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Important Safety Information

Eligard®(leuprolide acetate for injectable suspension)

Indication

Eligard is indicated for the palliative treatment of advanced prostate cancer.

Important Safety information for ELIGARD (leuprolide acetate for injectable suspension)

Eligard is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of Eligard. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Eligard is also contraindicated in women who are pregnant or may become pregnant. Expected hormonal changes that occur with Eligard treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman.

Eligard, like other GnRH agonists, causes a transient increase in serum testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms during the first weeks of treatment, including bone pain, neuropathy, hematuria, spinal compression, or bladder outlet obstruction. Cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using GnRH agonists.

Patients with metastatic vertebral lesions and/or urinary tract obstruction should be closely observed during the first few weeks of therapy.

Therapy with leuprolide acetate results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after leuprolide therapy may be affected.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

Please click here for the full Prescribing Information.

ELITEK®(rasburicase) IV infusion

Indication

ELITEK® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated for only a single course of treatment.

Important Safety information for ELITEK (rasburicase) IV infusion

WARNING: ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.

Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.

Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence ≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).

Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with the ELITEK alone and 1.1% of patients treated with the ELITEK/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 adverse reactions regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.

The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

Please click here for the full Prescribing Information including boxed WARNING.

ELOXATIN® (oxaliplatin injection)

Indications

ELOXATIN® (oxaliplatin injection), used in combination with infusional 5-FU/LV, is indicated for

  • Adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor.
  • Treatment of advanced carcinoma of the colon or rectum.
Important Safety information for ELOXATIN® (oxaliplatin injection)

Anaphylactic reactions to ELOXATIN have been reported and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.

  • ELOXATIN should not be administered to patients with a history of known allergy to ELOXATIN or other platinum compounds.
  • Hypersensitivity and anaphylactic/anaphylactoid reactions to ELOXATIN have been reported and were similar in nature and severity to those reported with other platinum compounds (ie, rash, urticaria, erythema, pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within minutes of administration, should be managed with appropriate supportive therapy, and require discontinuation of therapy. Rechallenge is contraindicated in these patients. Drug-related deaths from this reaction have been reported.
  • Reversible Posterior Leukoencepphalopathy Syndrome (RPLS, also know as PRES, Posterior Reversible Encephalopathy Syndrom) has been observed in clinical trials (<0.1%) and postmarketing experience. Signs and symptoms of RPLS could be headache, altered mental functioning, seizures, abnormal vision from blurriness to blindness, associated or not with hypertension. Diagnosis of RPLS is based upon confirmation by brain imaging.
  • ELOXATIN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving ELOXATIN. It is not known whether ELOXATIN or its derivatives are excreted in human milk.
  • ELOXATIN has been associated with pulmonary fibrosis (<1% of study patients), which may be fatal. The combined incidence of cough and dyspnea was 7.4% (<1% grade 3, no grade 4) in the ELOXATIN plus 5-FU/LV arm compared to 4.5% (no grade 3, 0.1% grade 4) in the 5-FU/LV alone arm in the adjuvant colon cancer study. In this study, one patient died from eosinophilic pneumonia in the ELOXATIN combination arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7% grade 3 and 4) in the ELOXATIN plus 5-FU/LV arm compared to 32% (5% grade 3 and 4) in the irinotecan plus 5-FU/LV arm in patients with previously untreated colorectal cancer. In case of unexplained respiratory symptoms, ELOXATIN should be discontinued until pulmonary investigation excludes interstitial lung disease or pulmonary fibrosis
  • ELOXATIN is associated with two types of primarily peripheral sensory neuropathy: an acute, reversible type of early onset and a persistent type (>14 days). In patients with advanced colorectal cancer paresthesias occurred in 77% (all grades) and 18% (grade 3/4) of previously untreated patients.In previously treated patients, acute neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients; persistent neuropathy occurred in 48% (all grades) and 6% (grade 3/4) of patients. In patients with stage II and III colon cancer, paresthesia was seen in 92% (all grades) and 13% (grade 3/4) of patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia at 18-month follow-up•
  • Hepatotoxicity, as evidenced in the adjuvant study by increase in transaminases and alkaline phosphatase was observed more commonly in the ELOXATIN combination arm. The incidence of increased bilirubin was similar on both arms. Changes noted on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular disorders should be considered and, if appropriate, investigated in case of abnormal liver function test results or portal hypertension not explained by liver metastases.
  • Monitoring of white blood cell count with differential, hemoglobin, platelet count and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended before each ELOXATIN cycle
  • The exposure (AUC) of unbond platinum in plasma unltrfiltrate tends to increase in renally impaired patients. Caution and close monitoring should be exercised when ELOXATIN is administered to patients with renal impairment. The starting dose of ELOXATIN does not need to be reduced in patients with mild (creatinine clearance = 50-80 mL/min) or moderate (creatinine clearance = 30-49 mL/min) renal impairment. However, the starting dose of ELOXATIN should be reduced in patients with severe renal impairment (creatinine clearance = <30 mL/min).
  • The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope were higher in patients ≥65 years old
  • Extravasation may result in local pain and inflammation that may be severe and lead to complications, including necrosis. Injection site reaction, including redness, swelling and pain, has been reported
  • There have been reports of prolonged prothrombin time and INR occasionally associated with hemorrhage in patients receiving ELOXATIN plus 5-FU/LV while on anticoagulants. Patients receiving ELOXATIN plus 5-FU/LV and requiring oral anticoagulants may require closer monitoring.
  • The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant therapy were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. The most common adverse reactions in patients with advanced colorectal cancer were peripheral sensory neuropathy, fatigue, neutropenia, nausea, emesis, and diarrhea.

