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Daptomycin 350 mg/7mL Injection, Powder, Lyophilized, For Solution — NDC 70594-0066-01 package photo

Daptomycin 350 mg/7mL Injection, Powder, Lyophilized, For Solution

by Xellia Pharmaceuticals USA LLC · 1 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE
NDC 70594-0066-01
🏷️ FDA NDC (as labeled) 70594-066-01 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) 70594-066-01
Product NDC 70594-066
11-digit billing NDC 70594006601
NCPDP billing unit EA — each (per item)
RxCUI 403920, 1996246
UNII NWQ5N31VKK
Application # NDA217415
SPL Set ID 5e1f739a-eb81-43d8-9a14-89f32b7e1ba1
Established class (EPC) Lipopeptide Antibacterial
Chemical class Lipopeptides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-03
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance DAPTOMYCIN
GPI-14 16270030002130
GCN Seq No 060477
GCN 26638
HICL code 025673
Ingredient (HICL) Daptomycin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9B
Therapeutic class — specific (HIC3) Cyclic Lipopeptides
AHFS code 08:12.28.12
AHFS class Cyclic Lipopeptide Antibiotics
FDB label name DAPTOMYCIN 350 MG VIAL
FDB brand name Daptomycin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70594-066-01 — 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 → 70594-0066-01. 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 Lipopeptide Antibacterial class.

Pharmacologic class Lipopeptide Antibacterial
Drug family (ATC) Other antibacterials
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

LabelerXellia Pharmaceuticals USA LLC
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationNDA217415 (NDA)
Labeler code70594
First marketedNov 2023
Product typeHuman Prescription Drug
Portfolio34 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 DAPTOMYCIN 350 MG VIAL Ingredient Daptomycin
📗 Our plain-language guide HelloPharmacist
  • Daptomycin only works when given directly into a vein — there's no oral (pill or liquid) form supported for the infections it treats. It's designed for serious infections like bloo...
  • Why am I getting this antibiotic instead of a pill?
  • The main signs to watch for are new muscle aching, tenderness, or weakness — especially in your arms or legs. Your care team will also check a blood test called CPK (creatine phosp...
  • How will I know if daptomycin is causing a muscle problem?
📖 Read our full Daptomycin guide →
7
Nutrient depletion considerations

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

🧪 Full Daptomycin 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.

  • 188.1 mg / 7 mL UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • 100.5 mg / 7 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 28.3 mg / 7 mL UNII 04Y7590D77
    A naturally occurring amino acid used as a buffering agent and pH stabilizer in medications. It helps maintain the chemical balance of the formulation to protect drug stability.

