Monoclonal antibodies (antineoplastic agents).

Trastuzumab

1 vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody manufactured from a mammalian cell line (Chinese hamster ovary, CHO) by continuous perfusion. Reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.

Powder for concentrate for solution for infusion. Herceptin is a white to pale yellow lyophilised powder.

Metastatic Breast Cancer (MBC) Herceptin is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2:

a) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.

b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.

c) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.

d) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. Early Breast Cancer (EBC) Herceptin is indicated for the treatment of patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

HER2 testing is mandatory prior to initiation of Herceptin therapy. Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy.

MBC Weekly schedule:

The following loading and subsequent doses are recommended for monotherapy and in combination with paclitaxel, docetaxel or an aromatase inhibitor.

Loading dose

The recommended initial loading dose of Herceptin is 4 mg/kg body weight.

Subsequent doses

The recommended weekly dose of Herceptin is 2 mg/kg body weight, beginning one week after the loading dose.

Method of administration

Herceptin is administered as a 90-minute intravenous infusion. Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms. Interruption of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate.

If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion. Emergency equipment must be available.

Administration in combination with paclitaxel or docetaxel

In the pivotal trials, paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.

Administration in combination with an aromatase inhibitor

In the pivotal trial Herceptin and anastrozole were administered from day 1. There were no restrictions on the relative timing of Herceptin and anastrozole at administration (for dose, see the Summary of Product Characteristics for anastrozole or other aromatase inhibitors).

Duration of treatment

Herceptin should be administered until progression of disease.

MBC 3-weekly schedule:

Alternatively the following loading and subsequent doses are recommended for monotherapy and in combination with paclitaxel, docetaxel or an aromatase inhibitor.

Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes.

Duration of treatment

Herceptin should be administered until progression of disease.

EBC 3-weekly schedule:

In the HERA trial, Herceptin was initiated after completions of standard chemotherapy (most commonly, anthracycline-containing regimens or anthracyclines plus a taxane).

Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes.

Patients with early breast cancer should be treated for 1 year or until disease recurrence.

EBC weekly schedule:

In the adjuvant setting, Herceptin has also been investigated as a weekly regimen (an initial loading dose of 4 mg/kg followed by 2 mg/kg every week for one year) concomitantly with paclitaxel (administered weekly (80 mg/m²) or every 3 weeks (175 mg/m²) for a total of 12 weeks) following 4 cycles of AC (doxorubicin 60 mg/m² IV push concurrently with cyclophosphamide 600 mg/m² over 20–30 minutes).

MBC and EBC:

Do not administer as an intravenous push or bolus.

Dose reduction

No reductions in the dose of Herceptin were made during clinical trials. Patients may continue Herceptin therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Refer to the Summary of Product Characteristics for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.

Missed doses during 3-weekly schedule

If the patient misses a dose of Herceptin by one week or less, then the usual dose of Herceptin (6 mg/kg) should be given as soon as possible (do not wait until the next planned cycle). Subsequent maintenance Herceptin doses of 6 mg/kg should then be given every 3 weeks, according to the previous schedule.

If the patient misses a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be given (8 mg/kg over approximately 90 minutes). Subsequent maintenance Herceptin doses of 6 mg/kg should then be given every 3 weeks from that point.

Special patient populations

Clinical data show that the disposition of Herceptin is not altered based on age or serum creatinine. In clinical trials, elderly patients did not receive reduced doses of Herceptin. Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out. However in a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition.

Paediatric use

Herceptin is not recommended for use in children below 18 due to insufficient data on safety and efficacy.

Not recommended.

Patients with known hypersensitivity to trastuzumab, murine proteins, or to any of the excipients.

Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

HER2 testing must be performed in a specialised laboratory which can ensure adequate validation of the testing procedures.

Currently no data from clinical trials are available on Herceptin re-treatment of patients with previous exposure to Herceptin in the adjuvant setting.

