Jevtana

Last reviewed on RxList: 3/24/2020
Jevtana Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Jevtana?

Jevtana (cabazitaxel) is a cancer (antineoplastic) medication used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic). Jevtana is usually given after other cancer medicines have been tried without success.

What Are Side Effects of Jevtana?

Common side effects of Jevtana include:

Tell your doctor if you have serious side effects of Jevtana including:

  • a change in the amount of urine,
  • bloody urine,
  • muscle cramps,
  • weakness,
  • dizziness,
  • extreme thirst,
  • unusual tiredness,
  • fast or irregular heartbeat,
  • easy bruising or bleeding,
  • persistent constipation,
  • severe stomach or abdominal pain,
  • black or tarry stools, or
  • vomit that looks like coffee grounds.

Dosage for Jevtana

The individual dosage of Jevtana is based on calculation of the Body Surface Area (BSA) and is 25 mg/m2 administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout treatment.

What Drugs, Substances, or Supplements Interact with Jevtana?

Jevtana may interact with conivaptan, imatinib, isoniazid, aprepitant, cimetidine, cyclosporine, haloperidol, lidocaine, antibiotics, antifungals, antidepressants, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use.

Jevtana During Pregnancy and Breastfeeding

Jevtana is not recommended for use during pregnancy. It may harm a fetus. Discuss the use of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Jevtana (cabazitaxel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Jevtana Consumer Information

Cabazitaxel can cause a serious allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives, rash or skin redness; chest tightness or trouble breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Cabazitaxel can cause serious or fatal side effects. Call your doctor at once if you have:

  • numbness, burning pain, or tingly feeling in your hands or feet;
  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
  • stomach pain or tenderness, severe vomiting or diarrhea, ongoing constipation;
  • blood in your urine, urinating more often, pain or burning when you urinate;
  • low blood cell counts--fever, chills, muscle pain, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your hands or feet; feeling tired or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Some side effects may be more likely in older adults.

Common side effects may include:

  • fever, low blood cell counts;
  • numbness or tingling;
  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation, diarrhea;
  • weakness, tired feeling;
  • blood in your urine;
  • back pain, joint pain;
  • cough, shortness of breath;
  • altered sense of taste; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Jevtana (Cabazitaxel Injection)

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Jevtana Professional Information

SIDE EFFECTS

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

  • Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicities in Elderly Patients [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Renal Failure [see WARNINGS AND PRECAUTIONS]
  • Urinary Disorders Including Cystitis [see WARNINGS AND PRECAUTIONS]
  • Respiratory Disorders [see WARNINGS AND PRECAUTIONS]
  • Use in Patients with Hepatic Impairment [see WARNINGS AND PRECAUTIONS]

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.

TROPIC Trial (JEVTANA + Prednisone Compared To Mitoxantrone)

The safety of JEVTANA in combination with prednisone was evaluated in 371 patients with metastatic castration-resistant prostate cancer treated in the randomized TROPIC 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, 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.

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 Adverse Reactions* and Hematologic Abnormalities in ≥5% of Patients Receiving JEVTANA in Combination with Prednisone or Mitoxantrone in Combination with Prednisone in TROPIC

JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg daily
n=371
Mitoxantrone 12 mg/m2 every 3 weeks with prednisone 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
  Neutropenia347 (94%)303 (82%)325 (87%)215 (58%)
  Febrile Neutropenia27 (7%)27 (7%)5 (1%)5 (1%)
  Anemia361 (98%)39 (11%)302 (82%)18 (5%)
  Leukopenia355 (96%)253 (69%)343 (93%)157 (42%)
  Thrombocytopenia176 (48%)15 (4%)160 (43%)6 (2%)
Cardiac Disorders
  Arrhythmia18 (5%)4 (1%)6 (2%)1 (<1%)
Gastrointestinal Disorders
  Diarrhea173 (47%)23 (6%)39 (11%)1 (<1%)
  Nausea127 (34%)7 (2%)85 (23%)1 (<1%)
  Vomiting83 (22%)6 (2%)38 (10%)0
  Constipation76 (20%)4 (1%)57 (15%)2 (<1%)
  Abdominal Pain§64 (17%)7 (2%)23 (6%)0
  Dyspepsia36 (10%)09 (2%)0
General Disorders and Administration Site Conditions
  Fatigue136 (37%)18 (5%)102 (27%)11 (3%)
  Asthenia76 (20%)17 (5%)46 (12%)9 (2%)
  Pyrexia45 (12%)4 (1%)23 (6%)1 (<1%)
  Peripheral Edema34 (9%)2 (<1%)34 (9%)2 (<1%)
  Mucosal Inflammation22 (6%)1 (<1%)10 (3%)1 (<1%)
  Pain20 (5%)4 (1%)18 (5%)7 (2%)
Infections and Infestations
  Urinary Tract Infection#29 (8%)6 (2%)12 (3%)4 (1%)
Investigations
Weight Decreased32 (9%)028 (8%)1 (<1%)
Metabolism and Nutrition Disorders
  Anorexia59 (16%)3 (<1%)39 (11%)3 (<1%)
  Dehydration18 (5%)8 (2%)10 (3%)3 (<1%)
Musculoskeletal and Connective Tissue Disorders
  Back Pain60 (16%)14 (4%)45 (12%)11 (3%)
  Arthralgia39 (11%)4 (1%)31 (8%)4 (1%)
  Muscle Spasms27 (7%)010 (3%)0
Nervous System Disorders
  Peripheral NeuropathyÞ50 (13%)3 (<1%)12 (3%)3 (<1%)
  Dysgeusia41 (11%)015 (4%)0
  Dizziness30 (8%)021 (6%)2 (<1%)
  Headache28 (8%)019 (5%)0
  Hematuria62 (17%)7 (2%)13 (4%)1 (<1%)
  Dysuria25 (7%)05 (1%)0
Respiratory, Thoracic and Mediastinal Disorders
  Dyspnea43 (12%)4 (1%)16 (4%)2 (<1%)
  Cough40 (11%)022 (6%)0
Skin and Subcutaneous Tissue Disorders
  Alopecia37 (10%)018 (5%)0
Vascular Disorders
  Hypotension20 (5%)2 (<1 %)9 (2%)1 (<1%)
  Median Duration of Treatment6 cycles4 cycles
* Graded using NCI CTCAE version 3.
Based on laboratory values, JEVTANA: 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.
Þ Includes peripheral motor neuropathy and peripheral sensory neuropathy.

PROSELICA Trial (Comparison Of Two Doses Of JEVTANA)

In a noninferiority, multicenter, randomized, open-label study (PROSELICA), 1175 patients with metastatic castration-resistant prostate cancer, previously treated with a docetaxel-containing regimen, were treated with either JEVTANA 25 mg/m2 (n=595) or the 20 mg/m2 (n=580) dose.

Deaths within 30 days of last study drug dose were reported in 22 (3.8%) patients in the 20 mg/m2 and 32 (5.4%) patients in the 25 mg/m2 arm. The most common fatal adverse reactions in JEVTANA-treated patients were related to infections, and these occurred more commonly on the 25 mg/m2 arm (n=15) than on the 20 mg/m2 arm (n=8). Other fatal adverse reactions in JEVTANA-treated patients included cerebral hemorrhage, respiratory failure, paralytic ileus, diarrhea, acute pulmonary edema, disseminated intravascular coagulation, renal failure, sudden death, cardiac arrest, ischemic stroke, diverticular perforation, and cardiorenal syndrome.

Grade 1-4 adverse reactions occurring ≥5% more commonly in patients on the 25 mg/m2 versus 20 mg/m2 arms were leukopenia, neutropenia, thrombocytopenia, febrile neutropenia, decreased appetite, nausea, diarrhea, asthenia, and hematuria.

Grade 3-4 adverse reactions occurring ≥5% more commonly in patients on the 25 mg/m2 versus 20 mg/m2 arms were leukopenia, neutropenia, and febrile neutropenia.

Treatment discontinuations due to adverse drug reactions occurred in 17% of patients in the 20 mg/m2 group and 20% of patients in the 25 mg/m2 group. The most common adverse reactions leading to treatment discontinuation were fatigue and hematuria. The patients in the 20 mg/m2 group received a median of 6 cycles (median duration of 18 weeks), while patients in the 25 mg/m2 group received a median of 7 cycles (median duration of 21 weeks). In the 25 mg/m2 group, 128 patients (22%) had a dose reduced from 25 to 20 mg/m2, 19 patients (3%) had a dose reduced from 20 to 15 mg/m2 and 1 patient (0.2%) had a dose reduced from 15 to 12 mg/m2. In the 20 mg/m2 group, 58 patients (10%) had a dose reduced from 20 to 15 mg/m2, and 9 patients (2%) had a dose reduced from 15 to 12 mg/m2.

Table 3: Incidence of Adverse Reactions* in ≥5% of Patients Receiving JEVTANA 20 mg/m2 or 25 mg/m2 in Combination with Prednisone in PROSELICA

JEVTANA 20 mg/m2 every 3 weeks with prednisone 10 mg daily
n=580
JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg daily
n=595
Primary System Organ Class Preferred TermGrade 1-4
n (%)
Grade 3-4
n (%)
Grade 1-4
n (%)
Grade 3-4
n (%)
Blood and Lymphatic System Disorders
  Febrile Neutropenia12 (2%)12 (2%)55 (9%)55 (9%)
  Neutropenia18 (3%)14 (2%)65 (11%)57 (10%)
Infections and Infestations
  Urinary tract infection43 (7%)12 (2%)66 (11%)14 (2%)
  Neutropenic infection§15 (3%)13 (2%)42 (7%)36 (6%)
Metabolism and Nutrition Disorders
  Decreased appetite76 (13%)4 (0.7%)110 (19%)7 (1%)
Nervous System Disorders
  Dysgeusia41 (7%)063 (11%)0
  Peripheral sensory neuropathy38 (7%)063 (11%)4 (0.7%)
  Dizziness24 (4%)032 (5%)0
  Headache29 (5%)1 (0.2%)24 (4%)1 (0.2%)
Respiratory, Thoracic and Mediastinal Disorders
  Dyspnea30 (5%)5 (0.9%)46 (8%)4 (0.7%)
  Cough34 (6%)035 (6%)0
Gastrointestinal Disorders
  Diarrhea178 (31%)8 (1%)237 (40%)24 (4%)
  Nausea142 (25%)4 (0.7%)191 (32%)7 (1%)
  Vomiting84 (15%)7 (1.2%)108 (18 %)8 (1%)
  Constipation102 (18%)2 (0.3%)107 (18%)4 (0.7%)
  Abdominal pain34 (6%)3 (0.5%)52 (9%)7 (1%)
  Stomatitis27 (5%)030 (5%)2 (0.3%)
Skin and Subcutaneous Tissue Disorders
  Alopecia15 (3%)036 (6.1%)0
Musculoskeletal and Connective Tissue Disorders
  Back pain64 (11%)5 (0.9%)83 (14%)7 (1%)
  Bone pain46 (8%)10 (2%)50 (8%)13 (2 %)
  Arthralgia49 (8%)3 (0.5%)41 (7%)5 (0.8%)
  Pain in extremity30 (5%)1 (0.2%)41 (7%)3 (0.5%)
Renal and Urinary Disorders
  Hematuria82 (14%)11 (2%)124 (21%)25 (4%)
  Dysuria31 (5%)2 (0.3%)24 (4%)0
General Disorders and Administration Site Conditions
  Fatigue143 (25%)15 (3%)161 (27%)22 (4%)
  Asthenia89 (15%)11 (2%)117 (20%)12 (2%)
  Edema peripheral39 (7%)1 (0.2%)53 (9%)1 (0.2%)
  Pyrexia27 (5%)1 (0.2%)38 (6 %)1 (0.2%)
Investigations
  Weight decreased24 (4%)1 (0.2%)44 (7%)0
Injury, Poisoning and Procedural Complications
  Wrong technique in drug usage process2 (0.3%)032 (5%)0
* Grade from NCI CTCAE version 4.03.
Based on adverse event reporting.
Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis.
§ Includes neutropenic sepsis.

Table 4: Incidence of Hematologic Laboratory Abnormalities in Patients Receiving JEVTANA 20 mg/m2 or 25 mg/m2 in Combination with Prednisone in Study PROSELICA

Laboratory AbnormalityJEVTANA 20 mg/m2 every 3 weeks with prednisone 10 mg daily
n=577
JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg daily
n=590
Grade 1-4
n (%)
Grade 3-4
n (%)
Grade 1-4
n (%)
Grade 3-4
n (%)
Neutropenia384 (67%)241 (42%)522 (89%)432 (73%)
Anemia576 (99.8%)57 (10%)588 (99.7%)81 (14%)
Leukopenia461 (80%)167 (29%)560 (95%)351 (60%)
Thrombocytopenia202 (35%)15 (3%)251 (43%)25 (4%)

Hematuria

In study TROPIC, adverse reactions 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.

In study PROSELICA, hematuria of all grades was observed in 18% of patients overall.

Hepatic Laboratory Abnormalities

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

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.

Renal and urinary disorders: Radiation recall hemorrhagic cystitis.

Read the entire FDA prescribing information for Jevtana (Cabazitaxel Injection)

© Jevtana Patient Information is supplied by Cerner Multum, Inc. and Jevtana Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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