4 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 eaPer package
Retail pharmacies payNADAC · weekly $13.418 $13.42 / 1 vial
Medicaid paysCMS SDUD · 12 mo $29.22 $29.22 / 1 vial
Medicare drug plans payPart D · Q2 2026 $55.37 $55.37 / 1 vial
Medicare Part B allowsASP · J0872 $0.042 / J0872 unit —
NADAC price history (per ea) — tap or hover for the price & month
Jul 2025 $13.418 $13.418
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)70594-066-01
11-digit billing NDC70594-0066-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0872
DescriptorINJECTION, DAPTOMYCIN (XELLIA), UNREFRIGERATED, NOT THERAPEUTICALLY EQUIVALENT TO J0878 OR J0873, 1 MG
Billing units / pkg350 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
Daptomycin 350 mg/7mL 00143-9455-01 Hikma 1 vial $13.418 — Availability likely —
Daptomycin 350 mg/7mL 00409-0120-01 Hospira, 1 vial $13.418 — Availability likely —
Daptomycin 350 mg/7mL 16729-0434-05 Accord 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 25021-0179-15 Sagent 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 31722-0215-01 Camber 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 43598-0476-11 Dr. 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 70594-0053-01 Xellia 1 vial $13.418 — Availability likely —
Daptomycin 350 mg/7mLthis 70594-0066-01 Xellia 1 vial $13.418 — Availability likely —
Daptomycin 350 mg/7mL 71288-0017-91 Meitheal 1 vial $13.418 AP Availability likely —
daptomycin 350 mg/7mL 71839-0108-01 BE 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 72572-0100-01 Civica, 1 vial $13.418 — Availability likely —
Daptomycin 350 mg/7mL 72603-0147-01 NorthStar 1 vial $13.418 AP Availability likely —
Daptomycin 350 mg/7mL 00143-9456-01 Hikma 1 vial — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2023
First FDA approval
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2043
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 30, 2023 RLD RS ⏳ ~16.3 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 12053502 — method of use (U-3981)
US 12053502 — method of use (U-3981)
US 12629337 — drug product
US 12629337 — drug product
US 11759497 — drug product
US 11759497 — drug product
2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (6)
PatentTypeUse codeExpires
US 12053502 ↗ Method of use U-3981 Aug 28, 2038
US 12053502 ↗ Method of use U-3981 Aug 28, 2038
US 12629337 ↗ Drug product — Jan 9, 2043
US 12629337 ↗ Drug product — Jan 9, 2043
US 11759497 ↗ Drug product — Aug 28, 2038
US 11759497 ↗ Drug product — Aug 28, 2038
Common questions
Is there a generic version of DAPTOMYCIN 350 MG VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for DAPTOMYCIN 350 MG VIAL. See the alternatives section for substitutable, lower-cost products.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70594-0066-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
53
Units reimbursed last 4 qtrs
116
Gross reimbursed last 4 qtrs
$3.4K
Avg / prescription
$63.96
Avg / unit
$29.2243
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$29.2243
gross reimbursed
vs
NADAC / ea
$13.4180
acquisition cost
=
Spread
+$15.8063
+118% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 53 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 40 units · 0.4 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 76 units · 0.3 per 100k residents FL
Units reimbursed · per 100k residents
0.30.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 0.4 /100k
2 Florida 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Daptomycin — the program that covers self-administered drugs. 20 manufacturers.
⚠️ 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 Daptomycin. 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.
Period
Total Part D spend
$33.47M
Claims incl. refills
40.5K
Beneficiaries
11.8K
Spend / beneficiary
$2,832.21
Spend / claim
$826.52
Trend by period
💵 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Daptomycin — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury599
Pyrexia478
Eosinophilic Pneumonia465
Rhabdomyolysis370
Eosinophilia364
Drug Reaction With Eosinophilia And Systemic Symptoms334
Blood Creatine Phosphokinase Increased331

Age at onset

Neonate5
Infant13
Child25
Adolescent24
Adult924
Elderly1,052

Reporter sex

9,174 reports
Male · 61%
Female · 39%
Unknown · 0%

Serious outcomes

Hospitalization5,225
Death1,268
Life-threatening964
Disabling123
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,107 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70594-0066-01 You're viewing this 1 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE 2023-11-03 Active

📄 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 👥 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 ~3 min read ▾

1 INDICATIONS AND USAGE Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use: Daptomycin for Injection is not indicated for the treatment of pneumonia.

( 1.4 ) Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.4 ) Daptomycin for Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs. ( 1.4 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.5 )

1.1Complicated Skin and Skin Structure Infections (cSSSI) Daptomycin for Injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

1.2Staphylococcus aureus Bloodstream Infections (Bacteremia) in Adult Patients, Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates Daptomycin for Injection is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

1.3Staphylococcus aureus Bloodstream Infections (Bacteremia) in Pediatric Patients (1 to 17 Years of Age) Daptomycin for Injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia).

1.4Limitations of Use Daptomycin for Injection is not indicated for the treatment of pneumonia. Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . The clinical trial of daptomycin for injection in adult patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see Clinical Studies (14.2) ].

Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis. Daptomycin for Injection is not recommended in pediatric patients younger than 1 year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2) ] .

1.5Usage Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection 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 is available, it should be considered in selecting or modif…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Patients Administer to adult patients intravenously, either by injection over a 2-minute period or by infusion over a 30-minute period. ( 2.1 , 2.7 ) Recommended dosage regimen for adult patients ( 2.2 , 2.4 , 2.6 ): Creatinine Clearance (CL CR ) Dosage Regimen cSSSI For 7 to 14 days S. aureus Bacteremia For 2 to 6 weeks ≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours <30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours Administered following hemodialysis on hemodialysis days.

