Mitoxantrone Injection Concentrate

Name: Mitoxantrone Injection Concentrate

Mitoxantrone Injection Concentrate - Clinical Pharmacology

Mechanism of Action

Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity.

Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFα, and IL-2.


Pharmacokinetics of mitoxantrone in patients following a single intravenous administration of mitoxantrone can be characterized by a three-compartment model. The mean alpha half-life of mitoxantrone is 6 to 12 minutes, the mean beta half-life is 1.1 to 3.1 hours and the mean gamma (terminal or elimination) half-life is 23 to 215 hours (median approximately 75 hours). Pharmacokinetic studies have not been performed in humans receiving multiple daily dosing. Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2. Tissue concentrations of mitoxantrone appear to exceed those in the blood during the terminal elimination phase. In the healthy monkey, distribution to brain, spinal cord, eye, and spinal fluid is low.

In patients administered 15 to 90 mg/m2 of mitoxantrone intravenously, there is a linear relationship between dose and the area under the concentration-time curve (AUC).

Mitoxantrone is 78% bound to plasma proteins in the observed concentration range of 26 to 455 ng/mL. This binding is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.

Metabolism and Elimination

Mitoxantrone is excreted in urine and feces as either unchanged drug or as inactive metabolites. In human studies, 11% and 25% of the dose were recovered in urine and feces, respectively, as either parent drug or metabolite during the 5-day period following drug administration. Of the material recovered in urine, 65% was unchanged drug. The remaining 35% was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates. The pathways leading to the metabolism of mitoxantrone have not been elucidated.

Special Populations


The effect of gender on mitoxantrone pharmacokinetics is unknown.


In elderly patients with breast cancer, the systemic mitoxantrone clearance was 21.3 L/hr/m2, compared with 28.3 L/hr/m2 and 16.2 L/hr/m2 for non-elderly patients with nasopharyngeal carcinoma and malignant lymphoma, respectively.


Mitoxantrone pharmacokinetics in the pediatric population are unknown.


The effect of race on mitoxantrone pharmacokinetics is unknown.

Renal Impairment

Mitoxantrone pharmacokinetics in patients with renal impairment are unknown.

Hepatic Impairment

Mitoxantrone clearance is reduced by hepatic impairment. Patients with severe hepatic dysfunction (bilirubin > 3.4 mg/dL) have an AUC more than three times greater than that of patients with normal hepatic function receiving the same dose. Patients with multiple sclerosis who have hepatic impairment should ordinarily not be treated with mitoxantrone. Other patients with hepatic impairment should be treated with caution and dosage adjustment may be required.

Drug Interactions

In vitro drug interaction studies have demonstrated that mitoxantrone did not inhibit CYP450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 across a broad concentration range. The results of in vitro induction studies are inconclusive, but suggest that mitoxantrone may be a weak inducer of CYP450 2E1 activity.

Pharmacokinetic studies of the interaction of mitoxantrone with concomitantly administered medications in humans have not been performed. The pathways leading to the metabolism of mitoxantrone have not been elucidated. To date, post-marketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited.


Mitoxantrone is contraindicated in patients who have demonstrated prior hypersensitivity to it.

Adverse Reactions

Multiple Sclerosis

Mitoxantrone has been administered to 149 patients with multiple sclerosis in two randomized clinical trials, including 21 patients who received mitoxantrone in combination with corticosteroids.

In Study 1, the proportion of patients who discontinued treatment due to an adverse event was 9.7% (n = 6) in the 12 mg/m2 mitoxantrone arm (leukopenia, depression, decreased LV function, bone pain and emesis, renal failure, and one discontinuation to prevent future complications from repeated urinary tract infections) compared to 3.1% (n = 2) in the placebo arm (hepatitis and myocardial infarction). The following clinical adverse experiences were significantly more frequent in the mitoxantrone groups: nausea, alopecia, urinary tract infection, and menstrual disorders, including amenorrhea.

