Truqap

In combination w/ fulvestrant for adults w/ hormone receptor +ve, human epidermal growth factor receptor 2 -ve locally advanced or metastatic breast cancer w/ ≥1 PIK3CA/AKT1/PTEN-alteration following recurrence or progression on or after an endocrine-based regimen.

Recommended dose: 400 mg bd (approx 12 hr apart) for 4 days followed by 3 days off treatment in combination w/ fulvestrant 500 mg on days 1, 15, 29 & once mthly thereafter. Continue until disease progression or unacceptable toxicity occurs. Concomitant use w/ moderate/strong CYP3A4 inhibitors 320 mg bd for 4 days followed by 3 days off.

May be taken with or without food. Swallow whole w/ water; do not chew/crush/dissolve/divide. Not to be ingested if it is broken, cracked, or otherwise not intact.

Hypersensitivity.

Possible severe hyperglycaemia associated w/ diabetic ketoacidosis (DKA) & ketoacidosis. Higher risk of hyperglycemia progressing to DKA in a setting of additional co-morbidities & treatments (eg, dehydration, malnourishment, concurrent chemotherapy/steroids, sepsis). Immediately interrupt treatment in patients where DKA is suspected & permanently discontinue use if DKA is confirmed. Test for fasting blood glucose levels & HbA1c prior to start treatment. More frequent blood glucose monitoring is recommended in patients who develop hyperglycaemia during treatment, those w/ baseline DKA risk factors (including but not exclusive to DM, pre-diabetes, those receiving regular oral steroids) & in those who develop DKA risk factors during treatment (eg, infection, sepsis, raised HbA1c). Monitor ketones (preferably in blood) & other metabolic parameters when patient experiences hyperglycaemia. Patients w/ types 1 & 2 diabetes requiring insulin. Closely monitor patients w/ history of DM who may require intensified diabetic treatment. Possible severe diarrhoea associated w/ dehydration. Advise patients to start anti-diarrheal treatment at 1st sign of diarrhoea, increase oral fluids if diarrhoea symptoms occur while taking Truqap. Maintain normovolaemia & electrolyte balance in patients w/ diarrhoea to avoid complications related to hypovolaemia & low electrolyte levels. Possible severe cutaneous AR including erythema multiforme, palmar-plantar erythrodysesthesia & DRESS; rash (including erythema; erythematous, macular, maculo-papular, papular & pruritic rash). Monitor for signs & symptoms of rash or dermatitis & interrupt, reduce or permanently discontinue use based on severity of skin drug reactions; consult w/ a dermatologist to ensure greater diagnostic accuracy & appropriate management. Possible fatigue; observe caution when driving or operating machinery. Closely monitor patients w/ moderate hepatic impairment for signs of toxicity. Not recommended for patients w/ severe renal & hepatic impairment. Advise women of childbearing potential to avoid pregnancy while receiving Truqap; perform pregnancy test prior to initiating treatment & verify as -ve prior to initiating treatment & consider re-testing throughout treatment. Advise patients to use effective contraception during treatment w/ Truqap & at least 4 wk for females & 16 wk for males after treatment completion. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding during treatment. Not indicated for paed patients. Elderly ≥75 yr.

Diarrhoea, rash, nausea, fatigue & vomiting. Hyperglycaemia, anaemia & stomatitis.

Increased conc w/ strong CYP3A4 inhibitors (eg, boceprevir, ceritinib, clarithromycin, cobicistat, conivaptan, ensitrelvir, idelalisib, indinavir, itraconazole, josamycin, ketoconazole, lonafarnib, mibefradil, mifepristone, nefazodone, nelfinavir, posaconazole, ribociclib, saquinavir, ritonavir, telaprevir, telithromycin, troleandomycin, tucatinib, voriconazole). Avoid high dose intake of grapefruit. Increased exposure & AR risk w/ moderate CYP3A4 inhibitors. Decreased conc w/ strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampicin, St. John's wort); moderate CYP3A4 inducers (eg, bosentan, cenobamate, dabrafenib, elagolix, etravirine, lersivirine, lesinurad, lopinavir, lorlatinib, metamizole, mitapivat, modafinil, nafcillin, pexidartinib, phenobarb, rifabutin, semagacestat, sotorasib, talviraline, telotristat ethyl, thioridazine). Increased toxicity of CYP3A substrates (eg, carbamazepine, cyclosporine, fentanyl, pimozide, simvastatin, tacrolimus); hepatic transporters (OATP1B1, OATP1B3) eg, simvastatin; renal transporters (MATE1, MATE2K, OCT2) eg, dofetilide, procainamide.

Targeted Cancer Therapy

L01EX27 - capivasertib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

POM