Please click here for the full Prescribing Information including boxed WARNING.

JEVTANA® (cabazitaxel) Injection

Indication

JEVTANA® is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

Important Safety information for JEVTANA® (cabazitaxel) Injection

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA®. JEVTANA® should not be given to patients with neutrophil counts of ≤1,500 cells/mm3
  • Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA® infusion and administration of appropriate therapy. Patients should receive premedication
  • JEVTANA® must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA® or to other drugs formulated with polysorbate 80
Contraindications
  • JEVTANA® should not be used in patients with neutrophil counts of ≤1,500/mm3
  • JEVTANA® is contraindicated in patients who have a history of severe hypersensitivity reactions to JEVTANA® or to other drugs formulated with polysorbate 80
Warnings and Precautions
  • Neutropenic deaths have been reported
    • Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed
    • Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed
    • Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features
  • Severe hypersensitivity reactions can occur
    • Premedicate with antihistamines, corticosteroids and H2 antagonists
    • Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions
    • Discontinue infusion immediately if hypersensitivity is observed and treat as indicated
  • Mortality related to diarrhea has been reported
    • Rehydrate and treat with anti-emetics and anti-diarrheals as needed
    • If experiencing grade ≥3 diarrhea, dosage should be modified
  • Nausea, vomiting and severe diarrhea, at times, may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trial. Intensive measures may be required for severe diarrhea and electrolyte imbalance.
  • Gastrointestinal (GI) hemorrhage, perforation and other serious GI events, including fatal outcome, have been reported
    • Caution is advised with treatment of patients most at risk of developing GI complications
    • Monitor for symptoms of GI toxicity including abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, and treat promptly
    • JEVTANA® treatment delay or discontinuation may be necessary
  • Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively.
  • Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely
  • Patients with impaired hepatic function were excluded from the randomized clinical trial
    • Hepatic impairment is likely to increase the JEVTANA® concentrations
    • JEVTANA® should not be given to patients with hepatic impairment
  • JEVTANA® can cause fetal harm when administered to a pregnant woman
    • There are no adequate and well-controlled studies in pregnant women using JEVTANA®
    • Women of childbearing potential should be advised to avoid becoming pregnant during treatment with JEVTANA®
Adverse Reactions
  • Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA®-treated patients. The most common fatal adverse reactions in JEVTANA®-treated patients were infections (n=5) and renal failure (n=4)
  • The most common (≥10%) grade 1–4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia
  • The most common (≥5%) grade 3–4 adverse reactions in patients who received JEVTANA® were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia

Please click here for the full Prescribing Information including boxed WARNING.

