Safety

Jevtana (cabazitaxel) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

June 2015

Summary View

CONTRAINDICATIONS

  • Severe hepatic impairment (Total Bilirubin > 3 x ULN)

WARNINGS AND PRECAUTIONS

  • Bone marrow suppression (particularly neutropenia) and its clinical consequences (febrile neutropenia, neutropenic infections): Monitor blood counts frequently to determine if dosage modification or initiation of G-CSF is needed. Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features. Use caution in patients with hemoglobin < 10 g/dL.
  • JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN). Dose should be reduced for patients with mild (total bilirubin > 1 to ≤ 1.5 x ULN or AST > 1.5 x ULN) and moderate (total bilirubin > 1.5 to ≤ 3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administration of cabazitaxel to patients with mild and moderate hepatic impairment should be undertaken with caution and close monitoring of safety.

 

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Gastrointestinal Disorders
  • Gastrointestinal (GI) hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported in patients treated with JEVTANA [see Adverse Reactions (6.2)}. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

ADVERSE REACTIONS

Postmarketing Experience

The following adverse reactions have been identified from clinical trials and/or post-marketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.

  • Gastrointestinal: Gastritis, intestinal obstruction.

 

Page Last Updated: 07/14/2015
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