Jevtana
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Jevtana
Jevtana Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Jevtana in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Jevtana Overview - Patient Information: Side Effects
Loss of appetite, stomach/abdominal pain, or change in sense of taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor immediately if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, or diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Many people using this medication develop serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, bloody urine, muscle cramps, weakness, dizziness, extreme thirst, unusual tiredness, fast/irregular heartbeat, easy bruising/bleeding, numbness/tingling of arms/legs.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Jevtana (Cabazitaxel Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Jevtana FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in another section of the label:
- Neutropenia [see WARNINGS AND PRECAUTIONS].
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS].
- Gastrointestinal Symptoms [see WARNINGS AND PRECAUTIONS].
- Renal Failure [see WARNINGS AND PRECAUTIONS].
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 entire FDA prescribing information for Jevtana (Cabazitaxel Injection) »
Additional Jevtana Information
Jevtana - User Reviews
Jevtana User Reviews
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Here is a collection of user reviews for the medication Jevtana sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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