Details About Generic Salt ::  Carmusti

Main Medicine Class::    

(CAR-muss-teen)

BiCNU

Powder for injection

100 mg

Gliadel

Wafer

7.7 mg

Class: Alkylating agent

Nitrosoureas

 Indications Brain tumors, multiple myeloma, Hodgkin and non-Hodgkin lymphomas; adjunct to surgical resection in recurrent glioblastoma multiforma (wafer).

Bone marrow transplantation, mycosis fungoides.

 Contraindications Standard considerations.

 Route/Dosage

Brain Tumors, Multiple Myeloma, Hodgkin and Non-Hodgkin Lymphomas (Single Agent in Previously Untreated Patients)

ADULTS: IV 150 to 200 mg/m² q 6 wk, as a single dose or divided into 2 to 3 successive daily infusions.

Dosage Reduction

ADULTS: IV Compromised bone marrow function or therapy with other myelosuppressive drugs requires a reduction in dose. Do not administer repeat courses until acceptable leukocyte and platelet counts have recovered (usually 4000/mm³ and 100,000/mm³, respectively). Subsequent doses are determined by the clinical and hematologic tolerance of the previous dose. The following leukocyte and platelet counts refer to the levels reached at nadir after prior dose. Give 100% of the prior dose given if the leukocytes > 3000 cells/mm³ and the platelets > 75,000 cells/mm³. Give 70% of the prior dose given if the leukocytes are 2000 to 2999 cells/mm³ and the platelets are 25,000 to 74,999 cells/mm³. Give 50% of the prior dose given if the leukocytes < 2000 cells/mm³ and the platelets < 25,000 cells/mm³.

Adjunct to Surgical Resection in Recurrent Glioblastoma Multiforma

ADULTS: Wafer for implantation 8 wafers placed in the resection cavity, for a total dose of 61.6 mg. If the cavity size and shape will not accommodate this, use the greatest number of wafers that will fit.

Interactions

Cimetidine

Cimetidine may enhance the myelosuppressive effects of carmustine.

Digoxin, phenytoin

Digoxin and phenytoin serum levels may be reduced by carmustine.

Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Seizures, confusion, somnolence, brain edema, intracranial infection (wafer). DERMATOLOGIC: Local burning pain at the injection site; intense flushing of the skin. GI: Nausea; vomiting; transient LFT elevations; hepatic necrosis and veno-occlusive disease after bone marrow transplantation. GU: Amenorrhea male infertility. HEMATOLOGIC: Bone marrow suppression; myelosuppression. RENAL: Dose-related, delayed onset, progressive renal failure. RESPIRATORY: Early pulmonary toxicity; delayed pulmonary fibrosis. SPECIALSENSES: Retinitis; optic neuritis; suffusion of the conjunctiva. OTHER: Surgical wound healing abnormalities, CSF leak, subdural fluid collection, subgaleal or wound effusion, wound breakdown, fever, pain (wafer).

 Precautions

Pregnancy: Category D. Lactation: Undetermined. Children: Safety and efficacy not established. Brain edema: Brain edema was noted in 4% of patients treated with the wafer. Brain herniation: Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with the wafer. Fertility impairment: There have been reports of persistent testicular damage causing infertility with injectable carmustine. GI: Nausea and vomiting afer IV administration. This dose-related toxicity appears within 2 hr of dosing and lasts 4 to 6 hr. Healing abnormalities: The majority of these events were mild to moderate in severity. Hematologic: The most frequent and serious toxic effect of injectable carmustine is delayed myelosuppression. Hepatic toxicity: Reversible hepatic toxicity, manifested by increased transaminase, alkaline phosphatase and bilirubin levels, has occurred in a small percentage of patients using injectable carmustine. Intracranial infection: Intracranial infection (eg, meningitis, abscess) occurred in 4% of patients treated with the wafer. Mutagenesis: Long-term use of nitrosoureas has been reported to be associated with the development of secondary malignancies. Obstructive hydrocephalus: Avoid communication between the surgical resection cavity and the ventricular system to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. Ocular: Toxicity manifested as nerve fiber-layer infarcts and retinal hemorrhages has been associated with high dose injectiable carmustine therapy. Pulmonary fibrosis: Delayed onset pulmonary fibrosis has occurred up to 15 yr after treatmentand has been reported in patients who received injectable carmustine in childhood and early adolescence. Pulmonary toxicity: Pulmonary toxicity from injectable carmustine appears to be dose-related. Patients receiving > 1400 mg/m² cumulative dose are at significantly higher risk than those receiving less. Other risk factors include history of lung disease and duration of treatment. Cases of fatal pulmonary toxicity have occurred. Renal toxicity: Decrease in kidney size, progressive azotemia, and renal failure have occurred in patients. Seizures: The majority of seizures in the placebo vs wafer study were mild or moderate in severity. Wafer remnants: Remnants of implanted wafers may be observed on brain imaging scans or during later operations even though all components are extensively degraded. Remnants removed from 2 patients after 64 and 92 days contained < 0.0004% and 0.034%, respectively, of the original carmustine content. Remnants may persist for up to 232 days after implantation.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Administer by IV infusion or intracranial implantation.
• Follow procedures for proper handling and disposal of chemotherapy drugs. Wear gloves and avoid skin exposure and inhalation of fumes.

