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Jevtana Side Effects

Generic Name: cabazitaxel

Note: This document contains side effect information about cabazitaxel. Some of the dosage forms listed on this page may not apply to the brand name Jevtana.

In Summary

Common side effects of Jevtana include: neutropenia, diarrhea, nausea, and vomiting. Other side effects include: febrile neutropenia, hypotension, and dehydration. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to cabazitaxel: intravenous solution

Along with its needed effects, cabazitaxel (the active ingredient contained in Jevtana) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cabazitaxel:

More Common

  • Black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • cough
  • difficult or labored breathing
  • difficult or painful urination
  • fever
  • lower back or side pain
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness in the arms, hands, legs, or feet

Less Common

  • Blurred vision
  • confusion
  • decreased urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • lightheadedness
  • rapid breathing
  • sunken eyes
  • sweating
  • thirst
  • wrinkled skin

Incidence Not Known

  • Blue lips, fingernails, or skin
  • burning feeling in the chest or stomach
  • fast breathing
  • frequent urination
  • general feeling of discomfort or illness
  • indigestion
  • lower abdominal cramping
  • nausea
  • severe constipation
  • stomach pain or upset
  • tenderness in the stomach area
  • thickening of bronchial secretions
  • vomiting

Some side effects of cabazitaxel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Back pain
  • difficulty with moving
  • muscle pain, spasm, or stiffness
  • pain in the joints
  • pain, itching, burning, swelling, or a lump under your skin where the needle is placed

For Healthcare Professionals

Applies to cabazitaxel: intravenous solution

General

The most common adverse events were anemia, leukopenia, neutropenia, thrombocytopenia, and diarrhea.[Ref]

Hematologic

Very common (10% or more): Anemia (98%), leukopenia (96%), neutropenia (94%), thrombocytopenia (48%)

Common (1% to 10%): Febrile neutropenia[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (47%), nausea (34%), vomiting (22%), constipation (20%), abdominal pain (17%), dyspepsia (10%)

Common (1% to 10%): Abdominal pain upper, hemorrhoids, gastroesophageal reflux disease, rectal hemorrhage, dry mouth, abdominal distension

Frequency not reported: Death related to diarrhea and electrolyte imbalance, GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, colitis

Postmarketing reports: Gastritis, intestinal obstruction[Ref]

Nervous system

Very common (10% or more): Fatigue (37%), dysgeusia (11%)

Common (1% to 10%): Dizziness, peripheral neuropathy, headache, peripheral sensory neuropathy, paresthesia, lethargy, hypoesthesia, tinnitus, vertigo, sciatica

Frequency not reported: Peripheral motor neuropathy, fatal cerebral hemorrhage[Ref]

Other

Very common (10% or more): Asthenia (20%), pyrexia (12%)

Common (1% to 10%): Mucosal inflammation, pain, death due to causes other than disease progression, malaise[Ref]

Respiratory

Very common (10% or more): Dyspnea (12%), cough (11%)

Common (1% to 10%): Oropharyngeal pain[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, arrhythmia, hypotension, deep vein thrombosis, hypertension, tachycardia, grade 3 or higher arrhythmias, orthostatic hypotension, hot flush, flushing, atrial fibrillation

Uncommon (0.1% to 1%): Cardiac failure, cardiac arrest, fatal ventricular fibrillation[Ref]

Renal

Uncommon (0.1% to 1%): Grade 3 to 4 increased AST, grade 3 to 4 increased ALT, increased bilirubin

Frequency not reported: Fatal renal failure[Ref]

Metabolic

Very common (10% or more): Anorexia (16%)

Common (1% to 10%): Weight decreased, dehydration, edema, hyperglycemia, hypokalemia[Ref]

Genitourinary

Very common (10% or more): Hematuria (17%)

Common (1% to 10%): Dysuria, pollakiuria, urinary retention, urinary incontinence, ureteric obstruction, pelvic pain[Ref]

Hepatic

Common (1% to 10%): AST increased, transaminases increased

Uncommon (0.1% to 1%): ALT increased, bilirubin increased[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity[Ref]

Musculoskeletal

Very common (10% or more): Back pain (16%), arthralgia (10.5%)

Common (1% to 10%): Pain in extremity, muscle spasms, myalgia, musculoskeletal chest pain, flank pain, chills[Ref]

Immunologic

Common (1% to 10%): Urinary tract infection, influenza, cystitis, upper respiratory tract infection, pneumonia, cellulitis, herpes zoster, septic shock, sepsis, candidiasis

Uncommon (0.1% to 1%): Neutropenic sepsis, neutropenic infections

Frequency not reported: Fatal infection[Ref]

Dermatologic

Very common (10% or more): Alopecia (10%)

Common (1% to 10%): Dry skin, erythema[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, increased lacrimation[Ref]

Psychiatric

Common (1% to 10%): Anxiety, confusional state[Ref]

References

1. "Product Information. Jevtana (cabazitaxel)." sanofi-aventis , Bridgewater, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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