NDC 45963-0614-85 — Irinotecan hydrochloride 20 mg/mL

🆔 Identity & classification

FDA NDC (as labeled) 45963-614-85

Product NDC 45963-614

11-digit billing NDC 45963061485

NCPDP billing unit ML — per mL (volume)

RxCUI 1726319, 1726324

UNII 042LAQ1IIS

Application # ANDA078589

SPL Set ID 5e1fdcaa-918f-4cd8-9c7a-4c538d866198

Established class (EPC) Topoisomerase Inhibitor

Mechanism of action Topoisomerase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Jun 2023)

Marketing start 2015-03-12

Marketing end 2027-09-30

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance IRINOTECAN HYDROCHLORIDE

GPI-14 21550040102025

GPI class Irinotecan HCl

GCN Seq No 062174

GCN 97956

HICL code 010778

Ingredient (HICL) Irinotecan Hcl

HIC1 code V

Therapeutic class — broad (HIC1) Neoplasms

HIC2 code V3

Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)

HIC3 code V3E

Therapeutic class — specific (HIC3) Antineoplastic - Topoisomerase I Inhibitors

AHFS code 10:00.00.00

AHFS class Antineoplastic Agents

FDB label name IRINOTECAN HCL 100 MG/5 ML VL

FDB brand name Irinotecan Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 45963-614-85 — 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 → 45963-0614-85. 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 Topoisomerase Inhibitor class.

Pharmacologic class Topoisomerase Inhibitor

Drug family (ATC) Topoisomerase 1 (TOP1) inhibitors

How it works Topoisomerase 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

LabelerActavis Pharma, Inc.

Application holderACTAVIS TOTOWA LLC

FDA applicationANDA078589 (ANDA)

Labeler code45963

First marketedMar 2015

Product typeHuman Prescription Drug

Portfolio324 products on file

🔎 All NDCs from Actavis Pharma, Inc.

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 IRINOTECAN HCL 100 MG/5 ML VL Ingredient Irinotecan Hcl

📗 Our plain-language guide HelloPharmacist

Irinotecan is a chemotherapy that targets cancer cells directly. Depending on which product you're receiving, it's used to treat metastatic colorectal cancer (cancer of the colon o...
What exactly is irinotecan treating in my body?
The two biggest ones to know are diarrhea and low white blood cell counts. Diarrhea that starts more than 24 hours after your infusion can be serious — start loperamide (Imodium) a...
What side effects should I really be watching out for?

📖 Read our full Irinotecan guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Irinotecan Hydrochloride — tap one for details:

GrapefruitMajor St. John's WortMajor Acacia RigidulaModerate AdrafinilModerate African Wild PotatoModerate American ElderModerate AstaxanthinModerate AyahuascaModerate

🌿 Every supplement checked against Irinotecan Hydrochloride (135 interactions) — ranked by severity →

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 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 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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.
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.

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 system	Per mL	Per 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 · J9206	$1.851 / J9206 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)45963-614-85

11-digit billing NDC45963-0614-85

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ9206

DescriptorINJECTION, IRINOTECAN, 20 MG

Billing units / pkg1 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Irinotecan Hydrochloride 20 mg/mL 00143-9583-01	Hikma	5 ml	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 00143-9701-01	Hikma	5 ml	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 00143-9702-01	Hikma	2 ml	—	AP	FDA listed	—
Irinotecan hydrochloride 20 mg/mL 16714-0027-01	Northstar	1 vial	—	AP	FDA listed	—
Irinotecan hydrochloride 20 mg/mL 16714-0131-01	Northstar	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 67184-0511-01	Qilu	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 67184-0512-01	Qilu	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 67184-0513-01	Qilu	1 vial	—	AP	FDA listed	—
Irinotecan hydrochloride 20 mg/mL 68083-0382-01	Gland	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 63323-0193-52	Fresenius	1 vial	—	AP	FDA listed	—
Irinotecan hydrochloride 20 mg/mLthis 45963-0614-85	Actavis	1 vial	—	AP	Discontinued	—
Camptosar 20 mg/mL 00009-7529-03	Pharmacia	1 vial	—	AP	Discontinued	—
Irinotecan Hydrochloride 20 mg/mL 55150-0353-01	Eugia	1 vial	—	AP	FDA listed	—
Irinotecan hydrochloride 20 mg/mL 70700-0170-22	Xiromed	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 55150-0355-01	Eugia	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 25021-0230-02	Sagent	1 vial	—	—	FDA listed	—
Camptosar 20 mg/mL 00009-0082-02	Pharmacia	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 55150-0354-01	Eugia	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 61703-0349-09	Hospira,	1 vial	—	AP	FDA listed	—
Camptosar 20 mg/mL 00009-0112-05	Pharmacia	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 60505-6128-00	Apotex	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 60505-6272-01	Apotex	1 vial	—	AP	FDA listed	—
Irinotecan Hydrochloride 20 mg/mL 55150-0352-01	Eugia	1 vial	—	AP	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2015

