Oritavancin

Oritavancin is an antibiotic for adults to treat specific bacterial skin infections.

Oritavancin may also be used for reasons not mentioned in this medication guide.

Oritavancin is given by infusion into a vein by a healthcare provider, usually as a single dose.

Your infusion time may change if you switch to a different brand of oritavancin.

Call your doctor if your symptoms do not improve, or if they get worse after receiving oritavancin.

Skipping the dose could let the infection become resistant to this medicine and other antibiotics. This medicine will not treat viral illnesses such as the flu or a common cold.

Oritavancin can affect the results of certain medical tests for up to 5 days after your injection. Tell any doctor who treats you that you have been treated with oritavancin.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Tell your doctor right away if you notice new pain, swelling, or warmth in a bone or joint area. If your doctor thinks you might have a bone infection (osteomyelitis), they may switch you to a different antibiotic.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not receive oritavancin if you are allergic to it, or if you will be using "unfractionated" heparin within 5 days after receiving the oritavancin injection.

Tell your doctor if you have or have ever had:

• an allergic reaction to medicines such as dalbavancin, telavancin, or vancomycin;
• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests; or
• any allergies.

Tell your doctor if you are pregnant or breastfeeding.

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

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Tell your medical caregivers right away if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose); or
• signs of osteomyelitis (bone infection)--new pain, swelling, or warmth in a bone or joint area.

Common side effects of oritavancin may include:

• nausea, vomiting, diarrhea;
• fever, chills;
• itching;
• headache; or
• skin infections.

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.

Usual Adult Dose for Skin and Structure Infection:

1200 mg administered as a single dose via IV infusion over 1 hour (Kimyrsa) or 3 hours (Orbactiv)Comment: -This drug is available as 2 different products that have different strengths (400 and 1200 mg), duration of infusion (1 or 3 hours), and preparation instructions. The manufacturer product information should be consulted.-This drug should be given as a single dose.-To reduce the development of drug-resistant bacteria and maintain the effectiveness of this antibacterial drug and others, use this drug only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.Use: For the treatment of acute bacterial skin and skin structure infections due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, S agalactiae, S dysgalactiae, S anginosus group (includes S anginosus, S intermedius, and S constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only)

In a medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

For at least 5 days after receiving oritavancin, do not use heparin.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medications work less effectively.

Tell your doctor about all your other medicines, especially:

• a blood thinner such as heparin or warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may affect oritavancin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.