May 23, 2017
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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 Trials 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 hormonerefractory 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 mitoxantronetreated patients.

Table 2: Incidence of Reported Adverse Reactions* and Hematologic Abnormalities in ≥5% of Patients Receiving JEVTANA in Combination with Prednis one or Mitoxantrone in Combination with Prednis one

  JEVTANA 25 mg/m2every
3 weeks with prednis one 10
mg daily
n=371
Mitoxantrone 12 mg/m2
every 3 weeks with
prednis one 10 mg daily
n=371
Grade 1–4
n (%)
Grade 3–4
n (%)
Grade 1–4
n (%)
Grade 3–4
n (%)
Any Adverse Reaction
Blood and Lymphatic System Disorders
  Neutropenia 347 (94%) 303 (82%) 325 (87%) 215 (58%)
  Febrile Neutropenia 27 (7%) 27 (7%) 5 (1%) 5 (1%)
  Anemia 361 (98%) 39 (11%) 302 (82%) 18 (5%)
  Leukopenia 355 (96%) 253 (69%) 343 (93%) 157 (42%)
  Thrombocytopenia 176 (48%) 15 (4%) 160 (43%) 6 (2%)
Cardiac Disorders
  Arrhythmia 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 Pain§ 64 (17%) 7 (2%) 23 (6%) 0
  Dyspepsia 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%) 22 (6%) 10 (3%) 1 (<1%)
  Pain 20 (5%) 4 (1%) 18 (5%) 7 (2%)
Infections and Infestations
  Urinary Tract Infection# 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 NeuropathyÞ 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
*Graded using NCI CTCAE version 3
Based on laboratory values, cabazitaxel: n =369, mitoxantrone: n = 370.
Includes atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block complete, bradycardia, palpitations,supraventricular tachycardia, tachyarrhythmia, and tachycardia.
§Includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and GI pain.
Includes gastroesophageal reflux disease and reflux gastritis.
#Includes urinary tract infection enterococcal and urinary tract infection fungal.
ÞIncludes 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 wellbalanced 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].

Postmarketing Experience

The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.

Gastrointestinal: Gastritis, intestinal obstruction.

Respiratory: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome.

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

DRUG INTERACTIONS

CYP3A Inhibitors

Cabazitaxel is primarily metabolized through CYP3A [see CLINICAL PHARMACOLOGY]. Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. Avoid the coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

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

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/1/2017

Side Effects
Interactions

Jevtana - User Reviews

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