Kadcyla Infusion

Trastuzumab

100mg

F. Hoffmann-La Roche Ltd.

Pack size	15ml Glass Vial (Dry)
Dispensing mode	POM
Source	SWITZERLAND
Agent	CITY MEDICAL STORE
Retail Price	11710.00 AED

Available as:

440mg - Infusion 600mg/5ml - Injection 160mg - Infusion 440mg - Infusion

Indications

Kadcyla Infusion is used for: Breast cancer, Gastric cancer

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

Renal Dose

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

Contra Indications

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

Precautions

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

Pregnancy-Lactation

Pregnancy May cause fetal harm when administered to a pregnant woman In postmarketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death Advise patient of the potential risks to a fetus Contraception Verify pregnancy status of females of reproductive potential prior to initiating Advise pregnant women and females of reproductive potential that exposure 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 last dose Lactation No information regarding the presence of trastuzumab in human milk, the effects on breastfed infants, or the effects on milk production Published data suggest human IgG is present in human milk but does not enter neonatal and infant circulation in substantial amounts Trastuzumab was present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity Assess the developmental and health benefits of breastfeeding along with the mother’s clinical need for treatment and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition (unwrap) Consider trastuzumab wash out period of 7 months

Interactions

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.

Adverse Effects

Side effects of Trastuzumab : >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).

Mechanism of Action

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.

Note

Kadcyla 100mg Infusion manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Trastuzumab. Kadcyla is availble in United Arab Emirates. Farmaco UAE drug index information on Kadcyla Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Trastuzumab :

Infusion

Herceptin ^440mg

F. Hoffmann-La Roche Ltd.

Injection

Herceptin ^600mg/5ml

F. Hoffmann-La Roche Ltd.

Powder for Concentrate for Solution for Infusion

Herzuma ^{150 mg}

Hikma Pharmaceuticals

Powder for Concentrate for Solution for Infusion

Herzuma ^{440 mg}

Hikma Pharmaceuticals

Infusion

Kadcyla ^160mg

F. Hoffmann-La Roche Ltd.