Trastuzumab

Indications & Dose:

Treatment of early breast cancer which overexpresses human epidermal growth factor receptor-2 (HER2) (initiated by a specialist) | Treatment of metastatic breast cancer in patients with HER2-positive tumours who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate (in combination with paclitaxel or docetaxel) (initiated by a specialist) | Treatment of metastatic breast cancer in postmenopausal patients with hormone-receptor positive HER2-positive tumours not previously treated with trastuzumab (in combination with an aromatase inhibitor) (initiated by a specialist) l

• BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION

Adult: (consult product literature or local protocols)

Monotherapy for metastatic breast cancer in patients with tumours that overexpress HER2 who have received at least 2 chemotherapy regimens including, where appropriate, an anthracycline and a taxane (initiated by a specialist) l

• BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION

Adult: Women with oestrogen-receptor-positive breast cancer should also have received hormonal therapy (consult product literature or local protocols)

Treatment of metastatic gastric cancer in patients with HER2-positive tumours who have not received treatment for metastatic gastric cancer (in combination with capecitabine or fluorouracil and cisplatin) (initiated by a specialist) l

• BY INTRAVENOUS INFUSION

Adult: (consult product literature or local protocols)

Contraindications:

Severe dyspnoea at rest Patients with known hypersensitivity to trastuzumab or to any other component of Rastuzumab.

Cardiovascular: Vasodilation.

Digestive: Anorexia, constipation, diarrhea, dyspepsia, flatulence, nausea, and vomiting,

Metabolic: Peripheral edema,

Musculoskeletal: Arthralgia, myalgia.

Nervous: Anxiety, depression, dizziness, insomnia, paresthesia, somnolence.

Respiratory: Asthma, increased cough, dyspnea, epistaxis, lung disorders, pleural effusion, pharyngitis, rhinitis, sinusitis. Skin: Pruritus, rash.

Infusion-Associated Symptoms: During the 1st infusion with Rastuzumab, a symptom complex most commonly consisting of chills and/or fever is observed in about 40% of patients. The symptoms are usually mild to moderate in severity. These symptoms, which rarely cause discontinuation of Rastuzumab, can be treated with an analgesic/ antipyretic eg, paracetamol or an antihistamine eg, diphenhydramine (see Dosage & Administration). Other signs and/or symptoms may include nausea, vomiting, pain, rigors, headache, dizziness, dyspnea, hypotension, rash and asthenia. The symptoms occur infrequently with subsequent Rastuzumab infusions.

Hypersensitivity Reaction: Anaphylactoid reactions were observed in isolated cases.

Cardiac Toxicity: Cardiac dysfunction was observed during clinical trials in patients treated with Rastuzumab (see Warnings). The incidence of moderate to severe cardiac dysfunction (NYHA class III/IV) was 5% in patients treated with Rastuzumab alone.

Hematological Toxicity: Hematological toxicity is infrequent following the administration of Rastuzumab as a single agent,

Side Effects:

Cautions:

Coronary artery disease . history of hypertension . symptomatic heart failure . uncontrolled arrhythmias

Precautions:

Interaction:

There have been no formal drug interaction b studies performed with Rastuzumab in humans. Clinically significant interactions with the concomitant medication used in clinical trials have not been observed.

Incompatibilities: No incompatibilities between Rastuzumab and s’ polyvinylchloride or polyethylene bags have been observed. e’ Dextrose (5%) solution should not be used since it causes of aggregation of the protein.

Rastuzumab should not be mixed or diluted with other drugs.

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: