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Orbactiv oritavancin 400 mg Injection, Powder, Lyophilized, For Solution, 3 vials — NDC 70842-0140-03 package photo

Orbactiv oritavancin 400 mg Injection, Powder, Lyophilized, For Solution, 3 vials

by Melinta Therapeutics, LLC · 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)
NDC 70842-0140-03
🏷️ FDA NDC (as labeled) 70842-140-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70842-140-03
Product NDC 70842-140
11-digit billing NDC 70842014003
NCPDP billing unit EA — each (per item)
RxCUI 1547615, 1547620
UNII PUG62FRZ2E
Application # NDA206334
SPL Set ID ff09a726-9f9b-4e30-b509-396781293220
Established class (EPC) Lipoglycopeptide Antibacterial
Mechanism of action Cytochrome P450 2C19 Inhibitors; Cytochrome P450 2C9 Inhibitors; Cytochrome P450 3A4 Inducers; Cytochrome P450 2D6 Inducers
Chemical class Lipoglycopeptides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ORITAVANCIN
GPI-14 16280050202120
GPI class Orbactiv
GCN Seq No 072732
GCN 37018
HICL code 041363
Ingredient (HICL) Oritavancin Diphosphate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9I
Therapeutic class — specific (HIC3) Lipoglycopeptide Antibiotics
AHFS code 08:12.28.16
AHFS class Glycopeptide Antibiotics
FDB label name ORBACTIV 400 MG VIAL
FDB brand name Orbactiv
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70842-140-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70842-0140-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMelinta Therapeutics, LLC
Application holderMELINTA THERAPEUTICS LLC
FDA applicationNDA206334 (NDA)
Labeler code70842
First marketedSep 2014
Product typeHuman Prescription Drug
Portfolio11 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ORBACTIV 400 MG VIAL Ingredient Oritavancin Diphosphate
📖 What it is MedlinePlus · NLM

Oritavancin injection is used to treat skin infections caused by certain types of bacteria. Oritavancin is in a class of medications called lipoglycopeptide antibiotics. It works by killing bacteria. Antibiotics such as oritavancin will not work for colds, flu, and other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 main...
  • Why is this just one IV infusion — is that really enough to treat my infection?
  • 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, w...
  • What side effects should I watch out for after the infusion?
📖 Read our full Oritavancin Injection guide →
7
Nutrient depletion considerations

Oritavancin Diphosphate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Oritavancin Diphosphate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2407 $29.727 / J2407 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)70842-140-03
11-digit billing NDC70842-0140-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2407
DescriptorINJECTION, ORITAVANCIN, 10 MG
Billing units / pkg40 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Orbactiv 400 mgthis 70842-0140-03 Melinta 3 vials — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
First FDA approval
Aug 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 6, 2014 RLD RS ⏳ ~8.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8420592 — method of use (U-1570)
US 12514899 — method of use (U-4398)
US 9682061 — method of use (U-1569)
US 9649352 — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 8420592 ↗ Method of use U-1570 Aug 29, 2029
US 12514899 ↗ Method of use U-4398 Aug 29, 2029
US 9682061 ↗ Method of use U-1569 Apr 26, 2030
US 9649352 ↗ Drug product — Jul 16, 2035
Common questions
Is there a generic version of ORBACTIV 400 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ORBACTIV 400 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Orbactiv — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Orbactiv. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$148.5K
Claims incl. refills
45
Beneficiaries
28
Spend / beneficiary
$5,303.12
Spend / claim
$3,299.72
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70842-0140-03 You're viewing this 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01) 2014-09-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70842-140-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70842-0140-03, written without dashes as 70842014003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70842-0140-03, the first segment (70842) is the labeler code FDA assigned to Melinta Therapeutics, LLC; the middle segment (0140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Melinta Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Melinta Therapeutics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2407 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.2 )

1.1Acute Bacterial Skin and Skin Structure Infections ORBACTIV ® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus dysgalactiae , Streptococcus anginosus group (includes S. anginosus , S. intermedius , and S. constellatus ), and Enterococcus faecalis (vancomycin-susceptible isolates only).

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION There are two oritavancin products (ORBACTIV and KIMYRSA™, another oritavancin product) that have differences in dose strength, duration of infusion and preparation instructions, including reconstitution and dilution instructions and compatible diluents ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer 1,200 mg of ORBACTIV as a single dose by intravenous infusion over 3 hours. ( 2.1 , 5.3 ) Carefully follow the recommended dosage and dose preparation instructions for ORBACTIV in the full prescribing information.

( 2.1 , 2.2 , 2.3 )

2.1Dosage and Administration Overview There are two oritavancin products (ORBACTIV and KIMYRSA™, another oritavancin product) that: Are supplied in different dose strengths of oritavancin [see Dosage Forms and Strengths (3) ] . Have different recommended durations of infusion [see Dosage and Administration (2.2) ]. Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents [see Dosage and Administration (2.3 , 2.4) ] .

Carefully follow the recommended dosage and dose preparation instructions for ORBACTIV in this prescribing information (PI) [see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4) ]. Refer to the KIMYRSA prescribing information for relevant information of the other oritavancin product.

2.2Recommended Dosage The recommended dosage of ORBACTIV is 1,200 mg administered as a single dose by intravenous infusion over 3 hours in patients 18 years and older [see Warnings and Precautions (5.3) ] .

2.3Preparation of ORBACTIV for Intravenous Infusion There are two oritavancin products (ORBACTIV and KIMYRSA, another oritavancin product) that have differences in dose strengths, duration of infusion, reconstitution and dilution instructions, and compatible diluents. Carefully follow the reconstitution, and dilution instructions with the appropriate compatible diluent for ORBACTIV specified in this prescribing information. Refer to the KIMYRSA prescribing information for relevant information of the other oritavancin product.

ORBACTIV is intended for intravenous infusion, only after reconstitution and dilution. Three ORBACTIV 400 mg vials need to be reconstituted and diluted to prepare a single 1,200 mg intravenous dose. Reconstitution : Aseptic technique should be used to reconstitute three ORBACTIV 400 mg vials.

Add 40 mL of sterile water for injection (WFI) to reconstitute each vial to provide a 10 mg/mL solution per vial. For each vial, gently swirl the contents to avoid foaming and ensure that all ORBACTIV powder is completely dissolved to form a reconstituted solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Each reconstituted vial should appear to be a clear, colorless to pale yellow solution, free of visible particles. Dilution : Use ONLY 5% dextrose injection (D5W) for dilution to prepare the final intravenous solution for infusion. Do NOT use Sodium Chloride Injection for dilution as it is incompatible with ORBACTIV and may cause precipitation of the drug.

Since no preservative or bacteriostatic agent is present in ORBACTIV, aseptic technique must be used in preparing the final intravenous solution as follows: Withdraw and discard 120 mL from a 1000 mL intravenous bag of D5W . Withdraw 40 mL from each of the three reconstituted vials of ORBACTIV and add to D5W intravenous bag to bring the bag volume to 1000 mL. This yields a concentration of 1.2 mg/mL.

Discard any unused portion of the reconstituted solution remaining in each vial. Storage and Use of Intravenous Solution : Diluted intravenous solution in an infusion bag should be used within 6 hours when stored at room temperature, or used within 12 hours when refrigerated at 2 to 8°C (36 to 46°F). The combined storage time (reconstituted solution in the vial and diluted solution in the bag) and 3 hour infusion time should not exceed 6 hours at room…

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS ORBACTIV is supplied as sterile, white to off-white lyophilized powder containing 400 mg of oritavancin (as oritavancin diphosphate) in a single-dose clear glass vial, which must be reconstituted and further diluted prior to intravenous administration. For injection: 400 mg of lyophilized powder in a single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 100 words ▾

4 CONTRAINDICATIONS Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. ( 4.1 , 5.1 ) Known hypersensitivity to oritavancin products. ( 4.2 , 5.2 )

4.1Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours (5 days) after ORBACTIV administration [see Warnings and Precautions (5.1) and Drug Interactions (7.2) ].

4.2Hypersensitivity ORBACTIV is contraindicated in patients with known hypersensitivity to oritavancin products.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Coagulation test interference: ORBACTIV has been shown to artificially prolong 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 ORBACTIV dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT. ( 5.1 , 7.2 ) Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV.

Discontinue infusion if signs of acute hypersensitivity occur. Carefully monitor patients with known hypersensitivity to glycopeptides. ( 5.2 ) Infusion Related Reactions: Administer ORBACTIV over 3 hours to minimize infusion.

Infusion related reactions have been reported with the glycopeptide class of antimicrobial agents, including oritavancin products (e.g. ORBACTIV). Stopping or slowing the infusion may result in cessation of these reactions.

( 5.3 ) Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.4 ) Concomitant warfarin use: ORBACTIV has been shown to artificially prolong PT/INR for up to 12 hours ( 5.1 ). Patients should be monitored for bleeding if concomitantly receiving ORBACTIV and warfarin.

( 5.5 ) Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis. ( 5.6 )

5.1Coagulation Test Interference ORBACTIV has been shown to artificially prolong aPTT for up to 120 hours, PT and INR for up to 12 hours, and activated clotting time (ACT) for up to 24 hours following administration of a single 1,200 mg dose by binding to and preventing action of the phospholipid reagents commonly used in laboratory coagulation tests. ORBACTIV has also been shown to elevate D-dimer concentrations up to 72 hours after ORBACTIV administration. For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered [see Contraindications (4.1) and Drug Interactions (7.2) ] .

ORBACTIV has no effect on the coagulation system in vivo.

5.2Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV. If an acute hypersensitivity reaction occurs during ORBACTIV infusion, discontinue ORBACTIV immediately and institute appropriate supportive care. Before using ORBACTIV, inquire carefully about previous hypersensitivity reactions to glycopeptides.

Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during ORBACTIV infusion in patients with a history of glycopeptide allergy. In the Phase 3 ABSSSI clinical trials, the median onset of hypersensitivity reactions in ORBACTIV-treated patients was 1.2 days and the median duration of these reactions was 2.4 days [see Adverse Reactions (6.1) ] .

5.3Infusion Related Reactions ORBACTIV is administered as a single dose by intravenous infusion, using a total infusion time of 3 hours to minimize the risk of infusion-related reactions. Infusion related reactions have been reported with the glycopeptide class of antimicrobial agents, including oritavancin products (e.g. ORBACTIV), including flushing of the upper body, urticaria, pruritus and/or rash [see Adverse Reactions (6.1) ] .

Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of ORBACTIV, including after the administration of more than one dose of ORBACTIV during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions. The safety and effectiveness of more than one dose of ORBACTIV during a single course of therapy have not been established [see Dosage and Administration (2.2) ].

5.…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Related Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Osteomyelitis [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ORBACTIV cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ORBACTIV has been evaluated in two, double-blind, controlled ABSSSI clinical trials, which included 976 adult patients treated with a single 1,200 mg intravenous dose of ORBACTIV and 983 patients treated with intravenous vancomycin for 7 to 10 days.

The median age of patients treated with ORBACTIV was 45.6 years, ranging between 18 and 89 years of age with 8.8% ≥65 years of age. Patients treated with ORBACTIV were predominantly male (65.4%), 64.4% were Caucasian, 5.8% were African American, and 28.1% were Asian. Safety was evaluated for up to 60 days after dosing.

In the pooled ABSSSI clinical trials, serious adverse reactions were reported in 57/976 (5.8%) patients treated with ORBACTIV and 58/983 (5.9%) treated with vancomycin. The most commonly reported serious adverse reaction was cellulitis in both treatment groups: 11/976 (1.1%) in ORBACTIV and 12/983 (1.2%) in the vancomycin arms, respectively. The most commonly reported adverse reactions (≥3%) in patients receiving a single 1,200 mg dose of ORBACTIV in the pooled ABSSSI clinical trials were: headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

In the pooled ABSSSI clinical trials, ORBACTIV was discontinued due to adverse reactions in 36/976 (3.7%) of patients; the most common reported reactions leading to discontinuation were cellulitis (4/976, 0.4%) and osteomyelitis (3/976, 0.3%). Table 1 provides selected adverse reactions occurring in ≥1.5% of patients receiving ORBACTIV in the pooled ABSSSI clinical trials. There were 540 (55.3%) patients in the ORBACTIV arm and 559 (56.9%) patients in the vancomycin arm, who reported ≥1 adverse reaction.

Table 1: Incidence of Selected Adverse Reactions Occurring in ≥1.5% of Patients Receiving ORBACTIV in the Pooled ABSSSI Clinical Trials Adverse Reactions ORBACTIV N=976 (%) Vancomycin N=983 (%) Gastrointestinal disorders Diarrhea 36 (3.7) 32 (3.4) Nausea 97 (9.9) 103 (10.5) Vomiting 45 (4.6) 46 (4.7) Nervous system disorders Dizziness 26 (2.7) 26 (2.6) Headache 69 (7.1) 66 (6.7) General disorders and administration Infusion site phlebitis 24 (2.5) 15 (1.5) Infusion site reaction 19 (1.9) 34 (3.5) Infections and infestations Abscess (limb and subcutaneous) 37 (3.8) 23 (2.3) Investigations Alanine aminotransferase increased 27 (2.8) 15 (1.5) Aspartate aminotransferase increased 18 (1.8) 15 (1.5) Cardiac disorders Tachycardia 24 (2.5) 11 (1.1) The following selected adverse reactions were reported in ORBACTIV-treated patients at a rate of less than 1.5%: Blood and lymphatic system disorders : anemia, eosinophilia General disorders and administration site conditions: infusion site erythema, extravasation, induration, pruritus, rash, edema peripheral Immune system disorders: hypersensitivity Infections and infestations: osteomyelitis Investigations: total bilirubin increased, hyperuricemia Metabolism and nutrition disorders: hypoglycemia Musculoskeletal and connective tissue disorders: tenosynovitis, myalgia Respiratory, thoracic and mediastinal d…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Effect of ORBACTIV on CYP Substrates A screening drug-drug interaction study indicated that ORBACTIV is a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or inducer (CYP3A4 and CYP2D6) of several CYP isoforms [see Clinical Pharmacology (12.3) ] . A drug-drug interaction study that assessed the interaction potential of a single 1,200 mg dose of ORBACTIV on the pharmacokinetics of S-warfarin (CYP2C9 probe substrate) showed no effect of ORBACTIV on S-warfarin C max or AUC. Avoid administering ORBACTIV concomitantly with drugs that are predominantly metabolized by one of the affected CYP450 enzymes, as co-administration may increase or decrease concentrations of those drugs.

Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given ORBACTIV while on a potentially affected compound (e.g. patients should be monitored for bleeding if concomitantly receiving ORBACTIV and warfarin).

7.2Drug-Laboratory Test Interactions Prolongation of Certain Laboratory Coagulation Tests ORBACTIV may artificially prolong certain laboratory coagulation tests (see Table 2 ) by binding to and preventing the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests [see Contraindications (4.1) and Warnings and Precautions (5.1 , 5.5) ] . For patients who require monitoring of anticoagulation effect within the indicated time after ORBACTIV dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.

ORBACTIV does not interfere with coagulation in vivo. In addition, ORBACTIV does not affect tests that are used for diagnosis of Heparin Induced Thrombocytopenia (HIT). Table 2: Coagulation Tests Affected and Unaffected by ORBACTIV Elevated by ORBACTIV Unaffected by ORBACTIV Prothrombin time (PT) up to 12 hours Chromogenic Factor Xa Assay International normalized ratio (INR) up to 12 hours Thrombin Time (TT) Activated partial thromboplastin time (aPTT) up to 120 hours Activated clotting time (ACT) up to 24 hours Silica clot time (SCT) up to 18 hours Dilute Russell's viper venom time (DRVVT) up to 72 hours D-dimer up to 72 hours Positive Indirect and Direct Antiglobulin Tests (IAT/DAT) Positive IAT/DAT were noted with administration of oritavancin products, including ORBACTIV, in studies with healthy volunteers and patients with ABSSSI.

Positive IAT may interfere with cross-matching before blood transfusion [see Adverse Reactions (6.2) ] .

🔄 Drug / Laboratory Test Interactions ~1 min read ▾

7.2Drug-Laboratory Test Interactions Prolongation of Certain Laboratory Coagulation Tests ORBACTIV may artificially prolong certain laboratory coagulation tests (see Table 2 ) by binding to and preventing the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests [see Contraindications (4.1) and Warnings and Precautions (5.1 , 5.5) ] . For patients who require monitoring of anticoagulation effect within the indicated time after ORBACTIV dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.

ORBACTIV does not interfere with coagulation in vivo. In addition, ORBACTIV does not affect tests that are used for diagnosis of Heparin Induced Thrombocytopenia (HIT). Table 2: Coagulation Tests Affected and Unaffected by ORBACTIV Elevated by ORBACTIV Unaffected by ORBACTIV Prothrombin time (PT) up to 12 hours Chromogenic Factor Xa Assay International normalized ratio (INR) up to 12 hours Thrombin Time (TT) Activated partial thromboplastin time (aPTT) up to 120 hours Activated clotting time (ACT) up to 24 hours Silica clot time (SCT) up to 18 hours Dilute Russell's viper venom time (DRVVT) up to 72 hours D-dimer up to 72 hours Positive Indirect and Direct Antiglobulin Tests (IAT/DAT) Positive IAT/DAT were noted with administration of oritavancin products, including ORBACTIV, in studies with healthy volunteers and patients with ABSSSI.

