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Alectinib/antihyperlipidaemics/pirfenidone Various toxicities: 8 case reports

In a review of case series by Uppsala Monitoring Centre, involving cases from Vigibase (submitted from six countries), 8 patients (6 men and 2 women) with 6 patients aged 49–64 years [not all ages stated] were described, who developed rhabdomyolysis and various associated toxicities following treatment with alectinib (n=5); alectinib and rosuvastatin, (n=1); alectinib, rosuvastatin and simvastatin (n=1) and alectinib and pirfenidone (n=1) [not all dosages, routes, times to reactions onsets and outcomes of ADRs stated]. Patient 1: A 57-year-old man [Roche ID 1492032], who had been diagnosed with non-small-cell lung carcinoma (NSCLC), started receiving oral alectinib 600mg twice daily on 30 October [year not stated]. Concomitant medications included pantoprazole and levetiracetam. On 13 November [year not stated] i.e. after 14 days of alectinib therapy, he showed elevated CPK level (1615 U/L) and developed rhabdomyolysis. He also had muscle pain. Therapy with alectinib was discontinued on the same day. The rhabdomyolysis resolved in 5 days (CPK was 705 U/L). After two days, he re-initiated alectinib at a reduced dose of 450 mg twice daily and CPK was noted as 380 U/L. Patient 2: A 53-year-old man [Roche ID 1596813], who had been diagnosed with NSCLC, started receiving alectinib. After 14 days of alectinib therapy, he showed elevated CPK level and developed rhabdomyolysis. Therapy with alectinib was discontinued, which led to resolution of rhabdomyolysis. Thereafter, he re-initiated alectinib at an unknown reduced dose and again showed elevated CPK level and developed rhabdomyolysis. Patient 3: A 64-year-old woman [Roche ID 1603916], who had been diagnosed with NSCLC, started receiving alectinib at a daily dose of 1200 mg. Concomitant medications included enoxaparin sodium [enoxaparin], dexamethasone, nadroparin calcium [nadroparin], mirtazapine, pantoprazole, zopiclone, naloxone, oxycodone, torasemide and calcium carbonate plus colecalciferol. After 12 days of alectinib therapy, she showed increased CPK level and was diagnosed with rhabdomyolysis. She also developed decreased appetite, pyrexia, gastritis, nausea, arthralgia, pelvic pain, large intestine perforation, peritonitis, pyelonephritis, sepsis, transaminases increased, pelvic haematoma, general physical health deterioration, retroperitoneal haematoma, retroperitoneal haemorrhage and diverticulitis. She also showed concurrent impaired medical condition including brain metastasis and cachexia. Her rhabdomyolysis recovered with some sequelae. She was re-challenged with alectinib, but at a reduced dose of 450mg twice daily and 300mg twice daily. Patient 4: A 49-year-old man [Roche ID 2175246], who had been diagnosed with NSCLC, started receiving oral alectinib at a dose of 600mg twice daily from 28 June [year not stated]. Concomitant medication included dexamethasone. After 13 days of alectinib therapy, he showed elevated CPK level and developed rhabdomyolysis along with symptoms