Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Home > Patient Information

Patient InformationSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Spectrum's core mission is to bring pharmaceutical products to patients for unmet medical needs. To this mission, we bring our years of drug development expertise, coupled with the insight of working in many different oncology indications.

 

Recognizing the application of drugs for specific indications takes knowledge and vision which we are proud to possess. The information about the indications presented here are in areas where we have developed drugs, either currently on the market or under development, and are for informational purposes only. Please consult with your personal physician about any treatment regimen you may be considering.

ZEVALIN

Low Grade or Follicular Non-Hodgkin's Lymphoma

For patients diagnosed with low-grade or follicular non-Hodgkin's lymphoma, you may wish to consult www.zevalin.com for more information on treatment choices.

Indications and Usage

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one injection of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin's lymphoma (NHL).

The ZEVALIN therapeutic regimen is used to treat patients with:

  • Low-grade or follicular B-cell NHL that has relapsed during or after treatment with other anticancer drugs.
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

What Is the Most Important Safety Information I Should Know About ZEVALIN Treatment?

The following section provides an overview of the most important safety information you should know about ZEVALIN, including side effects. Not all of the safety information about ZEVALIN treatment is included here. For complete safety information, please see the accompanying full prescribing information for ZEVALIN. Additional information may also be found on the ZEVALIN Website (www.ZEVALIN.com) or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

The ZEVALIN treatment can cause serious side effects including:
  • Serious Infusion Reactions: Rituximab, alone or as part of the ZEVALIN treatment, may cause serious infusion reactions. Deaths have occurred within 24 hours of rituximab infusion, an important component of the ZEVALIN treatment. Tell your doctor or infusion nurse or get medical treatment right away if you develop fever or chills, a rash, itching, dizziness, swelling of your hands, feet or face, throat irritation or trouble breathing during or after receiving the ZEVALIN treatment.
  • Extended and Severe Decreases in Your Blood Counts (Cytopenias): Your doctor will monitor your blood counts after receiving the ZEVALIN treatment. Decreased blood counts can occur late and continue for more than 12 weeks after receiving ZEVALIN. Tell your doctor if you have a fever, feel too tired to do daily activities, feel weak, develop bruises or pinpoint red or purple spots on your skin, have unusual bleeding or notice blood in your urine or stool.
  • Severe Skin or Mucous Membrane Reactions: If you experience any reactions related to your skin or mucous membranes (e.g. mouth, nose), your infusion of rituximab and Y-90 ZEVALIN should be discontinued.
Dosing Warning: 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 ZEVALIN may result in secondary malignancies. MDS (a type of pre-cancerous bone marrow abnormality) and/or Acute Myelogenous Leukemia (AML, a type of cancer of the blood) were reported in 5.2% (11/211) of patients treated with Y-90 ZEVALIN for relapsed or refractory non-Hodgkin's lymphoma (NHL) in clinical studies, and 1.5% (8/535) of all 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 the ZEVALIN therapy; however, the total incidence continues to increase. Among 204 newly diagnosed patients who received Y-90 ZEVALIN, following complete or partial response to initial anticancer therapy, 7 patients (3.4%) were diagnosed with MDS/AML after receiving ZEVALIN treatment, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to secondary new malignancies occurred in 8 (3.9%) patients treated with ZEVALIN compared to 3 (1.5%) patients in the control arm of the study. Deaths due to MDS or AML occurred in 5 (2.5%) patients treated with ZEVALIN compared to no patients in the control arm.
  • ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
  • ZEVALIN may leak from your vein or infusion site. Your doctor will monitor you during treatment and will stop the infusion and switch to another vein, if this occurs during treatment.
  • Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
  • Your doctor will discuss precautions with you to minimize radiation exposure.
  • Impairment of Fertility: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for a minimum of 12 months following ZEVALIN therapy.
  • Nursing: Patients should be advised to discontinue nursing during and after ZEVALIN treatment.

