Oritavancin

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

• 400mg per 50 mL vial supplied in a package of 3 vials for a 1200mg dose

Skin & Skin Structure Infections

Indicated for treatment of acute bacterial skin and skin structure infections

A single 1200-mg dose administered IV over 3 hr

Susceptible isolates of gram-positive microorganisms

• Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant S aureus [MRSA] isolates)
• Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
• Enterococcus faecalis (vancomycin-susceptible isolates only)

Dosage Modifications

Renal impairment

• Mild-to-moderate: No dosage adjustment required
• Severe: Not evaluated
• Not removed by hemodialysis

Hepatic impairment

• Mild-to-moderate: No dosage adjustment required
• Severe: Not evaluated

<18 years: Safety and efficacy not established

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Oritavancin falls into category C. There are no well-controlled studies that have been done in pregnant women. Oritavancin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if oritavancin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using oritavancin.

If you take too much oritavancin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If oritavancin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oritavancin is injected into a vein through an IV, and is usually given only one time in a single dose. A healthcare provider will give you this injection.

Oritavancin must be given slowly, and the IV infusion can take at least 3 hours to complete.

This medicine can cause unusual results with certain medical tests for up to 120 hours (5 days) after your injection. Tell any doctor who treats you that you have been treated with oritavancin.

Call your doctor promptly if your symptoms do not improve after receiving oritavancin.

• If you have an allergy to oritavancin or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take oritavancin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Irritation where the shot is given.
• Loose stools (diarrhea).
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• LY333328
• Oritavancin Diphosphate

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Orbactiv: 400 mg (1 ea, 3 ea)

Acute bacterial skin and skin structure infections (ABSSI): IV: 1,200 mg as a single dose

Adverse events were not observed in animal reproduction studies.

Mild or moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available