On the market since

Mar 2015

📍

2026

Currently FDA-listed

11 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 vial45963-0614-51 256 Rx · $22,397

1 vial45963-0614-55 198 Rx · $5,364

1 vial this page45963-0614-85 No Medicaid data

Drug total (last 4 qtrs): 454 Rx · 3,805 units · $27,761 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
45963-0614-85 You're viewing this	1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-85) / 5 mL in 1 VIAL, SINGLE-DOSE	2018-08-10	Discontinued by firm
45963-0614-51	1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE	2015-03-12	Active
45963-0614-55	1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE	2015-03-12	Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 45963-0614-85?

NDC 45963-0614-85 is listed by the FDA — 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose.

What NDC number is used to bill for this package of Irinotecan hydrochloride 20 mg/mL Injection, Solution?

Bill NDC 45963-0614-85 — the 11-digit billing format is 45963061485. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

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 45963-614-85, 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: 45963-0614-85, written without dashes as 45963061485. 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 45963-0614-85, the first segment (45963) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (0614) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (85) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 1 vial (45963-0614-51), 1 vial (45963-0614-55). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Actavis Pharma, 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 J9206 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.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 197 words ▾

WARNING: DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide.

Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt Irinotecan Hydrochloride Injection and reduce subsequent doses if severe diarrhea occurs [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] .

Severe myelosuppression may occur [see Warnings and Precautions ( 5.2 )] . WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning. Early and late forms of diarrhea can occur.

Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed.

Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt Irinotecan Hydrochloride Injection and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 ) Severe myelosuppression may occur.

( 5.2 )

🎯 Indications and Usage 110 words ▾

1 INDICATIONS AND USAGE Irinotecan Hydrochloride Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan Hydrochloride Injection is a topoisomerase inhibitor indicated for: First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

( 1 ) Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Colorectal cancer combination regimen 1: Irinotecan Hydrochloride Injection 125 mg/m 2 intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m 2 intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks. ( 2.1 ) Colorectal cancer combination regimen 2: Irinotecan Hydrochloride Injection 180 mg/m 2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m 2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m 2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m 2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30.

( 2.1 ) Colorectal cancer single-agent regimen 1: Irinotecan Hydrochloride Injection 125 mg/m 2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. ( 2.2 ) Colorectal cancer single-agent regimen 2: Irinotecan Hydrochloride Injection 350 mg/m 2 intravenous infusion over 90 minutes on day 1 every 3 weeks. ( 2.2 )

