CASODEX^® 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments.	ERLEADA^™ is an androgen receptor inhibitor indicated for the treatment of patients with non‑metastatic castration‑resistant prostate cancer.	JEVTANA^® is indicated in combination with prednisone for the treatment of patients with metastatic castration‑resistant prostate cancer previously treated with a docetaxel‑containing treatment regimen.	LUPRON DEPOT^® 7.5 mg for 1‑month administration, 22.5 mg for 3‑month administration, 30 mg for 4‑month administration, and 45 mg for 6‑month administration (leuprolide acetate) are indicated in the palliative treatment of advanced prostatic cancer. LUPRON DEPOT is a Gonadotropin releasing hormone (GnRH) agonist.	PROVENGE^® (sipuleucel‑T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate‑resistant (hormone‑refractory) prostate cancer.	TAXOTERE^® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. Additional Indications: Breast Cancer: single agent for locally advanced or metastatic breast cancer after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node‑positive breast cancer Non‑Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced, or metastatic untreated NSCLC Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN	Xofigo^® is indicated for the treatment of patients with castration‑resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease.	XTANDI^® is indicated for the treatment of patients with metastatic castration‑resistant prostate cancer (CRPC).	Yonsa is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration‑resistant prostate cancer (CRPC).*	ZYTIGA is indicated in combination with prednisone for the treatment of patients with: Metastatic castration‑resistant prostate cancer (CRPC) Metastatic high‑risk castration-sensitive prostate cancer (CSPC)
50 mg tablets	Tablets (60 mg): slightly yellowish to greyish green oblong‑shaped film‑coated tablets, debossed with "AR 60" on one side.	JEVTANA (cabazitaxel) injection is supplied as a kit consisting of the following Cabazitaxel injection: 60 mg/1.5 mL; a clear yellow to brownish‑yellow viscous solution Diluent: 5.7 mL of 13% (w/w) ethanol in water; a clear colorless solution	7.5 mg for 1‑month administration 22.5 mg for 3‑month administration 30 mg for 4‑month administration 45 mg for 6‑month administration Each is supplied as a kit with prefilled dual chamber syringe.	Each dose contains a minimum 50 million autologous CD54+ cells activated with PAP‑GM‑CSF, suspended in 250 mL of Lactated Ringer's Injection, USP.	One vial TAXOTERE (Injection concentrate): TAXOTERE 20 mg/mL TAXOTERE (docetaxel) Injection Concentrate 20 mg/1 mL: 20 mg docetaxel in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol TAXOTERE 80 mg/4 mL TAXOTERE (docetaxel) Injection Concentrate 80 mg/4 mL: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol	Available in single‑use vials containing 6 mL of solution at a concentration of 1100 kBq/mL (30 microcurie/mL) at the reference date with a total radioactivity of 6600 kBq/vial (178 microcurie/vial) at the reference date.	XTANDI 40 mg capsules are white to off‑white oblong soft gelatin capsules imprinted in black ink with ENZ.	Yonsa (abiraterone acetate) tablets, 125 mg, are white to off‑white, oval-shaped tablets debossed with "125 FP" on one side.	500 mg film‑coated Tablets are supplied as purple, oval‑shaped, film‑coated tablets debossed with "AA" one side and "500" on the other side. 250 mg film‑coated Tablets are supplied as pink, oval‑shaped, film‑coated tablets debossed with "AA250" on one side.* *ZYTIGA 250 mg film-coated tablets are not commercially available in the United States. 250 mg Tablets are supplied as white to off‑white, oval‑shaped tablets debossed with "AA250" on one side.
The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analog. If a dose of CASODEX is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.	The recommended dose of ERLEADA is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. ERLEADA can be taken with or without food. Patients should also receive a gonadotropin‑releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy Dose modifications may be required for patients experiencing ≥ Grade 3 toxicity or an intolerable side effect as outlined in the Prescribing Information.	The recommended dose of JEVTANA is based on calculation of the Body Surface Area (BSA), and is 20 mg/m² administered as a one‑hour intravenous infusion every 3 weeks in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment A dose of 25 mg/m² can be used in select patients at the discretion of the treating healthcare provider. Premedicate at least 30 minutes prior to each dose of JEVTANA with the following intravenous medications to reduce the risk and/or severity of hypersensitivity Antihistamine (dexchlorpheniramine 5 mg, or diphenhydramine 25 mg or equivalent antihistamine) Corticosteroid (dexamethasone 8 mg or equivalent steroid) H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist) Antiemetic prophylaxis is recommened and can be given orally or intravenously as needed. JEVTANA injection single‑use vial requires two dilutions prior to administration.	All doses: do not use concurrently a fractional dose, or combination of doses of any depot formulation due to different release characteristics. Lyophilized microspheres must be reconstituted and should be administered every 4 weeks as a single intramuscular injection. 7.5 mg for 1‑month administration – one injection every 4 weeks. 22.5 mg for 3‑month administration – one injection every 12 weeks. 30 mg for 4‑month administration – one injection every 16 weeks. 45 mg for 6‑month administration – one injection every 24 weeks.	Recommended course of therapy – 3 complete doses, given at approximately 2‑week intervals. To minimize potential acute infusion reactions, pre‑medicate orally with acetaminophen + antihistamine, such as diphenhydramine, approximately 30 minutes prior to administration of PROVENGE. If patient is unable to receive a scheduled infusion, patient will need to undergo an additional leukapheresis procedure prior to continuing treatment.	For all indications, toxicities may warrant dosage adjustments, as outlined in the Prescribing Information. For hormone‑refractory metastatic prostate cancer, the recommended dose of TAXOTERE is 75 mg/m² every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously. Recommended premedication regimen is oral dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour before TAXOTERE infusion Combination therapy with TAXOTERE for hormone‑refractory metastatic prostate cancer TAXOTERE should be administered when the neutrophil count is ≥1500 cells/mm³ Patients who experience either febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, severe or cumulative cutaneous reactions, or moderate neurosensory signs and/or symptoms during TAXOTERE therapy should have the dosage of TAXOTERE reduced from 75 mg/m² to 60 mg/m². If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.	55 kBq (1.49 microcurie) per kg body weight, given at 4‑week intervals for 6 injections. Safety and efficacy beyond 6 injections have not been studied. Volume to be administered should be calculated using: Body weight (kg) Dosage level 55 kBq/kg body weight or 1.49 microcurie/kg body weight Radioactivity concentration of the product (1100 kBq/mL; 30 microcurie/mL) at the reference date Decay correction factor to correct for physical decay of radium‑223 Administer Xofigo by slow intravenous injection over 1 minute. Flush the intravenous access line or cannula with isotonic saline before and after injection of XOFIGO.	The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered orally once daily. Can be taken with or without food Swallow capsules whole. Do not chew, dissolve, or open capsules. Dose modifications may be required as outlined in the Prescribing Information.	The recommended dose of Yonsa is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily. Important Administration Instructions: To avoid medication errors and overdose, be aware that Yonsa (abiraterone acetate) tablets may have different dosing and food effects than other abiraterone acetate products. Patients receiving Yonsa should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Yonsa tablets can be taken with or without food. The tablets should be swallowed whole with water. Do not crush or chew tablets. Dose modifications may be required as outlined in the Prescribing Information. Do not use Yonsa in patients with severe hepatic impairment (Child-Pugh Class C).	Recommended dose for metastatic CRPC: 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily. Recommended dose for metastatic high-risk CSPC: The recommended dose of ZYTIGA is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily. Important administration instructions: Patients receiving ZYTIGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA must be taken on an empty stomach, either one hour before or two hours after a meal. Swallow tablets whole with water. Do not crush or chew tablets. Dose modifications may be required as outlined in the full Prescribing Information.
Non‑steroidal androgen receptor inhibitor Competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue	Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand‑binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription.	Microtubule inhibitor Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly.	Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion.	Classified as an autologous cellular immunotherapy. The precise mechanism of action is unknown. Designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers.	Docetaxel is an antineoplastic agent, microtubule inhibitor that acts by disrupting the microtubular network in cells essential for mitotic and interphase cellular functions. Binds to free tubulin and promotes assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.	Alpha particle‑emitting radioactive therapeutic agent The active moiety is the alpha particle‑emitting isotope radium‑223 (as radium Ra 223 dichloride), which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double‑strand DNA breaks in adjacent cells, resulting in an anti‑tumor effect on bone metastases.	Androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway Shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with DNA Decreases proliferation and induced cell death of prostate cancer cells in vitro Decreased tumor volume in a mouse prostate cancer xenograft model	Abiraterone acetate (Yonsa) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α‑hydroxylase/C17, 20‑lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis.	Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α‑hydroxylase/C17,20‑lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and required for androgen biosynthesis.
5.8 days (standard deviation 2.29)	The mean effective half‑life for apalutamide in patients was approximately 3 days at steady‑state.	Following a one‑hour intravenous infusion, plasma concentrations of cabazitaxel can be described by a three‑compartment pharmacokinetic model with α‑, β‑, and γ‑ half‑lives of 4 minutes, 2 hours, and 95 hours, respectively.	Terminal elimination half‑life was approximately 3 hours based on a two‑compartment model.	—	Three‑compartment pharmacokinetic model Half‑lives for the α, β, and γ phases of 4 min, 36 min, and 11.1 hr, respectively	Radium‑223 half‑life is 11.4 days.	t_1/2 in patients after a single oral dose is 5.8 days (range 2.8 to 10.2 days) Following a single 160 mg oral dose of enzalutamide in healthy volunteers, mean terminal t_1/2 for N‑desmethyl enzalutamide is 7.8 to 8.6 days.	In patients with mCRPC, mean terminal half‑life of abiraterone in plasma (mean ± SD) is 12 ± 5 hours In subjects with mild hepatic impairment, approximately 18 hours Moderate hepatic impairment, approximately 19 hours	In patients with mCRPC, mean terminal half‑life of abiraterone in plasma (mean ± SD) is 12 ± 5 hours In subjects with mild hepatic impairment, approximately 18 hours Moderate hepatic impairment, approximately 19 hours
Adverse reactions that occurred in more than 10% of patients receiving CASODEX plus an LHRH‑A were: Hot flashes Pain (including general, back, pelvic, and abdominal) Asthenia Constipation Infection Nausea Peripheral edema Dyspnea Diarrhea Hematuria Nocturia Anemia	The most common adverse reactions (≥10%): Fatigue Hypertension Rash Diarrhea Nausea Weight decreased Arthralgia Fall Hot flush Decreased appetite Fracture Peripheral edema Additional clinically significant adverse reactions occurring in 2% or more of patients treated with ERLEADA included hypothyroidism (8.1% versus 2% on placebo), pruritus (6.2% versus 2% on placebo), ischemic heart disease (3.7% versus 2% on placebo), and heart failure (2.2% versus 1% on placebo). Rash: In SPARTAN, rash associated with ERLEADA was most commonly described as macular or maculo-papular. The onset of rash occurred at a median of 82 days of ERLEADA treatment. Rash resolved in 81% of patients within a median of 60 days (range: 2 to 709 days) from onset of rash.	The most common (≥10%) grade 1–4 adverse reactions occurring in patients treated with the combination of JEVTANA plus prednisone (TROPIC Trial) were: Anemia Leukopenia Neutropenia Thrombocytopenia Diarrhea Fatigue Nausea Vomiting Constipation Asthenia Abdominal pain Hematuria Back pain Anorexia Peripheral neuropathy Pyrexia Dyspnea Dysgeusia Cough Arthralgia Alopecia	LUPRON DEPOT 7.5 mg for 1‑month administration: The most common adverse reactions (>10%) were general pain, hot flashes/sweats, GI disorders, edema, respiratory disorder, urinary disorder. LUPRON DEPOT 22.5 mg for 3‑month administration: The most common adverse reactions (>10%) were general pain, injection site reaction, hot flashes/sweats, GI disorders, joint disorders, testicular atrophy, urinary disorders. LUPRON DEPOT 30 mg for 4‑month administration: The most common adverse reactions (>10%) were asthenia, flu syndrome, general pain, headache, injection site reaction, hot flashes/sweats, GI disorders, edema, skin reaction, urinary disorders. LUPRON DEPOT 45 mg for 6‑month administration: The most common adverse reactions (>10%) were hot flush, injection site pain, upper respiratory infection, and fatigue.	The most common all‑grade adverse reactions in clinical trials (≥15% of patients receiving PROVENGE) Chills Fatigue Fever Back pain Nausea Joint ache Headache	The most common adverse reactions (regardless of relationship) occurring in ≥10% of patients with hormone refractory prostate cancer who received TAXOTERE in combination with prednisone (TAX327): Anemia Alopecia Fatigue Nausea Neutropenia Diarrhea Infection Neuropathy sensory Nail changes Fluid retention Stomatitis/Pharyngitis Peripheral edema Taste disturbance Vomiting Anorexia Dyspnea Myalgia Cough Cardiac left ventricular function Tearing In patients treated with TAXOTERE every three weeks, the following treatment‑emergent adverse reactions occurred at rates 10% higher in patients 65 years of age or greater compared to younger patients: anemia (71% vs 59%), infection (37% vs 24%), nail changes (34% vs 23%), anorexia (21% vs 10%), weight loss (15% vs 5%), respectively. The most common adverse reactions with TAXOTERE across all indications: 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 Myalgia	Most common adverse reactions ≥10% occurring in patients receiving XOFIGO: Nausea Diarrhea Vomiting Peripheral edema	The most common adverse reactions (≥10%) that occurred more commonly (≥2% over placebo) in patients receiving XTANDI from the two randomized, placebo‑controlled clinical trials: Asthenia/fatigue Back pain Decreased appetite Constipation Arthralgia Diarrhea Hot flush Upper respiratory tract infection Peripheral edema Dyspnea Musculoskeletal pain Weight decreased Headache Hypertension Dizziness/vertigo In the two randomized, placebo‑controlled clinical trials, falls including fall‑related injuries occurred in 9% of patients treated with XTANDI compared to 4% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall‑related injuries were more severe in patients treated with XTANDI and included nonpathologic fractures, joint injuries, and hematomas. In the two randomized, placebo‑controlled trials, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in <1% of patients in each arm.	Most common adverse reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were: Fatigue Joint swelling or discomfort Edema Hot flush Diarrhea Vomiting Cough Hypertension Dyspnea Urinary tract infection Contusion In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with abiraterone acetate compared to patients on the placebo arm (2.1%�versus 0.7%).	Most common adverse reactions (≥10%) reported in the pooled data of five randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were: Fatigue Arthralgia Hypertension Nausea Edema Hypokalemia Hot flush Diarrhea Vomiting Urinary tract infection Cough Hedache In the combined data of 5 randomized, placebo‑controlled clinical studies, cardiac failure occurred more commonly in patients on the ZYTIGA arm compared to patients on the placebo arm (2.6% versus 0.9%).
Laboratory abnormalities including: elevated AST, ALT, bilirubin, BUN, and creatinine; and decreased hemoglobin and white cell count, have been reported in both CASODEX‑LHRH analog treated and flutamide‑LHRH analog treated patients.	The most common all‑grades laboratory abnormalities that occurred in ≥15% of patients, and more frequently (>5%) in the ERLEADA arm compared to placebo include: anemia, leukopenia, lymphopenia, hypercholesterolemia, hyperglycemia, hypertriglyceridemia and hyperkalemia.	The most common all‑grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m² or 25 mg/m² are neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, and anorexia.	LUPRON DEPOT 7.5 mg for 1‑Month Administration: the following were recorded in ≥5% of patients at final visit: decreased albumin, decreased hemoglobin/hematocrit, decreased prostatic acid phosphatase, decreased total protein, decreased urine specific gravity, hyperglycemia, hyperuricemia, increased BUN, increased creatinine, increased liver function tests (AST, LDH), increased phosphorus, increased platelets, increased prostatic acid phosphatase, increased total cholesterol, increased urine specific gravity, leukopenia.	—	—	Most common hematologic laboratory abnormalities in XOFIGO‑treated patients (≥10%): Anemia Lymphocytopenia Leukopenia Thrombocytopenia Neutropenia	Most common laboratory abnormalities occurring in the two, randomized placebo‑controlled clinical trials: Grade 1–4 neutropenia occurred in 15% of patients treated with XTANDI Grade 1–4 thrombocytopenia occurred in 6% of patients treated with XTANDI Grade 1–4 elevations in ALT occurred in 10% of patients treated with XTANDI Grade 1–4 elevations in bilirubin occurred in 3% of patients treated with XTANDI	The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.	The most common laboratory abnormalities (>20%) reported in the five randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia.
