Page 25 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

ABBREVIATED PRESCRIBING INFORMATION

Herceptin IV ® (Trastuzumab)
Active ingredient: Trastuzumab, for Intravenous Infusion.
Please refer to locally approved Product Information prior the use of Herceptin IV.
Before the start of Herceptin therapy, overexpression of HER2 in the tumour tissue of the patient must have been demonstrated either by
immunohistochemistry at a 3+ level or by molecular biology (detection of HER2 gene amplification using fluorescence in situ hybridisation [FISH] or
chromogenic in situ hybridisation [CISH]).
Therapeutic indications: Metastatic breast cancer, Herceptin is indicated for the treatment of HER2-overexpressing metastatic breast cancer: a) as
single-agent therapy in patients who have previously received one or more chemotherapy regimens for their metastatic disease, b) in combination
with paclitaxel or docetaxel in patients who have not yet received chemotherapy for their metastatic disease, c) in combination with an aromatase
inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer and who have not yet received
chemotherapy for their metastatic disease. No data are available on patients given Herceptin as adjuvant therapy in early breast cancer. Early breast
cancer Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer: a) following surgery, (neoadjuvant or adjuvant)
chemotherapy and (if applicable) radiotherapy, b) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with
paclitaxel or docetaxel. c) in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. d) in combination with neoadjuvant
chemotherapy followed by adjuvant Herceptin for locally advanced (including inflammatory) breast cancer or tumours >2 cm in diameter. Metastatic
gastric cancer or cancer of the gastroesophageal junction: Herceptin in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is
indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not
received chemotherapy for their metastatic disease. Herceptin should only be used in patients with metastatic gastric cancer whose tumours
overexpress HER2 defined by IHC2+ and confirmed by a positive FISH+ or silver in situ hybridisation (SISH) result, or by IHC 3+ determined in a validated
test. Posology and method of administration: Metastatic breast cancer – weekly schedule, Herceptin should be administered by intravenous infusion.
Do not administer as an intravenous bolus injection. The following loading and maintenance doses are recommended both for monotherapy and for
combination with chemotherapy: A) Monotherapy Initial dose: The recommended initial dose is 4 mg Herceptin/kg body weight administered as a
90-minute intravenous infusion. Subsequent doses: The recommended weekly maintenance dose is 2 mg Herceptin/kg body weight. If the loading
dose was well tolerated, this can be administered as a 30-minute infusion. B) Combination therapy with paclitaxel or docetaxel: The dosage of Herceptin
in combination therapy is the same as that in monotherapy. Paclitaxel or docetaxel is administered on the day following the first dose of Herceptin
treatment. Thereafter, they can be administered at 3-weekly intervals immediately after the subsequent Herceptin doses, provided that preceding
Herceptin administration was well tolerated. For the dosage of paclitaxel or docetaxel, see the relevant prescribing information. C) Administration in
combination with an aromatase inhibitor: The dosage of Herceptin in therapy based on this combination is the same as that in monotherapy. In
patients receiving tamoxifen, treatment with tamoxifen must be discontinued at least one day before starting combination therapy. Metastatic breast
cancer – 3-weekly schedule: As an alternative to weekly administration, the following 3�weekly schedule is recommended in monotherapy as well as
in combination with paclitaxel, docetaxel or an aromatase inhibitor: The loading dose of Herceptin is 8 mg/kg body weight, followed by 6 mg/kg body
weight 3 weeks later. The subsequent Herceptin doses of 6 mg/kg body weight are repeated at 3-weekly intervals. Treatment is administered by
infusion over approximately 90 minutes. If the initial dose was well tolerated, the maintenance dose can be administered as a 30-minute infusion. Early
breast cancer, for the following treatment regimens, Herceptin is given until recurrence or for a total of 52 weeks. Weekly dosing: With weekly
administration the initial dose is 4 mg/kg body weight, followed by 2 mg/kg body weight every week. Three-weekly dosing: With 3-weekly
administration the recommended initial dose of Herceptin is 8 mg/kg body weight. The recommended maintenance dose of Herceptin at 3-weekly
