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Jevtana

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Jevtana

Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in another section of the label:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

The safety of JEVTANA in combination with prednisone was evaluated in 371 patients with hormone-refractory metastatic prostate cancer treated in a single randomized trial, compared to mitoxantrone plus prednisone.

Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA-treated patients and 3 ( < 1%) mitoxantrone-treated patients. The most common fatal adverse reactions in JEVTANA-treated patients were infections (n=5) and renal failure (n=4). The majority (4 of 5 patients) of fatal infection-related adverse reactions occurred after a single dose of JEVTANA. Other fatal adverse reactions in JEVTANA-treated patients included ventricular fibrillation, cerebral hemorrhage, and dyspnea.

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, dysguesia, 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.

Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received JEVTANA and 8% of patients who received mitoxantrone. The most common adverse reactions leading to treatment discontinuation in the JEVTANA group were neutropenia and renal failure. Dose reductions were reported in 12% of JEVTANA-treated patients and 4% of mitoxantrone-treated patients. Dose delays were reported in 28% of JEVTANA-treated patients and 15% of mitoxantrone-treated patients.

Table 2 : Incidence of Reported Adverse Reactions1 and Hematologic Abnormalities in ≥ 5% of Patients Receiving JEVTANA in Combination with Prednisone or Mitoxantrone in Combination with Prednisone

Any Adverse Reaction JEVTANA 25 mg/m² every 3 weeks with prednisone 10 mg daily Mitoxantrone 12 mg/m² every 3 weeks with prednisone 10 mg daily
Grade 1-4
n (%)
Grade 3-4
n (%)
Grade 1-4
n (%)
Grade 3-4
n (%)
Blood and Lymphatic System Disorders
  Neutropenia2 347 (94%) 303 (82%) 325 (87%) 215 (58%)
  Febrile Neutropenia 27 (7%) 27 (7%) 5 (1%) 5 (1%)
  Anemia2 361 (98%) 39 (11%) 302 (82%) 18 (5%)
  Leukopenia2 355 (96%) 253 (69%) 343 (93%) 157 (42%)
  Thrombocytopenia2 176 (48%) 15 (4%) 160 (43%) 6 (2%)
Cardiac Disorders
  Arrhythmia3 18 (5%) 4 (1%) 6 (2%) 1 ( < 1%)
Gastrointestinal Disorders 
  Diarrhea 173 (47%) 23 (6%) 39 (11%) 1 ( < 1%)
  Nausea 127 (34%) 7 (2%) 85 (23%) 1 ( < 1%)
  Vomiting 83 (22%) 6 (2%) 38 (10%) 0
  Constipation 76 (20%) 4 (1%) 57 (15%) 2 ( < 1%)
  Abdominal Pain4 64 (17%) 7 (2%) 23 (6%) 0
  Dyspepsia5 36 (10%) 0 9 (2%) 0
General Disorders and Administration Site Conditions
  Fatigue 136 (37%) 18 (5%) 102 (27%) 11 (3%)
  Asthenia 76 (20%) 17 (5%) 46 (12%) 9 (2%)
  Pyrexia 45 (12%) 4 (1%) 23 (6%) 1 ( < 1%)
  Peripheral Edema 34 (9%) 2 ( < 1%) 34 (9%) 2 ( < 1%)
  Mucosal Inflammation 22 (6%) 1 ( < 1%) 10 (3%) 1 ( < 1%)
  Pain 20 (5%) 4 (1%) 18 (5%) 7 (2%)
Infections and Infestations
  Urinary Tract Infection6 29 (8%) 6 (2%) 12 (3%) 4 (1%)
Investigations
  Weight Decreased 32 (9%) 0 28 (8%) 1 ( < 1%)
Metabolism and Nutrition Disorders
  Anorexia 59 (16%) 3 ( < 1%) 39 (11%) 3 ( < 1%)
  Dehydration 18 (5%) 8 (2%) 10 (3%) 3 ( < 1%)
Musculoskeletal and Connective Tissue Disorders
  Back Pain 60 (16%) 14 (4%) 45 (12%) 11 (3%)
  Arthralgia 39 (11%) 4 (1%) 31 (8%) 4 (1%)
  Muscle Spasms 27 (7%) 0 10 (3%) 0
Nervous System Disorders
  Peripheral Neuropathy7 50 (13%) 3 ( < 1%) 12 (3.2%) 3 ( < 1%)
  Dysgeusia 41 (11%) 0 15 (4%) 0
  Dizziness 30 (8%) 0 21 (6%) 2 ( < 1%)
  Headache 28 (8%) 0 19 (5%) 0
Renal and Urinary Tract Disorders
  Hematuria 62 (17%) 7 (2%) 13 (4%) 1 ( < 1%)
  Dysuria 25 (7%) 0 5 (1%) 0
Respiratory, Thoracic and Mediastinal Disorders
  Dyspnea 43 (12%) 4 (1%) 16 (4%) 2 ( < 1%)
  Cough 40 (11%) 0 22 (6%) 0
Skin and Subcutaneous Tissue Disorders
  Alopecia 37 (10%) 0 18 (5%) 0
Vascular Disorders
  Hypotension 20 (5%) 2 ( < 1 %) 9 (2%) 1 ( < 1%)
  Median Duration of Treatment 6 cycles 4 cycles
1Graded using NCI CTCAE version 3
2Based on laboratory values, cabazitaxel: n =369, mitoxantrone: n = 370.
3Includes atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block complete, bradycardia, palpitations, supraventricular tachycardia, tachyarrhythmia, and tachycardia.
4Includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and GI pain.
5Includes gastroesophageal reflux disease and reflux gastritis.
6Includes urinary tract infection enterococcal and urinary tract infection fungal.
7Includes peripheral motor neuropathy and peripheral sensory neuropathy.