LEUKINE® (sargramostim)

Indication

Leukine® is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.

Important Safety information for LEUKINE® (sargramostim)
  • Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%); in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant use with chemotherapy and radiotherapy.
  • Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
  • Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
  • Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
  • Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
  • Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients — (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
  • If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
  • Leukine therapy should be discontinued if disease progression is detected during treatment.
  • Drugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving LEUKINE. Interactions between LEUKINE and other drugs have not been fully evaluated.

Please click here for the full Prescribing Information.

MOZOBIL® (plerixafor injection)

Indication

MOZOBIL® (plerixafor injection), is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

Important Safety information for Mozobil (plerixafor injection)
  • Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
  • Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil is not intended for HSC mobilization and harvest in patients with leukemia
  • Mozobil in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment.
  • Thrombocytopenia has been observed in patients receiving Mozobil. Platelet counts should be monitored in patients who receive Mozobil and then undergo apheresis
  • In patients treated with Mozobil in combination with G-CSF for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied
  • The effect of Mozobil on spleen size was not specifically evaluated in clinical studies. Individuals receiving Mozobil in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity
  • Mozobil may cause fetal harm when administered to a pregnant woman. Plerixafor was teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Advise women of childbearing potential to avoid becoming pregnant while receiving treatment with Mozobil.
  • The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2

Please click here for the full Prescribing Information.

TAXOTERE® (docetaxel) Injection Concentrate

Indications

Breast Cancer
Taxotere® (docetaxel) Injection Concentrate is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Taxotere® (docetaxel) Injection Concentrate in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

Non-Small Cell Lung Cancer (NSCLC)
Taxotere® (docetaxel) Injection Concentrate, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.
Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.

Prostate Cancer
Taxotere® (docetaxel) Injection Concentrate in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Gastric Cancer
Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

Head and Neck Cancer (SCCHN)
Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Important Safety information for TAXOTERE® (docetaxel) Injection Concentrate

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

  • The incidence of treatment-related mortality associated with Taxotere® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere® as a single agent at a dose of 100 mg/m2
  • Taxotere® should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN
    • Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death
    • Patients with isolated elevations of transaminase > 1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death
    • Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy
  • Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3
    • In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®
  • Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication
    • Hypersensitivity reactions require immediate discontinuation of Taxotere® infusion and administration of appropriate therapy
  • Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80
  • Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites)
  • Neutropenia (<2,000 neutrophils/mm3) occurs in virtually all patients given 60-100 mg/m2 of Taxotere® and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2
  • Patients should be premedicated with oral corticosteroids prior to each Taxotere® administration to reduce the incidence and severity of fluid retention. Patients with pre-existing effusions should be closely monitored from the first dose for possible exacerbation of the effusions
  • Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy of breast cancer
  • Localized erythema of the extremities with edema followed by desquamation has been observed
    • In case of severe skin toxicity, an adjustment in dosage is recommended
  • Severe neurosensory symptoms (e.g. paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%
    • When these symptoms occur, dosage must be adjusted; if symptoms persist, treatment should be discontinued
  • Cystoid macular edema (CME) has been reported in patients treated with Taxotere®
    • Patients with impaired vision should undergo a prompt and comprehensive ophthalmologic examination. If CME is diagnosed, Taxotere® should be discontinued and appropriate treatment initiated
  • Severe asthenia was reported in 14.9% (144/965) of metastatic breast cancer patients, but led to treatment discontinuation in only 1.8%
    • Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease
  • Taxotere® can cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Taxotere®
  • The most common adverse reactions across all Taxotere® indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions and myalgia
  • In patients treated with TCF for gastric cancer, the incidence of serious adverse events was higher in patients ≥65 years than in younger patients. Adverse events (all grades) occurring at rates >10% higher in elderly patients included lethargy, stomatitis, diarrhea, dizziness, edema, and febrile neutropenia/neutropenic infection
  • Taxotere® should be administered in a facility equipped to manage possible complications (e.g. anaphylaxis)

Please click here for full Prescribing Information including boxed WARNING.