6 mg/kg once every 48 hours Pediatric Patients Unlike in adults, do NOT administer by injection over a two (2) minute period to pediatric patients. ( 2.1 , 2.7 ) Administer to pediatric patients intravenously by infusion over a 30- or 60-minute period, based on age. ( 2.1 , 2.7 ) Recommended dosage regimen for pediatric patients (1 to 17 years of age) with cSSSI, based on age ( 2.3 ): Age group Dosage Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function.

Dosage adjustment for pediatric patients with renal impairment has not been established. Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes 1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes Recommended dosage regimen for pediatric patients (1 to 17 years of age) with S. aureus bacteremia, based on age ( 2.5 ): Age group Dosage Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function.

Dosage adjustment for pediatric patients with renal impairment has not been established. Duration of therapy 12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days 7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes 1 to 6 years 12 mg/kg once every 24 hours infused over 60 minutes There are other formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in this labeling.

( 2.7 ) Do not use in conjunction with ReadyMED ® elastomeric infusion pumps in adult and pediatric patients. ( 2.9 )

2.1Important Administration Duration Instructions Adults Administer the appropriate volume of the reconstituted Daptomycin for Injection (concentration of 50 mg/mL) to adult patients intravenously either by injection over a two (2) minute period or by intravenous infusion over a thirty (30) minute period [see Dosage and Administration (2.2 , 2.4 , 2.7) ] . Pediatric Patients (1 to 17 Years of Age) Unlike in adults, do NOT administer Daptomycin for Injection by injection over a two (2) minute period to pediatric patients.

Pediatric Patients 7 to 17 years of Age : Administer Daptomycin for Injection intravenously by infusion over a 30-minute period [see Dosage and Administration (2.3 , 2.5 , 2.7) ] . Pediatric Patients 1 to 6 years of Age: Administer Daptomycin for Injection intravenously by infusion over a 60-minute period [see Dosage and Administration (2.3 , 2.5 , 2.7) ] .

2.2Dosage in Adults for cSSSI Administer Daptomycin for Injection 4 mg/kg to adult patients intravenously once every 24 hours for 7 to 14 days.

2.3Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Administer Daptomycin for Injection intravenously once every 24 hours for up to 14 days. Table 1: Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with cSSSI, Based on Age Age Range Dosage Regimen Recommended dosage regimen is for pediatric patients (1 to 17 years of age) with normal renal function.

Dosage adjustment for pediatric patients with renal impairment has not been established. Duration of therapy 12 to 17 years 5 mg/kg once every 24 ho…

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 350 mg or 500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder or cake in a single-dose vial for reconstitution. For Injection: 350 mg and 500 mg of daptomycin as a lyophilized powder or cake in a single-dose vial for reconstitution ( 3 )

⛔ Contraindications 27 words ▾

4 CONTRAINDICATIONS Daptomycin for Injection is contraindicated in patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1) ]. Known hypersensitivity to daptomycin. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue Daptomycin for Injection and treat signs/symptoms. ( 5.1 ) Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of Daptomycin for Injection. ( 5.2 ) Eosinophilic pneumonia: Discontinue Daptomycin for Injection and consider treatment with systemic steroids.

( 5.3 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue Daptomycin for Injection and institute appropriate treatment. ( 5.4 ) Tubulointerstitial Nephritis (TIN): Discontinue Daptomycin for Injection and institute appropriate treatment. ( 5.5 ) Peripheral neuropathy: Monitor for neuropathy and consider discontinuation.

( 5.6 ) Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of Daptomycin for Injection in this age group. ( 5.7 ) Clostridioides difficile– associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.8 ) Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection.

( 5.9 ) Decreased efficacy was observed in adult patients with moderate baseline renal impairment. ( 5.10 )

5.1Anaphylaxis/Hypersensitivity Reactions Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including daptomycin for injection, and may be life-threatening. If an allergic reaction to Daptomycin for Injection occurs, discontinue the drug and institute appropriate therapy [see Adverse Reactions (6.2) ].

