(mye toe ZAN trone)
- Dihydroxyanthracenedione Dihydrochloride
- Mitoxantrone Dihydrochloride
- Mitoxantrone HCl
- Mitoxantrone Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 20 mg/10 mL (10 mL); 25 mg/12.5 mL (12.5 mL); 30 mg/15 mL (15 mL)
- Antineoplastic Agent, Anthracenedione
- Antineoplastic Agent, Topoisomerase II Inhibitor
Related to the anthracyclines, mitoxantrone intercalates into DNA resulting in cross-links and strand breaks; binds to nucleic acids and inhibits DNA and RNA synthesis by template disordering and steric obstruction; replication is decreased by binding to DNA topoisomerase II and seems to inhibit the incorporation of uridine into RNA and thymidine into DNA; active throughout entire cell cycle (cell-cycle nonspecific)
Vd: 14 L/kg; Vdss: >1,000 L/m2; distributes extensively into pleural fluid, kidney, thyroid, liver, heart, pancreas, spleen, bone marrow, and red blood cells; prolonged retention in tissues
Hepatic; pathway not determined
Feces (25%); urine (6% to 11%; 65% as unchanged drug)
Terminal: 23 to 215 hours (median: ~75 hours); may be prolonged with hepatic impairment
Special Populations: Hepatic Function Impairment
Ordinarily, do not treat patients with multiple sclerosis (MS) who have hepatic impairment with mitoxantrone. Dosage adjustment may be required for other patients with hepatic impairment. Patients with severe hepatic impairment have an AUC at least 3 times greater than patients with healthy hepatic function.
Special Populations: Elderly
Cl is reduced in elderly patients with breast cancer compared with younger patients with nasopharyngeal carcinoma and malignant lymphoma.
Use: Labeled Indications
Initial treatment of acute nonlymphocytic leukemias (ANLL [includes myelogenous, promyelocytic, monocytic and erythroid leukemias]); treatment of advanced hormone-refractory prostate cancer; secondary progressive or relapsing-remitting multiple sclerosis (MS)
Canadian labeling: Additional uses (not in U.S. labeling): Treatment of metastatic breast cancer, relapsed leukemia (adults), lymphoma, and hepatocellular carcinoma
Off Label Uses
Acute lymphocytic leukemia (ALL); Autologous hematopoietic stem cell transplantation (HSCT) (conditioning regimen); Breast cancer (metastatic); Hodgkin lymphoma (refractory); Non-Hodgkin lymphomas (NHL); Pediatric acute myelogenous leukemia (AML); Pediatric acute promyelocytic leukemia (APL); Relapsed acute myeloid leukemia (AML)
Hypersensitivity to mitoxantrone or any component of the formulation
Canadian labeling: Additional contraindications (not in U.S. labeling): Prior hypersensitivity to anthracyclines; prior substantial anthracycline exposure and abnormal cardiac function prior to initiation of mitoxantrone therapy; presence of severe myelosuppression due to prior chemo- and/or radiotherapy; severe hepatic impairment; intrathecal administration
Details concerning dosing in combination regimens should also be consulted.
Acute nonlymphocytic leukemias (ANLL): IV:
Acute myeloid leukemia (AML) induction: 12 mg/m2 once daily for 3 days (in combination with cytarabine); for incomplete response, may repeat (7-10 days later) at 12 mg/m2 once daily for 2 days (in combination with cytarabine) (Arlin 1990)
AML consolidation (beginning ~6 weeks after initiation of the final induction course): 12 mg/m2 once daily for 2 days (in combination with cytarabine), repeat in 4 weeks (Arlin 1990)
Multiple sclerosis: IV: 12 mg/m2 every 3 months (maximum lifetime cumulative dose: 140 mg/m2; discontinue use with LVEF <50% or clinically significant reduction in LVEF)
Prostate cancer (advanced, hormone-refractory): IV: 12 to 14 mg/m2 every 3 weeks (in combination with corticosteroids)
Acute nonlymphocytic leukemias (ANLL): IV:
AML induction: 10 to 12 mg/m2 once daily for 3 days (in combination with cytarabine); for incomplete response, may repeat at 10 to 12 mg/m2 once daily for 2 days (in combination with cytarabine)
AML consolidation (beginning ~6 weeks after initiation of the final induction course): 12 mg/m2 once daily for 2 days (in combination with cytarabine), repeat in 4 weeks
Acute leukemias (relapsed): IV: Induction: 12 mg/m2 once daily for 5 consecutive days; may repeat once if needed (at the same dose and duration)
Breast cancer (metastatic), lymphoma: IV: Initial: Single agent: 14 mg/m2 every 21 days; reduce initial dose to ≤12 mg/m2 for myelosuppression due to previous treatment or for poor general health. When used in combination with other agents, reduce initial dose to 10 to 12 mg/m2.
