Sivextro

Sivextro is a tablet for people 12 years of age and older who have a skin infection or an infection in the tissue below the skin. Sivextro is an antibiotic that works by stopping the growth of certain bacteria.

Children

Sivextro should not be used for people under 12 years old. It is not known if Sivextro works or is safe for people under age 12.

Sivextro may cause serious side effects, including diarrhea from C-diff (Clostridioides difficile) infection. Call your healthcare provider right away if you get stomach cramps, fever, watery diarrhea, diarrhea that does not go away, or bloody stools. C-diff infection can happen 2 or more months after you have finished your antibacterial medicine.

C-diff is an infection of your intestines (bowels) that can happen with many antibiotics like Sivextro and may cause mild diarrhea to life-threatening swelling of your intestines (colitis).

Common side effects of Sivextro include:

• nausea
• headache
• dizziness
• vomiting
• diarrhea
• increased liver enzymes

Some less common side effects are:

Problems with your skin

• itching, red or itchy rash, hives, acne
• hot flushes or feeling like you are blushing or your face, neck or chest is red
• not able to feel something as well
• a tingling or prickling sensation

Problems with your sleep

• hard time sleeping

Problems with your body

• numbness

Problems with infections

• vagina that is infected, inflamed or itchy
• fungal infections of skin, mouth

Problems with your eyes

• eye strain
• blurred or impaired vision
• seeing dots or spots in your eyes

Problems with your heart

• Your heartbeat does not feel normal. It could feel like your heart is beating too fast or pumping harder than usual.

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

If you have any side effect that bothers you or does not go away, tell your doctor.

These are not all the possible side effects of Sivextro. For information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosage

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 12 years of age or older.

The recommended dosage and administration of Sivextro are described in Table 1.

Table 1: Dosage of Sivextro

No dose adjustment is necessary when changing from intravenous to oral Sivextro.

If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

• 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.

• Based on animal reproduction studies, Sivextro may cause fetal harm when administered to pregnant women.
• The available data on the use of Sivextro in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Advise pregnant women of the potential risks to a fetus.
• There is no information on the presence of tedizolid in human milk. Tedizolid is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
• There are no data on the effects of Sivextro on the breastfed child or on milk production.