Neutropenia and Associated Clinical Events

Five patients experienced fatal infectious adverse events (sepsis or septic shock). All had grade 4 neutropenia and one had febrile neutropenia. One additional patient's death was attributed to neutropenia without a documented infection. Twenty-two (6%) patients discontinued JEVTANA treatment due to neutropenia, febrile neutropenia, infection, or sepsis. The most common adverse reaction leading to treatment discontinuation in the JEVTANA group was neutropenia (2%).

Hematuria

Adverse events of hematuria, including those requiring medical intervention, were more common in JEVTANA-treated patients. The incidence of grade ≥ 2 hematuria was 6% in JEVTANA-treated patients and 2% in mitoxantrone-treated patients. Other factors associated with hematuria were well-balanced between arms and do not account for the increased rate of hematuria on the JEVTANA arm.

Hepatic Laboratory Abnormalities

The incidences of grade 3-4 increased AST, increased ALT, and increased bilirubin were each ≤ 1%.

Elderly Population

The following grade 1-4 adverse reactions were reported at rates ≥ 5% higher in patients 65 years of age or greater compared to younger patients: fatigue (40% vs. 30%), neutropenia (97% vs. 89%), asthenia (24% vs. 15%), pyrexia (15% vs. 8%), dizziness (10% vs. 5%), urinary tract infection (10% vs. 3%) and dehydration (7% vs. 2%), respectively.

The incidence of the following grade 3-4 adverse reactions were higher in patients ≥ 65 years of age compared to younger patients; neutropenia (87% vs. 74%), and febrile neutropenia (8% vs. 6%) [see Use in Specific Populations].

Read the Jevtana (cabazitaxel injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal clinical drug-drug interaction trials have been conducted with JEVTANA.

Prednisone or prednisolone administered at 10 mg daily did not affect the pharmacokinetics of cabazitaxel.

Drugs That May Increase Cabazitaxel Plasma Concentrations

CYP3A4 Inhibitors

Cabazitaxel is primarily metabolized through CYP3A [see CLINICAL PHARMACOLOGY]. Though no formal drug interaction trials have been conducted for JEVTANA, concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) is expected to increase concentrations of cabazitaxel. Therefore, co-administration with strong CYP3A inhibitors should be avoided. Caution should be exercised with concomitant use of moderate CYP3A inhibitors.

Drugs That May Decrease Cabazitaxel Plasma Concentrations

CYP3A4 Inducers

Though no formal drug interaction trials have been conducted for JEVTANA, the concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) is expected to decrease cabazitaxel concentrations. Therefore, co-administration with strong CYP3A inducers should be avoided. In addition, patients should also refrain from taking St. John's Wort.

Read the Jevtana Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/16/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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