Paraplatin Adverse Reactions

The following frequency definitions are used: "Very common" (≥1/10); "common" (≥1/100, <1/10); "uncommon" (≥1/1000, <1/100); "rare" (≥1/10,000, <1/1000); "very rare" (<1/10,000).
Infections and infestations: Common: Infectious complications (sometimes lethal).
Rare: Pneumonia.
Benign, malignant and unspecified neoplasms (including cysts and polyps): Secondary tumors have been reported in the context of treatments with cytostatic combinations, but the connection with carboplatin has not been clarified.
Blood and lymphatic system disorders: Very common: Anemia (71%), thrombopenia (25%), leukopenia (14%), neutropenia (18%).
Common: Haemorrhages (sometimes lethal).
Very rare: Febrile neutropenia, hemolytic-uremic syndrome, autoimmune hemolytic anemia.
Immune system disorders: Common: Allergic reactions such as exanthema, urticaria, erythema, fever without detectable cause, itching, anaphylactic reactions with bronchospasms and hypotension at the start of the treatment.
The risk of an allergic reaction (including anaphylaxis) is greater in patients who were previously treated with a platinum-containing substance.
Metabolism and nutrition disorders: Very common: Diminished serum levels of sodium (29%), potassium (20%), calcium (22%) and magnesium (29%). Combined chemotherapy did not lead to increased electrolyte losses. If necessary, electrolyte losses should be compensated.
Very rare: Tumor lysis syndrome.
Nervous system disorders: Common: Central nervous symptoms, peripheral neuropathy including paresthesias and weakness of the tendon reflexes, peripheral sensory disturbances such as visual disorders, impairment of taste.
The frequency of the neurological adverse effects seems to be increased in elderly patients (>65 years), during a combination therapy, in patients who have already received cisplatin or a long-term PARAPLATIN therapy, or during a long-lasting cumulative exposure.
Very rare: Posterior Reversible Encephalopathy Syndrome (PRES) in patients receiving carboplatin in combined chemotherapy (see Precautions).
Eye disorders: Very rare: Inflammation of the optic nerves with visual disorders including blindness in patients with renal insufficiency, who received doses higher than those recommended. Normalisation of sight or a significant improvement of the disorders occurred within weeks of the high doses being discontinued.
Ear and labyrinth disorders: Common: Ototoxicity. It initially affects higher frequencies (≥4 kHz); it can progress and involve speech frequencies (<4 kHz). In patients with hearing impairment due to cisplatin, a further deterioration of the hearing function can occur during treatment with carboplatin.
Cardiac disorders: Common: Cardiovascular disturbances.
Uncommon: Heart failure, thromboembolism, apoplexia, all of them sometimes lethal (correlation with carboplatin is not proven), high blood pressure.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea, increased cough, pulmonary toxicity.
Gastrointestinal disorders: Very common: Abdominal pain (17%), nausea (15%), vomiting (65%; Grade 3/4: 20%). In general, nausea and vomiting did not occur after the first day. There are, however, cases of delayed vomiting. Patients who had been previously treated with cisplatin exhibited severe gastrointestinal adverse effects.
Common: Diarrhoea, constipation, mucositis.
Very rare: Loss of appetite, stomatitis.
Hepatobiliary disorders: Very common: Increase of SGOT (15%) and alkaline phosphatase (24%).
Common: Increase of bilirubin. In general, these changes are not pronounced and are reversible in 50% of the patients.
Skin and subcutaneous tissue disorders: Common: Skin reactions/skin change, alopecia.
Musculoskeletal, connective tissue and bone disorders: Uncommon: Arthralgia, myalgia.
Renal and urinary disorders: Very common: Creatinine clearance decrease (55%).
Common: Increase of uric acid, urinary incontinence, dysuria, increased urinary frequency, nocturia.
General disorders and administration site disorders: Common: Asthenia.
Rare: Attacks of fever without signs of an infection or an allergic reaction, malaise, dehydration.
Reactions at the application site such as redness, swelling, and pain have been reported during post-marketing surveillance. Necrosis, cellulitis, burning sensation, and rash associated with extravasation have also been reported.