEXTRO tablet is not for use in children weighing less than 77 pounds (35 kg).

…

Are you taking other medicines?

…

It is especially important to tell your healthcare provider if you take any of the following medicines:

Methotrexate (for cancer or rheumatoid arthritis)
Topotecan (for cancer)
Rosuvastatin (for cholesterol)
Depression or anxiety medicines
Migraine headache medicines called triptans

Prescription pain medicines

…

What are the possible side effects of SIVEXTRO?

SIVEXTRO may cause serious side effects, including

Serotonin syndrome. Taking SIVEXTRO with certain other medicines can cause a potentially life-threatening problem called serotonin syndrome. See “Are you taking other medicines?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs or symptoms of serotonin syndrome:
- high body temperature (hyperthermia)
- sweating too much
- agitation
- difficulty with coordination
- stiff muscles or muscle twitching
- unusual eye movement
- tremors
- fever

…

11/17/2021 (SUPPL-9)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Myelosuppression

Phase 1 studies conducted in healthy adults exposed to SIVEXTRO for 21 days showed a possible dose and duration effect on hematologic parameters beyond 6 days of treatment. In the Phase 3 trials, clinically significant changes in these parameters were generally similar for both treatment arms (see Table 3). In postmarketing experience, thrombocytopenia has been reported in patients treated with SIVEXTRO. In one postmarketing report, patients who experienced thrombocytopenia were treated with tedizolid for a median duration of 26.5 days. A duration of treatment beyond 6 days is not approved.

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during post approval use of SIVEXTRO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: thrombocytopenia

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

Newly added section; please refer to label

06/19/2020 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Clostridioides difficile-Associated Diarrhea

(“Clostridium” replaced with “Clostridioides”)

6 Adverse Reactions

(Extensive changes; please refer to label)

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of SIVEXTRO for the treatment of ABSSSI have been established in pediatric patients aged 12 years and older. Use of SIVEXTRO for the treatment of ABSSSI is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)].

Safety and effectiveness of SIVEXTRO in pediatric patients below the age of 12 years have not been established.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Newly added section; please refer to label)

03/06/2019 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Adverse Reactions in Clinical Trials

(subsection revised, additions and revisions underline)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.

Adverse reactions were evaluated for 1425 patients treated with SIVEXTRO in two Phase 2 and four Phase 3 clinical trials (three Phase 3 trials for 6 days of therapy and one Phase 3 trial for 7-21 days of therapy). The median age of patients treated with SIVEXTRO in the Phase 2 and Phase 3 trials was 44 years, ranging between 17 and 94 years old. The majority of patients treated with SIVEXTRO were male (66%) and White (67%).

Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation

Serious adverse reactions occurred in 37/1425 (2.6%) of patients treated with SIVEXTRO and in 25/1000 (2.5%) of patients treated with the comparator. SIVEXTRO was discontinued due to an adverse reaction in 14/1425 (1%) of patients and the comparator was discontinued due to an adverse reaction in 13/1000 (1.3%) of patients.

Most Common Adverse Reactions

The most common adverse reactions in patients treated with SIVEXTRO were nausea (7.1%), headache (4.5%), diarrhea (3.6%), vomiting (2.7%), and dizziness (1.6%). The median time of onset of adverse reactions was 5 days for both SIVEXTRO and linezolid with 12% occurring on the second day of treatment in both treatment groups.

Table 2 lists selected adverse reactions occurring in at least 2% of patients treated with SIVEXTRO in clinical trials.

(please refer to Table 2 in label)

Infusion- or Injection-Related Adverse Reactions*

*Includes adverse reactions in the following body system or organ classes: General disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, and vascular disorders, including but not limited to, phlebitis, injection- or infusion-site pain, injection- or infusion-site swelling, injection-site reaction, injection-site erythema, injection- site induration, and infusion-related reaction.

The following selected adverse reactions were reported in SIVEXTRO-treated patients at a rate of less than 2% in these clinical trials:

…

Investigations: hepatic transaminases increased (ALT increased, AST increased), gamma-glutamyltransferase (GGT) increased, white blood cell count decreased

…

Laboratory Parameters

Hematology laboratory abnormalities that were determined to be potentially clinically significant in the pooled Phase 3 ABSSSI clinical trials are provided in Table 3.

(please refer to Table 3 in label)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

(additions underlined)

…

Problems with your vascular system

high blood pressure

Problems with your blood work
Your doctor may tell you that you have the following while taking Sivextro:
a low white blood cell count
anemia (low red blood cells)
bleeding or bruising easily
increased levels of liver enzymes

…

08/12/2017 (SUPPL-3)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Newly added subsection; please refer to label)

08/12/2017 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Adverse Reactions in Clinical Trials

(Additions and/or revisions are underlined)

Safety was additionally evaluated in a randomized, double-blind, multicenter study conducted in China, the Philippines, Taiwan, and the US, which included a total of 292 adult patients treated with tedizolid 200 mg administered IV and/or oral once daily for 6 days for the treatment of ABSSSI. The safety profile in this study was similar to the Phase 3 clinical trials; however, infusion site reactions (phlebitis) were reported in 3.1% of tedizolid-treated subjects, particularly among Asian patients.

10/28/2016 (SUPPL-2)

Approved Drug Label (PDF)

7 Drug Interactions

(addition underlined)