intervals is 6 mg/kg body weight, beginning 3 weeks after the initial dose. When Herceptin is continued alone following combination with
chemotherapy, 6 mg/kg is given at 3-weekly intervals. Advanced gastric cancer or cancer of the gastroesophageal junction – 3-weekly schedule: The
initial dose is 8 mg/kg body weight, followed 3 weeks later by 6 mg/kg body weight. The subsequent 6 mg/kg Herceptin doses are repeated at 3-weekly
intervals. Treatment is administered by infusion over approximately 90 minutes. If the initial dose was well tolerated, the maintenance dose can be
administered as a 30-minute infusion. Contraindications: Herceptin is contraindicated in patients with known hypersensitivity to trastuzumab,
hamster (CHO) cell protein or any other product or solvent excipient. Herceptin and anthracycline should not be given concurrently in the metastatic
breast cancer or adjuvant treatment setting. In the neoadjuvant treatment setting concurrent administration of Herceptin and anthracyclines should
be used with caution and only in chemotherapy-naïve patients. Herceptin is also contraindicated in patients who suffer from dyspnea at rest due to
advanced malignancy or comorbidities. Special warnings and precautions for use: Infusion-related Reactions: Serious infusion-related reactions
including dyspnea, hypotension, gasping or wheezing, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation and respiratory
distress have been observed in rare patients during treatment with Herceptin. These adverse effects can occur as part of an infusion-related reaction
or as a delayed reaction. Cardiotoxicity Patients treated with Herceptin may develop NYHA II-IV congestive heart failure or asymptomatic cardiac
dysfunction. This has been observed during treatment with Herceptin alone or in combination with taxanes following anthracycline (doxorubicin or
epirubicin) therapy. Heart failure may be moderate to severe and lead to death. Caution should be exercised in treating patients with increased cardiac
risk (e.g. hypertension, documented coronary artery disease, congestive heart failure, diastolic dysfunction, older age). Herceptin and anthracyclines
should not be given concurrently in the metastatic breast cancer or adjuvant treatment setting. In the neoadjuvant treatment setting concurrent
administration of Herceptin and anthracyclines should be used with caution and only in chemotherapy-naïve patients Undesirable effects: The most
serious and/or frequently reported undesirable effects during treatment with Herceptin are cardiotoxicity, infusion reactions, hematotoxicity
(especially neutropenia) and pulmonary adverse events. NYHA II–IV cardiotoxicity (heart failure) is a common undesirable effect during treatment with
Herceptin and maybe fatal in some cases. An estimated 40% of patients treated with Herceptin will experience infusion-related reactions of any kind.
However, most of these infusion-related undesirable effects are of mild to moderate severity (based on NCI-CTC criteria) and occur mainly in the first
treatments, particularly during the first three infusions and with decreasing frequency in subsequent infusions. Reactions include chills, fever, rash,
nausea and vomiting, dyspnea and headache. Serious anaphylactic reactions necessitating immediate additional intervention occur very rarely and
normally during the first or second infusion of Herceptin. Febrile neutropenia is very common. Common adverse events include anemia, leukopenia,
thrombocytopenia and neutropenia. The frequency of hypoprothrombinemia is unknown. Serious pulmonary undesirable effects occur rarely during
treatment with Herceptin, but have occasionally been associated with fatal outcome. They include pulmonary infiltrates, acute respiratory distress
syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary edema and respiratory failure
Mode of Prescription: POM
Presentation: 1 vial containing Herceptin (trastuzumab) 440 mg multiple-dose vials: Pack containing 1 vial of a white lyophilized powder for
preparation of a concentrated solution for infusion with 440 mg trastuzumab and 1 vial of solvent contains:
water for injections containing 1.1% benzyl alcohol preservative (bacteriostatic water for injections).
Marketing Authorization Holder: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Date of preparation: 25th September 2017
Full prescribing information is available upon request. In case of any adverse event occurring with Herceptin, please forward details to e-mail:
dubai.drug_safety@roche.com or call +971544409415
Roche Pharmaceuticals Middle East FZCO- Dubai Branch P.0. Box 27309 Dubai, UAE, Tel: +97148164800, Fax: +97148800212, www.roche.com

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