HEMADY® (dexamethasone tablets) is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
Hypersensitivity: HEMADY is contraindicated in patients with hypersensitivity to dexamethasone, or to any components of this product. Rare instances of anaphylactic reactions have been reported.
Fungal Infections: HEMADY is contraindicated in patients with systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections.
Alterations in Endocrine Function: HEMADY can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients for Cushing’s syndrome and hyperglycemia while receiving corticosteroids and adrenal insufficiency and steroid “withdrawal syndrome” after corticosteroid withdrawal.
Increased Risk of Infection: Corticosteroids, including HEMADY, suppress the immune system and increase the risk of infection with any pathogen including viral, bacterial, fungal, protozoan, or helminthic. Monitor for the development of infection and consider withdrawal of HEMADY or reduction of the dose of corticosteroids as needed.
Alterations in Cardiovascular/Renal Function: Alterations in cardiovascular and renal function can occur. Monitor for elevated blood pressure and sodium, and decreased potassium levels. Use with caution in patients with congestive heart failure and recent myocardial infarction.
Venous and Arterial Thromboembolism: Thromboembolism is a known adverse reaction of dexamethasone, including HEMADY. When administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib) the risk for venous and arterial thromboembolism increases significantly. Refer to the prescribing information of these anti-myeloma products. Consider using anticoagulant prophylaxis and monitor for evidence of thromboembolism.
Vaccination: Avoid administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.
Ophthalmic Effects: Use of corticosteroids including HEMADY may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.
Gastrointestinal Perforation: There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders. Avoid corticosteroids such as HEMADY if there is a possibility of impending perforation, abscess, or other pyrogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.
Osteoporosis: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating HEMADY therapy.
Myopathy: An acute myopathy has been observed with the use of high doses of corticosteroids.
Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including HEMADY. Inform patients and caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if symptoms develop.
Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.
Embryo-Fetal Toxicity: HEMADY can cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during treatment and for one month after treatment with HEMADY. Refer to the prescribing information of the combination anti-myeloma product for additional Contraindications, Warnings and Precautions.
The most common adverse reactions are cardiovascular, dermatologic, endocrine, fluid and electrolyte disturbances, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, ophthalmic, abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, and weight gain.
Please see full Prescribing Information for HEMADY.
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. You also may contact Acrotech Biopharma, LLC at (866) 850-2876.
HEMADY® [Prescribing Information]. Acrotech Biopharma, LLC. February 2020.
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY
|
Contraindications
ISI-PP-EVO-00-0067
ISI-PP-KAP-00-0001
| 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:
|
ISI-0154-079702