FDA-filed SPL labeling · retrieved through openFDA

Oritavancin Injection

Oritavancin injection is an antibacterial medicine used to treat acute bacterial skin and skin structure infections caused by certain gram-positive bacteria, available as Kimyrsa and Orbactiv.

Brand names OrbactivKimyrsa
Drug class Lipoglycopeptide Antibacterial
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 17, 2025
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 2014
FDA-listed product records 8
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Oritavancin Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oritavancin injection (Kimyrsa, Orbactiv) is a single-dose IV antibiotic for serious bacterial skin infections caused by gram-positive organisms, including MRSA. The two products differ in infusion time and preparation — they are not interchangeable in terms of instructions. Key precautions include avoiding IV heparin for 5 days after Orbactiv, watching for serious allergic or infusion reactions, and monitoring for unusual bleeding if you take warfarin.

📖 Oritavancin Injection: Patient Information Guide

A plain-language walkthrough of Oritavancin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Oritavancin injection is an antibacterial medicine approved for adults with serious bacterial skin infections. Both Kimyrsa and Orbactiv share the same core indication.

  • Orbactiv and Kimyrsa are each indicated to treat acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible gram-positive bacteria, including:
    • Staphylococcus aureus — including methicillin-resistant strains (MRSA) and methicillin-susceptible strains
    • Streptococcus pyogenes, S. agalactiae, S. dysgalactiae
    • Streptococcus anginosus group
    • Enterococcus faecalis (vancomycin-susceptible strains only)
  • Should only be used when a bacterial infection is proven or strongly suspected, to help prevent antibiotic resistance
⚙️How it works

Oritavancin is a lipoglycopeptide antibacterial — a type of antibiotic that targets gram-positive bacteria. Its effectiveness is linked to how much drug is present in the body over time compared to the amount needed to stop bacterial growth. Animal and clinical studies support a single-dose treatment approach for clinically relevant gram-positive organisms causing skin infections.

Laboratory studies suggest oritavancin inhibits several liver enzymes (CYP450 pathways), which can affect how other drugs are processed in the body. It does not interfere with the heart's electrical system in any clinically meaningful way at the recommended dose.

💊How it's taken

Both Kimyrsa and Orbactiv are given as a single intravenous (IV) dose by a healthcare provider — meaning the full course of treatment is typically just one infusion. Orbactiv is infused over 3 hours; Kimyrsa is infused over 1 hour. These two products have different preparation instructions and are not prepared or administered the same way. Since this is a one-time hospital or clinic infusion, there is no at-home dosing schedule or missed-dose concern for most patients.

🤒Side effects — in detail

The most common side effects reported in clinical trials include:

  • Nausea and vomiting
  • Headache
  • Diarrhea
  • Abscess (skin or limb)
  • Dizziness
  • Fast heart rate (tachycardia)
  • Elevated liver enzymes (seen on blood tests)
  • Reactions at the IV infusion site, such as redness or irritation

More serious reactions — including severe allergic reactions (anaphylaxis), infusion reactions with chest or back pain, bone infection (osteomyelitis), and C. difficile-related diarrhea — require immediate medical attention.

⚠️Warnings & precautions
  • Lab test interference: Oritavancin falsely elevates several clotting tests (aPTT for up to 5 days, PT/INR for up to 12 hours, ACT for up to 24 hours) — not because it affects actual clotting, but because it interferes with the lab reagents. This means IV heparin is contraindicated for 5 days after Orbactiv, and warfarin monitoring is unreliable for up to 12 hours.
  • Serious allergic reactions: Anaphylaxis has been reported. Tell your care team immediately if you experience swelling, hives, or difficulty breathing during the infusion.
  • Infusion reactions: Flushing, rash, itching, chest pain, back pain, chills, or tremors can occur — slowing or stopping the infusion may help.
  • C. difficile diarrhea: As with any antibiotic, a gut infection caused by Clostridioides difficile is possible — even weeks after treatment. Report severe or persistent diarrhea to your doctor.
  • Osteomyelitis (bone infection): More cases were observed in Orbactiv-treated patients in clinical trials compared to the comparator. If bone infection is suspected, a different antibiotic should be used.
  • Blood transfusion interference: Oritavancin can cause a positive Coombs test (antiglobulin test), which may interfere with blood cross-matching before a transfusion.
🔀What it interacts with

Oritavancin can interact with several medications, mainly by affecting how the body processes other drugs or by interfering with certain lab tests:

  • IV unfractionated heparin: Contraindicated for 5 days after Orbactiv — oritavancin falsely elevates the aPTT test used to monitor heparin dosing
  • Warfarin: PT/INR tests are unreliable for up to 12 hours after a dose; patients should be monitored closely for signs of bleeding
  • Drugs metabolized by CYP450 liver enzymes: Oritavancin is a weak inhibitor or inducer of several CYP isoforms (including CYP2C9, CYP2C19, CYP3A4, CYP2D6), which can raise or lower levels of co-administered medications; your healthcare team should review all medications
  • Blood transfusion cross-matching: A positive Coombs test caused by oritavancin can interfere with pre-transfusion blood compatibility testing — alert any transfusion team to recent oritavancin use

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor about any known allergy to oritavancin or other glycopeptide antibiotics (such as vancomycin or telavancin) — this medication is contraindicated if you have a known hypersensitivity to oritavancin products
  • Tell your doctor if you take warfarin or any anticoagulant (blood thinner)
  • Tell your doctor if you have severe kidney or liver problems — oritavancin has not been fully studied in these patients
  • Tell your doctor if you are pregnant — no adequate human studies exist; animal studies at doses up to 25% of the clinical dose showed no harm, but higher doses were not tested
  • Tell your doctor if you are breastfeeding — oritavancin appears in animal milk; the effect on breastfed infants is unknown
  • Not approved for children under 18 years of age
  • Older adults (65+) were not studied in large numbers; greater sensitivity cannot be ruled out
  • Patients on dialysis: oritavancin is not removed by hemodialysis; use in dialysis patients has not been specifically studied
🚑If you take too much

No accidental overdoses were reported in clinical trials of Orbactiv. Oritavancin is unlikely to be removed from the blood by hemodialysis. If an overdose occurs, supportive medical care should be provided.

📡Pharmacodynamics — effects in the body

Oritavancin's antibacterial activity is related to the total amount of drug the body is exposed to over time, relative to how much is needed to inhibit bacterial growth (expressed as the AUC/MIC ratio). A single dose is supported by both animal and clinical studies for treating gram-positive skin infections. In a dedicated cardiac safety study, oritavancin at doses above the recommended level did not meaningfully prolong the QTc interval (the heart's electrical recovery time), suggesting a low risk of heart rhythm effects at therapeutic doses.

🔬Pharmacokinetics — how your body processes it

After a single IV infusion, oritavancin spreads widely into body tissues — about 85% is bound to proteins in the blood. It is not broken down (metabolized) by the body and is slowly excreted unchanged in urine and feces. Oritavancin has an exceptionally long half-life of approximately 245 hours (about 10 days), which is why a single dose can treat the entire infection. Kimyrsa infused over 1 hour and oritavancin (Orbactiv) infused over 3 hours achieve similar overall drug exposure (AUC), though peak concentrations differ. No dose adjustment is needed for mild-to-moderate kidney or liver impairment; the drug's behavior in severe impairment has not been fully studied.

📦How to store it

KIMYRSA is supplied as a sterile white to off-white or pink lyophilized powder in single-dose clear glass vials containing 1,200 mg of oritavancin. stored at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) .

📄 Written from Oritavancin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

48

Supplements & herbs that interact with Oritavancin Injection

48 supplements and herbal products have documented interactions with Oritavancin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 47
  • Minor · 1
Every supplement checked against Oritavancin Injection — ranked by severity The full interaction hub: 47 moderate · 1 minor · every one linked to its full report. Check Oritavancin Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

7

Nutrient depletion considerations

Oritavancin Injection has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
See the full Oritavancin Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Oritavancin Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why is this just one IV infusion — is that really enough to treat my infection?
Yes, for most people one infusion is the full course of treatment. Oritavancin stays in your body for a very long time — it has a half-life of about 10 days — so a single dose maintains effective levels long enough to clear the infection. Clinical trials confirmed this single-dose approach works well for serious bacterial skin infections.
What side effects should I watch out for after the infusion?
The most common ones are nausea, headache, vomiting, and diarrhea — generally manageable. During the infusion itself, you might notice flushing, itching, or rash. More seriously, watch for any signs of a severe allergic reaction (swelling, trouble breathing, hives) or new or worsening diarrhea in the days or weeks after treatment, which could signal a C. difficile gut infection. Let your care team know right away if anything concerns you.
I take warfarin every day — is that a problem with this medication?
It's important your doctor knows about this. Oritavancin can make the standard warfarin monitoring test (INR/PT) unreliable for up to 12 hours after your infusion. It doesn't actually change how warfarin works, but the lab result looks off. You'll need to be watched carefully for any signs of bleeding, and your team may time your INR check accordingly.
I heard you can't use heparin after this — why?
That's correct, specifically for IV unfractionated heparin. Oritavancin interferes with the lab test used to monitor IV heparin dosing (called aPTT), causing it to read falsely high for up to 5 days. This means the test can't be trusted to guide heparin dosing safely. If you need a blood thinner during that window, your team can use an alternative that doesn't rely on that test.
Is it safe to have this if I'm pregnant or breastfeeding?
There's no solid human data on oritavancin use during pregnancy, so the risk to a developing baby isn't fully known. Animal studies at lower doses didn't show harm, but higher doses weren't tested. Oritavancin does appear in animal breast milk, so it may pass into human milk as well. Your doctor will weigh the benefit of treating your infection against any potential risk and help you make the best decision.
Kimyrsa and Orbactiv — are they the same thing? Does it matter which one I get?
Both contain oritavancin and treat the same type of infection, but they're not identical in how they're prepared or given. Orbactiv is infused over 3 hours and requires a specific multi-step preparation process; Kimyrsa is infused over 1 hour and has different preparation instructions. Healthcare providers must follow the correct instructions for whichever product you receive — the two should not be mixed up. The decision of which product you get is made by your care team.
Is Oritavancin Injection available over the counter?
Oritavancin Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Oritavancin Injection first available?
Oritavancin Injection has been available in the United States since at least 2014, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Oritavancin Injection?
Oritavancin Injection is supplied by 3 manufacturers listed in the FDA NDC Directory, including Melinta Therapeutics, LLC, Patheon Italia S.p.A, Patheon Italia S.p.A..