THYMOGLOBULIN® (Anti-thymocyte Globulin (Rabbit))

Indication

Thymoglobulin® is indicated for the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.

Important Safety information for THYMOGLOBULIN® (Anti-thymocyte Globulin (Rabbit))

WARNING:

Thymoglobulin® should only be used by physicians experienced in immunosuppressive therapy for the management of renal transplant patients.

  • Thymoglobulin is contraindicated in patients with a history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression.
  • Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately.
  • Thymoglobulin should be used under strict medical supervision in a hospital setting, and patients should be carefully monitored during the infusion.
  • Severe, acute infusion-associated reactions (IARs) are consistent with CRS and can cause serious cardiorespiratory events and/or death. IARs may occur as soon as the first or second infusion during a single course of Thymoglobulin treatment.
  • During post-marketing surveillance, fever, rash, arthralgia and/or myalgia have been reported to occur 5 to 15 days after onset of Thymoglobulin therapy, indicating possible serum sickness. These symptoms are manageable with corticosteroid treatment.
  • Infections, reactivation of infection, sepsis, malignancies including post-transplant lymphoproliferative disorder (PTLD) and other lymphomas as well as solid tumors have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. Severe acute infections can be fatal.
  • Prolonged use or overdose of Thymoglobulin in association with other immunosuppressive agents may cause over-immunosuppression. During Thymoglobulin therapy, monitoring the lymphocyte count may help assess the degree of T-cell depletion. White blood cell (WBC) and platelet counts should also be monitored.
  • The most frequent reported adverse events (more than 25% of patients) include: fever, chills, leukopenia, pain, headache, abdominal pain, diarrhea, hypertension, nausea, thrombocytopenia, peripheral edema, infection, dyspnea, asthenia, hyperkalemia, and tachycardia.
  • Thrombocytopenia and/or leukopenia (including lymphopenia and neutropenia) have been identified and are reversible following dose adjustments.
  • Reactions at the infusion site can occur and may include pain, swelling, and erythema.

Please click here for the full Prescribing Information.

ZALTRAP®* (ZIV-AFLIBERCEPT) INJECTION FOR INTRAVENOUS INFUSION

Indication

ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

Important Safety Information for ZALTRAP® (ziv-aflibercept) injection for intravenous infusion

WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, COMPROMISED WOUND HEALING

Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage.

GI perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation.

Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed.

