Trilaciclib Injection
Trilaciclib is an intravenous kinase inhibitor used to reduce chemotherapy-related bone marrow damage in adults with extensive-stage small cell lung cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Trilaciclib Injection: Patient Information Guide
A plain-language walkthrough of Trilaciclib Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Trilaciclib (Cosela) is an intravenous kinase inhibitor with one main FDA-approved purpose: protecting the bone marrow during chemotherapy for extensive-stage small cell lung cancer.
- Cosela is indicated to decrease the incidence of chemotherapy-induced myelosuppression (bone marrow suppression) in adults with extensive-stage small cell lung cancer (ES-SCLC) when given before a platinum/etoposide-containing chemotherapy regimen
- Cosela is also indicated for adults with ES-SCLC receiving a topotecan-containing chemotherapy regimen
⚙️How it works▾
Trilaciclib temporarily blocks CDK 4 and 6 — proteins that act like an "on switch" for the division of blood-forming stem cells in the bone marrow. By briefly pausing these stem cells before chemotherapy is given, trilaciclib keeps them in a resting state so chemotherapy is less likely to destroy them. Once trilaciclib clears the system, the stem cells resume normal activity and continue producing white blood cells, red blood cells, and platelets.
This protective pause is transient (short-lived) — studies show the bone marrow begins recovering within about 32 hours after an infusion.
💊How it's taken▾
Cosela is given only as an intravenous (IV) infusion — never by mouth or any other route. It is infused over 30 minutes and must finish no more than 4 hours before the start of chemotherapy on each chemotherapy day. When doses are given on back-to-back days, the gap between doses should not exceed 28 hours.
- If a dose is missed, chemotherapy should also be held that day — plan with your care team to resume both on the next scheduled chemotherapy day
- If Cosela is permanently stopped, at least 96 hours should pass before chemotherapy is resumed alone
- Patients with moderate or severe liver impairment require a lower dose, as determined by their prescriber
🤒Side effects — in detail▾
The most commonly reported side effects with Cosela (occurring in at least 10% of patients and at least 2% more often than placebo) were:
- Fatigue
- Low calcium levels (hypocalcemia)
- Low potassium levels (hypokalemia)
- Low phosphate levels (hypophosphatemia)
- Elevated AST (a liver enzyme)
- Headache
- Pneumonia
- Injection-site reactions including vein inflammation (phlebitis) and blood clots in the vein (thrombophlebitis)
Serious reactions requiring immediate medical attention include severe allergic reactions (including anaphylaxis), serious lung inflammation (interstitial lung disease/pneumonitis), respiratory failure, unusual bleeding, and blood clots. Contact your care team right away if any of these occur.
⚠️Warnings & precautions▾
- Injection-site reactions: Pain, redness, vein swelling, or tissue damage at the infusion site occurred in about 21% of patients. Severe reactions require permanent discontinuation of Cosela.
- Acute allergic reactions: Reactions including facial swelling, hives, itching, and anaphylaxis have occurred. Severe or life-threatening reactions require immediate stopping and permanent discontinuation of Cosela.
- Interstitial lung disease (ILD)/Pneumonitis: Serious, potentially life-threatening lung inflammation can occur with this class of drugs. Watch for new or worsening cough, shortness of breath, or low oxygen and report them promptly.
- Embryo-fetal toxicity: Cosela can harm an unborn baby based on how it works. Females of reproductive potential must use effective contraception during treatment and for at least 3 weeks after the final dose. Pregnancy testing is recommended before starting.