5.2Myopathy and Rhabdomyolysis Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN), has been reported with the use of daptomycin for injection. Rhabdomyolysis, with or without acute renal failure, has been reported [see Adverse Reactions (6.2) ] . Patients receiving Daptomycin for Injection should be monitored for the development of muscle pain or weakness, particularly of the distal extremities.

In patients who receive Daptomycin for Injection, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with Daptomycin for Injection. In adult patients with renal impairment, both renal function and CPK should be monitored more frequently than once weekly [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. In Phase 1 studies and Phase 2 clinical trials in adults, CPK elevations appeared to be more frequent when daptomycin for injection was dosed more than once daily.

Therefore, Daptomycin for Injection should not be dosed more frequently than once a day. Daptomycin for Injection should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevations to levels >1,000 U/L (~5× ULN), and in patients without reported symptoms who have marked elevations in CPK, with levels >2,000 U/L (≥10× ULN). In addition, consideration should be given to suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors, temporarily in patients receiving Daptomycin for Injection [see Drug Interactions (7.1) ].

5.3Eosinophilic Pneumonia Eosinophilic pneumonia has been reported in patients receiving daptomycin for injection [see Adverse Reactions (6.2) ]. In reported cases associated with daptomycin for injection, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting daptomycin for injection and improved when daptomycin for injection was discontinued and steroid therapy was initiated.

Recurrence of…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.2) ] Eosinophilic Pneumonia [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.4) ] Tubulointerstitial Nephritis [see Warnings and Precautions (5.5) ] Peripheral Neuropathy [see Warnings and Precautions (5.6) ] Increased International Normalized Ratio (INR)/Prolonged Prothrombin Time [see Warnings and Precautions (5.11) and Drug Interactions (7.2) ] Adult cSSSI Patients : The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin for injection 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea.

( 6.1 ) Pediatric cSSSI Patients : The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin for injection were diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache. ( 6.1 ) Adult S. aureus bacteremia/endocarditis Patients: The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving daptomycin for injection 6 mg/kg were sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritus, increased sweating, insomnia, elevated CPK, and hypertension.

( 6.1 ) Pediatric S. aureus bacteremia Patients : The most common adverse reactions that occurred in ≥5% of pediatric patients receiving daptomycin for injection were vomiting and elevated CPK. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953 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 a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin for injection and 1,416 treated with comparator. Complicated Skin and Skin Structure Infection Trials in Adults In Phase 3 complicated skin and skin structure infection (cSSSI) trials in adult patients, daptomycin for injection was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients.

The rates of the most common adverse reactions, organized by body system, observed in adult patients with cSSSI (receiving 4 mg/kg daptomycin for injection) are displayed in Table 7. Table 7: Incidence of Adverse Reactions that Occurred in ≥2% of Adult Patients in the Daptomycin for Injection Treatment Group and ≥ the Comparator Treatment Group in Phase 3 cSSSI Trials Adverse Reaction Adult Patients (%) Daptomycin for Injection 4 mg/kg (N=534) Comparator Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).

(N=558) Gastrointestinal disorders Diarrhea 5.2

4.3Nervous system disorders Headache 5.4

5.4Dizziness 2.2

2.0Skin/subcutaneous disorders Rash 4.3

3.8Diagnostic investigations Abnormal liver function tests 3.0

1.6Elevated CPK 2.8

1.8Infections Urinary tract infections 2.4

0.5Vascular disorders Hypotension 2.4

1.4Respiratory disorders Dyspnea 2.1

1.6Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of adult patients receiving daptomycin for injection in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity Blood/Lymphatic System: leukocytosis, throm…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin for injection and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy [see Clinical Pharmacology (12.3) ]. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK [see Adverse Reactions (6.1) ].

Experience with the coadministration of HMG-CoA reductase inhibitors and daptomycin for injection in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving Daptomycin for Injection.

7.2Drug-Laboratory Test Interactions Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay. The possibility of an erroneously elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin.

