NEW
Enhertu

Enhertu

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Trastuzumab deruxtecan
Indications/Uses
Unresectable or metastatic HER2 +ve breast cancer in adult patients who have received ≥2 prior anti-HER2-based regimens in the metastatic setting. 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.
Dosage/Direction for Use
IV Initial dose: 90-min infusion. Subsequent dose: May be administered as 30-min infusion. May administer antiemetics as per patient tolerance for prophylaxis or management. 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.
Contraindications
Special Precautions
Not to be substituted for or w/ trastuzumab or trastuzumab emtansine. Slow or interrupt infusion rate if patient develops infusion-related symptoms. Permanently discontinued 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 (Grade 1) ILD/pneumonitis. 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 (Grade ≥2) ILD/pneumonitis. Increased risk in patients w/ a history of ILD/pneumonitis. Monitor CBC prior to initiation & to 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. Moderate & severe hepatic impairment. Not recommended to pregnant women due to potential fetal risks. Women of childbearing potential should use effective contraception during treatment & for at least 7 mth following the last dose. May impair male reproductive function & fertility. Men w/ female partners of childbearing potential should use effective contraception during treatment & for at least 4 mth following the last dose. Discontinue breastfeeding prior to initiating treatment; may begin breastfeeding 7 mth after concluding treatment. Childn & adolescents <18 yr.
Adverse Reactions
Neutropenia, anemia, leukopenia, lymphopenia, thrombocytopenia; nausea, vomiting, diarrhea, stomatitis, abdominal pain, constipation; fatigue; decreased appetite; alopecia. URTI; increased ALT & AST; hypokalemia; ILD, cough, epistaxis; rash. Febrile neutropenia; infusion-related reactions. Metastatic breast cancer: Dry eye; dyspepsia; headache, dizziness; dyspnea. Locally advanced or metastatic gastric cancer: Pyrexia, peripheral edema. Abnormal hepatic function; pneumonia; increased blood alkaline phosphatase & bilirubin; dehydration; pruritus.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD04 - trastuzumab deruxtecan ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Enhertu powd for conc for soln for infusion 100 mg
Packing/Price
1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in