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carmustine Kit — NDC 43598-0628-57 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

carmustine Kit — NDC 43598-628-57 (Billing 43598-0628-57)

by Dr. Reddy's Laboratories Inc. · 1 KIT in 1 CARTON * 3 mL in 1 VIAL * 30 mL in 1 VIAL, SINGLE-DOSE

This is a package of carmustine Kit from Dr. Reddy's Laboratories Inc., marketed since Oct 2021 and currently FDA-listed. It is this product's only package size.

NDC 43598-0628-57
🏷️ FDA NDC (as labeled) 43598-628-57 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 43598-628-57 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
43598 labeler · 628 product · 57 package
Package marketed since
Oct 4, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0343598860114, 0343598861111
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-628-57
Product NDC 43598-628
11-digit billing NDC 43598062857
NCPDP billing unit EA — each (per item)
RxCUI 309012
UPC 0343598860114, 0343598861111
Application # ANDA213207
SPL Set ID b946c396-34fc-1845-1944-f16028a8447d
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-04
Route INTRAVENOUS
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21102010002105
GPI class Carmustine
GCN Seq No 008782
GCN 38440
HICL code 003901
Ingredient (HICL) Carmustine
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name CARMUSTINE 100 MG VIAL
FDB brand name Carmustine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008782
  • GCN: 38440
  • GPI-14 (Medi-Span): 21102010002105
  • HICL (First Databank): 003901
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 309012
Why two NDCs? The FDA registers this code as 43598-628-57 — 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 → 43598-0628-57. 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 Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Nitrosoureas
How it works Alkylating Activity
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.

Clinical

Label name CARMUSTINE 100 MG VIAL Ingredient Carmustine
📖 What it is MedlinePlus · NLM

Carmustine injection is used to treat certain types of brain tumors. Carmustine injection is also used along with prednisone to treat multiple myeloma (a type of cancer of the bone marrow). It is also used with other medications to treat Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system) that has not improved or that has worsened after treatment with other medications. Carmustine is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is a chemotherapy drug. The injection treats brain tumors, multiple myeloma, Hodgkin's lymphoma and non-Hodgkin's lymphomas. The Gliadel wafer is placed in the brain for certain...
  • The injection is given slowly through an IV over at least 2 hours, and it is usually repeated no more often than every 6 weeks. You will get anti-nausea medicine first. The Gliadel...
  • Carmustine can lower your platelets and white blood cells, often 4 to 6 weeks after a dose. Blood is checked weekly for at least 6 weeks after each dose. The results guide your nex...
  • Call about bleeding, bruising, fever or signs of infection. Also report a new cough or trouble breathing, pain or swelling at the IV site, or signs of a new cancer. With Gliadel, r...
📖 Read our full Carmustine guide →
1
Nutrient depletion considerations

Carmustine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

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

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 eachPer 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 · J9050 $240.011 / J9050 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)43598-628-57
11-digit billing NDC43598-0628-57
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9050
DescriptorINJECTION, CARMUSTINE, 100 MG
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 100 MG, so one package = 1 billing unit.
Medicare Part B spend (2025 (Q1-Q4))$67,541 · 81 claims · $833.84 per claim (all NDCs under J9050)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0628-57 You're viewing this Main listing 1 KIT in 1 CARTON * 3 mL in 1 VIAL * 30 mL in 1 VIAL, SINGLE-DOSE 2021-10-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carmustine 00781-3474-32 Sandoz 1 kit — — FDA listed —
Carmustine 10702-0361-99 KVK-Tech, 1 kit — AP FDA listed —
Carmustine 23155-0649-41 Heritage 1 kit — AP FDA listed —
Carmustine 23155-0790-41 Heritage 1 kit — AP FDA listed —
carmustinethis 43598-0628-57 Dr. 1 kit — AP FDA listed —
Carmustine 46708-0659-02 Alembic 1 kit — AP FDA listed —
Carmustine 62332-0659-02 Alembic 1 kit — AP FDA listed —
Carmustine 68475-0503-01 Navinta 1 kit — AP FDA listed —
carmustine 70121-1482-02 Amneal 1 kit — AP FDA listed —
carmustine 70710-1525-09 Zydus 1 kit — AP FDA listed —
Carmustine 71288-0126-90 Meitheal 1 kit — AP FDA listed —
Carmustine 72205-0198-01 Novadoz 1 kit — AP FDA listed —
carmustine 75907-0327-11 Dr. 1 kit — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA213207 (ANDA)
Labeler code43598
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio160 products on file

More NDCs from Dr. Reddy's Laboratories Inc. labeler code 43598

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 215 words ▾

BOXED WARNING WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration ( 2.1 )].