Table 4a summarizes clinical adverse events of all intensities occurring in ≥5% of patients in either dose group of mitoxantrone and that were numerically greater on drug than on placebo in Study 1. The majority of these events were of mild to moderate intensity, and nausea was the only adverse event that occurred with severe intensity in more than one patient (three patients [5%] in the 12 mg/m2 group). Of note, alopecia consisted of mild hair thinning.

Two of the 127 patients treated with mitoxantrone in Study 1 had decreased LVEF to below 50% at some point during the 2 years of treatment. An additional patient receiving 12 mg/m2 did not have LVEF measured, but had another echocardiographic measure of ventricular function (fractional shortening) that led to discontinuation from the study.

Table 4a: Adverse Events of Any Intensity Occurring in ≥ 5% of Patients on Any Dose of Mitoxantrone and That Were Numerically Greater Than in the Placebo Group Study 1
Percent of Patients
Preferred Term Placebo (N = 64) 5 mg/m2
Mitoxantrone (N = 65)
12 mg/m2
Mitoxantrone (N = 62)
* Percentage of female patients.
Nausea 20 55 76
Alopecia 31 38 61
Menstrual disorder* 26 51 61
Amenorrhea* 3 28 43
Upper respiratory tract infection 52 51 53
Urinary tract infection 13 29 32
Stomatitis 8 15 19
Arrhythmia 8 6 18
Diarrhea 11 25 16
Urine abnormal 6 5 11
ECG abnormal 3 5 11
Constipation 6 14 10
Back pain 5 6 8
Sinusitis 2 3 6
Headache 5 6 6

The proportion of patients experiencing any infection during Study 1 was 67% for the placebo group, 85% for the 5 mg/m2 group, and 81% for the 12 mg/m2 group. However, few of these infections required hospitalization: one placebo patient (tonsillitis), three 5 mg/m2 patients (enteritis, urinary tract infection, viral infection), and four 12 mg/m2 patients (tonsillitis, urinary tract infection [two], endometritis).

Table 4b summarizes laboratory abnormalities that occurred in ≥ 5% of patients in either mitoxantrone dose group, and that were numerically more frequent than in the placebo group.

Table 4b: Laboratory Abnormalities Occurring in ≥ 5% of Patients* on Either Dose of Mitoxantrone and That Were More Frequent Than in the Placebo Group Study 1
Percent of Patients
Event Placebo (N = 64) 5 mg/m2
Mitoxantrone (N = 65)
12 mg/m2
Mitoxantrone (N = 62)
* Assessed using World Health Organization (WHO) toxicity criteria. † < 4000 cells/mm3 ‡ < 2000 cells/mm3
Leukopenia† 0 9 19
Gamma-GT increased 3 3 15
SGOT increased 8 9 8
Granulocytopenia‡ 2 6 6
Anemia 2 9 6
SGPT increased 3 6 5

There was no difference among treatment groups in the incidence or severity of hemorrhagic events.

In Study 2, mitoxantrone was administered once a month. Clinical adverse events most frequently reported in the mitoxantrone group included amenorrhea (53% of female patients), alopecia (33% of patients), nausea (29% of patients), and asthenia (24% of patients). Tables 5a and 5b respectively summarize adverse events and laboratory abnormalities occurring in > 5% of patients in the mitoxantrone group and numerically more frequent than in the control group.