WARNINGS AND PRECAUTIONS
  • Patients treated with ZALTRAP have an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
    • Bleeding/hemorrhage (all grades) occurred in 38% of ZALTRAP/FOLFIRI patients vs. 19% of placebo/FOLFIRI patients. Grade 3-4 hemorrhagic events, including GI hemorrhage, hematuria, and post-procedural hemorrhage, occurred in 3% of ZALTRAP/FOLFIRI patients vs. 1% of placebo/FOLFIRI patients. Severe intracranial hemorrhage and pulmonary hemorrhage/hemoptysis including fatal events have occurred in patients receiving ZALTRAP.
    • Monitor patients for signs and symptoms of bleeding. Do not initiate ZALTRAP in patients with severe hemorrhage. Discontinue ZALTRAP in patients who develop severe hemorrhage.
  • GI perforation including fatal GI perforation can occur in patients receiving ZALTRAP.
    • Across three clinical trials (colorectal, pancreatic, and lung cancer), GI perforation (all grades/Grade 3-4) occurred in 0.8% /0.8% of Zaltrap patients and 0.3% /0.2% for placebo patients.
    • Monitor patients for signs and symptoms of GI perforation. Discontinue ZALTRAP in patients who experience GI perforation.
  • ZALTRAP impairs wound healing in animal models. Grade 3 compromised wound healing occurred in 2 patients (0.3%) treated with ZALTRAP/FOLFIRI and none of the patients treated with placebo/FOLFIRI.
    • Discontinue ZALTRAP in patients with compromised wound healing.
    • Suspend ZALTRAP for at least 4 weeks prior to elective surgery and do not initiate/resume ZALTRAP until at least 4 weeks after major surgery and surgical wound is fully healed.
    • For minor surgery such as central venous access port placement, biopsy, and tooth extraction, ZALTRAP may be initiated/resumed once the surgical wound is fully healed.
  • Fistula formation involving GI and non-GI sites occurs at a higher incidence in patients treated with ZALTRAP. Fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 1.5% (9/611) of ZALTRAP/FOLFIRI treated patients and 0.5% (3/605) of placebo/FOLFIRI patients. Grade 3 GI fistula formation occurred in 2 patients treated with Zaltrap (0.3%) and 1 placebo-treated patient (0.2%). Discontinue ZALTRAP therapy in patients who develop fistula.
  • An increased risk of Grade 3-4 hypertension has been observed in patients receiving ZALTRAP.
    • There is no clinical trial experience administering ZALTRAP to patients with NYHA class III or IV heart failure. In patients with mCRC, Grade 3 hypertension (defined as requiring adjustment in existing anti-hypertensive therapy or treatment with more than one drug) was reported in 1.5% of patients treated with placebo/FOLFIRI and 19% treated with ZALTRAP/FOLFIRI. Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2%) treated with ZALTRAP/FOLFIRI. Of patients treated with ZALTRAP/FOLFIRI who developed Grade 3-4 hypertension, 54% had onset during the first two cycles of treatment.
    • Monitor blood pressure at least every two weeks, treat with appropriate anti-hypertensive therapy, and continue monitoring blood pressure regularly during ZALTRAP treatment. Temporarily suspend ZALTRAP until hypertension is controlled, and reduce ZALTRAP dose to 2 mg/kg for subsequent cycles. Discontinue Zaltrap in patients with hypertensive crisis or hypertensive encephalopathy.
  • Arterial thromboembolic events (ATE), including transient ischemic attack, cerebrovascular accident, and angina pectoris, occurred more frequently in patients who have received ZALTRAP. ATE occurred in 2.6% of ZALTRAP/FOLFIRI patients and 1.7% of placebo/FOLFIRI patients. Grade 3-4 events occurred in 11 patients (1.8%) treated with ZALTRAP/FOLFIRI and 4 patients (0.7%) treated with placebo/FOLFIRI. Discontinue ZALTRAP in patients who experience an ATE.
  • Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) occurred more frequently in patients treated with ZALTRAP.
    • Proteinuria was reported in 62% of ZALTRAP/FOLFIRI patients compared to 41% of placebo/FOLFIRI patients. Grade 3-4 proteinuria occurred in 8% of ZALTRAP/FOLFIRI patients compared to 1% of placebo/FOLFIRI patients. Nephrotic syndrome occurred in 2 patients (0.5%) treated with ZALTRAP/FOLFIRI compared to none of the patients treated with placebo/FOLFIRI. TMA was reported in 3 of 2258 patients with cancer enrolled across completed studies.
    • Monitor proteinuria by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria. Obtain a 24-hour urine collection in patients with a dipstick of ≥2+ for protein or UPCR >1.
