Enhertu

Trastuzumab deruxtecan

Unresectable or metastatic HER2 +ve breast cancer in adult patients who have received prior anti-HER2-based regimen. Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer in adult patients who have received at least 1 prior line of chemotherapy in the metastatic setting or developed disease recurrence during or w/in 6 mth of completing adjuvant chemotherapy. Patient w/ HR+ breast cancer should have received at least 1; no longer considered eligible for endocrine therapy. Locally advanced or metastatic HER2 +ve gastric or gastroesophageal junction adenocarcinoma in adult patients who have received ≥2 prior regimens including a trastuzumab-based regimen.

IV Initial dose: 90-min infusion. Subsequent doses: May be administered as 30-min infusions. Premed: Combination regimen of 2 or 3 medicinal products (eg, dexamethasone w/ 5-HT₃ receptor antagonist &/or NK₁ receptor antagonist) prior to each dose. Metastatic breast cancer Recommended dose: 5.4 mg/kg once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. Locally advanced or metastatic gastric cancer Recommended dose: 6.4 mg/kg once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity.

Hypersensitivity.

Not to be administered as IV push or bolus. Not to be substituted for or w/ trastuzumab or trastuzumab emtansine. Slow or interrupt infusion rate if patient develops infusion-related symptoms. Permanently discontinue use in case of severe infusion reactions. Monitor for signs & symptoms of ILD/pneumonitis; cough, dyspnea, fever &/or any new or worsening resp symptoms. Evaluate patients w/ suspected ILD/pneumonitis by radiographic imaging. Consider corticosteroid treatment (eg, ≥0.5 mg/kg daily prednisolone or equiv) for asymptomatic ILD/pneumonitis (Grade 1). Promptly initiate systemic corticosteroid treatment (eg, ≥1 mg/kg daily prednisolone or equiv) & continue for at least 14 days followed by gradual taper for at least 4 wk for symptomatic ILD/pneumonitis (Grade ≥2). Permanently discontinue in patients diagnosed w/ symptomatic ILD/pneumonitis (Grade ≥2). Possible cases of neutropenia including febrile neutropenia; monitor CBC prior to initiation of treatment & each dose, & as clinically indicated. Assess left ventricular ejection fraction (LVEF) prior to initiation & at regular intervals during treatment as clinically indicated. Permanently discontinue if LVEF is <40% or absolute >20% decrease from baseline is confirmed & in patients w/ symptomatic CHF. Carefully monitor patients w/ history of ILD/pneumonitis or w/ moderate or severe renal impairment. Moderate & severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 7 mth following the last dose. Men w/ female partners of childbearing potential should use effective contraception during treatment & for at least 4 mth following the last dose. Not recommended to be administered to pregnant women; closely monitor if a woman becomes pregnant during treatment w/in 7 mth following last dose. Discontinue breastfeeding prior to initiating treatment; may begin breastfeeding 7 mth after concluding treatment. Childn & adolescents <18 yr.

Neutropenia, anemia, leukopenia, thrombocytopenia; nausea, vomiting, diarrhea, abdominal pain, constipation, stomatitis; fatigue; decreased appetite; alopecia. Febrile neutropenia. Metastatic HER2 +ve breast cancer: Lymphopenia; dry eye; dyspepsia; URTI; increased ALT & AST; hypokalemia; headache, dizziness; ILD, dyspnea, cough, epistaxis; rash. Infusion-related reactions. Metastatic HER2-low breast cancer: Pyrexia; increased transaminase; URTI; decreased wt; hypokalemia; musculoskeletal pain; headache; ILD, epistaxis, dyspnea; rash. Lymphopenia; blurred vision; abdominal distension, gastritis, flatulence; increased blood alkaline phosphatase, bilirubin & creatinine; dehydration; dysgeusia; cough; pruritus, skin hyperpigmentation. Locally advanced or metastatic gastric cancer: Lymphopenia; pyrexia, peripheral edema. Abnormal hepatic function; pneumonia, URTI; infusion-related reactions; increased blood alkaline phosphatase, bilirubin, AST & ALT; hypokalemia, dehydration; ILD, cough, epistaxis; pruritis, rash.

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.

POM