2.1Colorectal Cancer Combination Regimens 1 and 2 Administer Irinotecan Hydrochloride Injection as a 90-minute intravenous infusion followed by LV and 5-FU. The currently recommended regimens are shown in Table 1. A reduction in the starting dose by one dose level of Irinotecan Hydrochloride Injection may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Dosing for patients with bilirubin > 2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients. Table 1. Combination-Agent Dosage Regimens and Dose Modifications a Regimen 1 6-wk cycle with bolus 5-FU/LV (next cycle begins on day 43) Irinotecan Hydrochloride Injection LV 5-FU 125 mg/m 2 intravenous infusion over 90 minutes, days 1,8,15,22 20 mg/m 2 intravenous injection bolus, days 1,8,15,22 500 mg/m 2 intravenous injection bolus, days 1,8,15,22 Starting Dose & Modified Dose Levels (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 Irinotecan Hydrochloride Injection 125 100 75 LV 20 20 20 5-FU 500 400 300 Regimen 2 6-wk cycle with infusional 5-FU/LV (next cycle begins on day 43) Irinotecan Hydrochloride Injection LV 5-FU Bolus 5-FU Infusion b 180 mg/m 2 intravenous infusion over 90 minutes, days 1,15,29 200 mg/m 2 intravenous infusion over 2 hours, days 1,2,15,16,29,30 400 mg/m 2 intravenous injection bolus, days 1,2,15,16,29,30 600 mg/m 2 intravenous infusion over 22 hours, days 1,2,15,16,29,30 Starting Dose & Modified Dose Levels (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 Irinotecan Hydrochloride Injection 180 150 120 LV 200 200 200 5-FU Bolus 400 320 240 5-FU Infusion b 600 480 360 a Dose reductions beyond Dose Level –2 by decrements of ≈ 20% may be warranted for patients continuing to experience toxicity.

Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. b Infusion follows bolus administration. Dosing for patients with bilirubin > 2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients [see Warnings and Precautions ( 5.10 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . Dose Modifications Based on recommended dose levels described in Table 1, Combination Regimens of Irinotecan Hydrochloride Injection and Dose Modifications, subsequent doses should be adjusted as suggested in Table 2, Recommended Dose Modifications for Combination Regimens.

All dose modifications should be based on the worst preceding toxicity. Table 2. Recommended Dose Modifications for Irinotecan Hydrochloride Injection/5-Fluorouracil (5-FU)/Leucovorin (LV) Combination Schedules Patients should return to pre-treatment bowel function without requiring antidiarrhea medications for at least 24 hours befor…

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) sterile, pale yellow, clear, aqueous solution in a single-dose vial. Injection: 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) solution in a single-dose vial. ( 3 )

⛔ Contraindications 30 words ▾

4 CONTRAINDICATIONS Irinotecan Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. Hypersensitivity to Irinotecan Hydrochloride Injection or its excipients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea and Cholinergic Reactions: Early diarrhea (occurring during or shortly after infusion of Irinotecan Hydrochloride Injection) is usually transient and may be accompanied by cholinergic symptoms. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). Late diarrhea (generally occurring more than 24 hours after administration of Irinotecan Hydrochloride Injection) can occur.

Monitor and replace fluid and electrolytes. Treat with loperamide. Use antibiotic support for ileus and fever.

Interrupt Irinotecan Hydrochloride Injection and reduce subsequent doses if severe diarrhea occurs. ( 5.1 ) Myelosuppression: Manage promptly with antibiotic support. Interrupt Irinotecan Hydrochloride Injection and reduce subsequent doses if necessary.

( 5.2 ) Increased Risk of Neutropenia in Patients with Reduced UGT1A1 Activity: Individuals with UGT1A1*28/*28, or *6/*6, or *6/*28 genotypes are at increased risk for severe neutropenia during Irinotecan Hydrochloride Injection treatment. ( 5.3 ) Hypersensitivity: Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. Discontinue Irinotecan Hydrochloride Injection if this occurs.

( 5.4 ) Renal Impairment/Renal Failure: Rare cases of renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhea. ( 5.5 ) Pulmonary Toxicity: Interstitial Pulmonary Disease (IPD)-like events, including fatalities, have occurred. Interrupt for new or progressive dyspnea, cough, and fever pending evaluation.

If IPD diagnosed, discontinue and institute appropriate treatment as needed. ( 5.6 ) Toxicity of the 5 Day Regimen: Irinotecan Hydrochloride Injection should not be used in combination with a regimen of 5-FU/LV administered for 4 to 5 consecutive days every 4 weeks outside of a clinical study. ( 5.7 ) Embryo-Fetal Toxicity: Irinotecan Hydrochloride Injection can cause fetal harm.

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise male patients with female partners of reproductive potential to use condoms. ( 5.9 , 8.1 , 8.3 ) Patients with Hepatic Impairment: In clinical trials, Irinotecan Hydrochloride Injection has not been administered to patients with serum bilirubin > 2.0 mg/dL, or transaminases > 3 times ULN if no liver metastases, or transaminases > 5 times ULN if liver metastases.