Do not administer a repeat course of carmustine until blood counts recover. Pulmonary Toxicity Carmustine causes dose-related pulmonary toxicity. Patients receiving greater than 1,400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less.

Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] . WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning • Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of carmustine. Monitor blood counts.

( 5 , 6 ). • Pulmonary toxicity from carmustine appears to be dose related. Patients receiving greater than 1,400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less ( 5 , 6 ).

🎯 Indications and Usage 150 words ▾

1 INDICATIONS AND USAGE Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: • Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) • Multiple myeloma-in combination with prednisone ( 1 ) • Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) • Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended Dosage: As a single agent, 150 to 200 mg/m 2 Carmustine for injection intravenously every 6 weeks as a single dose or divided into daily injections such as 75 to 100 mg/m 2 on 2 successive days. Adjust dose for combination therapy or in patients with reduced bone marrow reserve ( 2.1 ) • Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours. ( 2.2 )

2.1Dosage The recommended dose of carmustine for injection as a single agent in previously untreated patients is 150 to 200 mg/m 2 intravenously every 6 weeks. Administer as a single dose or divided into daily injections such as 75 to 100 mg/m 2 on two successive days. Lower the dose when carmustine is used with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted.

Administer carmustine for the duration according to the established regimen. Premedicate each dose with anti-emetics. Adjust doses subsequent to the initial dose according to the hematologic response of the patient to the preceding dose.

The following schedule is suggested as a guide to dosage adjustment: Nadir After Prior Dose Percentage of Prior Dose to be Given Leukocytes/mm 3 Platelets/mm 3 >4000 >100,000 100% 3000-3999 75,000-99,999 100% 2000-2999 25,000-74,999 70% <2000 <25,000 50% The hematologic toxicity can be delayed and cumulative. Monitor blood counts weekly. Do not administer a repeat course of carmustine until circulating blood elements have returned to acceptable levels (platelets above 100 Gi/L, leukocytes above 4 Gi/L and absolute neutrophil count above 1 Gi/L).

The usual interval between courses is 6 weeks. Evaluate renal function prior to administration and periodically during treatment. For patients with compromised renal function, monitor for toxicity more frequently.

Discontinue carmustine if the creatinine clearance is less than 10 mL/min. Do not administer carmustine to patients with compromised renal function. Monitor transaminases and bilirubin periodically during treatment. [see Adverse Reactions ( 6 )] .

2.2Preparation and Administration of Intravenous Solution Dissolve carmustine with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP). Aseptically add 27 mL Sterile Water for Injection, USP. o Each mL of resulting solution contains 3.3 mg of carmustine in 10% ethanol. Such solutions should be protected from light. o The reconstituted solution is a clear, colorless to yellowish solution.

Once reconstituted, the solution must be further diluted with Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. o Examine reconstituted vials for crystal formation prior to use. If crystals are observed, they may be re-dissolved by warming the vial to room temperature with agitation. o Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. o After reconstitution as recommended, carmustine is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F) in glass container.

Examine reconstituted vials for crystal formation prior to use. If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation. o Vials reconstituted as directed and further diluted with 500 mL Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, in glass or polypropylene containers to a concentration of 0.2 mg/mL, should be stored at room temperature, protected from light and utilized within 8 hours. These solutions are also stable 24 hours under refrigeration (2° to 8°C, 36° to 46°F) and an additional 6 hours at room temperature protected from light.

Administer reconstituted solution by slow intravenous infusion over at least two hours. Administration of carmustine over a period of less than two hours can lead to pain and burning at the site of injection. Monitor the injected area during the administration.

