Cabazitaxel Side Effects

Some side effects of cabazitaxel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cabazitaxel: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking cabazitaxel: 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 of cabazitaxel 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.

For Healthcare Professionals

Applies to cabazitaxel: intravenous solution

General

In general, the most common grade 3 to 4 adverse effects were neutropenia, leucopenia, anemia, diarrhea, fatigue, and asthenia. The most common adverse effects leading to treatment discontinuation were neutropenia and renal failure.

Hematologic

Hematologic side effects have included anemia (98%), leucopenia (96%), neutropenia (94%), thrombocytopenia (48%), and febrile neutropenia (7%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (47%), nausea (34%), vomiting (22%), constipation (20%), abdominal pain (17%), anorexia (16%), dysgeusia (11%), and dyspepsia (10%).

Cardiovascular

Cardiovascular side effects have included peripheral edema (9%), arrhythmias (5%), and hypotension (5%).

Dermatologic

Dermatologic side effects have included alopecia (10%).

Genitourinary

Genitourinary side effects have included hematuria (17%), urinary tract infection (8%), and dysuria (7%).

Hepatic

Hepatic side effects have included increased transaminases and increased bilirubin.

Hypersensitivity

Hypersensitivity reactions have included rash, erythema, hypotension, and bronchospasm.

Metabolic

Metabolic side effects have included weight loss (9%) and dehydration (5%).

Musculoskeletal

Musculoskeletal side effects have included back pain (16%), arthralgia (11%), and muscle spasms (7%).

Nervous system

Nervous system side effects have included peripheral neuropathy (13%), dizziness (8%), and headache (8%).

Other

Other side effects have included fatigue (37%), asthenia (20%), pyrexia (12%), mucosal inflammation (6%), and pain (5%).

Renal

Renal side effects have included renal failure.

Respiratory

Respiratory side effects have included dyspnea (12%) and cough (11%).

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