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COSELA trilaciclib 300 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 73594-0101-01 package photo

COSELA trilaciclib 300 mg/20mL Injection, Powder, Lyophilized, For Solution

by Pharmacosmos Therapeutics Inc. · 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS
NDC 73594-0101-01
🏷️ FDA NDC (as labeled) 73594-0101-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 73594-0101-1
Product NDC 73594-0101
11-digit billing NDC 73594010101
NCPDP billing unit EA — each (per item)
RxCUI 2479705, 2479710
UNII 4BX07W725T
UPC 0373594010114
Application # NDA214200
SPL Set ID b3179c19-78f3-4bf1-b73e-7f7638522ab1
Established class (EPC) Kinase Inhibitor; Organic Cation Tr
Mechanism of action Cyclin-dependent Kinase 4 Inhibitors; Cyclin-dependent Kinase 6 Inhibitors; Multidrug and Toxin Extrusion Transporter 1 Inhibitors; Multidrug and Toxin Extrusion Transporter 2 K Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-25
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance TRILACICLIB DIHYDROCHLORIDE
GPI-14 21756570202120
GCN Seq No 081942
GCN 49212
HICL code 047121
Ingredient (HICL) Trilaciclib Dihydrochloride
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1I
Therapeutic class — specific (HIC3) Chemotherapy Rescue/Antidote Agents
AHFS code 91:04.12.00
AHFS class Chemotherapy Antidotes/Protectants
FDB label name COSELA 300 MG VIAL
FDB brand name Cosela
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 73594-0101-1 — a 5-4-1 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 package segment → 73594-0101-01. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Detoxifying agents for antineoplastic treatment
How it works Organic Cation Transporter 2 Inhibitors, Multidrug and Toxin Extrusion Transporter 1 Inhibitors, Cyclin-dependent Kinase 4 Inhibitors, Cyclin-dependent Kinase 6 Inhibitors
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

LabelerPharmacosmos Therapeutics Inc.
Application holderPHARMACOSMOS AS
FDA applicationNDA214200 (NDA)
Labeler code73594
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio4 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 COSELA 300 MG VIAL Ingredient Trilaciclib Dihydrochloride
📖 What it is MedlinePlus · NLM

Trilaciclib injection is used to decrease the risk of myelosuppression (a decrease in red blood cells, white blood cells, and platelets) from certain chemotherapy medications in adults with small cell lung cancer (SCLC). Trilaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of certain substances in the body to protect the cells in the bone marrow and immune system from damage during chemotherapy.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, Cosela isn't chemotherapy itself. It's given before your chemo to help protect your bone marrow from damage. Chemotherapy can knock down your body's ability to make blood cells...
  • What exactly does Cosela do — is it part of my chemotherapy?
  • Cosela is given as a 30-minute IV infusion at your treatment center before chemotherapy on every day that chemo is scheduled. It must finish at least no more than 4 hours before yo...
  • How and when will I get this medication?
📖 Read our full Trilaciclib Injection guide →
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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 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 · J1448 $5.463 / J1448 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)73594-0101-1
11-digit billing NDC73594-0101-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1448
DescriptorInjection, trilaciclib, 1mg
Billing units / pkg300 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
Cosela 300 mg/20mL 73462-0101-01 G1 1 vial — — FDA listed —
Cosela 300 mg/20mLthis 73594-0101-01 Pharmacosmos 1 vial — — 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

