Cisplatin

Registered South African indications:

• Cancer
• Lymphoma

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Renal impairment
• Dehydration
• Myelosuppression
• Hearing impairment  
• Neuropathy caused by cisplatin
• The use of live vaccines
• Pre-existing neurological conditions
• Coadministration of phenytoin in prophylactic use
• Concurrent administration of yellow fever vaccine

Cautions 

• Hepatic impairment
• Elderly
• All aluminium containing IV sets, needles, catheters and syringes
• Hyperuricaemia
• Hyperalbuminaemia
• Peripheral neuropathy not caused by cisplatin
• Prior simultaneous cranial irradiation
• Acute bacterial or viral infections
• Patients with hearing problems
• Injection site reactions

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

Used for the treatment of

• Non-seminomatous testicular cancer
• Ovarian cancer
• Bladder cancer
• Head and neck cancers
• Endometrial cancer
• Small cell carcinoma of the lung
• Lymphomas

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Consult specialist for dosages and regimens

Paed. forms avail. in SA and covered in this monograph: inj

Used for the treatment of

• Germ cell tumours
• Hepatoblastoma
• Medullablastoma
• Neuroblastoma
• Osteosarcoma

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Consult specialist for dosages and regimens

Pregnancy 

• Contraindicated
• Cisplatin may be toxic to the foetus when administered to a pregnant woman
• Cisplatin should not be used during pregnancy unless the clinician considers the risk in an individual patient to be clinically justified
• During treatment with Cisplatin and for a minimum of the following 6 months, appropriate measures must be taken to avoid pregancy; this applies to patients of both sexes

Breastfeeding 

• Contraindicated 
• Cisplatin is excreted in breast milk. Patients treated with cisplatin must not breasfeed

Fertility 

• Male and female patients have to use effective contraception during and for at least 6 months after treatment with cisplatin
• Genetic consultation is recommended if the patient wishes to have children after ending treatment
• Since treatment with cisplatin may cause irreversible infertility, it is recommended that men who wish to become fathers in the future, ask for advice regarding cryoconservation of their sperm prior to treatment

Renal Impairment 

• Contraindicated

Hepatic Impairment 

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Central Nervous System Disorders

• Cerebrovascular accident
• Haemorrhagic stroke
• Ischaemic stroke ageusia
• Cerebral arteritis
• Lhermitte's sign
• Myelopathy
• Autonomic neuropathy
• Convulsion
• Asthenia
• Malaise
• Neuropathy peripheral
• Leukoencephalopathy
• Reversible posterior leukoencephalopathy syndrome

Cardiovascular Disorders

• Cardiac disorder
• Arrhythmia
• Bradycardia
• Tachycardia
• Myocardial infarction
• Cardiac arrest
• Thrombotic microangiopathy
• Raynaud's phenomenona
• Phlebitis at injection site

Respiratory Disorders

• Dyspnoea
• Pneumonia
• Respiratory failure
• Pulmonary embolism

Gastrointestinal Disorders

• Vomiting and nausea
• Anorexia
• Hiccups
• Diarrhoea
• Metallic setting on the gums
• Stomatitis

Hepatobiliary Disorders

• Increased hepatic enzymes
• Increased bilirubin
• Reduced blood albumin levels

Genitourinary Disorders

• Renal failure
• Renal tubular disorder
• Hyperuricaemia 

Endocrine and Metabolic Disorders

• Increased serum amylase
• Inappropriate antidiurectic hormone secretion
• Dehydration
• Hypokalaemia
• Hypophosphataemia
• Hypocalcaemia
• Tetany
• Muscle spasms
• Hypercholesterolemia
• Increased blood amylase
• Hypomagnesaemia
• Increased blood iron
• Hyponatraemia
• Abnormal spermatogenesis and ovulation
• Painful gynaecomastia

Musculoskeletal Disorders

• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Rash
• Alopecia
• Injection site extravasation

Immune, Blood and Lymphatic System Disorders

• Infection
• Sepsis
• Bone marrow failure
• Thrombocytopenia
• Leukopenia
• Anaemia
• Coombs positive haemolytic anaemia
• Acute leukaemia
• Anaphylactic reaction 
• Hypersensitivity

Sensory Disorders

• Vision blurred
• Colour blindness 
• Cortical blindness
• Optic neuritis
• Papilloedema
• Retinal pigmentation

Ear and labyrinth disorders

• Ototoxicity
• Tinnitus
• Deafness
• Inability to conduct a normal conversation

Others

• Pyrexia

• Phenytoin
• Furosemide
• Hydralazine
• Diazoxide
• Propranolol
• Nephrotoxic agents
• Ototoxic agents
• Methotrexate
• Bleomycin
• Vinblastin
• Ifosfamide
• Etoposide
• Allopurinol
• Colchicine
• Probenecid
• Sulfinpyrazone
• Docetaxel
• Penicillamine
• Ciclosporin  
• Live vaccines
• Yellow fever vaccine
• Oral anticoagulants
• Antihistamines
• Phenothiazines
• Buclizine
• Cyclizine
• Loxapine
• Meclozine
• Phenothiazines
• Thioxanthenes
• Trimethobenzamides
• Altretamine
• Pyridoxine/altretamine combination
• Paclitaxel

• Renal function 
• Hepatic function 
• Full blood count 
• Electrolytes 
• Urine output 
• Audiography
• Neurologic examination

Hydration 

Adequate hydration must be maintained from 2 to 12 hours prior to administration until a minimum of 6 hours after the administration of cisplatin. Hydration is necessary to cause sufficient diuresis during and after treatment with cisplatin. It is realised by intravenous infusion of one of the following solutions:

• sodium chloride solution 0.9%; or
• mixture of sodium chloride solution 0.9% and glucose solution 5% (1:1)

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Injection 50mg/vial - EML (Tertiary)

Cisplatin is a platinum co-ordination compound with antitumour properties. It inhibits DNA-synthesis by the formation of DNA cross- links. It also inhibits protein and RNA synthesis, but to a lesser extent. The most important mechanism of action seems to be inhibition of DNA synthesis, although other mechanisms can also contribute to the antineoplastic activity of cisplatin, including the increase of tumour immunogenicity.  The oncolytic properties of cisplatin are comparable to the alkylating agents. Cisplatin also has immunosuppressive, radiosensitising, and antibacterial properties and seems to be cell-cycle non-specific. The cytotoxic action of cisplatin is caused by binding to all DNA-bases, with a preference for the N-7 position of guanine and adenosine.

Injection (per 10ml) 10mg

• Abiplatin (Pharmachemie)
• Cisacor (Accord)
• Plastosin Rtu (Pharmachemie)
• P&U cisplatin CSV (Pfizer)

Injection (per 20ml) 10mg

• Platosin Rtu (Pharmachemie)

Injection (per 50ml) 50mg

• Abiplatin (Pharmachemie)
• Cisacor (Accord)
• Plastosin (Pharmachemie)
• P&U cisplatin CSV (Pfizer)

Injection (per 100ml) 50mg

• Platosin rtu (Pharmachemie)