However, sufficient daptomycin concentrations may be present at trough to cause interaction. If confronted with an abnormally high PT/INR result in a patient being treated with Daptomycin for Injection, it is recommended that clinicians: Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next Daptomycin for Injection dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method.

Evaluate for other causes of abnormally elevated PT/INR results.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed.

The 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 2-4% and 15-20%, respectively.

Data Animal Data In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. Maternal body weight gain was decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area).

In pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area).

In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area) 1 .

8.2Lactation Risk Summary Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose (see Data ) 2,3,4 . There is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for daptomycin for injection and any potential adverse effects on the breastfed infant from Daptomycin for Injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of daptomycin for injection in the treatment of cSSSI and S. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. Use of Daptomycin for Injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1 , 14.2) ] .

Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Daptomycin for Injection in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2) ]. Daptomycin for Injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients.

Daptomycin for injection has not been studied in pediatric patients with other bacterial infections.

8.5 Geriatric Use Of the 534 adult patients tre…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed.

The 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 2-4% and 15-20%, respectively.

Data Animal Data In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. Maternal body weight gain was decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area).

In pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area).

In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area) 1 .

🧒 Pediatric Use 195 words ▾

8.4Pediatric Use The safety and effectiveness of daptomycin for injection in the treatment of cSSSI and S. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. Use of Daptomycin for Injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1 , 14.2) ] .

Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Daptomycin for Injection in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see Warnings and Precautions (5.7) and Nonclinical Toxicology (13.2) ]. Daptomycin for Injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients.

Daptomycin for injection has not been studied in pediatric patients with other bacterial infections.

🧓 Geriatric Use 180 words ▾

8.5Geriatric Use Of the 534 adult patients treated with daptomycin for injection in Phase 3 controlled clinical trials of complicated skin and skin structure infections (cSSSI), 27% were 65 years of age or older and 12% were 75 years of age or older. Of the 120 adult patients treated with daptomycin for injection in the Phase 3 controlled clinical trial of S. aureus bacteremia/endocarditis, 25% were 65 years of age or older and 16% were 75 years of age or older. In Phase 3 adult clinical trials of cSSSI and S. aureus bacteremia/endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of age.

In addition, treatment-emergent adverse events were more common in patients ≥65 years of age than in patients <65 years of age. The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. However, no adjustment of Daptomycin for Injection dosage is warranted for elderly patients with creatinine clearance (CL CR ) ≥30 mL/min [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) ].

🆘 Overdosage 76 words ▾

10 OVERDOSAGE In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Daptomycin is cleared slowly from the body by hemodialysis (approximately 15% of the administered dose is removed over 4 hours) and by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours). The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with that removed by low-flux membranes.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Daptomycin is an antibacterial drug [see Clinical Pharmacology (12.4) ].

12.2Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including S. aureus . The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with daptomycin for injection.

12.3Pharmacokinetics Daptomycin for Injection Administered over a 30-Minute Period in Adults The mean and standard deviation (SD) pharmacokinetic parameters of daptomycin at steady-state following intravenous (IV) administration of daptomycin for injection over a 30-minute period at 4 to 12 mg/kg every 24h to healthy young adults are summarized in Table 12. Table 12: Mean (SD) Daptomycin Pharmacokinetic Parameters in Healthy Adult Volunteers at Steady-State Dose Daptomycin for injection was administered by IV infusion over a 30-minute period.