The following adverse reactions have been identified during post‑approval use of CASODEX: Interstitial lung disease (some fatal) including interstitial pneumonitis and pulmonary fibrosis, most often at doses greater than 50 mg. Increased PT/INR due to interaction between coumarin anticoagulants and CASODEX. Serious bleeding reported. Photosensitivity	—	The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance: Gastritis Intestinal obstruction Interstitial pneumonia/pneumonitis Interstitial lung disease Acute respiratory distress syndrome	Like other drugs in this class, mood swings, including depression, have been reported. There have been very rare reports of suicidal ideation and attempt. Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported. Decreased bone density has been reported. Rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported. In a majority of these cases, a pituitary adenoma was diagnosed. Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath). Cardiovascular System – Hypotension, Myocardial infarction, Pulmonary embolism Interstitial lung disease Serious drug‑induced liver injury Decreased WBC Central/Peripheral Nervous System ‑ Convulsion, Peripheral neuropathy, Spinal fracture/paralysis Diabetes Tenosynovitis‑like symptoms Prostate pain	Nervous system disorders: syncope, transient ischemic attack, strokes Hypotension Myocardial infarction Thromboembolic disorders: deep venous thrombosis and pulmonary embolism	Body as a whole: diffuse pain, chest pain, radiation recall phenomenon. Cardiovascular: atrial fibrillation, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction. Cutaneous: very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme, Stevens‑Johnson syndrome, toxic epidermal necrolysis, and Scleroderma‑like changes usually preceded by peripheral lymphedema. Severe hand and foot syndrome and cases of permanent alopecia have been reported. Gastrointestinal: abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage, gastrointestinal perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis and dehydration as a consequence to gastrointestinal events have been reported. Hematologic: bleeding episodes. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. Cases of acute myeloid leukemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy. Hypersensitivity: rare cases of anaphylactic shock Hepatic: rare cases of hepatitis Neurologic: confusion, rare cases of seizures or transient loss of consciousness Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or without conjunctivitis. Excessive tearing which may be attributable to lacrimal duct obstruction has been reported. Rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions. Cases of cystoid macular edema (CME) have been reported in patients treated with docetaxel. Hearing: rare cases of ototoxicity, hearing disorders and/or hearing loss Respiratory: dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome. Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy. Renal: renal insufficiency and renal failure have been reported. Metabolism and Nutritional Disorders: cases of hyponatremia	—	Hypersensitivity (tongue edema, lip edema, and pharyngeal edema) Vomiting Posterior reversible encephalopathy syndrome (PRES) Rash	Non‑infectious pneumonitis Myopathy, including rhabdomyolysis Fulminant hepatitis, including acute hepatic failure and death	Non‑infectious pneumonitis Myopathy, including rhabdomyolysis Fulminant hepatitis, including acute hepatic failure and death.
Hepatitis Hemorrhage with Concomitant Use of Coumarin Anticoagulant Gynecomastia and Breast Pain Reduction in Glucose Tolerance Laboratory Test: Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases.	Falls and Fractures Seizure	Neutropenia (BOXED WARNING) Severe hypersensitivity (BOXED WARNING) Bone Marrow Suppression Increased Toxicity in Elderly Patients Hypersensitivity Reactions Gastrointestinal Adverse Reactions Renal Failure Respiratory Disorders Use in Patients with Hepatic Impairment	Tumor Flare Hyperglycemia and Diabetes Cardiovascular Diseases Effect on QT/QTc Interval Convulsions Laboratory Tests: Monitor serum levels of testosterone following injection of LUPRON DEPOT 7.5 mg for 1‑month administration, 22.5 mg for 3‑month administration, 30 mg for 4‑month administration, or 45 mg for 6‑month administration. In the majority of patients, testosterone levels increased above baseline, and then declined thereafter to castrate levels (<50 ng/dL) within 4 weeks.	Acute Infusion Reactions Thromboembolic Events Vascular Disorders Handling Precautions for Control of Infectious Disease Concomitant Chemotherapy or Immunosuppressive Therapy Product Safety Testing	Toxic Deaths (Breast Cancer and Non‑Small Cell Lung Cancer) (BOXED WARNING) Hepatic Impairment Hepatotoxicity (BOXED WARNING) Hematologic Effects Neutropenia (BOXED WARNING) Hypersensitivity Reactions (BOXED WARNING) Fluid Retention (BOXED WARNING) Acute Myeloid Leukemia Cutaneous Reactions Neurologic Reactions Eye Disorders Asthenia Alcohol Content Use in Pregnancy	Bone Marrow Suppression	Seizure PRES	Hypertension, Hypokalemia and Fluid Retention due to Mineralocorticoid excess Adrenocortical insufficiency Hepatotoxicity	Hypertension, Hypokalemia and Fluid Retention due to Mineralocorticoid Excess Adrenocortical insufficiency Hepatotoxicity
Hypersensitivity Women Pregnancy	ERLEADA can cause fetal harm and potential loss of pregnancy.	Patients with: Neutrophil counts of ≤1500/mm³ History of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 Severe hepatic impairment (total bilirubin >3 × ULN) Pregnancy	Hypersensitivity Pregnancy	None	TAXOTERE is contraindicated in patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred. TAXOTERE should not be used in patients with neutrophil counts of <1500 cells/mm³.	Pregnancy	Pregnancy: fetal harm and potential loss of pregnancy	Can cause fetal harm and potential loss of pregnancy	Women who are or may become pregnant