What are the conditions to be met prior to starting Cabanuva (cabazitaxel) therapy?

Conditions to Be Met Prior to Starting Cabazitaxel (Cabanuva)

Cabazitaxel should only be initiated in patients who meet specific hematologic, hepatic, and clinical criteria, with the most critical being adequate neutrophil counts, absence of severe liver impairment, and prior docetaxel exposure. 1

Absolute Contraindications

Do not initiate cabazitaxel if any of the following conditions are present:

• Neutrophil count below adequate threshold - patients with low white blood cell (neutrophil) counts are contraindicated from receiving cabazitaxel 1
• Severe hepatic impairment - cabazitaxel is contraindicated in patients with severe liver problems 1, 2
• History of severe hypersensitivity to cabazitaxel or medications containing polysorbate 80 1

Required Prior Treatment

Cabazitaxel is specifically indicated for metastatic castration-resistant prostate cancer (mCRPC) that has:

• Progressed after treatment with a docetaxel-containing regimen 1, 2
• Spread to other parts of the body (metastatic disease) 1
• Remained resistant to medical or surgical treatments that lower testosterone 1

The NCCN guidelines recommend cabazitaxel as a preferred option (category 1) specifically after progression on docetaxel in patients with mCRPC 2. While the FIRSTANA study showed activity in chemotherapy-naïve patients, current guidelines do not recommend cabazitaxel in docetaxel-naïve patients 2.

Performance Status Requirements

Patients must have adequate performance status:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 is required 3
• Poor performance status (≥1) is associated with significantly worse outcomes (HR 2.107, p=0.039) 4
• Elderly patients (≥65 years) require particular caution as they experience more frequent and severe side effects 1

Laboratory and Organ Function Requirements

Before initiating cabazitaxel, the following must be assessed:

Hematologic Parameters

• Adequate white blood cell counts must be documented, as low neutrophil counts are an absolute contraindication 1
• Hemoglobin levels should be evaluated, as low hemoglobin at baseline predicts poor prognosis (HR 0.142, p=0.010) 4
• Neutrophil-lymphocyte ratio should be assessed, as high ratios (HR 9.150, p=0.032) indicate poor prognosis 4

Hepatic Function

• Liver function must be assessed - cabazitaxel was tested in mild to moderate hepatic impairment and found tolerable, but severe hepatic dysfunction is an absolute contraindication 2, 1

Renal Function

• Baseline renal function should be evaluated, as kidney failure can occur during treatment due to severe infection, dehydration, and other causes 1

Pulmonary Assessment

• Pre-existing lung disease must be identified, as patients with prior lung disease have higher risk for developing severe or fatal lung/breathing problems during cabazitaxel treatment 1

Medical History Requirements

The following medical history must be obtained:

• History of allergic reactions, particularly to polysorbate 80-containing medications 1
• Prior pelvic radiation exposure - patients who received pelvic radiation have increased risk of severe cystitis and hematuria requiring hospitalization 1
• Cardiac history in elderly patients, as they may experience more toxicities 1

Mandatory Concurrent Medications

Cabazitaxel requires concurrent steroid therapy:

• Daily prednisone or prednisolone must be prescribed and taken throughout cabazitaxel treatment 2, 1
• Dexamethasone on the day of chemotherapy is also required 2
• Patient compliance with oral corticosteroid regimen must be confirmed before each cycle 1

Prophylactic Medications Required

Before each infusion, patients must receive:

• Premedication to prevent hypersensitivity reactions, including antihistamines, H2 antagonists, and corticosteroids 2
• Antiemetic prophylaxis 2
• G-CSF (granulocyte colony-stimulating factor) should be considered for prophylaxis, particularly in this heavily pretreated, high-risk population 2

The NCCN guidelines specifically recommend following current guidelines for prophylactic white blood cell growth factor use 2. Growth factors should be started 24-72 hours after completion of chemotherapy and continued through post-nadir recovery, but not administered on the same day as chemotherapy 2.

Drug Interaction Assessment

A comprehensive medication review is mandatory:

• All prescription and over-the-counter medicines, vitamins, and herbal supplements must be reviewed 1
• Cabazitaxel can interact with many medications, and no new medicines should be started without provider approval 1

Patient Counseling Requirements

Before initiating cabazitaxel, patients must be informed about:

• The risk of severe and potentially fatal infections, particularly when white blood cell counts are low 1
• The need for frequent temperature monitoring and immediate reporting of fever 1
• Signs and symptoms of severe allergic reactions that can occur within minutes of infusion 1
• Risk of severe gastrointestinal toxicity including potentially fatal vomiting, diarrhea, and dehydration 1
• Potential for hematuria and cystitis, especially in those with prior pelvic radiation 1

Fertility and Contraception Requirements

For male patients with female partners of reproductive potential:

• Effective contraception must be used during treatment and for 3 months after the last dose 1
• Patients should be counseled that cabazitaxel may impair fertility 1