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The information provided on this Spectrum Pharmaceuticals, Inc. Website is for general informational and educational use only and is subject to the following terms and conditions. By accessing and using this website, you acknowledge and accept, without limitation or qualification, this Terms of Use Agreement. If you do not wish to be bound by this agreement, you may not access or use any materials on this website.

1. Scope of Use. Spectrum Pharmaceuticals, Inc. ("Spectrum") maintains this website for your personal information and education. The information, documents and related graphics are available for your personal use, provided that the materials are not modified in any way and all copyright and other proprietary notices contained on the provided materials are maintained. This website and all its contents are intended to comply with United States laws that it may be subject to and Spectrum makes no representation that the information is appropriate for use in locations outside of the United States. Other countries may have laws, regulatory requirements, and medical practices that differ from those in the U.S. Those who access this site from other locations do so on their own initiative and are responsible to comply with applicable local laws and regulations. Any offer, product, or service available through this website is void where prohibited.

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6. Disclaimer of Warranties. While Spectrum uses reasonable efforts to include accurate and up-to-date information in this site, we make no warranties or representations of any kind as to the accuracy, currency or completeness of the information provided. We assume neither responsibility for any errors or omissions in the content of this site nor any liability to update the information contained in this site. Spectrum provides this information "as is" and disclaims all warranties of any kind, both express and implied, including, but not limited to, merchantability, fitness for a particular purpose, or non-infringement. Please note that some jurisdictions do not allow the exclusion of implied warranties, so the above disclaimer may not apply to you.

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8. Third Party Websites and Links. This site may contain references or links to other websites maintained by third parties not under Spectrum's control. Such references or links are provided merely for convenience and Spectrum makes no representations or warranties of any kind with respect to any third party site. The inclusion of the reference or link does not imply endorsement of the site and Spectrum is not liable for any damages or injuries of any kind arising from such content or information.

9. Governing Law. This Terms of Use Agreement and your use of this website shall be governed by the laws of the United States and the State of California without regard to its conflicts of law provisions. Any legal action or proceeding arising from or relating to your access or use of this website shall be brought exclusively in a federal or state court of proper jurisdiction in the State of California.

10. Modifications. Spectrum Pharmaceuticals reserves the right to revise the terms and conditions of this agreement at any time without notice and such changes will be deemed effective upon posting. Continued use of the website following posting of an amended Terms of Use will indicate acceptance of such changes and therefore, this agreement should be reviewed periodically.

© 2016 Spectrum Pharmaceuticals, Inc. All rights reserved.

Indications and Usage for MARQIBO

MARQIBO is indicated for the treatment of adult patients with Philadelphia chromosome–negative (Ph–) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.

Important Safety Information for MARQIBO

WARNING:

For Intravenous Use only—Fatal if Given by Other Routes

Death has occurred with intrathecal administration

MARQIBO (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage

Contraindications

• MARQIBO is contraindicated in patients with demyelinating conditions, including Charcot-Marie-Tooth syndrome; in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO; and for intrathecal administration

Warnings and Precautions

• MARQIBO is for intravenous use only—fatal if given by other routes. Intrathecal use is fatal.
• Extravasation causes tissue injury. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures
• Sensory and motor neuropathy are common and cumulative. Monitor patients for peripheral motor and sensory, central and autonomic neuropathy and reduce, interrupt, or discontinue dosing. Patients with preexisting severe neuropathy should be treated with MARQIBO only after careful risk-benefit assessment
• Neutropenia, thrombocytopenia, or anemia may occur. Monitor blood counts prior to each dose. Consider dose modification or reduction as well as supportive care measures if Grade 3 or 4 myelosuppression develops
• Anticipate, monitor for, and manage tumor lysis syndrome
• A prophylactic bowel regimen should be instituted with MARQIBO to prevent constipation, bowel obstruction, and/or paralytic ileus
• Severe fatigue can occur requiring dose delay, reduction, or discontinuation of MARQIBO
• Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Monitor liver function and modify or interrupt dosing for hepatic toxicity
• MARQIBO can cause fetal harm. Advise women of potential risk to fetus