With the weekly dosage schedule, patients with total bilirubin levels 1.0 to 2.0 mg/dL had greater likelihood of grade 3 to 4 neutropenia. ( 5.10 )

5.1Diarrhea and Cholinergic Reactions Early diarrhea (occurring during or shortly after infusion of Irinotecan Hydrochloride Injection) is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Early diarrhea and other cholinergic symptoms may be prevented or treated. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). These symptoms are expected to occur more frequently with higher irinotecan doses.

Late diarrhea (generally occurring more than 24 hours after administration of Irinotecan Hydrochloride Injection) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Grade 3 to 4 late diarrhea occurred in 23 to 31% of patients receiving weekly dosing. In the clinical studies, the median time to the onset of late diarrhea was 5 days with 3-week dosing and 11 days with weekly dosing.

Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Common adverse reactions (≥ 30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia. ( 6.1 ) Common adverse reactions (≥ 30%) observed in single-agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Common adverse reactions (≥ 30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, and alopecia.

Common adverse reactions (≥ 30%) observed in single-agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, and alopecia. First-Line Combination Therapy A total of 955 patients with metastatic colorectal cancer received the recommended regimens of irinotecan in combination with 5-FU/LV, 5-FU/LV alone, or irinotecan alone. In the two phase 3 studies, 370 patients received irinotecan in combination with 5-FU/LV, 362 patients received 5-FU/LV alone, and 223 patients received irinotecan alone [see Dosage and Administration ( 2 )] .

In Study 1, 49 (7.3%) patients died within 30 days of last study treatment: 21 (9.3%) received irinotecan in combination with 5-FU/LV, 15 (6.8%) received 5-FU/LV alone, and 13 (5.8%) received irinotecan alone. Deaths potentially related to treatment occurred in 2 (0.9%) patients who received irinotecan in combination with 5-FU/LV (2 neutropenic fever/sepsis), 3 (1.4%) patients who received 5-FU/LV alone (1 neutropenic fever/sepsis, 1 CNS bleeding during thrombocytopenia, 1 unknown) and 2 (0.9%) patients who received irinotecan alone (2 neutropenic fever).

Deaths from any cause within 60 days of first study treatment were reported for 15 (6.7%) patients who received irinotecan in combination with 5-FU/LV, 16 (7.3%) patients who received 5-FU/LV alone, and 15 (6.7%) patients who received irinotecan alone. Discontinuations due to adverse events were reported for 17 (7.6%) patients who received irinotecan in combination with 5FU/LV, 14 (6.4%) patients who received 5-FU/LV alone, and 26 (11.7%) patients who received irinotecan alone. In Study 2, 10 (3.5%) patients died within 30 days of last study treatment: 6 (4.1%) received irinotecan in combination with 5-FU/LV and 4 (2.8%) received 5-FU/LV alone.

There was one potentially treatment-related death, which occurred in a patient who received irinotecan in combination with 5-FU/LV (0.7%, neutropenic sepsis). Deaths from any cause within 60 days of first study treatment were reported for 3 (2.1%) patients who received irinotecan in combination with 5-FU/LV and 2 (1.4%) patients who received 5-FU/LV alone. Discontinuations due to adverse events were reported for 9 (6.2%) patients who received irinotecan in combination with 5FU/LV and 1 (0.7%) patient who received 5-FU/LV alone.

The most clinically significant adverse events for patients receiving irinotecan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia. The most clinically significant adverse events for patients r…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with Irinotecan Hydrochloride Injection. ( 7.2 ) Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with Irinotecan Hydrochloride Injection. ( 7.3 ) 7.1 5-Fluorouracil (5-FU) and Leucovorin (LV) In a phase 1 clinical study involving irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in 26 patients with solid tumors, the disposition of irinotecan was not substantially altered when the drugs were co-administered.

Although the C max and AUC 0-24 of SN-38, the active metabolite, were reduced (by 14% and 8%, respectively) when irinotecan was followed by 5-FU and LV administration compared with when irinotecan was given alone, this sequence of administration was used in the combination trials and is recommended [see Dosage and Administration ( 2 )] . Formal in vivo or in vitro drug interaction studies to evaluate the influence of irinotecan on the disposition of 5-FU and LV have not been conducted.