🔀What it interacts with▾
Cosela inhibits certain kidney transport proteins (OCT2, MATE1, and MATE-2K), which can raise blood levels of some medications. Key interactions include:
- Dofetilide (heart-rhythm drug) — Cosela may increase dofetilide levels, raising the risk of dangerous heart-rhythm abnormalities, including a potentially fatal condition called torsade de pointes
- Dalfampridine (used to improve walking in multiple sclerosis) — Cosela may increase dalfampridine levels, which raises the risk of seizures
- Cisplatin (chemotherapy) — concurrent use with Cosela may increase cisplatin's buildup in the kidneys, potentially worsening kidney toxicity; close monitoring is required
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Cosela if you have had a serious allergic reaction (including anaphylaxis) to trilaciclib in the past — this is a contraindication
- Tell your doctor if you have moderate or severe liver disease; a lower dose is required
- Tell your doctor if you are pregnant — Cosela can cause fetal harm; effective contraception must be used during treatment and for at least 3 weeks after the last dose
- Do not breastfeed while taking Cosela or for at least 3 weeks after the last dose, due to potential risk to the infant
- Pregnancy testing is recommended before starting Cosela for females of reproductive potential
- Cosela may impair female fertility based on animal studies; discuss family planning with your doctor before starting
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults (65+): No overall difference in safety or effectiveness was seen compared with younger patients in clinical trials
- Patients with mild liver impairment do not need a dose adjustment
📡Pharmacodynamics — effects in the body▾
Cosela temporarily pauses blood-forming stem cells in the bone marrow in a resting phase called G1 arrest, protecting them from chemotherapy damage. Studies in healthy subjects showed this cell-cycle pause lasted up to 32 hours across multiple types of bone marrow progenitor cells, with partial recovery of bone marrow activity beginning by that point. At the approved clinical dose, Cosela did not cause a clinically meaningful change in heart-rhythm (QTc interval), though higher doses have been associated with QTc prolongation.
🔬Pharmacokinetics — how your body processes it▾
Trilaciclib is given intravenously and distributes widely through the body (volume of distribution approximately 1,130 liters). It has a mean half-life of about 14 hours and does not accumulate with repeated dosing. It is extensively metabolized, primarily in the liver via aldehyde oxidase, CYP3A4, and CYP2C8 enzymes, and is eliminated mainly through the feces (about 79%) with a smaller amount in the urine (about 14%). No clinically significant pharmacokinetic differences were seen based on age, sex, race, or mild-to-moderate kidney impairment; however, moderate or severe liver impairment does increase drug exposure, requiring a dose reduction.
📦How to store it▾
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) .
📄 Written from Trilaciclib Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Trilaciclib Injection
13 supplements and herbal products have documented interactions with Trilaciclib Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 7
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Trilaciclib Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Cosela do — is it part of my chemotherapy? ▾
How and when will I get this medication? ▾
What side effects should I watch out for? ▾
Are there any medicines I should avoid while getting Cosela? ▾
Can I get pregnant or breastfeed while on Cosela? ▾
What happens if I miss a Cosela infusion? ▾
Is Trilaciclib Injection available over the counter? ▾
When was Trilaciclib Injection first available? ▾
Who makes Trilaciclib Injection? ▾
💬 Answers drafted from Trilaciclib Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Trilaciclib Injection comes
Trilaciclib Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Cosela is used to decrease chemotherapy-induced myelosuppression (bone marrow damage) in adults with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing chemotherapy regimen
- Cosela is used to decrease chemotherapy-induced myelosuppression in adults with extensive-stage small cell lung cancer receiving a topotecan-containing chemotherapy regimen
- Cosela is given as a 30-minute intravenous infusion, completed no more than 4 hours before chemotherapy starts, on each day chemotherapy is administered
- Cosela must not be mixed or co-administered with other drugs through the same infusion line
- If a Cosela dose is missed, chemotherapy should also be skipped that day; discuss resuming both with your care team on the next scheduled chemotherapy day
- Cosela requires a dose reduction in patients with moderate or severe liver impairment; follow your prescriber's instructions
📊 Trilaciclib Injection across the U.S. market
How Trilaciclib Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Trilaciclib Injection is used
A general measure of how commonly Trilaciclib Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Trilaciclib Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Trilaciclib Injection prescribed? Of the 1,596 medications we measure, Trilaciclib Injection ranks #1,170 by Medicaid prescriptions — more than 27% of them.
Utilization by Trilaciclib Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
trilaciclib 300 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2479705
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trilaciclib Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Trilaciclib Injection NDCs with Medicaid activity.
🔍 Compare Trilaciclib Injection products
A representative set of FDA-listed product records for Trilaciclib Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 300 mg/20 mL | Intravenous | G1 Therapeutics, Inc. × 3 listings | NDA | View NDC → |
| 300 mg/20 mL | Intravenous | Pharmacosmos Therapeutics Inc. | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Trilaciclib Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trilaciclib Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trilaciclib Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Trilaciclib Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2479690 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2479704In current FDA listingsClinical drug / strength (SCD) 300 MGRxCUI 2479705
Look up RxCUI 2479690 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Trilaciclib Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Trilaciclib Injection belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. G1 Therapeutics, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.