Doses of Daptomycin for injection in excess of 6 mg/kg have not been approved. (mg/kg) Pharmacokinetic Parameters AUC 0-24 , area under the concentration-time curve from 0 to 24 hours; t 1/2 , elimination half-life; V ss , volume of distribution at steady-state; CL T , total plasma clearance; C max , maximum plasma concentration. AUC 0-24 (mcg∙h/mL) t 1/2 (h) V ss (L/kg) CL T (mL/h/kg) C max (mcg/mL) 4 (N=6) 494 (75) 8.1 (1.0) 0.096 (0.009) 8.3 (1.3) 57.8 (3.0) 6 (N=6) 632 (78) 7.9 (1.0) 0.101 (0.007) 9.1 (1.5) 93.9 (6.0) 8 (N=6) 858 (213) 8.3 (2.2) 0.101 (0.013) 9.0 (3.0) 123.3 (16.0) 10 (N=9) 1039 (178) 7.9 (0.6) 0.098 (0.017) 8.8 (2.2) 141.1 (24.0) 12 (N=9) 1277 (253) 7.7 (1.1) 0.097 (0.018) 9.0 (2.8) 183.7 (25.0) Daptomycin pharmacokinetics were generally linear and time-independent at daptomycin for injection doses of 4 to 12 mg/kg every 24h administered by IV infusion over a 30-minute period for up to 14 days.

Steady-state trough concentrations were achieved by the third daily dose. The mean (SD) steady-state trough concentrations attained following the administration of 4, 6, 8, 10, and 12 mg/kg every 24h were 5.9 (1.6), 6.7 (1.6), 10.3 (5.5), 12.9 (2.9), and 13.7 (5.2) mcg/mL, respectively. Daptomycin for Injection Administered over a 2-Minute Period in Adults Following IV administration of daptomycin for injection over a 2-minute period to healthy adult volunteers at doses of 4 mg/kg (N=8) and 6 mg/kg (N=12), the mean (SD) steady-state systemic exposure (AUC) values were 475 (71) and 701 (82) mcg∙h/mL, respectively.

Values for maximum plasma concentration (C max ) at the end of the 2-minute period could not be determined adequately in this study. However, using pharmacokinetic parameters from 14 healthy adult volunteers who received a single dose of daptomycin for injection 6 mg/kg IV administered over a 30-minute period in a separate study, steady-state C max values were simulated for daptomycin for injection 4 and 6 mg/kg IV administered over a 2-minute period. The simulated mean (SD) steady-state C max values were 77.7 (8.1) and 116.6 (12.2) mcg/mL, respectively.

Distribution Daptomycin is reversibly bound to human plasma proteins, primarily to serum albumin, in a concentration-independent manner. The overall mean binding ranges from 90 to 93%. In clinical studies, mean serum protein binding in adult subjects with creatinine clearance (CL CR ) ≥30 mL/min was comparable to that observed in healthy adult subjects with normal renal function.

However, there was a trend toward decreasing serum protein binding among subjects with CL CR <30 mL/min (88%), including those receiving hemodialysis (86%) and continuous ambulatory peritoneal dialysis (CAPD) (84%). The protein binding of daptomycin in adult subjects with moderate hepatic impairment (Child-Pugh Class B) was similar to that in healthy adult subjects. The volume of…

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Daptomycin is an antibacterial drug [see Clinical Pharmacology (12.4) ].

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized powder or cake in a single-dose vial containing either 350 mg or 500 mg of daptomycin: Unit of Sale Strength NDC 70594- 066 -01 Carton containing 1 single-dose vial 350 mg/vial NDC 70594- 060 -01 Carton containing 1 single-dose vial 500 mg/vial Store original packages 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]. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7) ] .

📦 Storage and Handling 48 words ▾

Store original packages 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]. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7) ] .

📋 Description 189 words ▾

11 DESCRIPTION Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67.

Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7) ]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH.

Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7.

Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Allergic Reactions Advise patients that allergic reactions, including serious skin, kidney, lung, or other organ reactions, could occur and that these serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1 , 5.4 , 5.5) ]. Muscle Pain or Weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy) Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness [see Warnings and Precautions (5.2 , 5.6) ].

Cough, Breathlessness or Fever (Eosinophilic Pneumonia) Advise patients to report any symptoms of cough, breathlessness, or fever [see Warnings and Precautions (5.3) ]. C. difficile -Associated Diarrhea (CDAD) Advise patients that diarrhea is a common problem caused by antibacterials, including Daptomycin for Injection, that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, including Daptomycin for Injection, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial.

If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.8) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including Daptomycin for Injection, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When Daptomycin for Injection 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 administered 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 Daptomycin for Injection or other antibacterial drugs in the future.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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