🏛️
2021
First FDA approval
Feb 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2040
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 Nov 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 12, 2021 RLD RS ⏳ ~14.2 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 12527798 — method of use (U-3504)
US 9487530 — method of use (U-3079)
US 9487530 — method of use (U-3080)
US 10085992 — method of use (U-3081)
US 11529352 — method of use (U-3504)
US 11717523 — method of use (U-3678)
US 11717523 — method of use (U-3679)
US 10966984 — method of use (U-3079)
US 10966984 — method of use (U-3080)
US 11040042 — drug product
US 10189850 — drug product
US 10189849 — drug substance
US 10927120 — drug product
US 8598186 — drug substance
US 9957276 — drug substance
US 8598197 — drug substance
US 12168666 — drug substance
Exclusivity NCE
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (17)
PatentTypeUse codeExpires
US 12527798 ↗ Method of use U-3504 Dec 5, 2037
US 9487530 ↗ Method of use U-3079 Mar 14, 2034
US 9487530 ↗ Method of use U-3080 Mar 14, 2034
US 10085992 ↗ Method of use U-3081 Mar 14, 2034
US 11529352 ↗ Method of use U-3504 Jul 23, 2039
US 11717523 ↗ Method of use U-3678 Mar 14, 2034
US 11717523 ↗ Method of use U-3679 Mar 14, 2034
US 10966984 ↗ Method of use U-3079 Mar 14, 2034
US 10966984 ↗ Method of use U-3080 Mar 14, 2034
US 11040042 ↗ Drug product — Oct 25, 2031
US 10189850 ↗ Drug product — Oct 25, 2031
US 10189849 ↗ Drug substance — Oct 25, 2031
US 10927120 ↗ Drug product — Oct 25, 2031
US 8598186 ↗ Drug substance — Dec 30, 2034
US 9957276 ↗ Drug substance — Oct 25, 2031
US 8598197 ↗ Drug substance — Oct 25, 2031
US 12168666 ↗ Drug substance — Nov 13, 2040
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Feb 12, 2026
Common questions
Is there a generic version of COSELA 300 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for COSELA 300 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2040 — 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 Cosela — 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 Cosela. 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
$324.7K
Claims incl. refills
37
Beneficiaries
14
Spend / beneficiary
$23,194.26
Spend / claim
$8,776.21
💵 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 COSELA (this brand).

Top reported reactions

Myelosuppression36
Dyspnoea19
White Blood Cell Count Decreased18
Platelet Count Decreased17
Death16
Pneumonia15
Anaemia14

Age at onset

Adult24
Elderly20

Reporter sex

241 reports
Male · 58%
Female · 42%

Serious outcomes

Hospitalization78
Death25
Life-threatening11
Disabling3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 28 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
73594-0101-01 You're viewing this 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS 2025-08-25 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 73594-0101-1, 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: 73594-0101-01, written without dashes as 73594010101. 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 73594-0101-01, the first segment (73594) is the labeler code FDA assigned to Pharmacosmos Therapeutics Inc.; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Pharmacosmos Therapeutics Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmacosmos Therapeutics Inc. 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 J1448 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION COSELA is for intravenous use only. The recommended dose of COSELA is 240 mg/m 2 as a 30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy on each day chemotherapy is administered. ( 2.1 ) Reduce dose in patients with moderate or severe hepatic impairment. ( 2.2 ). See Full Prescribing Information for instructions on preparation and administration. ( 2.3 )

2.1Recommended Dosage The recommended dose of COSELA is 240 mg/m 2 per dose. Administer as a 30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy on each day chemotherapy is administered. The interval between doses of COSELA on sequential days should not be greater than 28 hours.

Missed Treatment Session(s) If the COSELA dose is missed, discontinue chemotherapy on the day the COSELA dose was missed. Consider resuming both COSELA and chemotherapy on the next scheduled day for chemotherapy. Discontinuation of Treatment If COSELA is discontinued, wait 96 hours from the last dose of COSELA before resumption of chemotherapy only.

2.2Dose Modification Dose Modification for Adverse Reactions Withhold, discontinue, or alter the administration of COSELA to manage adverse reactions as described in Table 1 [see Warnings and Precautions ( 5 )]. Table 1: Recommended Actions for Adverse Reactions Adverse Reaction Severity Grade* Recommended Action * National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version

4.03Injection-site reactions including phlebitis and thrombophlebitis Grade 1: Tenderness with or without symptoms (e.g., warmth, erythema, itching) Interrupt or slow infusion of COSELA. If 0.9% Sodium Chloride Injection, USP is being used as a diluent/flush, consider changing to 5% Dextrose Injection, USP as appropriate for subsequent infusions. Grade 2: Pain; lipodystrophy; edema; phlebitis Interrupt infusion of COSELA.

If pain not severe, follow instructions for Grade 1. Otherwise, stop infusion in extremity and rotate site of infusion to site in alternative extremity. If 0.9% Sodium Chloride Injection, USP is being used as a diluent/flush, consider changing to 5% Dextrose Injection, USP as appropriate for subsequent infusions.

Central access may also be considered. Grade 3: Ulceration or necrosis; severe tissue damage; operative intervention indicated. OR Grade 4: Life-threatening consequences; urgent interventions indicated.

