Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
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Marketed ProductsSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Spectrum and its subsidiaries has four FDA-approved oncology/hematology products available through our Commercial Team of regional oncology specialists. For more information on the Spectrum's marketed products, please click on the respective product web site links below.


Fusilev is indicated for the treatment of colorectal cancer Folotyn® is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma Zevalin is indicated for the treatment of non-Hodgkin's lymphoma Marqibo is indicated for the treatment of acute lymphoblastic leukemia

Fusilev -colorectal cancer

FUSILEV® (levoleucovorin) for injection

FUSILEV, a folate analog, is available commercially in vials for injection as freeze-dried powder.

In 2011, Spectrum Pharmaceuticals sought multiple supply sources for FUSILEV, to offset any demand increase. Currently, Spectrum is able to meet all supply requirements.

INDICATIONS AND USAGE

FUSILEV is a folate analog indicated for:
• Rescue after high-dose methotrexate therapy in osteosarcoma.
• Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
• Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

LIMITATIONS OF USE

FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.

IMPORTANT SAFETY INFORMATION

Contraindications
• FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.

Warnings and Precautions
• Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute
• FUSILEV enhances the toxicity of fluorouracil.
• Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study.

Adverse Reactions
Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.
The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving Fusilev in combination with 5-FU were diarrhea, nausea and stomatitis.

Drug Interactions
FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

Reporting of Suspected Adverse Reactions
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the FUSILEV (levoleucovorin) for injection full prescribing information for complete safety information.


Folotyn.com

FOLOTYN® (pralatrexate injection)

INDICATIONS AND USAGE

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

The indication for FOLOTYN is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.

FOLOTYN was the first chemotherapy approved by the U.S. Food & Drug Administration (FDA) for the treatment of relapsed or refractory PTCL.

Please find information about FOLOTYN on this website, including efficacy, safety, dosing & administration, side effect management and the Allos patient support program ASAP.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
• FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit and/or reduce dose for hematologic toxicities.

• Mucositis may occur. Monitor at least weekly. If ≥Grade 2 mucositis is observed, omit and/or reduce dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.

• Dermatologic reactions, including fatal reactions, have occurred and may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and omit, and/or reduce dose or discontinue FOLOTYN.

• Tumor lysis syndrome may occur. Monitor patients and treat promptly.

• FOLOTYN can cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and if abnormalities are ≥Grade 3, omit until recovery then reduce dose or discontinue FOLOTYN as required.

• Patients with moderate to severe renal function impairment may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly. Avoid FOLOTYN use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk.

• FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.

Adverse Reactions

• The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Drug Interactions

• Co-administration with probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), requires close monitoring for signs of systemic toxicity.

Drug Interactions

• Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

• Approximately one third of the administered dose of FOLOTYN is cleared by the kidneys. FOLOTYN has not been studied in patients with renal impairment.

Please see the FOLOTYN full prescribing information for complete safety information.



Zevalin non-Hodgkin's lymphoma

ZEVALIN® (ibritumomab tiuxetan) Injection for intraveneous use

ZEVALIN is a combination of two prescription medications. It is given with two treatments of rituximab and one treatment of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the amount of B-cells in the blood and Y-90 ZEVALIN is given to treat follicular non-Hodgkin’s lymphoma (fNHL).

INDICATIONS AND USAGE

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

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. 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.

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. 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. 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).



Marqibo is indicated for the treatment of acute lymphoblastic leukemia

INDICATION

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 antileukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.

IMPORTANT SAFETY INFORMATION

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

IMPORTANT SAFETY INFORMATION

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 nonleukemiarelated 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.


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