IV

• Refrigerate vials of the dry powder. Protect from light.
• The reconstituted solution is administered by IV drip over 1 to 2 hr. Shorter infusion times may produce intense pain and burning at the site of injection.
• Store unopened vials of the dry powder in a refrigerator. After reconstitution, the solution is stable for 8 hr at room temperature or for 24 hr under refrigeration in glass protected from light. Vial further diluted to a concentration of 0.2 mg/mL should be utilized within 8 hr at room temperature or can be stoerd for 48 hr under refrigeration followed by 8 hr at room temperature in glass protected from light.
• Temperatures of ³ 30.5°C (³ 86°F) cause carmustine to decompose and appear oily; discard these vials. The drug can still be used if it appears as dry flakes or as a dry, congealed mass when viewed under a bright light.
• Dissolve 1 vial with 3 mL of the dehydrated alcohol diluent, followed by 27 mL of Sterile Water for Injection for a final concentration of 3.3 mg/mL in 10% alcohol. This solution may be further diluted with 0.9% Sodium Chloride or 5% Dextrose for a concentration of 0.2 mg/mL in glass containers.
• Carmustine is preservative-free and should be used as a single-dose vial. The possibility of microbial contamination of reconstituted solutions must be considered.
• Accidental contact of carmustine with skin can cause temporary hyperpigmentation; wear gloves when handling. Double gloving is recommended.
• When administered with polyvinyl chloride (PVC) tubing, longer infusion times may result in unacceptable drug loss. To avoid drug loss, polyethylene tubing, such as nitroglycerin tubing, can be utilized for infusions of carmustine.
• Oxidized regenerated cellulose (Oxycel, Surgicel) may be placed on top of the wafers to secure them against the cavity surface.
• Avoid communication between the resection cavity and the ventricular system to prevent wafers from migrating and causing obstructive hydrocephalus.

Wafer

• Open the foil pouches containing the wafer in the operating room immediately prior to implantation.
• Store wafers for implantation in the freezer.
• Unopened foil pouches are stable at room temperature for up to 6 hr at a time. Administer by IV infusion, intracranial implantation.
• Wafers may be used if broken in half. Do not use if broken in > 2 pieces; dispose of as a hazardous chemical waste.
• Use a dedicated surgical instrument for handling the wafers during implantation.
• Wafers may overlap slightly and should cover as much of the resection cavity as possible.

High doses

• When preparing doses of carmustine > 900 mg/m², only 50% of the alcohol will be used to reconstitute carmustine powder. Reconstituted carmustine is further diluted with 500 mL of 5% Dextrose and infused over 2 hr.¹

 Assessment/Interventions

IV

• Because of delayed bone marrow suppression, monitor blood counts weekly for ³ 6 wk after a dose.
• Conduct baseline pulmonary function studies and frequent pulmonary function tests during treatment. Patients with a baseline < 70% of predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DL_co) are at particular risk. Monitor liver and renal function tests periodically.
• Delayed myleosuppression usually occurs 4 to 6 wk after adminstration and is dose related. Thrombocytopenia occurs at » 4 wk post-administration and persists for 1 to 2 wk. Leukopenia occurs at 5 to 6 wk after a dose and persists for 1 to 2 wk. Thrombocytopenia is generally more severe than leukopenia.

Wafer

• Monitor patients undergoing craniotomy for malignant glioma and implantation of the wafer closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing and brain edema.

 Patient/Family Education

• Contraceptive measures are recommended during therapy.

Medicscientist Drug Facts

Drugs Class ::

Indications for Drugs ::

 Indications Brain tumors, multiple myeloma, Hodgkin and non-Hodgkin lymphomas; adjunct to surgical resection in recurrent glioblastoma multiforma (wafer).

