Carmustine IV Infusion

Carmustine IV Infusion is used for: Brain tumour, Hodgkin's disease, Multiple myeloma, Non-Hodgkin's lymphoma, Malignant glioma, Recurrent glioblastoma multiforme

Intravenous Brain tumour, Hodgkin's disease, Multiple myeloma, Non-Hodgkin's lymphoma Adult: As a single dose of 150-200 mg/m2 or divided into doses of 75-100 mg/m2 given on 2 successive days. Doses are given via IV infusion over 1-2 hours. Doses may be repeated every 6 weeks provided that blood counts have returned to acceptable levels. Adjust subsequent doses based on haematological toxicity. Used in combination with prednisolone for the treatment of multiple myeloma. Used as secondary therapy (with other approved drugs) in the treatment of Hodgkin's disease and non-Hodgkin's lymphomas. Intracavitary Malignant glioma, Recurrent glioblastoma multiforme Adult: Implantation of wafers containing 7.7 mg/wafer into the cavity left by removal of the tumour. Max: 8 wafers.

Renal Impairment CrCl 46-80 mL/min: Administer 80% of regular dose CrCl 31-45 mL/min: Administer 75% of regular dose CrCl <30 mL/min: Not recommended

IV Preparation Initially dilute with 3 mL of supplied diluent (dehydrated alcohol); further dilute aseptically with 27 mL SWI to result in a concentration of 3.3 mg/mL in 10% alcohol Standard dilution: dose/150-500 mL D5W or NS IV Administration Significant absorption to PVC containers; should be administered in either glass or Excel container Infuse over 1-2 hr High dose carmustine: maximum rate of infusion <3 mg/sq.meter/min to avoid excessive flushing, agitation, & hypotension; infusions should run over at least 2 hr

Hypersensitivity. Pregnancy and Lactation.

Bone marrow suppression (notably thrombocytopenia and leukopenia) is the most common and severe of the toxic effects that may result from carmustine administration. It may contribute to bleeding and infections; monitor blood counts for at least 6 weeks after a dose. Pulmonary toxicity is dose-related; risk increases with cumulative doses > 1400 mg/m², history of lung disease and duration of therapy; delayed cases of pulmonary fibrosis that can result in death have been reported 15 years after administration in children. Do not give more frequently than q6-8wk due to delayed myelosuppression; complete blood count should be monitored weekly for at least six weeks after each dose Risk of irreversible pulmonary fibrosis on long-term treatment Injection site reactions may occur during administration; rapid infusion may cause burning along the vein and flushing of skin Extravasation risk, monitor closely during infusion Ocular toxicity associated with an intracarotid route (investigational); safety and efficacy not established Associated with moderate to high emetic potential; administer antiemetics to prevent nausea and vomiting Monitor liver function tests periodically during therapy; reversible increases (rare) in bilirubin, alkaline phosphatase levels, and transaminases reported Wafer implant associated with intracranial hypertension; brain edema reported in patients with newly diagnosed glioma; monitor closely for intracranial hypertension related to brain edema, inflammation, or necrosis of brain tissues surrounding resection; in refractory cases, removing the wafer may be necessary Meningitis reported in patients with recurrent glioma receiving wafer implants; monitor postoperatively for signs/symptoms of meningitis and CNS infection Renal failure, decreased kidney size, and progressive azotemia reported in patients receiving low or large cumulative doses or prolonged treatment; Long-term use associated with development of secondary malignancies (acute leukemia and bone marrow dysplasias) Wafer implants associated with seizures; treatment-emergent seizures reported within 5 days of surgery; initiate optimal anti-seizure therapy prior to surgery Impaired neurosurgical wound healing, including wound dehiscence, delayed healing, and subdural, subgleal or wound effusions associated with wafer implant treatment; cerebrospinal fluid leaks also reported; monitor for impaired neurosurgical wound healing following surgery Avoid pregnancy Monitoring Parameters Monitor CBC, pulmonary function, LFTs, renal function periodically during therapy

Pregnancy Therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women Animal data Drug is embryotoxic and teratogenic in rats at exposures less than exposure at recommended human dose based on body surface area (BSA) and embryotoxic in rabbits at exposures similar to exposures at the recommended human dose based on BSA; advise pregnant women of potential risk to a fetus Verify pregnancy status of females of reproductive potential prior to therapy Therapy can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception for 6 months after therapy Based on its mechanism of action, advise males with female partners of reproductive potential to use effective contraception for 3 months following therapy Carmustine caused testicular degeneration in animals; advise male patients of potential risk of infertility Lactation No data are available regarding presence of drug or metabolites in human milk or effects on breastfed child or on milk production; because of potential for serious adverse reactions in breastfed children from therapy, advise women not to breastfeed following treatment and for at least 7 days after treatment

May enhance myelosuppressive effects with cimetidine. Increased risk of pulmonary toxicity with melphalan. Decreased antiepileptic activity of phenytoin. Decreased absorption of digoxin. Contraindicated (0) Serious (13) adenovirus types 4 and 7 live, oral axicabtagene ciloleucel brexucabtagene autoleucel ciltacabtagene autoleucel etrasimod idecabtagene vicleucel influenza virus vaccine quadrivalent, adjuvanted influenza virus vaccine trivalent, adjuvanted lisocabtagene maraleucel palifermin ropeginterferon alfa 2b tisagenlecleucel tofacitinib

Side effects of Carmustine : >10% Convulsions (19%) Hemiplegia (19%) Headache (15%) Metabolic disorder (14%) Somnolence (14%) Fever (12%) 1-10% Confusion (10%) Aphasia (9%) Nausea (8%) Vomiting (8%) Pain (7%) Rash (5%) Abscess (4%) Cranial edema (4%) ICP elevation (4%) Meningitis (4%) Hyperglycemia (3%) HTN (3%) Constipation (2%) Diarrhea (2%) Dizziness (2%) Depression (2%) Frequency Not Defined Greater myelotoxicity reported when coadministered with cimetidine 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: Infections: Opportunistic infections (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

Carmustine, a cell cycle non-specific antineoplastic agent belonging to nitrosourea group, interferes with the normal function of DNA and RNA by alkylation and cross-linking the strands of DNA and RNA, and by possible protein modification. It inhibits enzymatic processes by carbamoylation of amino acids in proteins.

Carmustine 100 mg/vial IV Infusion manufactured by Renata PLC.. Its generic name is Carmustine. Carmustine is availble in Bangladesh. Farmaco BD drug index information on Carmustine IV Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.