Stop infusion and permanently discontinue COSELA. Acute drug hypersensitivity reactions Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting Activities of Daily Living (ADL). Stop infusion and hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA.

If Grade 2 recurs, permanently discontinue COSELA. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. OR Grade 4: Life-threatening consequences; urgent intervention indicated.

Permanently discontinue COSELA. Interstitial lung disease/pneumonitis Grade 2 (symptomatic) Hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA. If Grade 2 recurs, permanently discontinue COSELA.

Grade 3: Severe symptoms; limiting self-care ADL; oxygen indicated. OR Grade 4: Life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation) Permanently discontinue COSELA. Other toxicities Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.

Hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA. If Grade 3 recurs, permanently discontinue COSELA. Grade 4: Life-threatening consequences; urgent intervention indicated.

Permanently discontinue COSELA. Dose Modifications for Hepatic Impairment Reduce the…

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: Contains the equivalent of 300 mg of trilaciclib (provided as 349 mg of trilaciclib dihydrochloride) as a sterile, preservative-free, yellow, lyophilized cake in a single-dose vial for reconstitution and further dilution. For injection: 300 mg of trilaciclib as a lyophilized cake in a single-dose vial. ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )] . Patients with a history of serious hypersensitivity reactions to COSELA. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Injection-Site Reactions, Including Phlebitis and Thrombophlebitis: Monitor for signs and symptoms of injection-site reactions, including phlebitis and thrombophlebitis during infusion. Stop infusion and permanently discontinue COSELA for severe or life-threatening reactions. ( 5.1 ) Acute Drug Hypersensitivity Reactions: Monitor for signs and symptoms of acute drug hypersensitivity reactions, including edema (facial, eye, and tongue), urticaria, pruritus, and anaphylactic reactions.

Withhold COSELA for moderate reactions, and permanently discontinue for severe or life-threatening reactions. ( 5.2 ) Interstitial Lung Disease (ILD)/Pneumonitis: Patients treated with CDK4/6 inhibitors should be monitored for pulmonary symptoms indicative of ILD/pneumonitis. Interrupt and evaluate patients with new or worsening symptoms suspected to be due to ILD/pneumonitis.

Permanently discontinue COSELA in patients with recurrent symptomatic or severe/life-threatening ILD/pneumonitis. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

( 5.4 )

5.1Injection-Site Reactions, Including Phlebitis and Thrombophlebitis COSELA administration can cause injection-site reactions including phlebitis and thrombophlebitis. Injection-site reactions including phlebitis and thrombophlebitis occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions (ARs). The median time to onset from start of COSELA was 15 days (range 1 to 542) and from the preceding dose of COSELA was 1 day (1 to 15).

The median duration was 1 day (range 1 to 151 for the resolved cases). Injection-site reactions including phlebitis and thrombophlebitis resolved in 49 (88%) of the 56 patients and led to discontinuation of treatment in 3 (1%) of the 272 patients. Monitor patients for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including infusion-site pain and erythema during infusion.

For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA [see Dosage and Administration ( 2.2 )] .

5.2Acute Drug Hypersensitivity Reactions COSELA administration can cause acute drug hypersensitivity reactions, including facial edema and urticaria. Acute drug hypersensitivity reactions occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). One patient experienced a Grade 2 anaphylactic reaction 4 days after receiving COSELA, which resolved with epinephrine, and treatment with COSELA was continued.

The median time to onset from start of COSELA was 77 days (range 2 to 256) and from the preceding dose of COSELA was 1 day (range 1 to 28). The median duration was 6 days (range 1 to 69 for the resolved cases). Acute drug hypersensitivity reactions resolved in 12 (75%) of the 16 patients.

Monitor patients for signs and symptoms of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA [see Dosage and Administration ( 2.2 )] .

5.3Interstitial Lung Disease/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, the same drug class as COSELA. ILD/pneumonitis occurred in 1 (0.4%) of 272 patients receiving COSELA…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the label: Injection-Site Reactions, including phlebitis and thrombophlebitis [ s ee Warnings and Precautions ( 5.1 )] Acute Drug Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] ILD/Pneumonitis [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥10% of patients with ≥2% difference in incidence compared to placebo) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 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 clinical practice. The safety of COSELA was evaluated in Studies 1, 2, and 3 [see Clinical Studies ( 14 )] . Patients received COSELA 240 mg/m 2 by 30-minute intravenous infusion prior to chemotherapy on each chemotherapy day.

