Uses of Herceptin: - Breast cancer - Stomach cancer Breast cancer, Gastric cancer Lactation (start only 6 mth after last dose of drug). Do not admin by rapid IV or bolus inj.

Targeted Cancer Therapy

Trastuzumab and trastuzumab emtansine (also known as ado-trastuzumab emtansine) is a recombinant humanised monoclonal antibody that has action directed against a cell surface protein produced by the human epidermal growth factor receptor 2 (HER2). It inhibits proliferation of tumour cells that overexpress HER2 protein.

How to use Trastuzumab: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Administration Not for IV push or bolus administration Administer initial IV infusion over 90 min Subsequent weekly IV infusions may be administered over 30 min if prior infusions are well tolerated Adult Dose: Intravenous Breast Cancer Adjuvant treatment Indicated for adjuvant treatment of HER-2 overexpressing breast cancer Administer during and following paclitaxel, docetaxel, or docetaxel/carboplatin 4 mg/kg IV over 90 minutes, THEN 2 mg/kg IV over 30 minutes qWeek during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin) One week following the last weekly dose administer at 6 mg/kg as an IV infusion over 30?90 min every three weeks As single agent within three wk following completion of multi-modality, anthracycline based chemotherapy regimens: Initial dose at 8 mg/kg as an IV infusion over 90 min; subsequent doses at 6 mg/kg as an IV infusion over 30?90 min every three wks Extending adjuvant treatment beyond one year not recommended Metastatic breast cancer Treat as a single agent or in combination with paclitaxel 4 mg/kg IV over 90 minutes, THEN 2 mg/kg IV over 30 minutes qWeek Gastric Cancer Indicated for treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma Administered in combination with cisplatin and capecitabine or 5-fluorouracil who have not received prior treatment for metastatic disease First cycle: 8 mg/kg IV; infuse IV over 90 min Subsequent cycles: 6 mg/kg IV q3wk; infuse IV over 30-90 min Continue q3week cycles until disease progression Child Dose: Safety and efficacy not established

Increased risk of severe cardiotoxicity with anthracyclines. Increased risk of leukopenia and anaemia in combination chemotherapy (e.g. paclitaxel). Paclitaxel may decrease the clearance of trastuzumab. Increased risk of bleeding with warfarin.

Lactation (start only 6 mth after last dose of drug). Do not admin by rapid IV or bolus inj.

Common - Anemia (low number of red blood cells) - Chills - Common cold - Cough - Decreased blood cells (red cells, white cells, and platelets) - Diarrhea - Fatigue - Fever - Headache - Heart failure - Infection - Insomnia (difficulty in sleeping) - Mucosal inflammation - Nausea - Rash - Stomatitis (Inflammation of the mouth) - Taste change - Upper respiratory tract infection - Weight loss >10% Pain (47%),Asthenia (42%),Fever (36%),Nausea (33%),Chills (32%),Cough (26%),Headache (26%),Diarrhea (25%),Vomiting (23%),Abdominal pain (22%),Back pain (22%),Dyspnea (22%),Infection (20%),Rash (18%),Anorexia (14%),Insomnia (14%),Dizziness (13%) 1-10% Flu-like syndrome (10%),Peripheral edema (10%),CHF (7%),Depression (6%),Tachycardia (5%),UTI (5%),Anemia (4%),Hypersensitivity (3%),Leukopenia (3%) Potentially Fatal: Severe hypersensitivity (anaphylaxis) and infusion reactions; pulmonary events e.g. acute respiratory distress syndrome; cardiotoxicity. Neutropenia (especially when given with chemotherapy).

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Precaution: Patient w/ pre-existing CV and pulmonary disease; extensive pulmonary tumour involvement. Pregnancy and lactation. Monitoring Parameters Monitor cardiac function prior and during treatment. Lactation: not known if excreted in breast milk, discontinue nursing during treatment and for 6 months after last dose

Store the vial in original carton at 2 o -8 o C. Protect from light. Keep out of the reach of children. Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze. The solution of Trastuzumab for infusion diluted in 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C for no more than 24 hours prior to use. Do not freeze.

Trastuzumab, a monoclonal antibody, has action directed against a cell surface protein produced by human epidermal growth factor receptor 2 (HER2). It inhibits proliferation of tumour cells that overexpress HER2 e.g. in 1/3 of breast cancer.

It can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab. Advise pregnant women and females of reproductive potential that exposure to Trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab. There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.