The use of Herceptin is associated with cardiotoxicity. All candidates for treatment should undergo careful cardiac monitoring .The risk of cardiotoxicity is greatest when Herceptin is used in combination with anthracyclines. Therefore Herceptin and anthracyclines should not be used currently in combination except in a well-controlled clinical trial setting with cardiac monitoring. Patients who have previously received anthracyclines are also at risk of cardiotoxicity with Herceptin treatment, although the risk is lower than with concurrent use of Herceptin and anthracyclines. Because the half-life of Herceptin is approximately 28.5 days (95 % confidence interval, 25.5 – 32.8 days), Herceptin may persist in the circulation for up to 24 weeks after stopping Herceptin treatment. Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiotoxicity. If possible, physicians should avoid anthracycline-based therapy for up to 24 weeks after stopping Herceptin. If anthracyclines are used, the patient's cardiac function should be monitored carefully. Serious adverse reactions including infusion reactions, hypersensitivity, allergic-like reactions and pulmonary events have been observed in patients receiving Herceptin therapy. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction. These severe reactions were usually associated with the first infusion of Herceptin and generally occurred during or immediately following the infusion. For some patients, symptoms progressively worsened and led to further pulmonary complications. Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported. Fatalities have occurred within hours and up to one week following infusion. On very rare occasions, patients have experienced the onset of infusion symptoms or pulmonary symptoms more than six hours after the start of the Herceptin infusion. Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.

Infusion reactions, allergic-like reactions and hypersensitivity

Serious adverse reactions to Herceptin infusion that have been reported infrequently include dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema (see 4.8). The majority of these events occur during or within 2.5 hours of the start of the first infusion. Should an infusion reaction occur the Herceptin infusion should be discontinued and the patient monitored until resolution of any observed symptoms (see 4.2). The majority of patients experienced resolution of symptoms and subsequently received further infusions of Herceptin. Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids. In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction. Therefore, these patients should not be treated with Herceptin (see 4.3).

Pulmonary events

Severe pulmonary events have been reported rarely with the use of Herceptin in the post-marketing setting (see 4.8). These rare events have occasionally been fatal. In addition, rare cases of pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported. These events may occur as part of an infusion-related reaction or with a delayed onset. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events. Therefore, these patients should not be treated with Herceptin (see 4.3). Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.

Cardiotoxicity

Heart failure (New York Heart Association [NYHA] class II-IV) has been observed in patients receiving Herceptin therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin)–containing chemotherapy. This may be moderate to severe and has been associated with death (see 4.8).

All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, ECG, echocardiogram, or MUGA scan or magnetic resonance imaging. A careful risk-benefit assessment should be made before deciding to treat with Herceptin.

In EBC, the following patients were excluded from the HERA trial, there are no data about the benefit:risk balance, and therefore treatment can not be recommended in such patients:

• History of documented CHF

• High-risk uncontrolled arrhythmias

• Angina pectoris requiring medication

• Clinically significant valvular disease

• Evidence of transmural infarction on ECG

• Poorly controlled hypertension

Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening. Cardiac function should be further monitored during treatment (e.g. every three months). Monitoring may help to identify patients who develop cardiac dysfunction. For early breast cancer patients, cardiac assessment, as performed at baseline, should be repeated every 3 months during treatment and at 6, 12 and 24 months following cessation of treatment. Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6-8 weeks). If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herceptin therapy has been seen. Caution should be exercised in treating patients with symptomatic heart failure, a history of hypertension or documented coronary artery disease, and in early breast cancer, in those patients with an LVEF of 55 % or less.

If LVEF drops 10 ejection points from baseline AND to below 50 %, Herceptin should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. If LVEF has not improved, or declined further, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. All such patients should be referred for assessment by a cardiologist and followed up.

If symptomatic cardiac failure develops during Herceptin therapy, it should be treated with the standard medications for this purpose. Discontinuation of Herceptin therapy should be strongly considered in patients who develop clinically significant heart failure unless the benefits for an individual patient are deemed to outweigh the risks.

The safety of continuation or resumption of Herceptin in patients who experience cardiotoxicity has not been prospectively studied. However, most patients who developed heart failure in the pivotal trials improved with standard medical treatment. This included diuretics, cardiac glycosides, beta-blockers and/or angiotensinconverting enzyme inhibitors. The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on weekly therapy with Herceptin without additional clinical cardiac events.

No interaction studies have been performed. A risk for interactions with concomitant medication cannot be excluded.

MBC

The adverse event data reflect the clinical trial and post marketing experience of using Herceptin at the recommended dose regimen, either alone or in combination with paclitaxel.

Patients received Herceptin as monotherapy or in combination with paclitaxel in the two pivotal clinical trials. The most common adverse reactions are infusion-related symptoms, such as fever and chills, usually following the first infusion of Herceptin.

