Scemblix

Newly diagnosed or c-abl tyrosine kinase inhibitor-pretreated Philadelphia chromosome +ve chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) in adults. Ph+ CML-CP harbouring a T315I mutation in adults.

Ph+ CML-CP 80 mg once daily at approx the same time each day or 40 mg bd at approx 12-hr intervals. Ph+ CML-CP harbouring a T315I mutation 200 mg bd at approx 12-hr intervals.

Should be taken on an empty stomach: Swallow whole w/ water. Do not break/crush/chew. Avoid intake of food for at least 2 hr before & 1 hr after taking Scemblix.

Hypersensitivity.

Risk of thrombocytopenia, neutropenia & anaemia; pancreatitis; asymptomatic elevations of serum lipase & amylase; ECG QT prolongation; HTN; hypersensitivity; HBV reactivation in chronic HBV carriers. Monitor for signs & symptoms of myelosuppression; pancreatic toxicity; hypersensitivity. Perform more frequent monitoring in patients w/ history of pancreatitis. Monitor HTN & manage w/ standard antihypertensive therapy during Scemblix treatment as clinically indicated. Perform CBC every 2 wk in the 1st 3 mth of treatment & then mthly thereafter or as clinically indicated. Assess serum lipase & amylase levels mthly during treatment or as clinically indicated. Perform ECG prior to start of treatment & monitor during treatment as clinically indicated. Correct hypokalaemia & hypomagnesaemia prior to treatment & monitor during treatment as clinically indicated. Caution when co-administering Scemblix at a total daily dose of 80 mg w/ medicinal products w/ known risk of torsades de pointes. Avoid co-administration of Scemblix 200 mg bd w/ medicinal products w/ known risk of torsades de pointes. Test for HBV infection before start of Scemblix treatment. HBV carriers who require Scemblix treatment should be closely monitored for signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Patients w/ severe or uncontrolled medical conditions, including any bleeding disorders, w/ history of or risk factors for pancreatitis, or w/ clinically significant cardiac impairment or cardiac repolarisation abnormalities were excluded from clinical studies for asciminib. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients experiencing adverse effects w/ potential impact on the ability to drive or use machines should refrain from these activities as long as adverse effects persist. Caution in patients w/ severe hepatic or severe renal impairment receiving Scemblix 200 mg bd. Can cause foetal harm when administered to a pregnant woman. Sexually active women of childbearing potential should use effective contraception during treatment & for at least 3 days after the last dose. Not recommended during pregnancy & in women of childbearing potential who do not use contraceptives. Breast-feeding is not recommended during treatment & for at least 3 days after the last dose. Safety & efficacy in patients <18 yr have not been established.

URTI, COVID-19; thrombocytopenia, neutropenia, anaemia; dyslipidaemia; headache, dizziness; HTN; cough; increased pancreatic enzymes, vomiting, diarrhoea, nausea, abdominal pain, constipation; increased hepatic enzymes; rash, pruritus; musculoskeletal pain, arthralgia; fatigue. Lower resp tract infection, flu; hypothyroidism; decreased appetite; blurred vision, dry eye; palpitations, atrial fibrillation; pleural effusion, dyspnoea, non-cardiac chest pain; pancreatitis; increased blood bilirubin; urticaria; oedema, pyrexia; increased blood creatine phosphokinase.

Increased plasma conc w/ strong CYP3A4 inhibitors (eg, clarithromycin, telithromycin, troleandomycin, itraconazole, ketoconazole, voriconazole, ritonavir, indinavir, nelfinavir, saquinavir). Decreased plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort). Increased plasma conc of CYP3A4 substrates w/ narrow therapeutic index (eg, midazolam, fentanyl, alfentanil, dihydroergotamine, ergotamine); CYP2C9 substrates (eg, warfarin); BCRP substrates (eg, sulfasalazine, MTX, rosuvastatin); P-gp substrates w/ narrow therapeutic index (eg, digoxin, dabigatran, colchicine). Decreased bioavailability w/ food. Altered exposure w/ medicinal products that inhibit or induce multiple metabolic pathways.

Targeted Cancer Therapy

L01EA06 - asciminib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.

P₁S₁S₃