Details About Generic Salt ::  Mitoxant

Main Medicine Class::    

(MY-toe-ZAN-trone)

Novantrone

Sterile solution for injection

2 mg/mL

Class: Antineoplastic antibiotic

 Indications Adult acute nonlymphocytic leukemia (ANLL), advanced hormone-refractory prostrate cancer, multiple sclerosis (MS).

Breast cancer, non-Hodgkin’s lymphoma, autologous bone marrow transplantation.

 Contraindications Standard considerations.

 Route/Dosage

MS

ADULTS: IV The recommended dosage of mitoxantrone is 12 mg/m² given as a short (» 5 to 15 min) IV infusion every 3 mo.

Prostate Cancer

ADULTS: IV Recommended dosage of mitoxantrone is 12 to 14 mg/m² given as a short IV infusion every 21 days.

Combination Initial Therapy for ANLL

ADULTS: IV For induction, give 12 mg/m²/day on days 1 to 3, and give 100 mg/m² of cytarabine for 7 days as a continuous 24-hr infusion on days 1 to 7. A second induction course may be given. Give mitoxantrone for 2 days and cytarabine for 5 days using the same daily dosage levels.

Autologous Bone Marrow Transplantation

ADULTS: IV 60 to 75 mg/m² (total dose prior to transplantation) divided and given in 3 to 5 fractionated doses.

Adjustment in Hepatic Insufficiency

ADULTS: IV If bilirubin levels are 1.5 to 3 mg/dL, give 50% of dose. If bilirubin is > 3 mg/dL, give 25% of dose.

Maximum Lifetime Cumulative Dose

ADULTS: IV If patient has no prior anthracycline therapy, the lifetime cumulative dose is 140 to 160 mg/m². If patient has had previous doxorubicin or daunorubicin therapy, the lifetime cumulative dose is 100 to 120 mg/m².

Interactions

Quinolone antibiotics

Mitoxantrone may decrease oral absorption of quinolone antibiotics.

Topoisomerase II inhibitors and other antineoplastic agents

Have been associated with the development of acute leukemia.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Functional cardiac changes including irreversible CHF and decreases in LVEF can occur. Previous therapy with other anthracyclines (eg, doxorubicin, daunorubicin, idarubicin) or mediastinal radiation may increase risk of cardiotoxicity. Acute arrhythmias (rare). DERMATOLOGIC: Blue discoloration of the skin around injection site; alopecia; rash; urticaria. GI: Moderate potential for nausea and vomiting with doses < 15 mg/m²; higher doses may be more emetogenic; mucositis within 1 wk of therapy; transient elevation of LFTs. HEMATOLOGIC: Bone marrow suppression, nadir at 10 to 14 days. HYPERSENSITIVITY: Angioedema.

 Precautions

Pregnancy: Category D. Lactation: Discontinue breastfeeding starting treatment. Children: Safety and efficacy for use in children have not been established. Myelosuppression: Mitoxantrone administered at any dose can cause myelosuppression. Patients with preexisting myelosuppression as the result of prior drug therapy should not receive mitoxantrone. Hepatic function impairment: Patients with MS who have hepatic impairment should ordinarily not be treated with mitoxantrone. A dosage adjustment may be required. Extravasation risk: Local irritation or phlebitis may occur. Refer to your institution specific protocol.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Store at room temperature and do not freeze.
• The remaining portion of the undiluted mitoxantrone concentrate should be stored £ 7 days between 15° and 25°C (59° and 77°F) or 14 days under refrigeration.
• Dilute solution ³ 50 mL with 0.9% Sodium Chloride or 5% Dextrose.
• Use within 24 hr of preparation.
• Infuse diluted solution in freely running IV infusion of 0.9% Sodium Chloride or 5% Dextrose ³ 3 min.
• For IV use only. Safety for use by routes other than IV administration has not been established.
• Never give SC, IM, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration.
• Not for intrathecal use. Severe injury with permanent sequelae can result from intrathecal administration.
• If extravasation occurs, stop administration immediately and restart in another vein. Carefully monitor the extravasation site for signs of necrosis or phlebitis that may require further medical attention.
• If skin is accidentally exposed to mitoxantrone, rinse copiously with warm water; if the eyes are involved, use standard irrigation techniques immediately. The use of goggles, gloves and protective gowns is recommended during preparation and administration of the drug.

