Paclitaxel

Registered South African indications:

• Ovarian cancer
• Breast cancer
• Lung cancer

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Baseline neutrophils < 1.5 x 10⁹/l (< 1 x 10⁹/l for Kaposi Sarcoma (KS) patients)
• Baseline platelets < 100 x 10⁹/l (< 75 x 10⁹/l for KS patients)
• Concurrent, serious, uncontrolled infections (KS patients)

Cautions

• Mild to moderate hepatic impairment
• Elderly
• Administer under the supervision of a physician experienced in the use of chemotherapeutic agents
• Avoid intra-arterial administration ₂
• Combined with radiotherapy
• Alcoholism
• Febrile neutropenia
• Coadministration with erlotinib

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

• Kaposi's sarcoma
• Ovarian cancer -  stage I-III
• Palliative treatment of metastatic ovarian cancer
• Adjuvant therapy in breast cancer
• Metastatic breast cancer
• Palliative treatment of metastatic non-small cell lung cancer 

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Consult specialist for dosages and regimens

Not established for use in children

Pregnancy

• Contraindicated
• There are very limited data on the use of paclitaxel in human pregnancy
• Paclitaxel is suspected to cause serious birth defects when administered during pregnancy. Studies in animals have shown reproductive toxicity
• Women of childbearing potential should have a pregnancy test prior to starting treatment with paclitaxel
• Paclitaxel should not be used in pregnancy, and in women of childbearing potential not using effective contraception unless the clinical condition of the mother requires treatment with paclitaxel
• Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with paclitaxel. Male patients treated with paclitaxel are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment

Breastfeeding

• Contraindicated
• Because of the potential serious adverse reactions in breast-feeding infants, paclitaxel is contraindicated during lactation
• Breastfeeding must be discontinued for the duration of therapy
• Paclitaxel and/or its metabolites were excreted into the milk of lactating rats. It is not known if paclitaxel is excreted in human milk

Fertility

• Paclitaxel induced infertility in male rats
• Based on findings in animals, male and female fertility may be compromised
• Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with paclitaxel

Renal Impairment

• eGFR ≥30- 69 mL/min: No dose adjustment  recommended
• eGFR ≤29 mL/min: Monitor renal function closely. Dose reduction by 20% can be adopted

Hepatic Impairment

• Mild (Child-Pugh Class A): No dose adjustment recommended
• Moderate (Child-Pugh Class B): Dose adjustment recommended.
  Reduce the recommended posology dose by 20%. The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles
• Severe (Child-Pugh Class C): Contraindicated

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably porphyrinogenic (PRP)

Central Nervous System Disorders

• Neurotoxicity
• Motor neuropathy 
• Autonomic neuropathy
• Grand mal seizures
• Convulsions
• Encephalopathy
• Dizziness
• Headache
• Ataxia
• Asthenia

Cardiovascular Disorders

• Bradycardia
• Cardiomyopathy
• Asymptomatic ventricular tachycardia
• Tachycardia with bigeminy
• Atrioventricular block 
• Syncope
• Myocardial infarction
• Cardiac failure
• Atrial fibrillation
• Supraventricular tachycardia
• Hypotension
• Hypertension
• Thrombosis
• Thrombophlebitis
• Shock
• Phlebitis

Respiratory Disorders

• Dyspnoea
• Pleural effusion
• Interstitial pneumonia
• Lung fibrosis
• Pulmonary embolism
• Respiratory failure
• Cough
• Upper respiratory tract infections
• Pneumonia

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Bowel obstruction
• Bowel perforation
• Ischaemic colitis
• Pancreatitis
• Mesenteric thrombosis
• Neutropenic colitis
• Oesophagitis
• Constipation
• Ascites
• Pseudomembranous colitis

Hepatobiliary Disorders

• Hepatic necrosis
• Hepatic encephalopathy 

Genitourinary Disorders

• Urinary tract infection

Endocrine and Metabolic Disorders

• Dehydration
• Anorexia
• Tumour lysis syndrome
• Psychiatric disorders
• Confusional state

Musculoskeletal Disorders

• Arthralgia
• Myalgia
• Systemic lupus erythematosus
• Scleroderma

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Transient and mild nail and skin changes
• Pruritus
• Rash
• Erythema
• Stevens-Johnson syndrome
• Epidermal necrolysis
• Erythema multiforme
• Exfoliative dermatitis
• Injection site reactions
• Urticaria
• Onycholysis 

Immune, Blood and Lymphatic System Disorders

• Myelosuppression
• Neutropenia
• Anaemia
• Thrombocytopenia
• Leucopenia
• Bleeding
• Febrile neutropenia
• Acute myeloid leukaemia
• Myelodysplastic syndrome
• Disseminated intravascular coagulation 
• Minor hypersensitivity reactions
• Significant hypersensitivity reactions 
• Anaphylactic reactions
• Anaphylactic shock
• Bronchospasm
• Septic shock
• Peritonitis
• Sepsis

Sensory Disorders

• Optic nerve
• Visual disturbances 
• Macular oedema
• Photopsia
• Vitreous floaters
• Ototoxicity
• Hearing loss
• Tinnitus
• Vertigo

Others

• Mucosal inflammation
• Pyrexia
• Oedema

• Cisplatin
• Doxorubicin
• CYP2C8 inhibitors
• CYP2C8  inducers
• CYP3A4 inhibitors
• CYP3A4 inducers
• Protease inhibitors

• Full blood count

Specific cases may require

• Cardiac function
• Vital signs
• Hepatic function

• Paclitaxel should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents
• Paclitaxel products should not be substituted for or with other paclitaxel formulations

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Injection 100mg, Injection 30mg/5ml - EML (Tertiary)

Paclitaxel interferes with the normal function of microtubule growth. It binds to the beta-subunit of tubulin. Tubulin is the "building block" of mictotubules, and the binding of paclitaxel locks these building blocks in place. The resulting microtubule/paclitaxel complex does not have the ability to disassemble affecting vital interphase and mitotic cellular functions.

Injection (per ml) 6mg

• Anzatax (Pharmaplan)
• Biolyse paclitaxel (Key Oncologics)

Injection (per 5ml) 30mg

• Accord paclitaxel (Accord)
• Aspen paclitaxel (Pharmacare)
• Cipla paclitaxel (Cipla)
• Ebetaxel (Adcock)
• Mylan paclitaxel (Xixia)
• Paxitas (Accord)
• PCH-Paclitaxel (Pharmachemie)
• Sandoz Paclitaxel (Sandoz)
• Taxol (Bristol-Myer) originator
• Teva-Paclitaxel (Teva)

Injection (per 16.7ml) 100mg

• Accord paclitaxel (Accord)
• Aspen paclitaxel (Pharmacare)
• Cipla paclitaxel(Cipla)
• Ebetaxel (Adcock)
• Genexol (Pharmacorp)
• Mylan paclitaxel (Xixia)
• Paxitas (Accord)
• PCH-Paclitaxel (Pharmachemie)
• Sandoz Paclitaxel (Sandoz)
• Teva-Paclitaxel (Teva)

Injection (per 25ml) 150mg

• Ebetaxel (Adcock)

Injection (per 50ml) 300mg

• Accord paclitaxel (Accord)
• Aspen piclitaxel (Pharmacare)
• Cipla paclitaxel (Cipla)
• Ebetaxel (Adcock)
• Mylan paclitaxel (Xixia)
• Paxitas (Accord)
• PCH-Paclitaxel (Pharmachemie)
• Sandoz Paclitaxel (Sandoz)
• Taxol (Bristol-Myer Squibb) originator
• Teva-Paclitaxel (Teva)