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by afukuma | Jan 29, 2019 | Uncategorized
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FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Adverse Reaction | Levoleucovorin/5FU n=318 | d,l-Leucovorin/5FU n=307 | ||
Adverse Event N (%) | Grade 1-4 | Grade 3-4 | Grade 1-4 | Grade 3-4 |
Gastrointestinal Disorders | ||||
Stomatitis | 229 (72%) | 37 (12%) | 221 (72%) | 44 (14%) |
Diarrhea | 222 (70%) | 61 (19%) | 201 (65%) | 51 (17%) |
Nausea | 197 (62%) | 25 (8%) | 186 (61%) | 26 (8%) |
Vomiting | 128 (40%) | 17 (5%) | 114 (37%) | 18 (6%) |
Abdominal Pain1 | 45 (14%) | 10 (3%) | 57 (19%) | 10 (3%) |
General Disorders | ||||
Asthenia/Fatigue/Malaise | 91 (29%) | 15 (5%) | 99 (32%) | 34 (11%) |
Metabolism and Nutrition | ||||
Anorexia/Decreased Appetite | 76 (24%) | 13 (4%) | 77 (25%) | 5 (2%) |
Skin Disorders | ||||
Dermatitis | 91 (29%) | 3 (1%) | 86 (28%) | 4 (1%) |
Alopecia | 83 (26%) | 1 (0.3%) | 87 (28%) | 3 (1%) |
1 Includes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness
ISI-0154-079600
Do not take HEMADY if you:
Your doctor will tell you how to take HEMADY based on the treatment regimen in the other anti-myeloma product prescribed for you.
HEMADY can cause serious side effects including:
Alterations in endocrine function (hormones). This is especially important in patients with diabetes as HEMADY can cause blood glucose levels to rise. Your healthcare provider may monitor glucose levels more frequently. If you have diabetes, talk to your healthcare provider as adjustments in your diabetes medications may be needed.
An increased risk of infection. HEMADY can suppress your immune system. Tell your healthcare provider if you have had any recent or ongoing infections and if you develop any sign of infection while taking HEMADY. Avoid live or live attenuated vaccines.
An increase in blood pressure, salt and water retention, and potassium and calcium excretion. Speak to your healthcare provider to discuss monitoring blood pressure and identifying signs of fluid retention and loss of potassium, especially if you have congestive heart failure, a recent heart attack, or hypertension.
Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take HEMADY and the risk may be greater when taking HEMADY with other anti-myeloma drugs. Your doctor may prescribe a blood thinner medicine to help prevent clots.
HEMADY may cause cataracts or glaucoma. Your healthcare provider may monitor you for these effects.
Increase the risk of developing gastrointestinal perforation. Promptly seek medical attention if you develop unusually severe, persistent or worsening abdominal pain.
Prolonged use of HEMADY can cause osteoporosis, which can lead to bone fractures.
Unexplained muscle pain, tenderness, or weakness. If you experience these effects, contact your healthcare provider, it may be a condition known as myopathy.
Irritability, mood swings, personality changes, and severe depression. HEMADY can also cause insomnia. Inform your healthcare provider if you notice behavioral and mood changes or have experienced difficulty sleeping.
Corticosteroids, including HEMADY, can cause fetal harm. Women should not become pregnant while taking HEMADY and for one month after stopping HEMADY. Talk to your healthcare provider if you are pregnant or are planning to become pregnant. Women should not breastfeed while taking HEMADY and for two weeks after the last dose.
These are not all the possible side effects of HEMADY. Call your Healthcare Provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for HEMADY.
Leucovorin products increase the toxicity of fluorouracil.
Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information.
ISI-PP-KAP-00-0001
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 |
ISI-0154-079702
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). |
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.
Monitor patients for hematological toxicity including development of MDS or AML.
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. Advise patients of potential risk to a fetus and to use effective contraception during treatment and for a minimum of 12 months after the last dose of ZEVALIN treatment.
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.
Lactation: Patients should be advised to discontinue breastfeeding during and for 6 months after the last dose of ZEVALIN treatment.
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).
ISI-0154-079503
ISI-0154-096200
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY
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Contraindications
ISI-PP-EVO-00-0067
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