Adverse Reactions (Side Effects):

  • The most common adverse reactions (>10%) in clinical trials with ZEVALIN were: decreases in blood counts, tiredness, inflammation of the nose and upper throat, nausea (upset stomach), abdominal (stomach) pain, weakness, cough, diarrhea, and fever.
  • The most serious adverse reactions of ZEVALIN are prolonged and severe reduction in the number of blood counts and secondary cancers.
  • When administered following initial anticancer therapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe decrease in blood counts (decrease in platelets [51%], decrease in neutrophils (a type of white blood cell) [41%], decrease in total white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers (12.7%). Reductions in blood cells were more severe and more prolonged among 11 (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing anticancer 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 (fever and infection due to decrease in the number of neutrophils [1%]), bronchitis, catheter sepsis (bacterial infection in the blood related to catheter), diverticulitis (inflammation in the intestines), shingles or blistering skin rash caused from herpes virus reactivation, flu, lower air passage infection, sinusitis (swelling of the sinuses), and upper air passage infection.
  • Grade 3/4 adverse reactions of ZEVALIN in recurring NHL patients include prolonged and severe reduction of blood cells (decrease in platelets [63%], decrease in neutrophils [60%], decrease in red blood cells or hemoglobin [17%], and ecchymosis (small blue or purple patch on the skin or mucous membrane [<1%])) and secondary cancers (5.2%). Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis (type of skin infection), colitis (swelling of the large intestine), diarrhea, osteomyelitis (bone infection), and upper-air passage infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema (collection of pus in a cavity in the body), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for ZEVALIN. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).

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

ISI-1120-035603


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


Meet JanSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Jan W. ZEVALIN patient

Jan is an actual ZEVALIN patient.

The summer of 1997 started as the happiest time of my life. I was close to retirement and looking forward to spending some quality time with my husband. What's more, my fondest wish - to become a grandmother - came true that June with the birth of my first grandson, Ian. But it's remarkable what a difference a month can make. In July, I was diagnosed with small cell follicular lymphoma.

Indications and Usage

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one injection of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin's lymphoma (NHL).

  • Low-grade or follicular B-cell NHL that has relapsed during or after treatment with other anticancer drugs
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

FUSILEV

Advanced Metastatic Colorectal Cancer and Osteosarcoma

For patients diagnosed with advanced metastatic colorectal cancer or osteosarcoma, you may wish to visit www.fusilev.com for more information.

Indications and Usage for FUSILEV

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.

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 for FUSILEV

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. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly d,l-leucovorin and 5-fluorouracil. When these drugs are administered concurrently in the palliative treatment of advanced colorectal cancer, the dosage of 5-FU must be lower than usually administered. Although the toxicities observed in patients treated with the combination of FUSILEV and 5-FU are qualitatively similar to those observed with 5-FU alone, gastrointestinal toxicities (particularly stomatitis and diarrhea) are observed more commonly and may be of greater severity and of prolonged duration in patients treated with the combination.
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.
The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-FU were diarrhea, nausea and stomatitis.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.

Drug Interactions

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

FUSILEV adverse event profile
Adverse reactions (≥ 10% in either arm) in patients with advanced metastatic colorectal cancer

Adverse ReactionLevoleucovorin/5FU
n=318
d,l-Leucovorin/5FU
n=307
Adverse Event N (%)Grade 1–4Grade 3–4Grade 1–4Grade 3–4
Gastrointestinal Disorders
Stomatitis229 (72%)37 (12%)221 (72%)44 (14%)
Diarrhea222 (70%)61 (19%)201 (65%)51 (17%)
Nausea197 (62%)25 (8%)186 (61%)26 (8%)
Vomiting128 (40%)17 (5%)114 (37%)18 (6%)
Abdominal Pain*45 (14%)10 (3%)57 (19%)10 (3%)
General Disorders
Asthenia/Fatigue/Malaise91 (29%)15 (5%)99 (32%)34 (11%)
Metabolism and Nutrition
Anorexia/Decreased Appetite76 (24%)13 (4%)77 (25%)5 (2%)
Skin Disorders
Dermatitis91 (29%)3 (1%)86 (28%)4 (1%)
Alopecia83 (26%)1 (0.3%)87 (28%)3 (1%)

* Includes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness

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

ISI-0154-079600

Back to top

Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
FUSILEV for Advanced Metastatic Colorectal Cancer