The rate of administration of the intrav… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg of carmustine USP, as a lyophilized powder in a single-dose vial for reconstitution and a vial containing 3 mL sterile diluent (Dehydrated Alcohol Injection, USP). For injection: 100 mg of carmustine lyophilized powder in a single-dose vial for reconstitution and a vial containing 3 mL sterile diluent (Dehydrated Alcohol Injection, USP) ( 3 )

⛔ Contraindications 20 words ▾

4 CONTRAINDICATIONS Carmustine is contraindicated in patients with previous hypersensitivity to carmustine or its components. • Hypersensitivity ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Administration Reactions: Extravasation may occur; monitor infusion site closely during administration ( 5.3 ) • Carcinogenicity: Potentially carcinogenic to humans. Monitor patient periodically for such signs and apprise the patient of the symptoms for which they need to seek medical help. ( 5.4 ) • Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route.

( 5.5 ) • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. ( 5.6 )

5.1Myelosuppression Bone marrow toxicity is a dose-limiting, common and severe toxic effect of carmustine occurring 4 to 6 weeks after drug administration (thrombocytopenia occurs at about 4 weeks post-administration persisting for 1 to 2 weeks; leukopenia occurs at 5 to 6 weeks after a dose of carmustine persisting for 1 to 2 weeks; thrombocytopenia is generally more severe than leukopenia; anemia is less frequent and less severe compared to thrombocytopenia and/or leukopenia) Complete blood count should therefore be monitored weekly for at least six weeks after a dose.

Repeat doses of carmustine should not be given more frequently than every six weeks. The bone marrow toxicity of carmustine is cumulative and therefore the dosage adjustment must be considered on the basis of nadir blood counts from prior dose [see Adverse Reactions ( 6 )] . Greater myelotoxicity (e.g., leukopenia and neutropenia) has been reported when carmustine was combined with cimetidine [see Drug Interactions ( 7 )].

5.2Pulmonary toxicity Cases of fatal pulmonary toxicity with carmustine have been reported. Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis has been reported to occur from 9 days to 43 months after treatment with carmustine and related nitrosoureas. Pulmonary toxicity from carmustine is dose-related.

Patients receiving greater than 1,400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less. However, there have been reports of pulmonary fibrosis in patients receiving lower total doses. Interstitial fibrosis (with lower doses) occurred rarely.

Additionally, delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients who received carmustine (in cumulative doses ranging from 770 to 1,800 mg/m 2 combined with cranial radiotherapy for intracranial tumors) in childhood and early adolescence. Other risk factors include past history of lung disease and duration of treatment. Baseline pulmonary function studies should be conducted along with frequent pulmonary function tests during treatment.

Patients with a baseline below 70% of the predicted forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) are particularly at risk.

5.3Administration Reactions Injection site reactions may occur during the administration of carmustine. Rapid intravenous infusion of carmustine may produce intensive flushing of the skin and suffusion of the conjunctiva within 2 hours, lasting about 4 hours. It is also associated with burning at the site of injection although true thrombosis is rare.

Given the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended. A specific treatment for extravasation reactions is unknown at this time.

5.4Carcinogenicity Long-term use of nitrosoureas, such as carmustine, has been reported to be associated with the development of secondary malignancies. Carmustine was carcinogenic when administered to laboratory animals [see Nonclinical Toxicity ( 13.1 )] . Nitrosourea therapy, such as carmustine, has carcinogenic potential in humans. Patients treated with carmustine should be monitored long-term for development of second malignancies.

5.5Ocular Toxicity Carmustine has been administered through an intraarterial intracarotid route; this procedure is investigational and ha… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: · Myelosuppression [see Warnings and Precautions ( 5.1 )] · Pulmonary toxicity [see Warnings and Precautions ( 5.2 )] · Administration Reactions [see Warnings and Precautions ( 5.3 )] · Carcinogenicity [see Warnings and Precautions ( 5.4 )] · Ocular Toxicity [see Warnings and Precautions ( 5.5 )] The following adverse reactions associated with the use of carmustine were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders Tachycardia and chest pain. Eye Disorders Conjunctival edema, conjunctival hemorrhage, blurred vision and loss of depth perception Gastrointestinal Toxicity Nausea, vomiting, anorexia, and diarrhea Hepatotoxicity Increased transaminase, increased alkaline phosphatase, increased bilirubin levels Infections and Infestations Opportunistic infection (including with fatal outcome).