Hepatocellular cancer: IV: Initial: Single agent: 14 mg/m2 every 21 days; reduce initial dose to ≤12 mg/m2 for myelosuppression due to previous treatment or for poor general health
Adult off-label uses and/or dosing:
AML, refractory: IV:
CLAG-M regimen: 10 mg/m2 once daily for 3 days (in combination with cladribine, cytarabine, and filgrastim), may repeat once if needed (Wierzbowska 2008)
MEC or EMA regimen: 6 mg/m2 once daily for 6 days (in combination with cytarabine and etoposide) (Amadori 1991)
Mitoxantrone/Etoposide: 10 mg/m2 once daily for 5 days (in combination with etoposide) (Ho 1988)
APL consolidation phase (second course): IV: 10 mg/m2 once daily for 5 days (Sanz 2004)
Hodgkin lymphoma, refractory: IV:
MINE-ESHAP regimen: 10 mg/m2 on day 1 every 28 days for up to 2 cycles (MINE is combination with mesna, ifosfamide, mitoxantrone, and etoposide; MINE alternates with ESHAP for up to 2 cycles of each) (Fernandez 2010)
VIM-D regimen: 10 mg/m2 on day 1 every 28 days (in combination with etoposide, ifosfamide, mesna, and dexamethasone) (Phillips 1990)
Non-Hodgkin lymphoma (as part of combination chemotherapy regimens): IV:
CNOP regimen: 10 mg/m2 every 21 days (Bessell 2003)
FCMR regimen: 8 mg/m2 every 28 days (Forstpointner 2004)
FMR regimen: 10 mg/m2 every 21 days (Zinzani 2004)
FND regimen: 10 mg/m2 every 28 days (Tsimberidou 2002)
MINE-ESHAP regimen: 8 mg/m2 every 21 days for 6 cycles (MINE is combination with mesna, ifosfamide, mitoxantrone, and etoposide; followed by ESHAP) (Rodriguez 1995)
Stem cell transplantation, autologous: IV: 60 mg/m2 administered 4 to 5 days prior to autografting (as 3 divided doses over 1 hour each at 1-2 hour intervals on the same day; in combination with other chemotherapeutic agent[s]) (Oyan 2006; Tarella 2001)
Refer to adult dosing.
Details concerning dosing in combination regimens should also be consulted.
Acute nonlymphocytic leukemias: IV:
Acute myeloid leukemia (AML) consolidation phase (second course; off-label use): 10 mg/m2 once daily for 5 days (in combination with cytarabine) (Stevens, 1998)
Acute promyelocytic leukemia (APL) consolidation phase (second course; off-label use): 10 mg/m2 once daily for 5 days (Ortega, 2005; Sanz, 2004)
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling (has not been studied).
Hemodialysis: Supplemental dose is not necessary
Peritoneal dialysis: Supplemental dose is not necessary
Elderly: Clearance is decreased in elderly patients; use with caution
Dosing: Hepatic Impairment
U.S. labeling: No dosage adjustment provided in the manufacturer’s labeling; however, clearance is reduced in hepatic dysfunction. Patients with severe hepatic dysfunction (bilirubin >3.4 mg/dL) have an AUC of 3 times greater than patients with normal hepatic function; consider dose adjustments. Note: MS patients with hepatic impairment should not receive mitoxantrone.
Mild-to-moderate impairment: No specific dosage adjustment provided; consider dose adjustments and monitor closely.
Severe impairment: Use is contraindicated.
