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Enhertu

Enhertu

trastuzumab deruxtecan

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Trastuzumab deruxtecan
Indications/Uses
Unresectable or metastatic HER2 +ve breast cancer in adults who have received prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting & have developed disease recurrence during or w/in 6 mth of completing therapy. Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer in adults who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or w/in 6 mth of completing adjuvant chemotherapy.
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Dosage/Direction for Use
Administer initial dose as 90-min IV infusion & subsequent doses as 30-min infusions if well tolerated. 5.4 mg/kg given as IV infusion once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity.
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Overdosage
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Contraindications
Hypersensitivity.
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Special Precautions
Not to be administered as IV push or bolus. Permanently discontinue use in patients diagnosed w/ symptomatic (≥grade 2) ILD/pneumonitis; CHF. Monitor CBC prior to initiation, prior to each dose & as clinically indicated. Perform standard cardiac function testing (echocardiogram or multigated acquisition scanning) to assess left ventricular ejection fraction prior to initiation & at regular intervals during treatment. May affect ability to drive & use machines. Severe renal impairment or ESRD; moderate & severe hepatic impairment. May impair male fertility. Women of childbearing potential should use effective contraception during & for at least 7 mth after last dose. Male partners should not donate sperm & use effective contraception during & for at least 4 mth after last dose. Not recommended during pregnancy. Not to be used during lactation. Childn & adolescents <18 yr. Elderly ≥75 yr.
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Adverse Reactions
URTI; anaemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia; hypokalaemia, decreased appetite; headache, dizziness; ILD, dyspnoea, cough, epistaxis; nausea, vomiting, constipation, diarrhoea, abdominal pain, stomatitis, dyspepsia; increased transaminases; alopecia; musculoskeletal pain; fatigue, pyrexia; decreased ejection fraction & wt. Pneumonia; dehydration; dysgeusia; dry eye, blurred vision; abdominal distension, gastritis, flatulence; rash, pruritus, skin hyperpigmentation; peripheral oedema; increased blood alkaline phosphatase, bilirubin & creatinine; infusion-related reactions.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Enhertu detailed prescribing information
Storage
View Enhertu storage conditions for details to ensure optimal shelf-life.
Description
View Enhertu description for details of the chemical structure and excipients (inactive components).
Action
View Enhertu mechanism of action for pharmacodynamics and pharmacokinetics details.
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 infusion (vial) 100 mg
Packing/Price
1's
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