Medicinal Products

AVASTIN 25 mg / ml solution to be diluted for infusion box of 1 vial of 16 ml

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Bevacizumab
laboratory: Roche

Solution to be diluted for IV infusion
All forms

Indication

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated in adult patients with metastatic colorectal cancer.

Bevacizumab in combination with paclitaxel is indicated for first-line treatment in adult patients with metastatic breast cancer. For additional information regarding the status of Human Epidermal Growth Factor Receptor 2 (HER2), refer to the section on Pharmacodynamic properties .

Bevacizumab in combination with capecitabine is indicated for first-line treatment in adult patients with metastatic breast cancer for whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients treated with adjuvant taxanes and anthracyclines in the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information regarding HER2 status, see the topic Pharmacodynamic properties .

Bevacizumab, in combination with platinum-based chemotherapy, is indicated for first-line therapy in adult patients with advanced, non-operable, metastatic or relapsed non-small cell lung cancer, as long as histology is not predominantly squamous.

Bevacizumab, in combination with erlotinib, is indicated for first-line therapy in adult patients with non-squamous, advanced and non-operable, metastatic or relapsed non-small cell lung cancer and EGFR-activating mutations. (Epidermal Growth Factor Receptor) (see section Pharmacodynamic properties ).

Bevacizumab, in combination with interferon alfa-2a, is indicated for first-line treatment in adult patients with advanced and / or metastatic renal cell carcinoma.

Bevacizumab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of advanced stages (FIGO (International Federation of Obstetric Gynecology) III B, III C and IV stages) of epithelial ovarian cancer, fallopian tubes or peritoneal primitive in adult patients.

Bevacizumab, in combination with carboplatin and gemcitabine, is indicated in adult patients with epithelial carcinoma of the ovary, fallopian tubes, or primary peritoneal, at first recurrence, sensitive to platinum salts, and have not been previously treated with bevacizumab or other VEGF inhibitors or other agents targeting the VEGF receptor.

Bevacizumab, in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, is indicated in adult patients with epithelial carcinoma of the ovary, fallopian tubes or primary peritoneal, relapsed, platinum-resistant, who have not received more than two previous chemotherapy protocols and who have not been previously treated with bevacizumab or other VEGF inhibitors or other agents targeting the VEGF receptor (see section 5.1 ).

Bevacizumab, in combination with paclitaxel and cisplatin, or in combination with paclitaxel and topotecan in patients who can not receive platinum-containing therapy, is indicated in adult patients with cervical carcinoma. persistent, relapsed or metastatic uterus (see section 5.1 ).

Dosage AVASTIN 25 mg / ml solution to be diluted for infusion box of 1 vial of 16 ml

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated in adult patients with metastatic colorectal cancer.

Bevacizumab in combination with paclitaxel is indicated for first-line treatment in adult patients with metastatic breast cancer. For additional information regarding the status of Human Epidermal Growth Factor Receptor 2 (HER2), refer to the section on Pharmacodynamic properties .

Bevacizumab in combination with capecitabine is indicated for first-line treatment in adult patients with metastatic breast cancer for whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients treated with adjuvant taxanes and anthracyclines in the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information regarding HER2 status, see the topic Pharmacodynamic properties .

Bevacizumab, in combination with platinum-based chemotherapy, is indicated for first-line therapy in adult patients with advanced, non-operable, metastatic or relapsed non-small cell lung cancer, as long as histology is not predominantly squamous.

Bevacizumab, in combination with erlotinib, is indicated for first-line therapy in adult patients with non-squamous, advanced and non-operable, metastatic or relapsed non-small cell lung cancer and EGFR-activating mutations. (Epidermal Growth Factor Receptor) (see section Pharmacodynamic properties ).

Bevacizumab, in combination with interferon alfa-2a, is indicated for first-line treatment in adult patients with advanced and / or metastatic renal cell carcinoma.

Bevacizumab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of advanced stages (FIGO (International Federation of Obstetric Gynecology) III B, III C and IV stages) of epithelial ovarian cancer, fallopian tubes or peritoneal primitive in adult patients.

Bevacizumab, in combination with carboplatin and gemcitabine, is indicated in adult patients with epithelial carcinoma of the ovary, fallopian tubes, or primary peritoneal, at first recurrence, sensitive to platinum salts, and have not been previously treated with bevacizumab or other VEGF inhibitors or other agents targeting the VEGF receptor.

Bevacizumab, in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, is indicated in adult patients with epithelial carcinoma of the ovary, fallopian tubes or primary peritoneal, relapsed, platinum-resistant, who have not received more than two previous chemotherapy protocols and who have not been previously treated with bevacizumab or other VEGF inhibitors or other agents targeting the VEGF receptor (see section 5.1 ).

Bevacizumab, in combination with paclitaxel and cisplatin, or in combination with paclitaxel and topotecan in patients who can not receive platinum-containing therapy, is indicated in adult patients with cervical carcinoma. persistent, relapsed or metastatic uterus (see section 5.1 ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.