Dosing: Adjustment for Toxicity
ANLL patients: Severe or life-threatening nonhematologic toxicity: Withhold treatment until toxicity resolves
Neutrophils <1500/mm3: Use is not recommended.
Signs/symptoms of HF: Evaluate for cardiac signs/symptoms and LVEF.
LVEF <50% or baseline LVEF below the lower limit of normal (LLN): Use is not recommended.
Canadian labeling (not in U.S. labeling): Hepatocellular cancer, lymphoma, or breast cancer (metastatic):
WBC nadir >1500/mm3 and platelet nadir >50,000/mm3 and recovery ≤21 days: Repeat previous dose or increase dose by 2 mg/m2 if myelosuppression is inadequate.
WBC nadir >1500/mm3 and platelet nadir >50,000/mm3 and recovery >21 days: Withhold treatment until recovery then resume at previous dose.
WBC nadir <1500/mm3 or platelet nadir <50,000/mm3 (regardless of recovery time): Withhold treatment until recovery then decrease previous dose by 2 mg/m2.
WBC nadir <1000/mm3 or platelet nadir <25,000/mm3 (regardless of recovery time): Withhold treatment until recovery then decrease previous dose by 4 mg/m2.
ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient’s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs, 2012).
Dilute in at least 50 mL of NS or D5W. May further dilute in D5W, NS or D5NS, use immediately after preparation.
For IV administration only; do not administer intrathecally, subcutaneously, intramuscularly or intra-arterially. Must be diluted prior to use. Usually administered as a short IV infusion over 5-15 minutes; do not infuse over <3-5 minutes.
High doses for bone marrow transplant (off-label use) are usually given as 3 divided doses over 1 hour each at 1-2 hour intervals on the same day (Oyan, 2006; Tarella, 2001).
Irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate antidote (dexrazoxane or dimethyl sulfate [DMSO]). Apply dry cold compresses for 20 minutes 4 times daily for 1-2 days (Perez Fidalgo, 2012); withhold cooling beginning 15 minutes before dexrazoxane infusion; continue withholding cooling until 15 minutes after infusion is completed. Topical DMSO should not be administered in combination with dexrazoxane; may lessen dexrazoxane efficacy.
Dexrazoxane: Adults: 1000 mg/m2 (maximum dose: 2000 mg) IV (administer in a large vein remote from site of extravasation) over 1-2 hours days 1 and 2, then 500 mg/m2 (maximum dose: 1000 mg) IV over 1-2 hours day 3; begin within 6 hours of extravasation. Day 2 and day 3 doses should be administered at approximately the same time (± 3 hours) as the dose on day 1 (Mouridsen, 2007; Perez Fidalgo, 2012). Note: Reduce dexrazoxane dose by 50% in patients with moderate to severe renal impairment (CrCl <40 mL/minute).
DMSO: Children and Adults: Apply topically to a region covering twice the affected area every 8 hours for 7 days; begin within 10 minutes of extravasation; do not cover with a dressing (Perez Fidalgo, 2012).
Store intact vials at 15°C to 25°C (59°F to 77°F); do not freeze. Opened vials may be stored at room temperature for 7 days or under refrigeration for up to 14 days. Solutions diluted in D5W or NS for administration are stable for 7 days at room temperature or under refrigeration, although the manufacturer recommends immediate use.
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
CycloSPORINE (Systemic): May increase the serum concentration of MitoXANTRONE. Management: Consider mitoxantrone dose reduction, as clinically appropriate, when used with cyclosporine. Use this combination with caution and monitor closely for toxic effects of mitoxantrone. Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
Includes events reported with any indication; incidence varies based on treatment, dose, and/or concomitant medications.
