Herceptin SC

Herceptin SC

trastuzumab

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Trastuzumab
Indications/Uses
Human epidermal growth factor receptor 2 protein (HER2) +ve metastatic breast cancer (MBC) as monotherapy for patients who have received at least 2 chemotherapy regimens, prior chemotherapy must include at least an anthracycline & taxane unless unsuitable; in combination w/ paclitaxel for patients who have not received chemotherapy & for whom an anthracycline is not suitable; in combination w/ docetaxel for patients who have not received chemotherapy; in combination w/ aromatase inhibitor for postmenopausal patients w/ hormone-receptor +ve MBC not previously treated w/ trastuzumab. HER2 +ve early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) & RT (if applicable); following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide, in combination w/ paclitaxel or docetaxel; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Use only in patients w/ MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification.
Dosage/Direction for Use
Contraindications
Hypersensitivity to trastuzumab, murine proteins, hyaluronidase. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary O2 therapy.
Special Precautions
Increased risk for developing CHF or asymptomatic cardiac dysfunction. Perform cardiac assessments at baseline, every 3 mth during treatment & every 6 mth following discontinuation until 24 mth from last administration. Do not give concurrently w/ anthracyclines in the MBC setting & EBC adjuvant treatment setting. Not recommended in patients w/ history of MI, angina pectoris, history or existing CHF, left ventricular ejection fraction <55%, other cardiomyopathy, cardiac arrhythmia, clinically significant cardiac valvular disease, poorly controlled HTN, hemodynamic effective pericardial effusion. Concurrent use w/ anthracyclines only in chemotherapy-naive patients & only w/ low-dose anthracycline regimens in patients w/ EBC eligible for neoadjuvant-adjuvant treatment. Administration-related reactions; use premed to reduce risk of occurrence. Reports of pulmonary events; ILD including lung infiltrates, acute resp distress syndrome, pneumonia, pneumonitis, pleural effusion, resp distress & insufficiency, acute pulmonary oedema. Minor influence on the ability to drive or use machines; dizziness & somnolence may occur. Advise women of childbearing potential to use effective contraception during treatment & for 7 mth after treatment conclusion. Pregnancy. Do not breastfeed during therapy & for 7 mth after last dose. No relevant use in paed population.
Adverse Reactions
Infection, nasopharyngitis; febrile neutropenia, anaemia, neutropenia, leukopenia, thrombocytopenia; wt loss, anorexia; insomnia; tremor, dizziness, headache, paraesthesia, dysgeusia; conjunctivitis, increased lacrimation; decreased/increased BP, irregular heartbeat, cardiac flutter, decreased ejection fraction; hot flush; dyspnoea, cough, epistaxis, rhinorrhoea; diarrhoea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis; erythema, rash, swelling face, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome; arthralgia, muscle tightness, myalgia; asthenia, chest pain, chills, fatigue, flu-like symptoms, infusion-related reaction, pain, pyrexia, mucosal inflammation, peripheral oedema. Neutropenic sepsis, cystitis, flu, sinusitis, skin infection, rhinitis, URTI, UTI, pharyngitis; hypersensitivity; anxiety, depression; peripheral neuropathy, hypertonia, somnolence; dry eye; cardiac failure, supraventricular tachyarrhythmia, cardiomyopathy, palpitation; hypotension, vasodilatation; pneumonia, asthma, lung disorder, pleural effusion; haemorrhoids, dry mouth; hepatocellular injury, hepatitis, liver tenderness; acne, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, pruritus, onychoclasis, dermatitis; arthritis, back, bone & neck pain, muscle spasms, pain in extremity; renal disorder; mastitis; malaise, oedema; contusion.
Drug Interactions
May elevate overall exposure of doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone). Higher conc & longer t½ of capecitabine.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Herceptin SC soln for inj 600 mg/5 mL
Packing/Price
1's
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