View Caprelsa overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Take at about the same time each day. For patients w/ swallowing difficulties, disperse tab in ½ glass plain, non-carbonated drinking water & stir w/o crushing (approx 10 min) then, swallow immediately. No other liqd should be used. Mix residue w/ ½ glass water & drink. Mixt may also be administered via nasogastric or gastrostomy tubes.
Contraindications
Hypersensitivity. Congenital long QTc syndrome; QTc interval >480 msec. Concomitant use w/ medicinal products known to prolong QTc interval &/or induce Torsades de pointes (eg, arsenic, cisapride, erythromycin IV, toremifene, mizolastine, moxifloxacin, class IA & III antiarrhythmics). Lactation.
Risk of QTc prolongation & Torsades de Pointes; increased risk of Torsades de pointes in patients w/ electrolyte imbalance. Possible lower benefit in patients w/ -ve rearranged during transfection (RET) mutation status. RET mutation testing is recommended. Risk of posterior reversible encephalopathy syndrome; skin reactions eg, rash, photosensitivity & palmar-plantar erythrodysaesthesia syndrome; diarrhoea; heart failure; HTN, including hypertensive crisis; formation of aneurysms &/or artery dissections; ALT elevations; ILD. Use cautiously in patients w/ brain metastases, as intracranial haemorrhage has been reported. Obtain ECG, & levels of serum K, Ca & Mg & TSH at baseline, at 1, 3, 6 & 12 wk after starting treatment & every 3 mth for at least a yr thereafter. Additional monitoring of QTc, electrolytes & renal function in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance &/or impaired renal function. Not recommended w/ ondansetron. Avoid concomitant use w/ strong CYP3A4 inducers (eg, rifampicin, St. John's Wort, carbamazepine, phenobarb). Fatigue & blurred vision may affect ability to drive & use machines. Not recommended in patients w/ moderate or severe renal impairment; hepatic impairment (serum bilirubin >1.5 x ULN). Women of childbearing potential must use effective contraception during therapy & for at least 4 mth following the last dose. Potential for foetal abnormalities or loss of pregnancy. Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs risk to the foetus. Limited clinical data in elderly >75 yr. Not indicated for use in paed patients. Benefit in patients w/ calcitonin <500 pg/mL has not been determined.
Increased AUC(0-t) & Cmax of metformin (OCT2 substrate); digoxin (P-gp substrate). Clinical monitoring is recommended w/ other P-gp substrates (eg, dabigatran). Reduced exposure w/ rifampicin (potent CYP3A4 inducer). Combinations contraindicated: Cisapride, erythromycin IV, toremifene, mizolastine, moxifloxacin, arsenic, class IA & III antiarrhythmics. Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine & lumefantrine. Small additive effect on the prolongation of the QTc interval w/ ondansetron. Possible interaction w/ vit K antagonists.
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