    • Suspend ZALTRAP when proteinuria ≥2 grams/24 hours and resume ZALTRAP when proteinuria <2 grams/24 hours.
    • If recurrent, suspend until proteinuria <2 grams/24hours and then reduce ZALTRAP dose to 2 mg/kg.
    • Discontinue ZALTRAP if nephrotic syndrome or TMA develops.
  • A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) occurred in patients receiving ZALTRAP.
    • Grade 3-4 neutropenia occurred in 37% of ZALTRAP/FOLFIRI patients compared to 30% of placebo/FOLFIRI patients. Grade 3-4 febrile neutropenia occurred in 4% of ZALTRAP/FOLFIRI patients compared to 2% of placebo/FOLFIRI patients. Grade 3-4 neutropenic infection/sepsis occurred in 1.5% of ZALTRAP/FOLFIRI patients compared to 1.2% of placebo/FOLFIRI patients.
    • Monitor CBC with differential count at baseline and prior to initiation of each cycle of ZALTRAP. Delay administration of ZALTRAP/FOLFIRI until neutrophil count is ≥1.5 x 109/L.
  • Incidence of severe diarrhea and dehydration is increased in patients treated with ZALTRAP/FOLFIRI.
    • Grade 3-4 diarrhea was reported in 19% of ZALTRAP/FOLFIRI patients compared to 8% of placebo/FOLFIRI patients. Grade 3-4 dehydration was reported in 4% of ZALTRAP/FOLFIRI patients compared to 1% of placebo/FOLFIRI patients.
    • The incidence of diarrhea is increased in patients ≥65 years of age compared to patients <65 years of age. Monitor closely.
  • RPLS (also known as posterior reversible encephalopathy syndrome) was reported in 0.5% of 3795 patients treated with ZALTRAP monotherapy or in combination with chemotherapy. Confirm diagnosis of RPLS with MRI and discontinue ZALTRAP in patients who develop RPLS. Symptoms usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae or death.
ADVERSE REACTIONS
  • The most common adverse reactions (all grades, ≥20% incidence) reported at a higher incidence (2% or greater between-arm difference) in the ZALTRAP/FOLFIRI arm, in order of decreasing frequency, were leukopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache.
  • The most common Grade 3-4 adverse reactions (≥5%) reported at a higher incidence (2% or greater between-arm difference) in the ZALTRAP/FOLFIRI arm, in order of decreasing frequency, were neutropenia, diarrhea, hypertension, leukopenia, stomatitis, fatigue, proteinuria, and asthenia.
  • Infections occurred at a higher frequency in patients receiving ZALTRAP/FOLFIRI (46%, all grades; 12%, Grade 3-4) than in patients receiving placebo/FOLFIRI (33%, all grades; 7%, Grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
  • In patients with mCRC, venous thromboembolic events (VTE), consisting primarily of deep venous thrombosis and pulmonary embolism, occurred in 9% of patients treated with ZALTRAP/FOLFIRI and 7% of patients treated with placebo/FOLFIRI.
PREGNANCY AND NURSING MOTHERS
  • ZALTRAP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Females and males of reproductive potential should use highly effective contraception during and up to a minimum of 3 months after the last dose of treatment.
  • It is not known whether ZALTRAP is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Please click here for the full Prescribing Information including boxed WARNING.

In the U.S., ZALTRAP® is a registered trademark of Regeneron Pharmaceuticals, Inc.

Sanofi joins the fight against prostate cancer

ON THE LINE is a prostate cancer awareness campaign and Sanofi is co-sponsoring this initiative to help educate men and women about the importance of prostate screening. The campaign focuses on health education that harnesses the power of sports and celebrities to challenge men to take charge of their health. ON THE LINE offers educational materials for both men and women on prostate cancer, to promote a true "team" approach.

And Sanofi is fighting prostate cancer every way we can too. We know the stakes. Prostate cancer is the most commonly diagnose cancer in American men today. Every five minutes two more men are diagnosed with the disease. And it's the second leading cause of cancer death in the U.S.

From our earliest days, the goals of our cancer research have remained steadfast: to battle cancer with the most effective agents we can develop, to reduce the side effects of chemotherapy and to create breakthrough therapies for cancer patients. With the availability of new research techniques, we are also investigating targeted agents and novel approaches that may one day play an important role in advancing cancer management.

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