Hypersensitivity to products of Chinese hamster ovary cells (CHO) or other recombinant human or human antibodies.

Pregnancy (see section on Pregnancy and lactation ).

Avastin side effects

Tolerance Profile Summary

The safety profile of Avastin is based on data collected in clinical trials in more than 5, 400 patients with different types of malignancies who were mostly treated with Avastin combined with chemotherapy. .

The most serious side effects were:

• Gastrointestinal perforation (see Warnings and Precautions section ).

• Hemorrhage, including pulmonary haemorrhage / haemoptysis, more common in patients with non-small cell lung cancer (see Warnings and Precautions section ).

• Arterial thromboembolism (see section Warnings and Precautions ).

In all clinical studies, the most common adverse events observed in patients receiving Avastin were: high blood pressure, fatigue or asthenia, diarrhea, and abdominal pain.

Analyzes of clinical safety data suggest that arterial hypertension and proteinuria during treatment with Avastin are likely dose dependent.

List of adverse reactions in tabular form

Adverse reactions reported in this section fall into the following frequency groups: very common (≥ 1/10), common (≥ 1/100 - <1/10), uncommon: (≥ 1/1000 to <1/100) ), rare (≥ 1/10000 to <1/1000), very rare (<1/10000), not known (can not be estimated from the available data).

Table 1 presents, according to their frequency, all the undesirable effects defined as having a causal relation with the taking of Avastin through:

• the comparison of the effects observed between the clinical trial treatment arms (with a difference of at least 10% compared to the control group for NCI-CTCAE grade 1-5 effects or a difference greater than 2 % compared to control group for NCI-CTCAE Grade 3-5 effects),

• post-authorization safety studies,

• spontaneous declarations,

• non-interventional or observational epidemiological studies,

• or through the evaluation of individual case reports.

Table 2 shows the frequency of serious adverse events. Serious adverse events are considered as such, when a difference of at least 2% is observed compared to the control group for NCI-CTCAE Grade 3-5 effects in clinical studies. Table 2 also includes adverse reactions considered clinically significant or serious by the MAH.

Post-marketing adverse events are included in Tables 1 and 2, if applicable. Detailed information on post-marketing adverse reactions is presented in Table 3.

Adverse reactions are classified in the appropriate frequency group in the tables below, based on the highest incidence observed regardless of the indication.

Within each frequency category, adverse effects are presented in descending order of severity.

Some of the side effects are effects commonly seen with chemotherapy; however, Avastin, in combination with chemotherapy agents, may exacerbate these adverse effects. For example, palmar-plantar rythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel and paronychia with erlotinib.

Table 1: Adverse reactions according to their frequency

System

organ

Class

Very common

Frequent

Rare

Rare

Very rare

Frequency

unknown

Infections and infestations

sepsis,

Abcess b, d,

Cellulite,

Infection,

Infection

urinary

fasciitis

necrotizing

Hematologic disorders and lymphatic system

neutropenia

febrile,

leukopenia,

Neutropenia b,

Thrombocyto

penia

Anemia,

lymphopenia

Immune system disorders

Hypersensitivity, reactions related to infusion a, b, d

Metabolism and nutrition disorders

Anorexia

Déshydratatio

not

Nervous system disorders

neuropathy

sensory

device b,

dysarthria,

headache,

dysgeusia

Accident

vascular

cerebral,

Syncope,

Drowsiness

Syndrome

of encephalomyelitis

pathy

posterior

reversible a, b, d

encephalo

pathy

hypertensive

affections

eye

Affection

ocular,

Increase

of

watering

affections

heart

insufficiency

cardiac

congestive b, d,

tachycardia

supraventricul

area

affections

vascular

Hypertension b, d

Thromboem

Bolie

(venous) b, d

Thromboem

Bolie

(arterial) b, d,

Haemorrhage b, d,

Thrombosis

venous

deep

Microangio

pathy

thrombotic

renal a, b

Respiratory, thoracic and mediastinal disorders

Dyspnea,

rhinitis

Hemorrhage

pulmonary/

Hemoptysis b, d,

Embolism

pulmonary,

Epistaxis,

hypoxia,

Dysphonia has

Pulmonary hypertension, Perforation of nasal septum a

System

organ

Class

Very common

Frequent

Rare

Rare

Very rare

Frequency

unknown

affections

gastro

intestinal

rectal bleeding,

stomatitis,

Constipation,

Diarrhea,

nausea,

vomiting

Pain

abdominal

Perforation

gastrointestinal

intestinal b, d,

Perforation

intestinal,

ileus,

Occlusion

intestinal,

Rectovaginal fistulas ^ 6, Gastrointestinal disorders, Proctalgia

Gastrointestinal ulcer

affections

Hepatobiliary

Perforation of the gallbladder

biliary a, b

Skin and subcutaneous tissue disorders

Complications of the

wound healing b, d Exfoliating dermatitis, Dry skin, discolouration of pea

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