Adverse Events

• The most commonly reported adverse reactions (incidence >30%) in clinical studies include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%)
• A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%)
• Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%)
• Deaths occurred in 23% of patients in study 1. The nonleukemia-related causes of death were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multisystem organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1)

Drug Interactions

• MARQIBO is expected to interact with drugs known to interact with nonliposomal vincristine sulfate, therefore the concomitant use of strong CYP3A inhibitors or the use of potent P-glycoprotein inhibitors or inducers should be avoided

Use in Specific Populations

• The safety and effectiveness of MARQIBO in pediatric patients have not been established
• It is not known whether MARQIBO is excreted in human milk

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for MARQIBO.

ISI-0154-079702


Indications and Usage for ZEVALIN

ZEVALIN is a CD20-directed radiotherapeutic antibody administered as part of the ZEVALIN therapeutic regimen indicated for the treatment of patients with:

  • Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
  • Previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy.

Important Safety Information for ZEVALIN

WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS

Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab and Y-90 ZEVALIN infusions in patients who develop severe infusion reactions.

Prolonged and Severe Cytopenias: Y-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 ZEVALIN to patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve.

Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen. Discontinue rituximab and Y-90 ZEVALIN infusions in patients experiencing severe cutaneous or mucocutaneous reactions.

Dosing: The dose of Y-90 ZEVALIN should not exceed 32.0 mCi (1184 MBq).

Risk of Developing Myelodysplastic Syndrome, Leukemia and Other Malignancies:

The radiation dose resulting from therapeutic exposure to Y-90 radiolabeled ZEVALIN may result in secondary malignancies.

Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients with relapsed or refractory NHL enrolled in clinical studies and 1.5% (8/535) of patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to diagnosis of MDS or AML was 1.9 years following treatment with the ZEVALIN therapeutic regimen; however, the cumulative incidence continues to increase.

Among 204 patients receiving Y-90-ZEVALIN following first-line chemotherapy, 26 (12.7%) patients in the ZEVALIN arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm. Seven patients (3.4%, 7/204) were diagnosed with MDS/AML after receiving ZEVALIN, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to second primary malignancy included 8 (3.9%) patients in the ZEVALIN arm compared to 3 (1.5%) patients in the control arm. Deaths due to MDS/AML included five (2.5%) patients in the ZEVALIN arm compared to no patients in the control arm.

Extravasation:

Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb.

Immunization:

Do not administer live viral vaccines to patients who recently received ZEVALIN.

Laboratory Monitoring:

Obtain complete blood counts (CBC) and platelet counts at least weekly.

Radionuclide Precautions:

During and after radiolabeling ZEVALIN with Y-90, minimize radiation exposure to patients and to medical personnel, consistent with institutional good radiation safety practices and patient management procedures.

Embryo-fetal Toxicity:

May cause fetal harm if given during pregnancy.

Impairment of Fertility:

There is a potential risk that the ZEVALIN therapeutic regimen could cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for up to 12 months following the ZEVALIN therapeutic regimen.

Nursing Mothers:

Patients should be advised to discontinue nursing during and after ZEVALIN treatment.

Adverse Reactions:

The most common adverse reactions of ZEVALIN are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. Common adverse reactions (≥10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. The most serious adverse reactions of ZEVALIN are prolonged and severe cytopenias (thrombocytopenia, anemia, lymphopenia, neutropenia) and secondary malignancies.

When administered following first-line chemotherapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe cytopenias (thrombocytopenia [51%], neutropenia [41%], leukopenia [36%], lymphopenia [18%], and anemia [5%]) and secondary malignancies (12.7%). Cytopenias were more severe and more prolonged among eleven (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing chemotherapy regimen as compared to patients receiving non–fludarabine-containing regimens. Grade 3/4 infections occurred in 8% of ZEVALIN-treated patients and in 2% of controls and included neutropenic sepsis (1%), bronchitis, catheter sepsis, diverticulitis, herpes zoster, influenza, lower respiratory tract infection, sinusitis, and upper respiratory tract infection.