Cardiovascular: Edema (10% to 30%), cardiac disease (≤18%), cardiac arrhythmia (3% to 18%), ECG changes (≤11%)
Central nervous system: Pain (8% to 41%), fatigue (≤39%), headache (6% to 13%)
Dermatologic: Alopecia (20% to 61%), nail bed changes (≤11%)
Endocrine & metabolic: Menstrual disease (26% to 61%), amenorrhea (28% to 53%), hyperglycemia (10% to 31%), weight gain (≤17%), weight loss (≤17%), increased gamma-glutamyl transferase (3% to 15%)
Gastrointestinal: Nausea (26% to 76%), vomiting (6% to 72%), diarrhea (14% to 47%), mucositis (10% to 29%; onset: ≤1 week), stomatitis (8% to 29%; onset: ≤1 week), anorexia (22% to 25%), constipation (10% to 16%), gastrointestinal hemorrhage (2% to 16%), abdominal pain (9% to 15%), dyspepsia (5% to 14%)
Genitourinary: Urinary tract infection (7% to 32%), hematuria (≤11%), urine abnormality (5% to 11%)
Hematologic & oncologic: Neutropenia (79% to 100%; onset: ≤3 weeks; grade 4: 23% to 54%), leukopenia (9% to 100%), lymphocytopenia (72% to 95%), anemia (≤75%), decreased hemoglobin (≤75%), thrombocytopenia (33% to 39%; grades 3/4: 3% to 4%), bruise (≤11%), febrile neutropenia (≤11%), petechia (≤11%)
Hepatic: Increased serum alkaline phosphatase (≤37%), increased serum transaminases (5% to 20%)
Infection: Infection (4% to 60%), sepsis (≤34%), fungal infection (9% to 15%)
Neuromuscular & skeletal: Weakness (≤24%)
Renal: Increased blood urea nitrogen (≤22%), increased serum creatinine (≤13%)
Respiratory: Upper respiratory tract infection (7% to 53%), pharyngitis (≤19%), dyspnea (6% to 18%), cough (5% to 13%)
Miscellaneous: Fever (6% to 78%)
1% to 10%:
Cardiovascular: Cardiac failure (≤5%), ischemia (≤5%), decreased left ventricular ejection fraction (≤5%), hypertension (≤4%)
Central nervous system: Chills (≤5%), anxiety (5%), depression (5%), seizure (2% to 4%)
Dermatologic: Diaphoresis (≤9%), skin infection (≤5%)
Endocrine & metabolic: Hypocalcemia (10%), hypokalemia (7% to 10%), hyponatremia (9%), hypermenorrhea (7%)
Gastrointestinal: Aphthous stomatitis (≤10%)
Genitourinary: Impotence (≤7%), proteinuria (≤6%), sterility (≤5%)
Hematologic & oncologic: Granulocytopenia (6%), hemorrhage (5% to 6%), acute leukemia (≤3%; secondary; includes AML, APL)
Hepatic: Jaundice (3% to 7%)
Infection: Fungal infection (cutaneous: ≤10%)
Neuromuscular & skeletal: Back pain (6% to 8%), arthralgia (≤5%), myalgia (≤5%)
Ophthalmic: Conjunctivitis (≤5%), blurred vision (≤3%)
Renal: Renal failure (≤8%)
Respiratory: Rhinitis (10%), pneumonia (≤9%), sinusitis (≤6%)
<1% (Limited to important or life-threatening): Anaphylactoid reaction, anaphylaxis, chest pain, dehydration, hypersensitivity reaction, interstitial pneumonitis (with combination chemotherapy), hyperuricemia, hypotension, ocular discoloration (blue discoloration of sclera), phlebitis (at infusion site), skin rash, tachycardia, urine discoloration (blue-green), urticaria
Concerns related to adverse effects:
• Bone marrow suppression: Treatment may lead to severe myelosuppression; unless the expected benefit outweighs the risk, use is generally not recommended in patients with pre-existing myelosuppression from prior chemotherapy. [U.S. Boxed Warning]: Usually should not be administered if baseline neutrophil count <1500 cells/mm3 (except for in the treatment of ANLL). Monitor blood counts and monitor for infection due to neutropenia.
• Extravasation: Irritant with vesicant-like properties. [U.S. Boxed Warning]: For IV administration only, into a free-flowing IV; may cause severe local tissue damage if extravasation occurs. Extravasation resulting in burning, erythema, pain, swelling and skin discoloration (blue) has been reported; may result in tissue necrosis and require debridement for skin graft. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
• Hyperuricemia: Rapid lysis of tumor cells may lead to hyperuricemia.