Table 5a: Adverse Events of Any Intensity Occurring in > 5% of Patients* in the Mitoxantrone Group and Numerically More Frequent Than in the Control Group Study 2
Percent of Patients
Event MP (N = 21) M + MP (N = 21)
M = mitoxantrone, MP = methylprednisolone
* Assessed using National Cancer Institute (NCI) common toxicity criteria. † Percentage of female patients.
Amenorrhea† 0 53
Alopecia 0 33
Nausea 0 29
Asthenia 0 24
Pharyngitis/throat infection 5 19
Gastralgia/stomach burn/epigastric pain 5 14
Aphthosis 0 10
Cutaneous mycosis 0 10
Rhinitis 0 10
Menorrhagia† 0 7
Table 5b: Laboratory Abnormalities Occurring in > 5% of Patients* in the Mitoxantrone Group and Numerically More Frequent Than in the Control Group Study 2
Percent of Patients
Event MP (N = 21) M + MP (N = 21)
M = mitoxantrone, MP = methylprednisolone
* Assessed using National Cancer Institute (NCI) common toxicity criteria. † < 4000 cells/mm3 ‡ < 1500 cells/mm3 § < 100,000 cells/mm3
WBC low† 14 100
ANC low‡ 10 100
Lymphocytes low 43 95
Hemoglobin low 48 43
Platelets low§ 0 33
SGOT high 5 15
SGPT high 10 15
Glucose high 5 10
Potassium low 0 10

Leukopenia and neutropenia were reported in the M + MP group (see Table 5b).

Neutropenia occurred within 3 weeks after mitoxantrone administration and was always reversible. Only mild to moderate intensity infections were reported in 9 of 21 patients in the M + MP group and in 3 of 21 patients in the MP group; none of these required hospitalization. There was no difference among treatment groups in the incidence or severity of hemorrhagic events. There were no withdrawals from Study 2 for safety reasons.


Mitoxantrone has been studied in approximately 600 patients with acute non-lymphocytic leukemia (ANLL). Table 6 represents the adverse reaction experience in the large U.S. comparative study of mitoxantrone + cytarabine vs daunorubicin + cytarabine. Experience in the large international study was similar. A much wider experience in a variety of other tumor types revealed no additional important reactions other than cardiomyopathy (see WARNINGS). It should be appreciated that the listed adverse reaction categories include overlapping clinical symptoms related to the same condition, e.g., dyspnea, cough and pneumonia. In addition, the listed adverse reactions cannot all necessarily be attributed to chemotherapy as it is often impossible to distinguish effects of the drug and effects of the underlying disease. It is clear, however, that the combination of mitoxantrone + cytarabine was responsible for nausea and vomiting, alopecia, mucositis/stomatitis, and myelosuppression.

Table 6 summarizes adverse reactions occurring in patients treated with mitoxantrone + cytarabine in comparison with those who received daunorubicin + cytarabine for therapy of ANLL in a large multicenter randomized prospective U.S. trial.

Adverse reactions are presented as major categories and selected examples of clinically significant subcategories.

Table 6: Adverse Events Occurring in ANLL Patients Receiving Mitoxantrone or Daunorubicin
[% pts entering induction]
[% pts entering induction]
Event MIT
N = 102
N = 102
N = 55
N = 49
MIT = mitoxantrone, DAUN = daunorubicin.
Cardiovascular 26 28 11 24
  CHF 5 6 0 0
  Arrhythmias 3 3 4 4
Bleeding 37 41 20 6
  GI 16 12 2 2
  Petechiae/ecchymoses 7 9 11 2
Gastrointestinal 88 85 58 51
  Nausea/vomiting 72 67 31 31
  Diarrhea 47 47 18 8
  Abdominal pain 15 9 9 4
  Mucositis/stomatitis 29 33 18 8
Hepatic 10 11 14 2
  Jaundice 3 8 7 0
Infections 66 73 60 43
  UTI 7 2 7 2
  Pneumonia 9 7 9 0
  Sepsis 34 36 31 18
  Fungal infections 15 13 9 6
Renal failure 8 6 0 2
Fever 78 71 24 18
Alopecia 37 40 22 16
Pulmonary 43 43 24 14
  Cough 13 9 9 2
  Dyspnea 18 20 6 0
CNS 30 30 34 35
  Seizures 4 4 2 8
  Headache 10 9 13 8
Eye 7 6 2 4
  Conjunctivitis 5 1 0 0

Hormone-Refractory Prostate Cancer

Detailed safety information is available for a total of 353 patients with hormone-refractory prostate cancer treated with mitoxantrone, including 274 patients who received mitoxantrone in combination with corticosteroids.

