Cabazitaxel parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Concentration for solution for infusions of cabazitaxel
Drugs List
Therapeutic Indications
Uses
Metastatic castration-resistant prostate cancer
Treatment of metastatic castration resistant prostate cancer (in combination with prednisone or prednisolone) in patients previously treated with a docetaxel-containing regimen.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Pre-medication is required at least 30 minutes prior to the administration of cabazitaxel.
Adults
Recommended dose: 25 mg per metre squared, every 3 weeks in combination with prednisone or prednisolone (10 mg orally daily).
Patients with Hepatic Impairment
Total bilirubin greater than 1 x upper limit of normal (ULN) and less than or equal to 1.5 x ULN or AST greater than 1.5 x ULN:
Reduce to 20 mg/metre squared.
Total bilirubin greater than 1.5 x ULN and less than or equal to 3 x ULN:
The dose should not exceed 15 mg/metre squared. However, there is limited efficacy data at this dose.
Additional Dosage Information
If patients require administration of a strong CYP3A inhibitor a 25% reduction in cabazitaxel should be considered.
Dose adjustments due to toxicities
Prolonged grade 3 or above neutropenia (longer than one week) despite appropriate treatment (including G-CSF)
Delay treatment until neutrophil count greater than 1,500 cells per cubic millimetre, then reduce dose from 25 mg to 20 mg per metre squared.
Febrile neutropenia or neutropenic infection
Delay treatment until improvement or resolution and until neutrophil count greater than 1,500 cells per cubic millimetre, then reduce dose from 25 mg to 20 mg per metre squared.
Grade 3 or above diarrhoea or persisting diarrhoea despite treatment
Delay treatment until improvement occurs or resolution, then reduce dose from 25 mg per square metre to 20 mg per metre squared.
Grade 2 or above peripheral neuropathy
Delay treatment until improvement, then reduce dose from 25 mg per square metre to 20 mg per metre squared.
Dose reduction in recurring toxicities
If the above adverse reactions continue to occur at 20 mg per square metre, further dose reduction to 15 mg per square metre or discontinuation of cabazitaxel may be considered.
Administration
For intravenous infusion over 1 hour, after dilution.
Use PVC-free and polyurethane-free infusion sets only.
Contraindications
Children under 18 years
Neutrophil count below 1.5 x 10 to the power of 9 / L
Serum bilirubin above 3 times upper limit of normal
Severe hepatic impairment
Precautions and Warnings
Haemoglobin concentration below 10g/dL
Patients over 65 years
Predisposition to gastrointestinal perforation
Predisposition to gastrointestinal ulceration
Previous pelvic radiotherapy
Acute porphyria
Alcoholism
Dehydration
Elevated serum bilirubin
Epileptic disorder
Gastrointestinal disorder
Mild hepatic impairment
Renal impairment - creatinine clearance below 15ml/minute
Administration of live vaccines is not recommended
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Avoid OATP1B1 substrate within 12hrs before and 3hrs after infusion
Give pre-treatment counselling and consideration of sperm cryopreservation
Monitor creatinine at baseline, with blood counts & change in urine output
Pre-medicate with corticosteroids, antihistamines and H2 antagonists
Prophylactic G-CSF should be considered
Treatment to be initiated and supervised by a specialist
Contains alcohol
Contains polysorbate
Concentrate must be diluted and used as an infusion
Resuscitation facilities must be immediately available
Monitor haemoglobin and haematocrit before and during treatment
Ensure adequate hydration prior to infusion
Monitor blood count weekly in 1st cycle and prior to each additional cycle
Monitor for hypersensitivity reactions-particularly 1st and 2nd infusions
Monitor serum electrolytes
Advise patient to report any new or worsening respiratory symptoms
Advise patient to report significant urine volume changes immediately
Advise patient to report signs of neuropathy
Advise patient to report unexplained nausea,vomiting,abdominal pain
Advise patients at risk of neutropenia to report any signs of infection
Consider dose reduction for subsequent doses if severe diarrhoea occurs
Prophylactic antiemetic recommended before each dose
Discontinue if renal function deteriorates
Discontinue if severe hypersensitivity reactions occur
Interrupt treatment if febrile neutropenia occurs
Suspend treatment and/or reduce dose if grade 3 or greater neutropenia
Suspend treatment if grade 2 or 3 neuropathy
Suspend treatment if grade 3 or greater diarrhoea occurs
Advise patient not to take St John's wort concurrently
May cause impaired fertility
Male: Contraception required during and for 6 months after treatment
Male: Use of condoms required during treatment
Pregnancy and Lactation
Pregnancy
Not indicated for use in women.
Lactation
Not indicated for use in women.
Side Effects
Abdominal distension
Abdominal pain
Acute renal failure
Alopecia
Anaemia
Anorexia
Anxiety
Arthralgia
Asthenia
Atrial fibrillation
Candidiasis
Cardiac failure
Cellulitis
Chest pain
Chills
Confusion
Conjunctivitis
Constipation
Cough
Cystitis
Deep vein thrombosis (DVT)
Dehydration
Diarrhoea
Dizziness
Dry mouth
Dry skin
Dysgeusia
Dyspepsia
Dyspnoea
Dysuria
Erythema
Fatigue
Febrile neutropenia
Flank pain
Gastro-intestinal symptoms
Gastroesophageal reflux disease
Haematuria
Haemorrhoids
Headache
Herpes zoster
Hot flushes
Hydronephrosis
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypokalaemia
Hypotension
Increase in AST level
Increase in serum transaminases
Influenza
Lacrimation disorder
Lethargy
Leukopenia
Malaise
Mucosal inflammation
Muscle spasm
Musculoskeletal pain
Myalgia
Nausea
Neutropenia
Oedema
Oropharyngeal pain
Orthostatic hypotension
Pain
Painful extremities
Paraesthesia
Pelvic pain
Peripheral neuropathy
Peripheral oedema
Pneumonia
Pollakiuria
Pyrexia
Rash
Rectal haemorrhage
Renal colic
Renal failure
Sciatica
Sepsis
Septic shock
Tachycardia
Thrombocytopenia
Tinnitus
Upper abdominal pain
Upper respiratory tract infection
Ureteric obstruction
Urinary incontinence
Urinary retention
Urinary tract infections
Vertigo
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2021
Reference Sources
NICE Evidence Services
Available at: www.nice.org.uk
Last accessed: 05 November 2021
Summary of Product Characteristics: Jevtana 60 mg concentrate and solvent for solution for infusion. Sanofi Genzyme. Revised September 2021.
Summary of Product Characteristics: Cabazitaxel 60 mg Concentrate and Solvent For Solution For Infusion. Dr Reddy's Laboratories (UK). Revised December 2021.
Summary of Product Characteristics: Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion. Accord Healthcare Limited. Revised April 2022.
Summary of Product Characteristics: Cabazitaxel EVER Pharma 10mg/ml concentrate for solution for infusion. EVER Valinject GmbH/Kent Pharma UK Ltd. Revised August 2020.
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