• Myocardial toxicity: [U.S. Boxed Warning]: May cause myocardial toxicity and potentially-fatal heart failure (HF); risk increases with cumulative dosing. Effects may occur during therapy or may be delayed (months or years after completion of therapy). Predisposing factors for mitoxantrone-induced cardiotoxicity include prior anthracycline or anthracenedione therapy, prior cardiovascular disease, concomitant use of cardiotoxic drugs, and mediastinal/pericardial irradiation, although may also occur in patients without risk factors. Prior to therapy initiation, evaluate all patients for cardiac-related signs/symptoms, including history, physical exam, and ECG; and evaluate baseline left ventricular ejection fraction (LVEF) with echocardiogram or multigated radionuclide angiography (MUGA) or MRI. Not recommended for use in MS patients when LVEF <50%, or baseline LVEF below the lower limit of normal (LLN). Evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) in MS patients prior to each dose and if signs/symptoms of HF develop. Use in MS should be limited to a cumulative dose of ≤140 mg/m2, and discontinued if LVEF falls below LLN or a significant decrease in LVEF is observed; decreases in LVEF and HF have been observed in patients with MS who have received cumulative doses <100 mg/m2. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity.
• Secondary malignancy: [U.S. Boxed Warning]: Treatment with mitoxantrone increases the risk of developing secondary acute myelogenous leukemia (AML) in patients with cancer and in patients with MS; acute promyelocytic leukemia (APL) has also been observed. Symptoms of acute leukemia include excessive bruising, bleeding and recurrent infections. The risk for secondary leukemia is increased in patients who are heavily pretreated, with higher doses, and with combination chemotherapy.
• Hepatic impairment: Clearance is reduced in patients with hepatic impairment; use with caution; dosage adjustment recommended. Not for treatment of multiple sclerosis in patients with concurrent hepatic impairment. Canadian labeling contraindicates use in severe impairment.
• Multiple sclerosis: Not for treatment of primary progressive multiple sclerosis.
• Appropriate administration: [U.S. Boxed Warning]: For IV administration only, into a free-flowing IV; do not administer subcutaneously, intramuscularly, or intra-arterially. Do not administer intrathecally; may cause serious and permanent neurologic damage.
• Blue-green coloration: May cause urine, saliva, tears, and sweat to turn blue-green for 24 hours postinfusion; whites of eyes may have blue-green tinge.
• Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of a physician experienced in cancer chemotherapy agents.
CBC with differential, serum uric acid (for leukemia treatment), liver function tests; for the treatment of multiple sclerosis, obtain pregnancy test; monitor injection site for extravasation
Cardiac monitoring: Prior to initiation, evaluate all patients for cardiac-related signs/symptoms, including history, physical exam, and ECG; evaluate baseline and periodic left ventricular ejection fraction (LVEF) with echocardiogram or multigated radionuclide angiography (MUGA) or MRI. In patients with MS, evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) prior to each dose and if signs/symptoms of HF develop. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Based on the mechanism of action, mitoxantrone may cause fetal harm if administered during pregnancy. Use of effective contraception during therapy is recommended. Information related to pregnancy outcomes following maternal use of mitoxantrone in pregnancy is limited (Amato 2015; Houtchens 2013; NTP 2013).
Infertility and amenorrhea have been reported in women with MS using mitoxantrone (Amato 2015; Houtchens 2013). Women with multiple sclerosis who are of reproductive potential should have a pregnancy test prior to each dose. Women who wish to become pregnant should discontinue therapy at least 2 to 3 months prior to conception (Houtchens 2013).
The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). In general, if chemotherapy is indicated, it should be avoided in the first trimester, there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (Peccatori 2013).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience blue or green urine, eye discoloration, nausea, vomiting, abdominal pain, diarrhea, constipation, lack of appetite, headache, mouth irritation, mouth sores, common cold symptoms, hair loss, back pain, or amenorrhea. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), signs of infection, signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), excessive weight loss, jaundice, severe loss of strength and energy, bone pain, night sweats, blue/gray skin discoloration, or severe injection site redness, pain, edema, or irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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Other brands: Novantrone