Positive IAT may interfere with cross-matching before blood transfusion [see Adverse Reactions (6.2) ] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ORBACTIV use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development or survival were observed in pregnant rats or rabbits treated at the highest doses throughout organogenesis with intravenous oritavancin, at doses equivalent to 25% of the single clinical dose of 1,200 mg (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oritavancin at the highest doses administered throughout organogenesis, 30 mg/kg/day (gestation days 6-17) and 15 mg/kg/day (gestation days 7-19), respectively.

Those doses would be equivalent to a human dose of 300 mg, or 25% of the single clinical dose of 1,200 mg. Higher doses were not evaluated in nonclinical developmental and reproductive toxicology studies.

8.2Lactation Risk Summary There are no data on the presence of oritavancin in human milk, the effects on the breastfed- child, or the effects on milk production. ORBACTIV is present in the breast milk of rats (see Data ) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ORBACTIV and any potential adverse effects on the breast-fed child from ORBACTIV or from the underlying maternal condition. Data Following a single intravenous infusion in lactating rats, radio-labeled [ 14 C]-oritavancin was excreted in milk and absorbed by nursing pups.

8.4Pediatric Use Safety and effectiveness of ORBACTIV in pediatric patients (younger than 18 years of age) have not been established.

8.5Geriatric Use The pooled Phase 3 ABSSSI clinical trials of ORBACTIV did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Renal Impairment No dosage adjustment of ORBACTIV is needed in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3) ] . The pharmacokinetics of ORBACTIV in severe renal impairment have not been evaluated. ORBACTIV is not removed from blood by hemodialysis.

8.7Hepatic Impairment No dosage adjustment of ORBACTIV is needed in patients with mild or moderate hepatic impairment. The pharmacokinetics of ORBACTIV in patients with severe hepatic insufficiency has not been studied [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] .

🤰 Pregnancy 211 words ▾

8.1Pregnancy Risk Summary There are no available data on ORBACTIV use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development or survival were observed in pregnant rats or rabbits treated at the highest doses throughout organogenesis with intravenous oritavancin, at doses equivalent to 25% of the single clinical dose of 1,200 mg (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oritavancin at the highest doses administered throughout organogenesis, 30 mg/kg/day (gestation days 6-17) and 15 mg/kg/day (gestation days 7-19), respectively.

Those doses would be equivalent to a human dose of 300 mg, or 25% of the single clinical dose of 1,200 mg. Higher doses were not evaluated in nonclinical developmental and reproductive toxicology studies.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use Safety and effectiveness of ORBACTIV in pediatric patients (younger than 18 years of age) have not been established.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use The pooled Phase 3 ABSSSI clinical trials of ORBACTIV did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 43 words ▾

10 OVERDOSAGE In the ORBACTIV clinical program there was no incidence of accidental overdose of ORBACTIV. Based on an in vitro hemodialysis study, ORBACTIV is unlikely to be removed from blood by hemodialysis. In the event of overdose, supportive measures should be taken.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Oritavancin is an antibacterial drug [see Microbiology (12.4) ] .

12.2Pharmacodynamics The antimicrobial activity of oritavancin appears to correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) based on animal models of infection. Exposure-response analyses from both preclinical and clinical studies support the treatment of clinically relevant Gram-positive microorganisms (e.g. S. aureus and S. pyogenes ) causative of ABSSSI with a single 1,200 mg dose of ORBACTIV.

Cardiac Electrophysiology In a thorough QTc study of 135 healthy subjects at a dose 1.3 times the 1,200 mg recommended dose, ORBACTIV did not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics The population PK analysis was derived using data from the two Phase 3 ABSSSI clinical trials in 297 patients. The mean ( ± SD) pharmacokinetic parameters of oritavancin in patients following a single 1,200 mg dose are presented in Table 3. Table 3: Mean (±SD) PK parameters for patients receiving a single ORBACTIV 1,200 mg dose for ABSSSI (n=297) Parameter Mean (±SD) C max , Maximum plasma concentration; AUC 0-24 , Area under the plasma concentration-time curve from time zero to 24 hours, AUC 0-∞, Area under the plasma concentration time curve from time zero to infinity; SD, Standard Deviation.

C max (µg/mL) 138 ( ± 31.7) AUC 0-24 (µg∙h/mL) 1110 ( ± 378) AUC 0-∞ (µg∙h/mL) 2800 ( ± 801) Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg. The mean, population-predicted oritavancin concentration-time profile displays a multi-exponential decline with a long terminal plasma half-life. Distribution Oritavancin is approximately 85% bound to human plasma proteins.

Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately

87.6L, indicating oritavancin is extensively distributed into the tissues. Exposures of oritavancin in skin blister fluid were approximately 20% of those in plasma (AUC 0-24 ) after single 800 mg dose in healthy subjects. Metabolism/Excretion Non-clinical studies including in vitro human liver microsome studies indicated that oritavancin is not metabolized.

No mass balance study has been conducted in humans. In humans, oritavancin is slowly excreted unchanged in feces and urine with less than 1% and 5% of the dose recovered in feces and urine, respectively, after 2 weeks of collection. Oritavancin has a terminal half-life of approximately 245 hours and a clearance of 0.445 L/h based on population pharmacokinetic analyses.

Specific Populations No dosage adjustments of ORBACTIV are required for patients with mild to moderate renal or mild to moderate hepatic impairment or other subpopulations including age, gender, race and weight. Renal Impairment The pharmacokinetics of oritavancin were examined in the Phase 3 ABSSSI trials in patients with normal renal function, CrCL ≥80 mL/min (n=238), mild renal impairment, CrCL 50-79 mL/min (n=48), and moderate renal impairment, CrCL 30-49 mL/min (n=11). Population pharmacokinetic analysis indicated that mild to moderate renal impairment had no clinically relevant effect on the exposure of oritavancin.

No dedicated studies in dialysis patients have been conducted. Dosage adjustment of ORBACTIV is not needed in patients with mild or moderate renal impairment. The pharmacokinetics of oritavancin in patients with severe renal impairment have not been evaluated.

Hepatic Impairment The pharmacokinetics of oritavancin were evaluated in study of subjects with moderate hepatic impairment (Child-Pugh Class B) (n=20) and compared with healthy subjects (n=20) matched for gender, age and weight. There were no relevant changes in pharmacokinetics of oritavancin in subjects with moderate hepatic impairment. Dosage adjustment of ORBACTIV is not needed in patients with mild or moderate hepatic impairment.

The pharmacokinetics of or…

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Oritavancin is an antibacterial drug [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied/Storage ORBACTIV is supplied as a sterile white to off-white lyophilized powder in single-dose clear glass vials containing 400 mg of oritavancin (NDC 70842-140-01), packaged in a carton of 3 vials (NDC 70842-140-03). ORBACTIV vials should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].

📦 Storage and Handling 62 words ▾

16.1How Supplied/Storage ORBACTIV is supplied as a sterile white to off-white lyophilized powder in single-dose clear glass vials containing 400 mg of oritavancin (NDC 70842-140-01), packaged in a carton of 3 vials (NDC 70842-140-03). ORBACTIV vials should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].

📋 Description 173 words ▾

11 DESCRIPTION ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug for intravenous infusion. The chemical name for oritavancin is [4"R]-22- O -(3-amino-2,3,6-trideoxy-3- C -methyl-α-L- arabino -hexopyranosyl)- N 3''-[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is C 86 H 97 N 10 O 26 Cl 3 ∙2H 3 PO 4 and the molecular weight is 1989.09.

The chemical structure is represented below: ∙2H 3 PO 4 ORBACTIV for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose clear glass vial that contains 400 mg of oritavancin (equivalent to 444 mg oritavancin diphosphate) and the following inactive ingredients: mannitol (200 mg) and phosphoric acid (to adjust pH 3.1 to 4.3). Each vial is reconstituted with sterile water for injection and further diluted with 5% dextrose injection (D5W) for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be a clear, colorless to pale yellow solution, free of visible particles [see Dosage and Administration (2.3) ] .

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Allergic Reactions Patients should be advised that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should inform their healthcare provider about any previous hypersensitivity reactions to oritavancin products, other glycopeptides (vancomycin, telavancin, or dalbavancin) or other allergens. Diarrhea Patients should be advised that diarrhea is a common problem caused by antibacterial drugs including ORBACTIV, which usually resolves when the drug is discontinued.

Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider. Development of Antibacterial Resistance Patients should be counseled that antibacterial drugs including ORBACTIV should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When ORBACTIV is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ORBACTIV or other antibacterial drugs in the future.

Marketed By: Melinta Therapeutics, LLC Parsippany, NJ 07054 USA ©2025 Melinta Therapeutics, LLC. All rights reserved. MEL060-R006

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