7.2Strong CYP3A4 Inducers Exposure to irinotecan or its active metabolite SN-38 is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John’s wort. The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined.

Consider substituting non-enzyme inducing therapies at least 2 weeks prior to initiation of Irinotecan Hydrochloride Injection therapy. Do not administer strong CYP3A4 inducers with Irinotecan Hydrochloride Injection unless there are no therapeutic alternatives.

7.3Strong CYP3A4 or UGT1A1 Inhibitors Irinotecan and its active metabolite, SN-38, are metabolized via the human cytochrome P450 3A4 isoenzyme (CYP3A4) and uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1), respectively, [see Clinical Pharmacology (12.3) ] . Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38. Coadministration of Irinotecan Hydrochloride Injection with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38.

Discontinue strong CYP3A4 inhibitors at least 1 week prior to starting Irinotecan Hydrochloride Injection therapy. Do not administer strong CYP3A4 or UGT1A1 inhibitors with Irinotecan Hydrochloride Injection unless there are no therapeutic alternatives.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) Geriatric Use: Closely monitor patients greater than 65 years of age because of a greater risk of early and late diarrhea in this population. ( 8.5 ) Patients with Renal Impairment: Use caution and do not use in patients on dialysis. ( 8.6 ) Patients with Hepatic Impairment: Use caution. (2.1, 5.10 , 8.7 , 12.3 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Available postmarketing and published data reporting the use of Irinotecan Hydrochloride Injection in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at exposures lower than the human exposure based on AUC at the clinical dose of 125 mg/m 2 ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Radioactivity related to 14 C-irinotecan crosses the placenta of rats following intravenous administration. Intravenous administration of irinotecan to rats at a dose of 6 mg/kg/day (approximately 0.2 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses; at doses ≥ 1.2 mg/kg/day (approximately 0.03 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) there were increases in a variety of external, visceral, and skeletal abnormalities.

Administration of irinotecan to pregnant rabbits at a dose of 6 mg/kg (approximately half of the clinical dose of 125 mg/m 2 based on BSA) resulted in similar findings to those in rats, with increased post-implantation loss, decreased live fetuses, and increased external, visceral, and skeletal abnormalities. Irinotecan administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring.

8.2Lactation Risk Summary Irinotecan and its metabolites are present in human milk. There is no information regarding the effects of irinotecan on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions from Irinotecan Hydrochloride Injection in the breastfed child, advise lactating women not to breastfeed during treatment with Irinotecan Hydrochloride Injection and for 7 days after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in female patients of reproductive potential prior to initiating Irinotecan Hydrochloride Injection. Contraception Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman. Females Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the final dose of Irinotecan Hydrochloride Injection [see Use in Specific Populations ( 8.1 ) and Nonclinical Toxicology ( 13.1 )] .

Males Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of Irinotecan Hydrochloride Injection [see Nonclinical Toxicology ( 13.1 )]. Infertility Females Based on postmarketing reports, female fertility may b…

🆘 Overdosage 118 words ▾

10 OVERDOSAGE In U.S. phase 1 trials, single doses of up to 345 mg/m 2 of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg/m 2 of irinotecan have been given in non-U.S. trials. The adverse events in these patients were similar to those reported with the recommended dosage and regimen.

There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhea. There is no known antidote for overdosage of Irinotecan Hydrochloride Injection.

Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks.

Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.

12.2Pharmacodynamics Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines.

In vitro cytotoxicity assays show that the potency of SN-38 relative to irinotecan varies from 2- to 2000-fold; however, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan [see Clinical Pharmacology (12.3) ] . The precise contribution of SN-38 to the activity of Irinotecan Hydrochloride Injection is thus unknown. Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form.

A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form. Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types.

12.3Pharmacokinetics After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. The mean terminal elimination half-life of the active metabolite SN-38 is about 10 to 20 hours. The half-lives of the lactone (active) forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are in equilibrium.