💬 Answers drafted from Oritavancin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Oritavancin Injection comes

Oritavancin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands Kimyrsa Orbactiv
How this form is used
What it may be used for
  • Orbactiv is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible gram-positive bacteria, including MRSA
  • Kimyrsa is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible gram-positive bacteria, including MRSA
Important instructions
  • Orbactiv is administered as a single intravenous dose infused over 3 hours; it must be diluted only in 5% dextrose (D5W) — never sodium chloride
  • Kimyrsa is administered as a single intravenous dose infused over 1 hour
  • Orbactiv requires reconstitution of three separate 400 mg vials before dilution; follow preparation instructions carefully as they differ from Kimyrsa
  • Orbactiv diluted solution must be used within 6 hours at room temperature or within 12 hours if refrigerated, including infusion time
Available strengths 2 strengths
8 FDA-listed product records

📊 Oritavancin Injection across the U.S. market

How Oritavancin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
3
Manufacturers
2
Brand names
8
FDA-listed product records
2014
First marketed
Melinta Therapeutics, LLC75%
Patheon Italia S.p.A13%
Patheon Italia S.p.A.13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Oritavancin Injection is used

A general measure of how commonly Oritavancin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Oritavancin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

79
Medicaid prescriptions filled (Q1–Q4 2025)
$401,835 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oritavancin Injection prescribed? Of the 1,596 medications we measure, Oritavancin Injection ranks #1,518 by Medicaid prescriptions — more than 5% of them.

Where Oritavancin Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Oritavancin Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

oritavancin 1200 MG Injection

79 Medicaid prescriptions (Q1–Q4 2025) 100% of Oritavancin Injection prescriptions shown $401,835 gross reimbursement (before rebates) ≈ $5,087 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2532361

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Oritavancin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Oritavancin Injection NDCs with Medicaid activity.

🔍 Compare Oritavancin Injection products

A representative set of FDA-listed product records for Oritavancin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
400 mg Intravenous Melinta Therapeutics, LLC × 3 listings NDA View NDC →
1200 mg/40 mL Intravenous Melinta Therapeutics, LLC × 3 listings NDA View NDC →
400 mg Patheon Italia S.p.A DRUG FOR FURTHER PROCESSING View NDC →
1200 mg/40 mL Patheon Italia S.p.A. DRUG FOR FURTHER PROCESSING View NDC →

Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Oritavancin Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Oritavancin Injection RxCUI 1547611 1 dose form · 2 strengths
  1. Dose form (SCDF) Injection RxCUI 1724161 In current FDA listings
    Clinical drug / strength (SCD) 400 MG RxCUI 1547615 1200 MG RxCUI 2532361

Look up RxCUI 1547611 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Orbactiv Kimyrsa

🏭 Manufacturers & labelers

Melinta Therapeutics, LLC 6 Patheon Italia S.p.A 1 Patheon Italia S.p.A. 1

RxNorm drug class

Oritavancin Injection belongs to the Lipoglycopeptide Antibacterial class.

Pharmacologic class Lipoglycopeptide Antibacterial
Drug family (ATC) Glycopeptide antibacterials
How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 3A4 Inducers, Cytochrome P450 2D6 Inducers

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 17, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oritavancin Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Oritavancin Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
8
Distinct labelers/manufacturers represented
3
Linked representative label
Melinta Therapeutics, LLC
Linked label effective
Jul 17, 2025
Composite sections available
23
Linked SPL Set ID
ff09a726-9f9b-4e30-b509-396781293220
Linked SPL Document ID
4c7649f3-4d38-47e2-aa0d-2ed606bb930a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Melinta Therapeutics, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.