Grade 3/4 adverse reactions of ZEVALIN in relapsed or refractory NHL patients include prolonged and severe cytopenias (thrombocytopenia [63%], neutropenia [60%], anemia [17%], and ecchymosis [<1%]) and secondary malignancies (5.2%). Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis, colitis, diarrhea, osteomyelitis, and upper respiratory tract infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema, pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis).

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for ZEVALIN. Because the ZEVALIN therapeutic regimen includes the use of rituximab, please also consult Prescribing Information for rituximab www.rituxan.com).

ISI-0154-079503


Indications and Usage for EVOMELA

EVOMELATM (melphalan) for Injection is an alkylating drug indicated for:

  • use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
  • the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Important Safety Information for EVOMELA

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

  • Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
  • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
  • Melphalan produces chromosomal aberrations in vitro and in vivo. EVOMELA should be considered potentially leukemogenic in humans.

Contraindications

  • History of serious allergic reaction to melphalan.

Warnings and Precautions

  • Bone Marrow Suppression: For patients receiving EVOMELA as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.
    For patients receiving EVOMELA as palliative treatment, if the bone marrow has been compromised by prior irradiation, prior chemotherapy or is recovering from chemotherapy, the risk of severe myelosuppression with EVOMELA is increased. Perform periodic complete blood counts during the course of treatment with EVOMELA. Provide supportive care for infections, bleeding, and symptomatic anemia.
  • Gastrointestinal Toxicity: For patients receiving EVOMELA as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis.
    For patients receiving EVOMELA as palliative treatment, nausea and vomiting, diarrhea, and oral ulceration may occur. Use prophylactic antiemetics. Provide supportive care for nausea, vomiting, diarrhea and mucositis.
  • Hepatotoxicity: Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan. Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries.
  • Hypersensitivity: Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of melphalan. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
  • Secondary Malignancies: Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. The potential benefit of EVOMELA therapy must be considered against the possible risk of the induction of a secondary malignancy.
  • Embryo-Fetal Toxicity: EVOMELA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during and after treatment with EVOMELA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus.
  • Infertility: Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported.

Adverse Events

  • The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with EVOMELA were neutrophil count decreased (100%), white blood cell count decreased (100%), lymphocyte count decreased (98%), platelet count decreased (98%), diarrhea (93%), nausea (90%), fatigue (77%), hypokalemia (74%), anemia (66%), and vomiting (64%).
  • For myeloablative conditioning in multiple myeloma patients undergoing ASCT, twelve (20%) patients experienced a treatment emergent serious adverse reaction while on study. The most common serious adverse reactions (>1 patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and renal failure. Treatment-related serious adverse reactions reported in >1 patient were pyrexia (n=2, 3%), febrile neutropenia (n=2, 3%), and hematochezia (n=2, 3%).
  • In a randomized clinical trial studying the palliative treatment of patients with multiple myeloma, severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV melphalan arm (28%) than in the oral melphalan arm (11%).
  • In this randomized study, the rate of severe leukopenia in the IV arm in the patients with BUN over 30 mg/dL decreased from 50% (8/16) to 11% (3/28) after 50% reduction in IV melphalan dose. In addition, the incidence of drug-related death in the IV arm decreased from 10% (8/77) to 3% (3/108) after this dose reduction. This compares to an overall 1% (1/100) incidence of drug-related death in the oral melphalan arm.

Drug Interactions

  • No formal drug interaction studies have been conducted. When nalidixic acid and IV melphalan are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients.

Use in Specific Populations

  • Lactation: It is not known whether melphalan is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from melphalan, breastfeeding is not recommended during treatment with EVOMELA.
  • Patients with Renal Impairment: For Palliative Treatment, consider dose reduction for patients with renal impairment receiving EVOMELA. Bone marrow suppression has been observed in patients with BUN levels ≥30 mg/dL. A 50% reduction in the IV melphalan dose decreased the incidence of severe bone marrow suppression in the latter portion of this study.

Please click here to see full Prescribing Information, including BOXED WARNINGS, for EVOMELA

ISI-PP-EVO-00-0067