IV incompatibility

• Do not mix in the same infusion as heparin; a precipitate may form. Do not mix mitoxantrone in the same infusion with other drugs.

 Assessment/Interventions

• Do not give to patients with baseline neutrophil counts £ 1500 cells/mm³. It is recommended that frequent peripheral blood cell counts be performed on all patients.
• Monitor patients for evidence of cardiac toxicity and question them about symptoms of heart failure prior to initiation of treatment. Monitor patients with MS who reach a cumulative dose of 100 mg/m² for evidence of cardiac toxicity. Ordinarily, patients with MS should not receive a cumulative dose > 140 mg/m².
• Evaluation of left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan is recommended prior to administration of the initial dose of mitoxantrone. Subsequent LVEF evaluations are recommended if signs or symptoms of CHF develop, and prior to all doses administered to patients who have received a cumulative dose of ³ 100 mg/m². Do not administer mitoxantrone to MS patients who have received a cumulative lifetime dose of ³ 140 mg/m², or those with either LVEF of < 50% or a clinically significant reduction in LVEF.
• Monitor CBCs, including platelets, prior to each course of mitoxantrone and in the event that signs or symptoms of infection develop. Do not administer mitoxantrone to MS patients with neutrophil counts < 1500 cells/mm³. Monitor LFTs prior to each course. Mitoxantrone therapy in MS patients with abnormal LFTs is not recommended because mitoxantrone clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.
• If severe or life-threatening nonhematologic toxicity is observed during the first induction course, withhold the second induction course until toxicity clears.
• Hyperuricemia may occur. Monitor serum uric acid levels and institute hypouricemic therapy prior to initiation.
• Women should have a pregnancy test before receiving each dose of mitoxantrone.
• Treat systemic infections concomitantly with or just before starting mitoxantrone.

 Patient/Family Education

• Provide MS patients with the patient package insert at the time that the decision is made to treat with mitoxantrone and prior to and in close temporal proximity to each treatment. In addition, the health care provider should discuss the issues addressed in the patient package insert with the patient.
• Mitoxantrone may impart a blue-green color to the urine for 24 hr after administration; advise patients to expect this during therapy. Bluish discoloration of the sclera may also occur. Advise patients of the signs and symptoms of myelosuppression.

Medicscientist Drug Facts

Drugs Class ::

Indications for Drugs ::

 Indications Adult acute nonlymphocytic leukemia (ANLL), advanced hormone-refractory prostrate cancer, multiple sclerosis (MS).

Breast cancer, non-Hodgkin’s lymphoma, autologous bone marrow transplantation.

Drug Dose ::

 Route/Dosage

MS

ADULTS: IV The recommended dosage of mitoxantrone is 12 mg/m² given as a short (» 5 to 15 min) IV infusion every 3 mo.

Prostate Cancer

ADULTS: IV Recommended dosage of mitoxantrone is 12 to 14 mg/m² given as a short IV infusion every 21 days.

Combination Initial Therapy for ANLL

ADULTS: IV For induction, give 12 mg/m²/day on days 1 to 3, and give 100 mg/m² of cytarabine for 7 days as a continuous 24-hr infusion on days 1 to 7. A second induction course may be given. Give mitoxantrone for 2 days and cytarabine for 5 days using the same daily dosage levels.

Autologous Bone Marrow Transplantation

ADULTS: IV 60 to 75 mg/m² (total dose prior to transplantation) divided and given in 3 to 5 fractionated doses.

Adjustment in Hepatic Insufficiency

ADULTS: IV If bilirubin levels are 1.5 to 3 mg/dL, give 50% of dose. If bilirubin is > 3 mg/dL, give 25% of dose.

Maximum Lifetime Cumulative Dose

ADULTS: IV If patient has no prior anthracycline therapy, the lifetime cumulative dose is 140 to 160 mg/m². If patient has had previous doxorubicin or daunorubicin therapy, the lifetime cumulative dose is 100 to 120 mg/m².

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category D. Lactation: Discontinue breastfeeding starting treatment. Children: Safety and efficacy for use in children have not been established. Myelosuppression: Mitoxantrone administered at any dose can cause myelosuppression. Patients with preexisting myelosuppression as the result of prior drug therapy should not receive mitoxantrone. Hepatic function impairment: Patients with MS who have hepatic impairment should ordinarily not be treated with mitoxantrone. A dosage adjustment may be required. Extravasation risk: Local irritation or phlebitis may occur. Refer to your institution specific protocol.

Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: Functional cardiac changes including irreversible CHF and decreases in LVEF can occur. Previous therapy with other anthracyclines (eg, doxorubicin, daunorubicin, idarubicin) or mediastinal radiation may increase risk of cardiotoxicity. Acute arrhythmias (rare). DERMATOLOGIC: Blue discoloration of the skin around injection site; alopecia; rash; urticaria. GI: Moderate potential for nausea and vomiting with doses < 15 mg/m²; higher doses may be more emetogenic; mucositis within 1 wk of therapy; transient elevation of LFTs. HEMATOLOGIC: Bone marrow suppression, nadir at 10 to 14 days. HYPERSENSITIVITY: Angioedema.

Drug Mode of Action ::  

Drug Interactions ::

Interactions

Quinolone antibiotics

Mitoxantrone may decrease oral absorption of quinolone antibiotics.

Topoisomerase II inhibitors and other antineoplastic agents

Have been associated with the development of acute leukemia.

Drug Assesment ::

 Assessment/Interventions

• Do not give to patients with baseline neutrophil counts £ 1500 cells/mm³. It is recommended that frequent peripheral blood cell counts be performed on all patients.
• Monitor patients for evidence of cardiac toxicity and question them about symptoms of heart failure prior to initiation of treatment. Monitor patients with MS who reach a cumulative dose of 100 mg/m² for evidence of cardiac toxicity. Ordinarily, patients with MS should not receive a cumulative dose > 140 mg/m².
• Evaluation of left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan is recommended prior to administration of the initial dose of mitoxantrone. Subsequent LVEF evaluations are recommended if signs or symptoms of CHF develop, and prior to all doses administered to patients who have received a cumulative dose of ³ 100 mg/m². Do not administer mitoxantrone to MS patients who have received a cumulative lifetime dose of ³ 140 mg/m², or those with either LVEF of < 50% or a clinically significant reduction in LVEF.
• Monitor CBCs, including platelets, prior to each course of mitoxantrone and in the event that signs or symptoms of infection develop. Do not administer mitoxantrone to MS patients with neutrophil counts < 1500 cells/mm³. Monitor LFTs prior to each course. Mitoxantrone therapy in MS patients with abnormal LFTs is not recommended because mitoxantrone clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.
• If severe or life-threatening nonhematologic toxicity is observed during the first induction course, withhold the second induction course until toxicity clears.
• Hyperuricemia may occur. Monitor serum uric acid levels and institute hypouricemic therapy prior to initiation.
• Women should have a pregnancy test before receiving each dose of mitoxantrone.
• Treat systemic infections concomitantly with or just before starting mitoxantrone.

Drug Storage/Management ::

 Administration/Storage

• Store at room temperature and do not freeze.
• The remaining portion of the undiluted mitoxantrone concentrate should be stored £ 7 days between 15° and 25°C (59° and 77°F) or 14 days under refrigeration.
• Dilute solution ³ 50 mL with 0.9% Sodium Chloride or 5% Dextrose.
• Use within 24 hr of preparation.
• Infuse diluted solution in freely running IV infusion of 0.9% Sodium Chloride or 5% Dextrose ³ 3 min.
• For IV use only. Safety for use by routes other than IV administration has not been established.
• Never give SC, IM, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration.
• Not for intrathecal use. Severe injury with permanent sequelae can result from intrathecal administration.
• If extravasation occurs, stop administration immediately and restart in another vein. Carefully monitor the extravasation site for signs of necrosis or phlebitis that may require further medical attention.
• If skin is accidentally exposed to mitoxantrone, rinse copiously with warm water; if the eyes are involved, use standard irrigation techniques immediately. The use of goggles, gloves and protective gowns is recommended during preparation and administration of the drug.

IV incompatibility

• Do not mix in the same infusion as heparin; a precipitate may form. Do not mix mitoxantrone in the same infusion with other drugs.

Drug Notes ::

 Patient/Family Education

• Provide MS patients with the patient package insert at the time that the decision is made to treat with mitoxantrone and prior to and in close temporal proximity to each treatment. In addition, the health care provider should discuss the issues addressed in the patient package insert with the patient.
• Mitoxantrone may impart a blue-green color to the urine for 24 hr after administration; advise patients to expect this during therapy. Bluish discoloration of the sclera may also occur. Advise patients of the signs and symptoms of myelosuppression.

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.