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Jevtana

Last reviewed on RxList: 10/2/2017
Jevtana Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/02/2017

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. 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.

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

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.

Jevtana Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • severe or ongoing diarrhea;
  • trouble breathing;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • swelling or rapid weight gain; or
  • blood in your urine, pain or burning when you urinate.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • constipation, mild diarrhea;
  • weakness, tired feeling;
  • joint pain, back pain;
  • numbness, burning pain, or tingly feeling en your hands or feet;
  • changes in your 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)

Jevtana Professional Information

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.

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
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&para; 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 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, 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.
&para; 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

Primary System Organ Class
Preferred Term
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
Grade 1-4
n (%)
Grade 3-4
n (%)
Grade 1-4
n (%)
Grade 3-4
n (%)
Blood and Lymphatic System Disorders
Febrile Neutropenia 12(2%) 12(2%) 55(9%) 55(9%)
Neutropenia 18(3%) 14(2%) 65(11%) 57(10%)
Infections and Infestations
Urinary tract infection 43(7%) 12(2%) 66(11%) 14(2%)
Neutropenic infection§ 15(3%) 13(2%) 42(7%) 36(6%)
Metabolism and Nutrition Disorders
Decreased appetite 76(13%) 4(0.7%) 110(19%) 7(1%)
Nervous System Disorders
Dysgeusia 41(7%) 0 63(11%) 0
Peripheral sensory neuropathy 38(7%) 0 63(11%) 4(0.7%)
Dizziness 24(4%) 0 32(5%) 0
Headache 29(5%) 1(0.2%) 24(4%) 1(0.2%)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 30(5%) 5(0.9%) 46(8%) 4(0.7%)
Cough 34(6%) 0 35(6%) 0
Gastrointestinal Disorders
Diarrhea 178(31%) 8(1%) 237(40%) 24(4%)
Nausea 142(25%) 4(0.7%) 191(32%) 7(1%)
Vomiting 84(15%) 7(1.2%) 108(18 %) 8(1%)
Constipation 102(18%) 2(0.3%) 107(18%) 4(0.7%)
Abdominal pain 34(6%) 3(0.5%) 52(9%) 7(1%)
Stomatitis 27(5%) 0 30(5%) 2(0.3%)
Skin and Subcutaneous Tissue Disorders
Alopecia 15(3%) 0 36(6.1%) 0
Musculoskeletal and Connective Tissue Disorders
Back pain 64(11%) 5(0.9%) 83(14%) 7(1%)
Bone pain 46(8%) 10(2%) 50(8%) 13(2 %)
Arthralgia 49(8%) 3(0.5%) 41(7%) 5(0.8%)
Pain in extremity 30(5%) 1(0.2%) 41(7%) 3(0.5%)
Renal and Urinary Disorders
Hematuria 82(14%) 11(2%) 124(21%) 25(4%)
Dysuria 31(5%) 2(0.3%) 24(4%) 0
General Disorders and Administration Site Conditions
Fatigue 143(25%) 15(3%) 161(27%) 22(4%)
Asthenia 89(15%) 11(2%) 117(20%) 12(2%)
Edema peripheral 39(7%) 1(0.2%) 53(9%) 1(0.2%)
Pyrexia 27(5%) 1(0.2%) 38(6 %) 1(0.2%)
Investigations
Weight decreased 24(4%) 1(0.2%) 44(7%) 0
Injury, Poisoning and Procedural Complications
Wrong technique in drug usage process 2(0.3%) 0 32(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 Abnormality JEVTANA 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 (%)
Neutropenia 384(67%) 241(42%) 522(89%) 432(73%)
Anemia 576(99.8%) 57(10%) 588(99.7%) 81(14%)
Leukopenia 461(80%) 167(29%) 560(95%) 351(60%)
Thrombocytopenia 202(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.

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

Related Resources for Jevtana

Read the Jevtana User Reviews »

© 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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