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Orbactiv (Intravenous)

Generic Name: oritavancin (Intravenous route)

or-it-a-VAN-sin

Commonly used brand name(s)

In the U.S.

  • Orbactiv

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Glycopeptide

Uses For Orbactiv

Oritavancin injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. It belongs to the family of medicines called antibiotics. Oritavancin works by killing bacteria or preventing their growth. Oritavancin will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using Orbactiv

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oritavancin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oritavancin injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Heparin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Phenytoin
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to glycopeptide (eg, dalbavancin, telavancin, vancomycin), history of—Use with caution. May increase risk of having an allergic reaction to occur again.
  • Diarrhea or
  • Osteomyelitis (bone infection)—Use with caution. May make these conditions worse.

Proper Use of Orbactiv

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 3 hours.

Precautions While Using Orbactiv

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Do not use heparin until 48 hours after receiving oritavancin.

Using this medicine together with warfarin may increase risk of bleeding. Tell your doctor right away if you have bleeding gums, coughing up blood, dizziness, nosebleeds, red or black, tarry stools, red or dark brown urine, or trouble breathing.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, coagulation tests) may be affected by this medicine.

This medicine may cause serious allergic reactions. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may cause infusion-related reactions. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, swelling in your face or hands, fever, chills, itching or hives, or feeling of warmth or redness on your upper body while you are receiving this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you have increased bone pain. This may be a symptom of osteomyelitis.

Orbactiv Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common
  • Changes in skin color
  • dry, red, hot, or irritated skin
  • fast, pounding, or irregular heartbeat or pulse
  • pain, swelling, or tenderness in the skin
Less common or rare
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • fever
  • hives, itching skin, or rash
  • increase in bone pain
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness, soreness, or itching skin
  • sores, welting, or blisters
  • swelling of the eyelids, face, lips, hands, or feet
  • swollen glands
  • tightness in the chest
  • unusual bleeding or bruising
Incidence not known
  • Abdominal or stomach tenderness
  • severe abdominal or stomach cramps and pain
  • watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare
  • Dizziness
  • headache
  • nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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