Sivextro

What Is Sivextro?

Sivextro (tedizolid phosphate) is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.

What Are Side Effects of Sivextro?

Common side effects of Sivextro include:

• nausea,
• headache,
• diarrhea,
• vomiting, and
• dizziness.

Other less common side effects of Sivextro include:

• anemia,
• heart palpitations,
• blurred vision,
• yeast infection,
• insomnia,
• itching and rash, and
• flushing.

Dosage for Sivextro

The recommended dosage of Sivextro is 200 mg administered once daily for six (6) days either orally (with or without food) or as an intravenous (IV) infusion in patients 18 years of age or older.

What Drugs, Substances, or Supplements Interact with Sivextro?

Sivextro may interact with other drugs. Tell your doctor all medications and supplements you use.

Sivextro During Pregnancy and Breastfeeding

During pregnancy, Sivextro should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Sivextro (tedizolid phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Sivextro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• numbness or tingling;
• vision problems, severe headache or pain behind your eyes;
• sores or white patches in your mouth or on your skin;
• vaginal itching or discharge;
• fast or pounding heartbeats; or
• low blood cell counts--fever, chills, tiredness, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• nausea, vomiting, diarrhea;
• headache;
• dizziness; or
• pain, swelling, bruising, redness, or a hard lump where a tedizolid injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sivextro (Tedizolid Phosphate Tablets)

 

Sivextro Professional Information

SIDE EFFECTS

Clinical Trials Experience

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.

Adult Patients

Adverse reactions were evaluated for 1425 adult 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 adult 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 adult patients treated with SIVEXTRO were male (66%) and White (67%).

Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation In Adults

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

Most Common Adverse Reactions In Adults

The most common adverse reactions in adult 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 adult patients treated with SIVEXTRO in clinical trials.

Table 2: Selected Adverse Reactions Occurring in ≥2% of Adult Patients Receiving SIVEXTRO in the Pooled Phase 3 ABSSSI Clinical Trials

Adverse Reactions	Pooled Phase 3 ABSSSI Clinical Trials
	SIVEXTRO (200 mg oral/intravenous once daily for 6 days) (N=1037)	Linezolid (600 mg oral/intravenous twice daily for 10 days) (N=1000)
Gastrointestinal Disorders
Nausea	7%	10%
Diarrhea	4%	5%
Vomiting	3%	5%
Nervous System Disorder
Headache	5%	5%
Dizziness	2%	2%
Infusion- or Injection-Related Adverse Reactions*
	4%	2%
*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 adult patients at a rate of less than 2% in these clinical trials:

Blood and Lymphatic System Disorders: anemia

Cardiovascular: palpitations, tachycardia

Eye Disorders: asthenopia, vision blurred, visual impairment, vitreous floaters

Immune System Disorders: drug hypersensitivity

Infections and Infestations: Clostridioides difficile colitis, oral candidiasis, vulvovaginal mycotic infection

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

Nervous System Disorders: hypoesthesia, paresthesia, VIIth nerve paralysis

Psychiatric Disorders: insomnia

Skin and Subcutaneous Tissue Disorders: pruritus, urticaria, dermatitis

Vascular Disorders: flushing, hypertension

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.

Table 3: Potentially Clinically Significant Lowest Laboratory Values in the Pooled Phase 3 ABSSSI Clinical Trials in Adults

Laboratory Assay	Potentially Clinically Significant Values*†
	SIVEXTRO (200 mg oral/intravenous once daily for 6 days) (N)‡	Linezolid (600 mg oral/intravenous twice daily for 10 days) (N)‡
Hemoglobin (<10.1 g/dL [M]) (<9 g/dL [F])	(994) 3.4%	(957) 3.4%
Platelet count (<112 x 103/mm³)	(989) 2.1%	(950) 3.8%
Absolute neutrophil count (<0.8 x 103/mm³)	(980) 0.4%	(941) 0.6%
M = male; F = female * <75% (<50% for absolute neutrophil count) of lower limit of normal (LLN) for post-baseline measurements † Represents laboratory values within two days after the last dose of active drug ‡ Number of subjects with at least one post-baseline test result that are within two days after the last dose of active drug

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).

Peripheral And Optic Neuropathy

Peripheral and optic neuropathy have been described in patients treated with another member of the oxazolidinone class for longer than 28 days. In Phase 3 trials in adults, reported adverse reactions for peripheral neuropathy and optic nerve disorders were similar between both treatment arms (peripheral neuropathy 1.2% vs. 0.7% for tedizolid phosphate and linezolid, respectively; optic nerve disorders 0.3% vs. 0.1%, respectively).

Pediatric Patients

Adverse reactions were evaluated in 91 pediatric patients with ABSSSI ranging from 12 to <18 years of age treated with IV and/or oral SIVEXTRO 200 mg for 6 days and 29 patients treated with comparator agents for 10 days. The majority of pediatric patients treated with SIVEXTRO were male (64%) and white (88%).

Serious adverse reactions occurred in 1/91 (1%) of pediatric patients treated with SIVEXTRO and in none of the 29 patients treated with the comparator. Adverse reactions leading to discontinuation occurred in 1 (1%) pediatric patient in the SIVEXTRO arm and in none in the comparator arm.

The most common adverse reactions occurring in pediatric patients receiving SIVEXTRO in the ABSSSI clinical trial were phlebitis (3%), increased hepatic transaminases (alanine aminotransferase, aspartate aminotransferase), (3%), anemia, and vomiting (1%).

Safety has not been evaluated in pediatric patients under 12 years of age.

Laboratory Parameters

Table 4: Potentially Clinically Significant Lowest Laboratory Values in the ABSSSI Clinical Trial in Pediatric Patients (12­<18 years)

Laboratory Assay	Potentially Clinically Significant Values*†
	SIVEXTRO (200 mg oral/intravenous once daily for 6 days) (N)‡	Comparators§ (for 10 days) (N)‡
Hemoglobin (<10.1 g/dL [M]) (<9 g/dL [F])	(85)2.4%	(26)0.0%
Platelet count (<112 x 103/mm³)	(82)1.2%	(26)0.0%
Absolute neutrophil count (<0.8 x 103/mm³)	(85)0.0%	(26)0.0%
M = male; F = female * <75% (<50% for absolute neutrophil count) of lower limit of normal (LLN) for post-baseline measurements † Represents laboratory values within two days after the last dose of active drug ‡ Number of subjects with at least one post-baseline test result that are within two days after the last dose of active drug § 5 IV and 4 oral comparators selected per local standard of care

Read the entire FDA prescribing information for Sivextro (Tedizolid Phosphate Tablets)