The data described in this section reflect exposure to COSELA among 240 patients (122 patients in the trilaciclib group and 118 patients in the placebo group) being treated for extensive stage-small cell lung cancer (ES-SCLC) in 3 randomized, double-blind, placebo-controlled trials: 32 patients with treatment naïve ES-SCLC received carboplatin (AUC 5 Day 1) + etoposide (100 mg/m 2 Days 1-3) every 21 days; 58 received carboplatin (AUC 5 Day 1) + etoposide (100 mg/m 2 Days 1-3) every 21 days + atezolizumab (1200 mg on Day 1) every 21 days; 32 patients with previously treated ES-SCLC received topotecan (1.5 mg/m 2 Days 1-5) every 21 days.

Study 1: COSELA Prior to Etoposide, Carboplatin, and Atezolizumab (E/P/A) Patients with newly diagnosed ES-SCLC not previously treated with chemotherapy Study 1 (G1T28-05; NCT03041311) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide, carboplatin, and atezolizumab (E/P/A) for patients with newly diagnosed ES-SCLC not previously treated with chemotherapy. The data presented below are for the 105 patients who received study treatment.

Eighty-five percent of patients receiving COSELA and 91% receiving placebo completed 4 cycles of induction therapy. Study 2: COSELA Prior to Etoposide and Carboplatin (E/P) Patients with newly diagnosed ES-SCLC not previously treated with chemotherapy Study 2 (G1T28-02; NCT02499770) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide and carboplatin (E/P) for patients with newly diagnosed ES-SCLC not previously treated with chemotherapy.

The data presented below are for the 75 patients who received study treatment. Seventy-six percent of patients in the COSELA group and 87% of patients in the placebo group completed at least 4 cycles of therapy. The median duration of treatment was 6 cycles in each treatment group.

Study 3: COSELA Prior to Topotecan Patients with ES-SCLC previously treated with chemotherapy Study 3 (G1T28-03; NCT02514447) was an international, randomized (2:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with topotecan for patients with ES-SCLC previously treated with chemotherapy. The data presented below are for the 60 patients who received study treatment with the 1.5 mg/m 2 dose of topotecan. Thirty-eight percent of patients receiving COSELA and 29% of patients receiving placebo completed 5 or more cycles of therapy.

The median duration of treatment was 3 cycles in each treatment group. Integrated Safety Analysis The adverse reaction summary presented in Table 3 are pooled safety results from Studies 1,…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Certain OCT2, MATE1, and MATE-2K substrates: Avoid concomitant use with certain OCT2, MATE1, and MATE-2K substrates where minimal concentration changes may lead to serious or life-threatening toxicities. ( 7.1 )

7.1Effect of COSELA on Other Drugs, Certain OCT2, MATE1, and MATE-2K Substrates COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin) [see Clinical Pharmacology ( 12.3 )]. Refer to the prescribing information for these concomitant medications for assessing the benefit and risk of concomitant use of COSELA.

Table 4: Potentially Significant Drug Interactions with COSELA Drugs Recommendations Comments Dofetilide The potential benefits of taking COSELA concurrently with dofetilide should be considered against the risk of QT interval prolongation. Increased dofetilide blood levels may occur in patients who are also receiving COSELA. Increased plasma concentrations of dofetilide may cause serious ventricular arrhythmias associated with QT interval prolongation, including torsade de pointes.

Dalfampridine The potential benefits of taking COSELA concurrently with dalfampridine should be considered against the risk of seizures in these patients. Increased dalfampridine blood levels may occur in patients who are also receiving COSELA. Elevated levels of dalfampridine increase the risk of seizure.

Cisplatin Closely monitor for nephrotoxicity. Concurrent treatment with COSELA may increase the exposure and alter the net accumulation of cisplatin in the kidney, which may associate with dose-related nephrotoxicity.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on the mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12 )] . There are no available human or animal data on COSELA use to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to a fetus.

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. However, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies in the United States general population.

8.2Lactation Risk Summary There are no data on the presence of trilaciclib in either human or animal milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise lactating women to not breastfeed while taking COSELA and for at least 3 weeks after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Based on its mechanism of action, COSELA can cause fetal harm if administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Pregnancy testing is recommended for females of reproductive potential prior to initiating COSELA. Contraception COSELA can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )].

