Trade Name: carmustine

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: KIT, HUMAN PRESCRIPTION DRUG

Storage and handling

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of carmustine (carmustine) which is also known as carmustine and Manufactured by Amneal Biosciences LLC. It is available in strength of .

carmustine (carmustine) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Myelosuppression
  • Carmustine for injection causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections and. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose . Do not administer a repeat course of carmustine for injection until blood counts recover.
  • Pulmonary Toxicity
  • Cn- armustine for injection causes dose-related pulmonary toxicity. Patients receiving greater than 1,400 mg/mcumulative 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 and .
  • WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY
  • See full prescribing information for complete boxed warning
  • Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following:
  • -u00a0u00a0u00a0 Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
  • -u00a0u00a0u00a0 Multiple myeloma in combination with prednisone.
  • -u00a0u00a0u00a0 Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
  • -u00a0u00a0u00a0 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. ()
  • 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. ()
  • No data
  • Recommended Dosage: As a single agent, 150 mg/m to 200 mg/m carmustine for injection intravenously every 6 weeks as a single-dose or divided into daily injections such as 75 mg/m to 100 mg/m on 2 successive days. Adjust dose for combination therapy or in patients with reduced bone marrow reserve. ()
  • Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours. ()
  • Carmustine for Injection, USP is a lyophilized pale yellow flakes or congealed mass containing carmustine, USP in an amber colored glass vial for single-dose use. It is supplied with 3 mL of dehydrated alcohol injection, USP (sterile diluent for carmustine for injection) for reconstitution.
  • For injection: 100 mg of carmustine lyophilized powder in a single-dose vial for reconstitution and a vial containing 3mL sterile diluent (Dehydrated Alcohol Injection, USP). ()n n
  • Carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components.
  • Hypersensitivity. ()
  • No data
  • Administration Reactions: Extravasation may occur; monitor infusion site closely during administration. ()
  • 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. ()
  • Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route. ()
  • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The following adverse reactions associated with the use of carmustine for injection 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.
  • Arrayn- Cardiac Disorders
  • Tachycardia and chest pain
  • Arrayn- Eye Disorders
  • Conjunctival edema, conjunctival hemorrhage, blurred vision and loss of depth perception
  • Arrayn- Gastrointestinal Toxicity
  • Nausea, vomiting, anorexia, and diarrhea
  • Arrayn- Hepatotoxicity
  • Increased transaminase, increased alkaline phosphatase, increased bilirubin levels
  • Arrayn- Infections and Infestations
  • Opportunistic infection (including with fatal outcome)
  • Arrayn- Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)
  • Acute leukemia, bone marrow dysplasias
  • Arrayn- Nephrotoxicity
  • Progressive azotemia, decrease in kidney size, renal failure
  • Arrayn- Nervous System Disorders
  • Headaches, encephalopathy, and seizures
  • Arrayn- Pulmonary Toxicity
  • Pneumonitis, interstitial lung disease
  • Arrayn- Reproductive System and Breast Disorders
  • Gynecomastia
  • Arrayn- Skin and Subcutaneous Tissue Disorders
  • Burning sensation, hyperpigmentation, swelling, pain, erythema, skin necrosis, alopecia, allergic reaction
  • Arrayn- Vascular Disorders
  • Veno-occlusive disease
  • Most common adverse reactions (> 1%) are nausea, vomiting, renal toxicity, pneumonitis, pulmonary toxicity, myelosuppression. ()
  • No data
  • Cimetidine: Increased myelosuppression with concomitant use. ()
  • Phenobarbital: Induces carmustine metabolism, reducing exposure. May lead to reduced efficacy. ()
  • Phenytoin: Carmustine for injection may reduce the efficacy of phenytoin. ()
  • No data
  • Lactation: Advise lactating females not to breastfeed. ()
  • The main result of overdose is myeloablation. No proven antidotes have been established for carmustine for injection overdosage.
  • The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.05 g/mol. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for injection is administered by intravenous infusion after reconstitution, as recommended.
  • The molecular formula of carmustine is CHClNO and the structural formula of carmustine is:
  • Carmustine for injection, USP is available in 100 mg single-dose vials of lyophilized material. Sterile diluent for constitution of carmustine for injection, USP 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.
  • No data
  • 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 .
  • Carmustine was mutagenic and clastogenic in multiple and genetic toxicology studies.
  • Male rats treated with carmustine at cumulative doses u2265 36 mg/kg (216 mg/m), approximately 0.15 times the maximum cumulative human dose on a mg/mbasis, showed decreases in reproductive potential when mated with untreated female rats (e.g., decreased implantations, increased resorption rate, and a decrease in viable fetuses).
  • 1. u201cOSHA Hazardous Drugs.u201d . n
  • No data
  • Arrayn- Arrayn- see ]
  • A serious and frequent toxicity of carmustineu00a0 for injection 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 for injection is cumulative.
  • Arrayn- [see ]
  • 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.
  • Arrayn- Arrayn- see ]
  • Inform the patient that they may suffer from fits and advise them to get medical attention immediately in such cases.
  • Arrayn- Arrayn- see n n- Arrayn- Array
  • Advise pregnant women and females of reproductive potential that carmustine for injection 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.
  • Arrayn- Arrayn- see ]
  • Advise the female patient to discontinue nursing while taking carmustine for injection.
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 10-2018-01
  • Carmustine n- for Injection, USP
  • Arrayn- Array
  • About Combi Kit Guard.
  • -u00a0u00a0u00a0u00a0 This Combi Kit Guard is specially designed for your safety.
  • -u00a0u00a0u00a0u00a0 Please do not remove the vials from the Combi Kit Guard.
  • -u00a0u00a0u00a0u00a0 Keep the Combi Kit Guard in a carton till the time of use.
  • How to use this Combi Kit Guard
  • The instructions below explain how to use this Combi Kit Guard.
  • The Combi Kit Guard has two compartments. One holds the 100 mg carmustine vial and the other holds the 3 mL sterile diluent (Dehydrated Alcohol Injection, USP) vial.
  • List of items required: gloves, alcohol swabs, sterile syringe.
  • Wear gloves at all times when handling COMBI KIT Guard.
  • Discard the COMBI KIT Guard after use.
  • Please refer the product information leaflet before administration.
  • For more information, go to www.amneal.com or call toll-free 1-855-266-3251.
  • u00a0
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 10-2018-01
  • NDC 70121-1668-1
  • Carmustine for Injection USP, 100 mg/vial
  • Rx Only
  • Vial Label
  • Amneal Biosciences LLC
  • NDC 70121-3639-1
  • Sterile Diluent (Dehydrated Alcohol Injection, USP), 3 mLn
  • Rx Only
  • Vial Label
  • Amneal Biosciences LLC
  • Arrayn- Array
  • NDC 70121-1482-2
  • Carmustine for Injection USP, 100 mg/vial
  • Rx Only
  • Carton Label
  • Amneal Biosciences LLC
  • Arrayn- Array
  • Arrayn- Array

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