Bone marrow transplantation, mycosis fungoides.

Drug Dose ::

 Route/Dosage

Brain Tumors, Multiple Myeloma, Hodgkin and Non-Hodgkin Lymphomas (Single Agent in Previously Untreated Patients)

ADULTS: IV 150 to 200 mg/m² q 6 wk, as a single dose or divided into 2 to 3 successive daily infusions.

Dosage Reduction

ADULTS: IV Compromised bone marrow function or therapy with other myelosuppressive drugs requires a reduction in dose. Do not administer repeat courses until acceptable leukocyte and platelet counts have recovered (usually 4000/mm³ and 100,000/mm³, respectively). Subsequent doses are determined by the clinical and hematologic tolerance of the previous dose. The following leukocyte and platelet counts refer to the levels reached at nadir after prior dose. Give 100% of the prior dose given if the leukocytes > 3000 cells/mm³ and the platelets > 75,000 cells/mm³. Give 70% of the prior dose given if the leukocytes are 2000 to 2999 cells/mm³ and the platelets are 25,000 to 74,999 cells/mm³. Give 50% of the prior dose given if the leukocytes < 2000 cells/mm³ and the platelets < 25,000 cells/mm³.

Adjunct to Surgical Resection in Recurrent Glioblastoma Multiforma

ADULTS: Wafer for implantation 8 wafers placed in the resection cavity, for a total dose of 61.6 mg. If the cavity size and shape will not accommodate this, use the greatest number of wafers that will fit.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category D. Lactation: Undetermined. Children: Safety and efficacy not established. Brain edema: Brain edema was noted in 4% of patients treated with the wafer. Brain herniation: Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with the wafer. Fertility impairment: There have been reports of persistent testicular damage causing infertility with injectable carmustine. GI: Nausea and vomiting afer IV administration. This dose-related toxicity appears within 2 hr of dosing and lasts 4 to 6 hr. Healing abnormalities: The majority of these events were mild to moderate in severity. Hematologic: The most frequent and serious toxic effect of injectable carmustine is delayed myelosuppression. Hepatic toxicity: Reversible hepatic toxicity, manifested by increased transaminase, alkaline phosphatase and bilirubin levels, has occurred in a small percentage of patients using injectable carmustine. Intracranial infection: Intracranial infection (eg, meningitis, abscess) occurred in 4% of patients treated with the wafer. Mutagenesis: Long-term use of nitrosoureas has been reported to be associated with the development of secondary malignancies. Obstructive hydrocephalus: Avoid communication between the surgical resection cavity and the ventricular system to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. Ocular: Toxicity manifested as nerve fiber-layer infarcts and retinal hemorrhages has been associated with high dose injectiable carmustine therapy. Pulmonary fibrosis: Delayed onset pulmonary fibrosis has occurred up to 15 yr after treatmentand has been reported in patients who received injectable carmustine in childhood and early adolescence. Pulmonary toxicity: Pulmonary toxicity from injectable carmustine appears to be dose-related. Patients receiving > 1400 mg/m² cumulative dose are at significantly higher risk than those receiving less. Other risk factors include history of lung disease and duration of treatment. Cases of fatal pulmonary toxicity have occurred. Renal toxicity: Decrease in kidney size, progressive azotemia, and renal failure have occurred in patients. Seizures: The majority of seizures in the placebo vs wafer study were mild or moderate in severity. Wafer remnants: Remnants of implanted wafers may be observed on brain imaging scans or during later operations even though all components are extensively degraded. Remnants removed from 2 patients after 64 and 92 days contained < 0.0004% and 0.034%, respectively, of the original carmustine content. Remnants may persist for up to 232 days after implantation.

Drug Side Effects ::

 Adverse Reactions

CNS: Seizures, confusion, somnolence, brain edema, intracranial infection (wafer). DERMATOLOGIC: Local burning pain at the injection site; intense flushing of the skin. GI: Nausea; vomiting; transient LFT elevations; hepatic necrosis and veno-occlusive disease after bone marrow transplantation. GU: Amenorrhea male infertility. HEMATOLOGIC: Bone marrow suppression; myelosuppression. RENAL: Dose-related, delayed onset, progressive renal failure. RESPIRATORY: Early pulmonary toxicity; delayed pulmonary fibrosis. SPECIALSENSES: Retinitis; optic neuritis; suffusion of the conjunctiva. OTHER: Surgical wound healing abnormalities, CSF leak, subdural fluid collection, subgaleal or wound effusion, wound breakdown, fever, pain (wafer).