Advise female patients of reproductive potential to use effective contraception during treatment with COSELA and for at least 3 weeks after the final dose. Infertility No studies have been performed in humans to evaluate the effects of COSELA on fertility in either sex. Based on animal toxicology studies, COSELA may impair fertility in females of reproductive potential [see Nonclinical Toxicology ( 13 )].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use In the pooled efficacy dataset from Studies 1, 2, and 3, 46% of 123 patients randomized to COSELA were ≥65 years of age, and 49% of 119 patients randomized to placebo were ≥65 years of age. No overall differences in safety or effectiveness of COSELA were observed between these patients and younger patients.

8.6Hepatic Impairment Reduce the dose of COSELA to 170 mg/m 2 in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C). No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A) [see Dosage and Administration ( 2.2 )]. Trilaciclib is mainly metabolized in the liver.

Trilaciclib exposure increased with moderate and severe hepatic impairment (Child-Pugh classes B and C) [see Clinical Pharmacology ( 12.3 )].

🤰 Pregnancy 124 words ▾

8.1Pregnancy Risk Summary Based on the mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12 )] . There are no available human or animal data on COSELA use to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to a fetus.

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. However, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies in the United States general population.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 56 words ▾

8.5Geriatric Use In the pooled efficacy dataset from Studies 1, 2, and 3, 46% of 123 patients randomized to COSELA were ≥65 years of age, and 49% of 119 patients randomized to placebo were ≥65 years of age. No overall differences in safety or effectiveness of COSELA were observed between these patients and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Trilaciclib is a transient inhibitor of CDK 4 and 6. Hematopoietic stem and progenitor cells (HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK4/6 activity.

12.2Pharmacodynamics Bone Marrow Trilaciclib exhibited dose-dependent inhibition of CD45+/CD3+ lymphocyte proliferation following administration of single-dose COSELA 96 or 192 mg/m 2 (0.4 or 0.8 times the approved recommended dose) in healthy subjects. Trilaciclib increased the percentage of cells arrested in G1 up to 32 hours post-infusion for all bone marrow progenitor subsets evaluated (hematopoietic stem cell/multipotent progenitor, oligopotent progenitor, monocyte lineage, granulocyte lineage, erythroid lineage, and megakaryocyte lineage) following a single dose of COSELA 192 mg/m 2 (0.8 times the approved recommended dose) in healthy subjects.

Partial recovery of the total bone marrow with resumption of proliferation of the bone marrow progenitor subsets was observed by 32 hours post-dose. This transient G1 arrest of hematopoietic stem cells contributed to the myeloprotective effect of trilaciclib. Cardiac Electrophysiology COSELA is associated with dose-dependent and delayed increase in the QTc interval.

The underlying mechanism of the delayed QT effect is unknown. At the clinical dose of 240 mg/m 2 , COSELA did not have a clinically relevant effect on QTc (i.e., >10 msec). QTc prolongation was observed at higher doses.

12.3Pharmacokinetics The maximum concentration (C max ) increased proportionally whereas the total plasma exposure (AUC 0-last ) increased slightly greater than proportional over a dosage range of trilaciclib 200 mg/m 2 to 700 mg/m 2 (0.83 to 2.9 times the approved recommended dose). There was no accumulation of trilaciclib following repeated dosing. Distribution The in vitro human plasma protein binding of trilaciclib is 69% and appeared independent of trilaciclib concentration from 0.75 to 3.0 μg/mL.

The blood/plasma ratio ranged from 1.21 to 1.53 for trilaciclib across concentrations of 0.5 μg/mL to 50 μg/mL in vitro. The volume of distribution at steady state was 1130 L. Elimination The mean terminal half-life of trilaciclib is approximately 14 hours.

Clearance was estimated to be 158 L/hr. Metabolism Trilaciclib undergoes extensive metabolism. Trilaciclib is the predominant circulating compound in plasma following intravenous administration, representing ~50% of plasma total radioactivity.

In vitro studies indicated that trilaciclib is primarily metabolized by aldehyde oxidase (AO), cytochrome P450 (CYP) 3A4 and CYP2C8. Excretion After a single dose of radiolabeled trilaciclib 192 mg/m 2 (0.8 times the approved recommended dosage), approximately 79.1% of the dose was recovered in feces (7% unchanged) and 14% was recovered in urine (2% unchanged). Trilaciclib is eliminated mainly via the fecal route, with a small contribution of the renal route.