Neoplasms Benign, Malignant and Unspecified (including cysts and polyps) Acute leukemia, bone marrow dysplasias. Nephrotoxicity Progressive azotemia, decrease in kidney size, renal failure Nervous System Disorders Headaches, encephalopathy, and seizures Pulmonary Toxicity Pneumonitis, interstitial lung disease Reproductive System and Breast Disorders Gynecomastia Skin and Subcutaneous Tissue Disorders Burning sensation, hyperpigmentation, swelling, pain, erythema, skin necrosis, alopecia, allergic reaction Vascular Disorders Veno-occlusive disease.

Most common adverse reactions (>1%) are nausea, vomiting, renal toxicity, pneumonitis, pulmonary toxicity, myelosuppression ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.Reddy's Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 188 words ▾

7 DRUG INTERACTIONS • Cimetidine: Increased myelosuppression with concomitant use. ( 7.1 ) • Phenobarbital: Induces carmustine metabolism, reducing exposure. May lead to reduced efficacy. ( 7.1 ) • Phenytoin: Carmustine may reduce the efficacy of phenytoin. ( 7.2 )

7.1Effect of Other Drugs on Carmustine Cimetidine : Greater myelosuppression (e.g., leukopenia and neutropenia) has been reported when oral cimetidine has been coadministered with carmustine. Consider alternative drugs to cimetidine. Phenobarbital : Phenobarbital induces the metabolism of carmustine and may compromise antitumor activity of carmustine. Consider alternative drugs to phenobarbital.

7.2Effect of Carmustine on Other Drugs Phenytoin: Carmustine when coadministered with phenytoin may reduce phenytoin serum concentrations. Consider alternative drugs to phenytoin.

7.1Effect of Other Drugs on Carmustine Cimetidine : Greater myelosuppression (e.g., leukopenia and neutropenia) has been reported when oral cimetidine has been coadministered with carmustine. Consider alternative drugs to cimetidine. Phenobarbital : Phenobarbital induces the metabolism of carmustine and may compromise antitumor activity of carmustine. Consider alternative drugs to phenobarbital.

7.2Effect of Carmustine on Other Drugs Phenytoin: Carmustine when coadministered with phenytoin may reduce phenytoin serum concentrations. Consider alternative drugs to phenytoin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Advise lactating females not to breastfeed ( 8.2 )

8.1Pregnancy Risk Summary Carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see Clinical Pharmacology (12.1)] and findings in animals [see Data]. Limited available data with carmustine use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area.

Consider the benefits and risks of carmustine for the mother and possible risks to the fetus when prescribing carmustine to a pregnant woman. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Intraperitoneal (IP) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥ 26 mg/kg (158 mg/ m 2 ), approximately 0.1 times the maximum cumulative human dose of 1,400 mg/m 2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity.

Carmustine administered IP to pregnant rats during the period of organogenesis at cumulative doses ≥ 4 mg/kg (24 mg/m 2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m 2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity.

Embryo-fetal death was observed at cumulative doses ≥ 8 mg/kg (48 mg/m 2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m 2 basis. Intravenous (IV) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m 2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m 2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months. Carmustine administered IV to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥ 13 mg/kg (156 mg/m 2 ), approximately 0.1 times the maximum cumulative human dose on a mg/m 2 basis.

8.2Lactation Risk Summary There is no information regarding the presence of carmustine in human milk, the effects on the breastfed infant, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse events (e.g., carcinogenicity and myelosuppression) in nursing infants, nursing should be discontinued while taking carmustine.

8.3Females and Males of Reproductive Potential Contraception Advise female patients to avoid pregnancy during treatment with carmustine because of the risk of fetal harm [see Use in Specific Populations ( 8.1 )]. Advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment. Advise males with female sexual partners of reproductive potential to use effective contraception during carmustine treatment and for at least three months after the final dose of carmustine [see Nonclinical Toxicology ( 13.1 )].

Infertility Based on nonclinical findings, male fertilit… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see Clinical Pharmacology (12.1)] and findings in animals [see Data]. Limited available data with carmustine use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area.

Consider the benefits and risks of carmustine for the mother and possible risks to the fetus when prescribing carmustine to a pregnant woman. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Intraperitoneal (IP) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥ 26 mg/kg (158 mg/ m 2 ), approximately 0.1 times the maximum cumulative human dose of 1,400 mg/m 2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity.

Carmustine administered IP to pregnant rats during the period of organogenesis at cumulative doses ≥ 4 mg/kg (24 mg/m 2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m 2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity.