Drug Mode of Action ::  

Drug Interactions ::

Interactions

Cimetidine

Cimetidine may enhance the myelosuppressive effects of carmustine.

Digoxin, phenytoin

Digoxin and phenytoin serum levels may be reduced by carmustine.

Drug Assesment ::

 Assessment/Interventions

IV

• Because of delayed bone marrow suppression, monitor blood counts weekly for ³ 6 wk after a dose.
• Conduct baseline pulmonary function studies and frequent pulmonary function tests during treatment. Patients with a baseline < 70% of predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DL_co) are at particular risk. Monitor liver and renal function tests periodically.
• Delayed myleosuppression usually occurs 4 to 6 wk after adminstration and is dose related. Thrombocytopenia occurs at » 4 wk post-administration and persists for 1 to 2 wk. Leukopenia occurs at 5 to 6 wk after a dose and persists for 1 to 2 wk. Thrombocytopenia is generally more severe than leukopenia.

Wafer

• Monitor patients undergoing craniotomy for malignant glioma and implantation of the wafer closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing and brain edema.

Drug Storage/Management ::

 Administration/Storage

• Administer by IV infusion or intracranial implantation.
• Follow procedures for proper handling and disposal of chemotherapy drugs. Wear gloves and avoid skin exposure and inhalation of fumes.

IV

• Refrigerate vials of the dry powder. Protect from light.
• The reconstituted solution is administered by IV drip over 1 to 2 hr. Shorter infusion times may produce intense pain and burning at the site of injection.
• Store unopened vials of the dry powder in a refrigerator. After reconstitution, the solution is stable for 8 hr at room temperature or for 24 hr under refrigeration in glass protected from light. Vial further diluted to a concentration of 0.2 mg/mL should be utilized within 8 hr at room temperature or can be stoerd for 48 hr under refrigeration followed by 8 hr at room temperature in glass protected from light.
• Temperatures of ³ 30.5°C (³ 86°F) cause carmustine to decompose and appear oily; discard these vials. The drug can still be used if it appears as dry flakes or as a dry, congealed mass when viewed under a bright light.
• Dissolve 1 vial with 3 mL of the dehydrated alcohol diluent, followed by 27 mL of Sterile Water for Injection for a final concentration of 3.3 mg/mL in 10% alcohol. This solution may be further diluted with 0.9% Sodium Chloride or 5% Dextrose for a concentration of 0.2 mg/mL in glass containers.
• Carmustine is preservative-free and should be used as a single-dose vial. The possibility of microbial contamination of reconstituted solutions must be considered.
• Accidental contact of carmustine with skin can cause temporary hyperpigmentation; wear gloves when handling. Double gloving is recommended.
• When administered with polyvinyl chloride (PVC) tubing, longer infusion times may result in unacceptable drug loss. To avoid drug loss, polyethylene tubing, such as nitroglycerin tubing, can be utilized for infusions of carmustine.
• Oxidized regenerated cellulose (Oxycel, Surgicel) may be placed on top of the wafers to secure them against the cavity surface.
• Avoid communication between the resection cavity and the ventricular system to prevent wafers from migrating and causing obstructive hydrocephalus.

Wafer

• Open the foil pouches containing the wafer in the operating room immediately prior to implantation.
• Store wafers for implantation in the freezer.
• Unopened foil pouches are stable at room temperature for up to 6 hr at a time. Administer by IV infusion, intracranial implantation.
• Wafers may be used if broken in half. Do not use if broken in > 2 pieces; dispose of as a hazardous chemical waste.
• Use a dedicated surgical instrument for handling the wafers during implantation.
• Wafers may overlap slightly and should cover as much of the resection cavity as possible.

High doses

• When preparing doses of carmustine > 900 mg/m², only 50% of the alcohol will be used to reconstitute carmustine powder. Reconstituted carmustine is further diluted with 500 mL of 5% Dextrose and infused over 2 hr.¹

Drug Notes ::

 Patient/Family Education

• Contraceptive measures are recommended during therapy.

Medicscientist Drug Facts

Disclaimer ::

The Information available on this site is for only Informational Purpose , before any use of this information please consult your Doctor .Price of the drugs indicated above may not match to real price due to many possible reasons may , including local taxes etc.. These are only approximate indicative prices of the drug.