Adverse reactions attributed to Herceptin in 10 % of patients in the two pivotal clinical trials were the following:

Adverse reactions attributed to Herceptin in > 1 % and < 10 % of patients in the two pivotal clinical trials were the following:

In a further randomised clinical trial (M77001), patients with metastatic breast cancer received docetaxel, with or without Herceptin. The following table displays adverse events which were reported in 10% of patients, by study treatment:

Table 1 Common Non-haematological Adverse Events Reported in 10% of Patients, by Study Treatment

There was an increased incidence of SAEs (40 % vs. 31%) and Grade 4 AEs (34 % vs. 23 %) in the combination arm compared to docetaxel monotherapy.

In a further randomised clinical trial (BO16216), patients with HER2 positive and hormone receptor positive metastatic breast cancer received anastrozole with or without Herceptin. In this trial, there was no change in the safety profile compared with previous trials in the metastatic population. The following table displays adverse events which were reported in 10% of patients, by study treatment:

Table 2 Summary of Adverse Events with an Incidence Rate of at Least 10 % by Trial Treatment

There was an increased incidence of SAEs (23% vs. 6%) and Grade 3/4 AEs (25% vs. 15%) in the combination arm compared to anastrozole monotherapy.

EBC

The HERA trial is a randomised, open label study in patients with HER2-positive early breast cancer. Table 3 displays adverse events which were reported at 1 year in 1% of patients, by study treatment.

Table 3 Adverse Events Reported at 1 year in 1% of Patients, by Study Treatment

* Adverse Events that were reported at higher incidence (>_2 % difference) in the Herceptin group compared with the observation group and therefore may be attributable to Herceptin.

The following information is relevant to all indications:

Serious Adverse Reactions

At least one case of the following serious adverse reactions has occurred in at least one patient treated with Herceptin alone or in combination with chemotherapy in clinical trials or has been reported during post marketing experience:

Body System	Adverse Event
Body as a Whole	hypersensitivity reaction, anaphylaxis and anaphylactic shock, angioedema, ataxia, sepsis, chills and fever, asthenia, fever, rigor, headache, paresis, chest pain, fatigue, infusion-related symptoms, peripheral oedema, bone pain, coma, meningitis, cerebral oedema, thinking abnormal, progression of neoplasia
Cardiovascular	cardiomyopathy, congestive heart failure, increased congestive heart failure, decreased ejection fraction, hypotension, pericardial effusion, bradycardia, cerebrovascular disorder, cardiac failure, cardiogenic shock, pericarditis
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Benlysta 120 mg polvo para concentrado para solución para perfusión. Qutenza 179 mg parche cutáneo MULTAQ 400 mg comprimidos recubiertos con película Onglyza 2,5 mg comprimidos recubiertos con película IRESSA 250 mg comprimidos recubiertos con película Mycamine 50 mg polvo para solución para perfusión Protopic 0,03% pomada Protopic 0,1% pomada Cayston 75 mg polvo y disolvente para solución para inhalación por nebulizador Altargo 1% pomada Xarelto 15 mg comprimidos recubiertos con película Xarelto 10 mg comprimidos recubiertos con película Xarelto 20 mg comprimidos recubiertos con película BRINAVESS 20 mg/ml, concentrado para solución para perfusión MEPACT 4 mg polvo para suspensión para perfusión. Fablyn Nebido 1000mg/4ml Testogel Nebido German Drugs Benlysta 120 mg Pulver zur Herstellung eines Infusionslösungskonzentrats. Benlysta 400 mg Pulver zur Herstellung eines Infusionslösungskonzentrats. MULTAQ® 400 mg Filmtabletten Qutenza 179 mg kutanes Pflaster Onglyza 2,5 mg Filmtabletten Protopic 0,1% Salbe IRESSA 250 mg Filmtabletten Mycamine 50 mg Pulver zur Herstellung einer Infusionslösung Vistide 75 mg/ml Konzentrat zur Herstellung einer Infusionslösung Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Protopic 0,03% Salbe Xarelto 20 mg Filmtabletten Xarelto 15 mg Filmtabletten Xarelto 10 mg Filmtabletten Mycophenolatmofetil Teva 250 mg Hartkapseln Humira 40 mg MEPACT 4 mg Pulver zur Herstellung einer Infusionssuspension FABLYN Testogel Nebido 1000mg/4ml Norweigan Drugs Benlysta 120 mg pulver til konsentrat til infusjonsvæske, oppløsning. Benlysta 400 mg pulver til konsentrat til infusjonsvæske, oppløsning. Qutenza 179 mg hudplaster Onglyza 2,5 mg filmdrasjerte tabletter. 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