Table 7 summarizes adverse reactions of all grades occurring in ≥5% of patients in Trial CCI-NOV22.

Table 7: Adverse Events of Any Intensity Occurring in ≥5% of Patients Trial CCI-NOV22
Event M + P (n = 80) % P (n = 81) %
M = mitoxantrone, P = prednisone.
No nonhematologic adverse events of Grade 3/4 were seen in > 5% of patients.
Nausea 61 35
Fatigue 39 14
Alopecia 29 0
Anorexia 25 6
Constipation 16 14
Dyspnea 11 5
Nail bed changes 11 0
Edema 10 4
Systemic infection 10 7
Mucositis 10 0
UTI 9 4
Emesis 9 5
Pain 8 9
Fever 6 3
Hemorrhage/bruise 6 1
Anemia 5 3
Cough 5 0
Decreased LVEF 5 0
Anxiety/depression 5 3
Dyspepsia 5 6
Skin infection 5 3
Blurred vision 3 5

Table 8 summarizes adverse events of all grades occurring in ≥ 5% of patients in Trial CALGB 9182.

Table 8: Adverse Events of Any Intensity Occurring in ≥ 5% of Patients. Trial CALGB 9182
M + H (n = 112) H (n = 113)
Event n % n %
M = mitoxantrone, H = hydrocortisone
Decreased WBC 96 87 4 4
Abnormal granulocytes/bands 88 79 3 3
Decreased hemoglobin 83 75 42 39
Abnormal lymphocytes count 78 72 27 25
Pain 45 41 44 39
Abnormal platelet count 43 39 8 7
Abnormal alkaline phosphatase 41 37 42 38
Malaise/fatigue 37 34 16 14
Hyperglycemia 33 31 32 30
Edema 31 30 15 14
Nausea 28 26 9 8
Anorexia 24 22 16 14
Abnormal BUN 24 22 22 20
Abnormal transaminase 22 20 16 14
Alopecia 20 20 1 1
Abnormal cardiac function 19 18 0 0
Infection 18 17 4 4
Weight loss 18 17 13 12
Dyspnea 16 15 9 8
Diarrhea 16 14 4 4
Fever in absence of infection 15 14 7 6
Weight gain 15 14 16 15
Abnormal creatinine 14 13 11 10
Other gastrointestinal 13 14 11 11
Vomiting 12 11 6 5
Other neurologic 11 11 5 5
Hypocalcemia 10 10 5 5
Hematuria 9 11 5 6
Hyponatremia 9 9 3 3
Sweats 9 9 2 2
Other liver 8 8 8 8
Stomatitis 8 8 1 1
Cardiac dysrhythmia 7 7 3 3
Hypokalemia 7 7 4 4
Neuro/constipation 7 7 2 2
Neuro/motor disorder 7 7 3 3
Neuro/mood disorder 6 6 2 2
Skin disorder 6 6 4 4
Cardiac ischemia 5 5 1 1
Chills 5 5 0 0
Hemorrhage 5 5 3 3
Myalgias/arthralgias 5 5 3 3
Other kidney/bladder 5 5 3 3
Other endocrine 5 6 3 4
Other pulmonary 5 5 3 3
Hypertension 4 4 5 5
Impotence/libido 4 7 2 3
Proteinuria 4 6 2 3
Sterility 3 5 2 3


Allergic Reaction

Hypotension, urticaria, dyspnea, and rashes have been reported occasionally. Anaphylaxis/anaphylactoid reactions have been reported rarely.


Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning, and/or blue discoloration of the skin. Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting. Phlebitis has also been reported at the site of the infusion.


Topoisomerase II inhibitors, including mitoxantrone, in combination with other antineoplastic agents or alone, have been associated with the development of acute leukemia (see WARNINGS).


Myelosuppression is rapid in onset and is consistent with the requirement to produce significant marrow hypoplasia in order to achieve a response in acute leukemia. The incidences of infection and bleeding seen in the U.S. trial are consistent with those reported for other standard induction regimens.

