Enhertu

Monotherapy in adults w/ unresectable or metastatic HER2 +ve breast cancer who have received ≥1 prior anti-HER2-based regimens; unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in metastatic setting or developed disease recurrence during or w/in 6 mth of completing adjuvant chemotherapy; advanced NSCLC whose tumours have activating HER2 (ERBB2) mutation & who require systemic therapy following platinum-based chemotherapy w/ or w/o immunotherapy; advanced HER2 +ve gastric or gastroesophageal junction adenocarcinoma who have received prior trastuzumab-based regimen.

IV infusion Administer initial dose for 90 min. If prior infusion is well tolerated, administer subsequent doses as 30-min infusions. Breast cancer, NSCLC 5.4 mg/kg once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. Dose reduction: 1st: 4.4 mg/kg, 2nd: 3.2 mg/kg. Gastric cancer 6.4 mg/kg once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. Dose reduction: 1st: 5.4 mg/kg, 2nd: 4.4 mg/kg.

Hypersensitivity.

Not to be administered as IV push or bolus. Not to be substituted w/ trastuzumab or trastuzumab emtansine. Permanently discontinue in patients who are diagnosed w/ symptomatic (Grade 2 or greater) ILD/pneumonitis; if left ventricular ejection fraction (LVEF) of <40% or absolute decrease from baseline of >20% is confirmed & in patients w/ symptomatic CHF. Cases of ILD/pneumonitis; neutropenia including febrile neutropenia; decreased LVEF. Patients w/ total bilirubin >1.5 x ULN, irrespective of AST value. Immediately report cough, dyspnoea, fever &/or any new or worsening resp symptoms. Consider corticosteroid treatment for asymptomatic (Grade 1) ILD/pneumonitis. Promptly initiate corticosteroid treatment (eg, ≥1 mg/kg daily prednisolone or equiv) for symptomatic ILD/pneumonitis (Grade 2 or greater), & continue for at least 14 days followed by gradual taper for at least 4 wk. Monitor CBC prior to treatment initiation & each dose. Perform cardiac function testing [echocardiogram or multigated acquisition (MUGA) scanning] prior to treatment initiation & at regular intervals during treatment. May affect ability to drive & use machines. Moderate or severe renal & hepatic impairment. ESRD. May cause foetal harm when administered to pregnant woman. Verify pregnancy status of females of reproductive potential prior to treatment initiation. Females of reproductive potential & male w/ female partners of reproductive potential should use effective contraception during treatment & for at least 7 mth & 4 mth, respectively, after last dose. May impair male reproductive function & fertility. Male patients should seek counselling on sperm storage & not freeze or donate sperm throughout treatment period, & for at least 4 mth after the final dose. Not recommended during pregnancy. Women should not breastfeed during treatment or for 7 mth after the last dose. Childn & adolescents <18 yr. Elderly ≥75 yr.

URTI, pneumonia; anaemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia; hypokalaemia, decreased appetite; headache, dizziness, dysgeusia; ILD, dyspnoea, cough, epistaxis; nausea, vomiting, constipation, diarrhoea, abdominal pain, stomatitis, dyspepsia; increased transaminases; alopecia; musculoskeletal pain; fatigue, pyrexia, peripheral oedema; decreased wt & ejection fraction. Febrile neutropenia; dehydration; dry eye, blurred vision; abdominal distension, gastritis, flatulence; rash, pruritus, skin hyperpigmentation; increased blood alkaline phosphatase, bilirubin, & creatinine; infusion-related reactions.

Targeted Cancer Therapy

L01FD04 - trastuzumab deruxtecan ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.

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