Specific Populations No clinically significant differences in the pharmacokinetics of trilaciclib were observed based on age (range: 19 to 80 years), sex, race, mild to moderate renal impairment (30 to 89 mL/min/1.73 m 2 measured by estimated glomerular filtration rate [eGFR]), or mild hepatic impairment (total bilirubin ≤ULN and AST >ULN, or total bilirubin >1.0 to 1.5 × ULN, irrespective of AST). The effect of severe renal impairment (<30 mL/min/1.73 m 2 ), end stage renal disease, or dialysis on trilaciclib pharmacokinetics has not been studied.

Subjects with Hepatic Impairment Trilaciclib unbound AUC inf increased by 40% and 63%, respectively, in subjects with moderate and severe hepatic impairment (Child-Pugh classes B and C). No clinically significant differences were observed in trilaciclib systemic exposures in subjects with mild hepatic impairment [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.6 )]. Drug Interaction Studies Clinical Studies Cyt…

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Trilaciclib is a transient inhibitor of CDK 4 and 6. Hematopoietic stem and progenitor cells (HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK4/6 activity.

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied COSELA (trilaciclib) for injection is a yellow lyophilized cake supplied in a single-dose vial. Each carton (NDC 73594-0101-1) contains one 300 mg strength single-dose vial.

16.2Storage and Handling Store COSELA vials at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . The vial stopper is not made with natural rubber latex.

16.1How Supplied COSELA (trilaciclib) for injection is a yellow lyophilized cake supplied in a single-dose vial. Each carton (NDC 73594-0101-1) contains one 300 mg strength single-dose vial.

📦 Storage and Handling 40 words ▾

16.2Storage and Handling Store COSELA vials at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . The vial stopper is not made with natural rubber latex.

📋 Description 118 words ▾

11 DESCRIPTION COSELA for injection contains trilaciclib dihydrochloride, a kinase inhibitor. The chemical name for trilaciclib is 2'-{[5-(4-methylpiperazin-1-yl)pyridin-2-yl]amino}-7',8'-dihydro-6' H -spiro[cyclohexane-1,9'-pyrazino[1',2':1,5]pyrrolo[2,3- d ]pyrimidin]-6'-one. Trilaciclib dihydrochloride is a water-soluble yellow solid, with molecular formula of C 24 H 30 N 8 O•2HCl, a molecular weight of 519.48 g/mol (Free base: 446.56 g/mol), and the following chemical structure: COSELA (trilaciclib) for injection is a sterile, preservative-free, yellow lyophilized cake in a single-dose vial for intravenous infusion after reconstitution and dilution.

Each single-dose vial contains the equivalent of 300 mg of trilaciclib (provided as 349 mg of trilaciclib dihydrochloride) and the following inactive ingredients: citric acid monohydrate (75.6 mg) and mannitol (300 mg); hydrochloric acid and sodium hydroxide to adjust pH. Figure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Injection-Site Reactions, Including Phlebitis and Thrombophlebitis Inform patients of the signs and symptoms of injection-site reactions, including phlebitis and thrombophlebitis. Advise patients to contact their healthcare provider immediately for signs and symptoms of injection-site reactions, including phlebitis and thrombophlebitis [see Warnings and Precautions ( 5.1 )]. Acute Drug Hypersensitivity Reactions Advise patients to contact their healthcare provider immediately for signs and symptoms of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritis, and anaphylactic reactions [see Warnings and Precautions ( 5.2 )].

Interstitial Lung Disease/Pneumonitis Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions ( 5.3 ) and Dosage and Administration ( 2.2 )]. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment with COSELA and for at least 3 weeks after the final dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

Lactation Advise women not to breastfeed during treatment with COSELA and for at least 3 weeks after the final dose of COSELA [see Use in Specific Populations ( 8.2 )] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions ( 7 )] . Distributed by: Pharmacosmos Therapeutics Inc., Morristown, NJ 07960 COSELA ® is a registered trademark of Pharmacosmos Holding A/S ©2025 Pharmacosmos A/S ######

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 73591-5886-01 · FARMASIERRA 73594-9301-02 · Pharmacosmos →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.