Embryo-fetal death was observed at cumulative doses ≥ 8 mg/kg (48 mg/m 2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m 2 basis. Intravenous (IV) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m 2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m 2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months. Carmustine administered IV to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥ 13 mg/kg (156 mg/m 2 ), approximately 0.1 times the maximum cumulative human dose on a mg/m 2 basis.

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use Safety and effectiveness in children have not been established. Delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in a long-term study of patients who received carmustine in childhood and early adolescence (1-16 years). Eight out of the 17 patients (47%) who survived childhood brain tumors, including all the 5 patients initially treated at less than 5 years of age, died of pulmonary fibrosis. [see Adverse Reactions ( 6.1 )].

🧓 Geriatric Use 138 words ▾

8.5Geriatric Use Clinical studies of carmustine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Carmustine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

🆘 Overdosage 18 words ▾

10 OVERDOSAGE The main result of overdose is myeloablation. No proven antidotes have been established for carmustine overdosage.

🧬 Clinical Pharmacology 160 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. The metabolites may contribute to antitumor activity and toxicities of carmustine.

12.2Pharmacodynamics The exposure-response relationship for efficacy or safety is unknown.

12.3Pharmacokinetics Distribution Carmustine crosses the blood-brain barrier. Levels of radioactivity in the CSF are greater than or equal to 50% of those measured concurrently in plasma. Elimination Following a short intravenous infusion, the reported elimination half-life ranges from 15 minutes to 75 minutes.

Metabolism Carmustine may be inactivated through denitrosation reactions catalyzed by both cytosolic and microsomal enzymes, including NADPH and glutathione-S-transferase. Excretion Approximately 60% to 70% of a total dose is excreted in the urine within 96 hours. Approximately 10% is eliminated as respiratory CO 2 .

🧬 Mechanism of Action 57 words ▾

12.1Mechanism of Action The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. The metabolites may contribute to antitumor activity and toxicities of carmustine.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Carmustine for injection, USP. Each package includes a vial containing 100 mg carmustine, USP and a vial containing 3 mL sterile diluent. NDC 43598-628-57

16.2Storage and Handling Store product and diluent in a refrigerator (2°C to 8°C, 36°F to 46°F). Stability Store the unopened vial of the dry drug in a refrigerator (2°C to 8°C, 36°F to 46°F). Store the diluent vials in a refrigerator (2°C to 8°C, 36°F to 46°F).

The recommended storage of unopened carmustine vials provides a stable product for up to 24 months. Compatibility/ Incompatibility with Containers The intravenous solution is unstable in polyvinyl chloride container. DO NOT USE PVC Containers .

Administer carmustine solution from the glass bottles or polypropylene container only. Ensure the polypropylene containers used are PVC free and DEHP free. Important Note Carmustine has a low melting point (30.5° to 32.0°C or 86.9° to 89.6°F).

Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton.

Hold the vial to a bright light for inspection. The carmustine will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the carmustine for injection is suitable for use and should be refrigerated immediately.

16.1How Supplied Carmustine for injection, USP. Each package includes a vial containing 100 mg carmustine, USP and a vial containing 3 mL sterile diluent. NDC 43598-628-57

16.2Storage and Handling Store product and diluent in a refrigerator (2°C to 8°C, 36°F to 46°F). Stability Store the unopened vial of the dry drug in a refrigerator (2°C to 8°C, 36°F to 46°F). Store the diluent vials in a refrigerator (2°C to 8°C, 36°F to 46°F).

The recommended storage of unopened carmustine vials provides a stable product for up to 24 months. Compatibility/ Incompatibility with Containers The intravenous solution is unstable in polyvinyl chloride container. DO NOT USE PVC Containers .

Administer carmustine solution from the glass bottles or polypropylene container only. Ensure the polypropylene containers used are PVC free and DEHP free. Important Note Carmustine has a low melting point (30.5° to 32.0°C or 86.9° to 89.6°F).

Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton.

Hold the vial to a bright light for inspection. The carmustine will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the carmustine for injection is suitable for use and should be refrigerated immediately.

📋 Description 119 words ▾

11 DESCRIPTION The active ingredient in carmustine for injection USP, is a nitrosourea with the chemical name1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and poorly soluble in water. Carmustine for injection USP, is administered by intravenous infusion after reconstitution, as recommended.