Hormone-Refractory Prostate Cancer

In a randomized study where dose escalation was required for neutrophil counts greater than 1000/mm3, Grade 4 neutropenia (ANC < 500/mm3) was observed in 54% of patients treated with mitoxantrone + low-dose prednisone. In a separate randomized trial where patients were treated with 14 mg/m2, Grade 4 neutropenia in 23% of patients treated with mitoxantrone + hydrocortisone was observed. Neutropenic fever/infection occurred in 11% and 10% of patients receiving mitoxantrone + corticosteroids, respectively, on the two trials. Platelets < 50,000/mm3 were noted in 4% and 3% of patients receiving mitoxantrone + corticosteroids on these trials, and there was one patient death on mitoxantrone + hydrocortisone due to intracranial hemorrhage after a fall.


Nausea and vomiting occurred acutely in most patients and may have contributed to reports of dehydration, but were generally mild to moderate and could be controlled through the use of antiemetics. Stomatitis/mucositis occurred within 1 week of therapy.


Congestive heart failure, tachycardia, EKG changes including arrhythmias, chest pain, and asymptomatic decreases in left ventricular ejection fraction have occurred. (See WARNINGS)


Interstitial pneumonitis has been reported in cancer patients receiving combination chemotherapy that included mitoxantrone.

MEDICATION GUIDE MitoXANTRONE (mito-xan-trone) Injection, USP (concentrate)


Read this Medication Guide before you start receiving MitoXANTRONE and each time you receive MitoXANTRONE. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about MitoXANTRONE?

MitoXANTRONE can cause serious side effects, including:

  • decrease in the ability of your bone marrow to make blood cells (myelosuppression). Your doctor may do blood tests during treatment with MitoXANTRONE to check your blood cell counts. The symptoms of myelosuppression can include:
    • feeling tired
    • increased infections
    • bruising and bleeding easily
  • heart problems (congestive heart failure) that may lead to death even in people who have never had heart problems before. Heart failure can happen while you receive MitoXANTRONE, or months to years after you stop receiving MitoXANTRONE. Your risk of heart failure increases the more MitoXANTRONE you receive.
    Call your doctor or get medical help right away if you have any of these problems during or after treatment with MitoXANTRONE:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain
    • fast heartbeat or pounding in your chest
    Before receiving MitoXANTRONE for the first time, you should have the following tests done:
    • physical examination
    • a test to check your heart's electrical activity (electrocardiogram)
    • a test to check your heart's ability to pump blood
    If you receive MitoXANTRONE to treat Multiple Sclerosis (MS), your doctor should also do the tests above:
    • before you receive each MitoXANTRONE dose
    • yearly after you stop receiving MitoXANTRONE treatment
  • acute myeloid leukemia (AML). Receiving MitoXANTRONE increases your risk of AML. AML is a cancer of the blood-forming cells of your bone marrow. Symptoms of AML can include:
  • feeling unusually tired and weak
  • increased infections
  • bruising and bleeding easily
  • fever
  • pain in your bones
  • trouble breathing
  • unexplained weight loss
  • night sweats
  • skin problems at your injection site. If MitoXANTRONE leaks out of your vein, skin problems can happen that may lead to serious skin damage (necrosis). Necrosis may need to be repaired surgically. Tell your doctor right away if you have any of the following problems at your injection site:
  • redness
  • swelling
  • pain
  • burning
  • skin turns a bluish color

What is MitoXANTRONE?

MitoXANTRONE is a prescription medicine used alone or with other medicines to treat people with:

  • secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS)
  • pain related to advanced hormone-refractory prostate cancer
  • acute nonlymphocytic leukemia (ANLL)

MitoXANTRONE is not for people with primary progressive MS. It is not known if MitoXANTRONE is safe and effective in children.

Who should not receive MitoXANTRONE?

Do not receive MitoXANTRONE if you are allergic to MitoXANTRONE or any of the ingredients in MitoXANTRONE. See the end of this Medication Guide for a complete list of ingredients in MitoXANTRONE.