Over the recommended dose range of 50 to 350 mg/m 2 , the AUC of irinotecan increases linearly with dose; the AUC of SN-38 increases less than proportionally with dose. Maximum concentrations of the active metabolite SN-38 are generally seen within 1 hour following the end of a 90-minute infusion of irinotecan. Pharmacokinetic parameters for irinotecan and SN-38 following a 90-minute infusion of irinotecan at dose levels of 125 and 340 mg/m 2 determined in two clinical studies in patients with solid tumors are summarized in Table 9: Table 9.

Summary of Mean (±Standard Deviation) Irinotecan and SN-38 Pharmacokinetic Parameters in Patients with Solid Tumors Irinotecan SN-38 Dose C max AUC 0-24 t 1/2 V z CL C max AUC 0-24 t 1/2 (mg/ m 2 ) (ng/mL) (ng·h/mL) (h) L/m 2 ) (L/h/m 2 ) (ng/mL) (ng·h/mL) (h) C max - Maximum plasma concentration AUC 0-24 - Area under the plasma concentration-time curve from time 0 to 24 hours after the end of the 90-minute infusion t 1/2 - Terminal elimination half-life V z - Volume of distribution of terminal elimination phase CL - Total systemic clearance a Plasma specimens collected for 24 hours following the end of the 90-minute infusion. b Plasma specimens collected for 48 hours following the end of the 90-minute infusion.

Because of the longer collection period, these values provide a more accurate reflection of the terminal elimination half-lives of irinotecan and SN-38. 125 1,660 10,200 5.8 a 110 13.3 26.3 229 10.4 a (N=64)…

📦 How Supplied / Storage and Handling 127 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Irinotecan Hydrochloride Injection, USP is available as a sterile, pale yellow, clear, aqueous solution in a single-dose, amber glass vial within a carton in the following presentations: 40 mg/2 mL (20 mg/mL) NDC 45963-614-51 100 mg/5 mL (20 mg/mL) NDC 45963-614-55 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. It is recommended that the vial should remain in the carton until the time of use.

Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package. Sterile, Nonpyrogenic, Preservative-free.

The vial stopper is not made with natural rubber latex. Irinotecan Hydrochloride Injection, USP is a hazardous drug. Follow special handling and disposal procedures.

1

📋 Description 178 words ▾

11 DESCRIPTION Irinotecan Hydrochloride Injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan Hydrochloride Injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride, USP (on the basis of the trihydrate salt), 45 mg of sorbitol, and 0.9 mg of lactic acid.

The pH of the solution has been adjusted to 3.4 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.

Irinotecan hydrochloride, USP is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S) -4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1 H -pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its molecular formula is C 33 H 38 N 4 O 6 •HCl•3H 2 O and molecular weight is 677.19.

It is slightly soluble in water and organic solvents. Its structural formula is as follows: 9a178e71-figure-01

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily available to begin treatment for late diarrhea (generally occurring more than 24 hours after administration of Irinotecan Hydrochloride Injection). Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal.

One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours.

Patients should contact their physician if any of the following occur: diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours. Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of Irinotecan Hydrochloride Injection. Explain the significance of routine blood cell counts.

Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever or infection. Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.3 ), Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with Irinotecan Hydrochloride Injection and for 6 months after the final dose.

Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of Irinotecan Hydrochloride Injection. Lactation Advise women not to breastfeed during treatment with Irinotecan Hydrochloride Injection and for at least 7 days after the final dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise females and males of reproductive potential that Irinotecan Hydrochloride Injection may impair fertility [see Use in Specific Populations ( 8.3 )].

Patients should be alerted to the possibility of alopecia. Contains sorbitol. Manufactured In Romania By: Sindan Pharma SRL Bucharest 1, Romania 011171 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

D 5/2025

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

bolus: A single dose given all at once, often as a quick push into a vein.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

cytotoxic: Describing a substance that kills cells, especially fast-growing ones such as cancer cells.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diluent: The liquid used to dissolve or thin a medicine before it is given.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolite: A new substance formed when the body breaks a medicine down.

mucositis: Painful swelling and sores in the moist lining of the mouth, throat, or digestive tract.

myelosuppression: A slowing of the bone marrow's job of making blood cells, which can lower red cells, white cells, or platelets.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutropenic fever: A fever in someone whose infection-fighting white blood cells (neutrophils) are very low, treated urgently because an infection can spread quickly.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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