The structural formula of carmustine USP is: Carmustine for injection USP, is available in 100 mg single dose vials of lyophilized material.Sterile diluent for constitution of carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Myelosuppression [see Warnings and Precautions ( 5.1 )]. A serious and frequent toxicity of carmustine is delayed myelosuppression and usually occurs 4 to 6 weeks after drug administration. Hence, patients should be advised to get blood counts monitored weekly for at least 6 weeks.

The bone marrow toxicity of carmustine is cumulative. Pulmonary Toxicity [see Warnings and Precautions ( 5.2 )]. Advise patients to contact a health care professional immediately for any of the following: shortness of breath, particularly during exercise, dry, hacking cough, fast, shallow breathing, gradual unintended weight loss, tiredness, aching joints and muscles, clubbing (widening and rounding) of the tips of the fingers or toes.

Seizures [see Adverse Reactions ( 6 )] Inform the patient that they may suffer from fits and advise them to get medical attention immediately in such cases. Pregnancy [see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.1 and 8.3 )] Advise pregnant women and females of reproductive potential that carmustine exposure during pregnancy can result in fetal harm. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.

Advise women of reproductive potential to avoid becoming pregnant. Advise females of reproductive potential to use effective contraception during treatment. Lactation [see Use in Specific Populations ( 8.2 )] Advise the female patient to discontinue nursing while taking carmustine.

🍼 Nursing Mothers 109 words ▾

8.3Females and Males of Reproductive Potential Contraception Advise female patients to avoid pregnancy during treatment with carmustine because of the risk of fetal harm [see Use in Specific Populations ( 8.1 )]. Advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment. Advise males with female sexual partners of reproductive potential to use effective contraception during carmustine treatment and for at least three months after the final dose of carmustine [see Nonclinical Toxicology ( 13.1 )].

Infertility Based on nonclinical findings, male fertility may be compromised by treatment with carmustine [see Nonclinical Toxicology ( 13.1 )].

🧬 Pharmacokinetics 89 words ▾

12.3Pharmacokinetics Distribution Carmustine crosses the blood-brain barrier. Levels of radioactivity in the CSF are greater than or equal to 50% of those measured concurrently in plasma. Elimination Following a short intravenous infusion, the reported elimination half-life ranges from 15 minutes to 75 minutes.

Metabolism Carmustine may be inactivated through denitrosation reactions catalyzed by both cytosolic and microsomal enzymes, including NADPH and glutathione-S-transferase. Excretion Approximately 60% to 70% of a total dose is excreted in the urine within 96 hours. Approximately 10% is eliminated as respiratory CO 2 .

🧬 Pharmacodynamics 11 words ▾

12.2Pharmacodynamics The exposure-response relationship for efficacy or safety is unknown.

🧪 Nonclinical Toxicology 110 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carmustine is carcinogenic in rats and mice, producing a marked increase in tumor incidence in doses approximating those employed clinically. Nitrosourea therapy does have carcinogenic potential in humans [see Adverse Reactions ( 6.1 )]. Carmustine was mutagenic and clastogenic in multiple in vitro and in vivo genetic toxicology studies.

Male rats treated with carmustine at cumulative doses ≥ 36 mg/kg (216 mg/ m 2 ), approximately 0.15 times the maximum cumulative human dose on a mg/m 2 basis, showed decreases in reproductive potential when mated with untreated female rats (e.g., decreased implantations, increased resorption rate, and a decrease in viable fetuses).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 107 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carmustine is carcinogenic in rats and mice, producing a marked increase in tumor incidence in doses approximating those employed clinically. Nitrosourea therapy does have carcinogenic potential in humans [see Adverse Reactions ( 6.1 )]. Carmustine was mutagenic and clastogenic in multiple in vitro and in vivo genetic toxicology studies.

Male rats treated with carmustine at cumulative doses ≥ 36 mg/kg (216 mg/ m 2 ), approximately 0.15 times the maximum cumulative human dose on a mg/m 2 basis, showed decreases in reproductive potential when mated with untreated female rats (e.g., decreased implantations, increased resorption rate, and a decrease in viable fetuses).

📚 References 8 words ▾

15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Package Label / Principal Display Panel 39 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Vial label: Carmustine for Injection, USP100 mg per Vial

Diluent Label:

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number Carton: Carmustine for Injection, USP 100 mg per Vial

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

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