Oritavancin

Oritavancin is a prescription medication used for the treatment of acute bacterial skin and skin structure infections. 

• Oritavancin is available under the following different brand names: Kimyrsa, Orbactiv

Common side effects of Oritavancin include:

• Headache,
• Nausea,
• Vomiting,
• Limb and subcutaneous abscesses,
• Diarrhea,
• Hypersensitivity,
• Itching,
• Chills,
• Fever,
• Dizziness,
• Infusion site phlebitis,
• Infusion site reaction,
• Increased alanine aminotransferase,
• Increased aspartate aminotransferase, and
• Fast heart rate

Serious side effects of Oritavancin include:

• Severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
• Swelling of the lips, face, hands, or legs, itching, hives, rash, wheezing
• Signs of new skin infections such as a new painful, red, swollen area on your skin

Rare side effects of Oritavancin include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 400 mg/vial (Orbactiv)
• 1200 mg/vial (Kimyrsa)

Skin & Skin Structure Infections

Adult dosage

• 1200 mg Intravenous as a single dose
• 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 Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Oritavancin has severe interactions with no other drugs.
• Oritavancin has serious interactions with the following drug:
  • cholera vaccine
• Oritavancin has moderate interactions with the following drugs.
  • carbamazepine
  • clonidine
  • disopyramide
  • ethosuximide
  • flecainide
  • fosphenytoin
  • phenobarbital
  • phenytoin
  • primidone
  • quinidine
  • quinine
  • sirolimus
  • tacrolimus
  • valproic acid
• Oritavancin has minor interactions with the following drug:
  • cyclosporine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Hypersensitivity to oritavancin products
• Use of intravenous unfractionated heparin sodium within 120 hours (5 days) of oritavancin administration

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Oritavancin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Oritavancin?”

Cautions

• Hypersensitivity, including anaphylaxis, reported, including possible cross-sensitivity to other glycopeptides (. g, dalbavancin, telavancin, vancomycin); discontinue infusion if signs of acute hypersensitivity occur; monitor closely patients with known hypersensitivity to glycopeptides.
• Infusion-related reactions, that resemble “Red-man Syndrome”, including flushing of the upper body, urticaria, pruritus, and/or rash reported; consider slowing infusion rate or interrupting the infusion
• Infusion reactions characterized by chest pain, back pain, chills, and tremors observed with the use of the drug, including after administration of more than one dose during a single course of therapy; stopping or slowing infusion may result in cessation of these reactions; safety and effectiveness of more than one dose during a single course of therapy have not been established.
• Clostridioides-difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs and may range from mild diarrhea to fatal colitis; evaluate patients if diarrhea occurs.
• In clinical trials, more cases of osteomyelitis were reported with oritavancin compared with vancomycin; if osteomyelitis is suspected, institute appropriate alternate antibacterial therapy.
• To reduce the development of drug-resistant bacteria and maintain effectiveness, use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria
• Coagulation test interference
  • Artificially prolongs aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours
  • For patients who require aPTT monitoring within 120 hours of dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT
  • Effects on activated clotting time (ACT) are expected since the phospholipid reagents are also used in this coagulation test.
  • Oritavancin does not affect the coagulation system.
• Drug interaction overview
  • Oritavancin is a nonspecific, weak CYP2C9 and CYP2C19 inhibitor; weak CYP3A4 and CYP2D6 inducer
  • Shown to artificially prolong PT/INR for up to 12 hours; coadministration with warfarin may result in higher exposure to warfarin and increase the risk for bleeding; monitor frequently for signs of bleeding.
  • Coadministration with Oritavancin and drugs that are predominantly metabolized by one of the affected CYP450 enzymes may increase or decrease concentrations of those drugs; closely monitor signs of toxicity or lack of efficacy if given Oritavancin while on a potentially affected compound

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Lactation
  • There are no data on the presence of oritavancin in human milk, the effects on the breastfed child, or the effects on milk production
  • Drug in the breast milk of rats
  • Therefore, it will be present in human milk
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on a breastfed child from the drug or the underlying maternal condition.