What should I tell my doctor before receiving MitoXANTRONE?

Before you receive MitoXANTRONE, tell your doctor if you have:

  • received MitoXANTRONE in the past
  • heart problems
  • liver problems
  • kidney problems
  • low blood cell counts
  • an infection
  • had radiation treatment in your chest area
  • any other medical conditions
  • are pregnant or plan to become pregnant. MitoXANTRONE may harm your unborn baby. Women who are able to become pregnant should use effective birth control (contraception) while using MitoXANTRONE and should have a pregnancy test, with known results, before receiving each dose of MitoXANTRONE. Talk to your doctor about using effective birth control while you receive MitoXANTRONE.
  • are breastfeeding or plan to breastfeed. MitoXANTRONE can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you receive MitoXANTRONE. Do not breastfeed while receiving MitoXANTRONE.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using MitoXANTRONE with certain other medicines may cause serious side effects.

Especially tell your doctor if you take or have taken:

  • medicines for cancer treatment called anthracyclines or anthracenediones
  • medicines that may affect your heart

Ask your doctor or pharmacist for a list of these medicines if you are not sure if you take or have taken any of these medicines.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I receive MitoXANTRONE?

  • MitoXANTRONE is given by slow infusion through a needle placed in a vein (intravenous infusion) in your arm.
  • Your doctor will tell you how often you will receive MitoXANTRONE.
  • If you receive MitoXANTRONE to treat MS, your doctor should check how well your heart is working before each MitoXANTRONE dose. Talk to your doctor if you have not had your heart tests done before your MitoXANTRONE dose.
  • Your doctor will do blood tests during your treatment with MitoXANTRONE to check your blood cell counts.
  • If you are a woman of childbearing age taking MitoXANTRONE to treat MS, your doctor should do a pregnancy test before each MitoXANTRONE dose, even if you are using birth control.
  • If you receive MitoXANTRONE to treat MS, there is a limit to the total amount of MitoXANTRONE you can receive during your lifetime. There is a higher risk of heart failure with increasing total lifetime doses of MitoXANTRONE.

What are the possible side effects of MitoXANTRONE?

MitoXANTRONE may cause serious side effects, including:

  • See "What is the most important information I should know about MitoXANTRONE?" The most common side effects of MitoXANTRONE include:
  • blue-green colored urine for about 24 hours after receiving MitoXANTRONE. This color change is harmless.
  • bluish coloring of the whites of your eyes for about 24 hours after receiving MitoXANTRONE. This color change is harmless.
  • nausea
  • constipation
  • diarrhea
  • stomach pain
  • hair loss
  • fever and chills due to infections
  • cough and sore throat due to upper respiratory tract infection
  • mouth sores due to mouth infection
  • loss of your menstrual period

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of MitoXANTRONE. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of MitoXANTRONE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about MitoXANTRONE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about MitoXANTRONE that is written for health professionals.

For more information go to or call 1-800-615-0187.

What are the ingredients in MitoXANTRONE?

Active ingredient: MitoXANTRONE hydrochloride

Inactive ingredients: sodium chloride, sodium metabisulfite, sodium acetate, and acetic acid

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mfd by: Zydus Hospira Oncology Private Ltd., Gujarat, India.

Dist. by: Hospira, Inc. Lake Forest, IL 60045 USA
Product of India GUJ-DRUGS/G/28/1267





1 x 10 mL Vial
NDC 61703-343-18

Rx only

Injection, USP
20 mg/ 10 mL
(2 mg/mL)

For Intravenous Infusion
After Dilution
Multi Dose Vial

Pharmacist dispense enclosed
medication guide to each

Cytotoxic Agent


15 mL Vial
NDC 61703-343-66

Rx only

Injection, USP
30 mg/ 15 mL
(2 mg/mL)

For IV Infusion After Dilution
Multi Dose Vial
Cytotoxic Agent

Pharmacist dispense enclosed
medication guide to each patient.