Medicinal Products

DOCETAXEL ACTAVIS 20 mg / ml 20 mg / 1 mL

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Docetaxel
laboratory: Actavis Group Ptc Ehf

Solution for solution for IV infusion
Box of 1 bottle of 7 ml
All forms

Indication

Breast cancer

DOCETAXEL ACTAVIS in combination with doxorubicin and cyclophosphamide is indicated for the adjunctive treatment of operable breast cancer in patients with lymph node involvement.

DOCETAXEL ACTAVIS in combination with doxorubicin is indicated for the treatment of locally advanced or metastatic breast cancer in patients who have not received prior cytotoxic chemotherapy for this condition.

DOCETAXEL ACTAVIS is indicated as monotherapy in the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline or alkylating agent.

DOCETAXEL ACTAVIS in combination with trastuzumab is indicated for the treatment of metastatic breast cancer with tumor overexpression of HER2 in patients who have not been pre-treated with chemotherapy for metastatic disease.

DOCETAXEL ACTAVIS in combination with capecitabine is indicated for the treatment of locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy with an anthracycline.

Non-small cell lung cancer

DOCETAXEL ACTAVIS is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

DOCETAXEL ACTAVIS in combination with cisplatin is indicated for the treatment of unresectable, locally advanced or metastatic non-small cell lung cancer in patients who have not received prior chemotherapy for this indication.

Prostate cancer

DOCETAXEL ACTAVIS in combination with prednisone or prednisolone is indicated for the treatment of metastatic hormone-resistant prostate cancer.

Gastric cancer

DOCETAXEL ACTAVIS, in combination with cisplatin and 5-fluorouracil, is indicated for the treatment of metastatic gastric adenocarcinoma, including gastroesophageal junction adenocarcinoma, in patients who have not been pre-treated with chemotherapy for metastatic disease.

Cancer of the upper aero-digestive tract

DOCETAXEL ACTAVIS in combination with cisplatin and 5-fluorouracil is indicated for the induction therapy of locally advanced squamous cell carcinoma of the upper aerodigestive tract.

Dosage DOCETAXEL ACTAVIS 20 mg / ml 20 mg / 1 mL Concentrate for solution for infusion IV Box of 1 vial of 7 ml

The use of docetaxel should be restricted to specialized cytotoxic units and docetaxel should be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section on Instructions for use, handling and treatment). elimination ).

Recommended dosage:

In breast, non-small-cell lung, gastric and upper aero-digestive tract cancers, and unless contraindicated, premedication with an oral corticosteroid may be used, such as dexamethasone at a dose of 16 mg per day ( for example: 8 mg twice daily) for 3 days starting the day before the infusion of docetaxel (see Warnings and Precautions ). Prophylaxis with G CSF can be used to reduce the risk of hematologic toxicity.

In prostate cancer, given the concomitant use of prednisone or prednisolone, the recommended oral premedication of dexamethasone is 8 mg, 12 hours, 3 hours and 1 hour prior to docetaxel infusion (see section 4.4). and precautions for use ).

Docetaxel is given as a one-hour infusion every three weeks.

Breast cancer :

In the adjuvant treatment of operable, node-positive breast cancer, the recommended dose of docetaxel is 75 mg / m 2 given 1 hour after 50 mg / m 2 of doxorubicin and 500 mg / m 2 of cyclophosphamide every 3 weeks. for 6 cycles (see Dosage Adjustment).

For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel monotherapy is 100 mg / m 2 . In the first line, docetaxel at the recommended dose of 75 mg / m² is associated with doxorubicin (50 mg / m²).

In combination with trastuzumab, the recommended dose of docetaxel is 100 mg / m 2 every 3 weeks, in combination with trastuzumab administered weekly. In the pivotal study, the first docetaxel infusion was performed the day after the first administration of trastuzumab. The following courses of docetaxel were given immediately after the completion of the trastuzumab infusion if the previous dose of trastuzumab had been well tolerated. For the dosage and method of administration of trastuzumab, see the Summary of Product Characteristics.

In combination with capecitabine, the recommended dose of docetaxel is 75 mg / m 2 every three weeks, combined with 1250 mg / m 2 of capecitabine twice daily (within 30 minutes after a meal) for two weeks followed by a period without treatment of one week. For capecitabine dose calculations based on body surface area, see capecitabine summary of product characteristics.

Non-small cell lung cancer:

In patients treated for non-small cell lung cancer who received no prior chemotherapy, the recommended doses are 75 mg / m² docetaxel followed immediately by 75 mg / m² cisplatin in 30-60 minutes. After failure of platinum-based chemotherapy, the recommended dose is 75 mg / m² of docetaxel monotherapy.

Prostate cancer :

The recommended dosage of docetaxel is 75 mg / m 2 . Prednisone or oral prednisolone is administered continuously at a dose of 5 mg twice daily (see section 5.1 Pharmacodynamic properties ).

Gastric cancer:

The recommended dose of docetaxel is 75 mg / m 2 followed on the same day by a 1 to 3 hour infusion of cisplatin at a dose of 75 mg / m 2. Immediately after the end of the cisplatin infusion, the continuous 5-day infusion of fluorouracil is begun at a dosage of 750 mg / m² / day. The treatment is repeated every 3 weeks. Premedication with antiemetics and adequate hydration prior to cisplatin administration should be performed.

Prophylaxis with G CSF should be used to reduce the risk of hematologic toxicity (see also dose adjustments during treatment).

Cancer of the upper aero-digestive tract:

Patients should be premedicated with anti-emetics and adequate hydration (before and after administration of cisplatin). G-CSF prophylaxis can be used to reduce the risk of haematological toxicity. All docetaxel arm patients in TAX323 and TAX324 were given antibiotic prophylaxis.

· Induction chemotherapy followed by radiotherapy (TAX323)

In the induction treatment of locally advanced and inoperable squamous cell carcinoma of the upper aero-digestive tract, the recommended dose of docetaxel is 75 mg / m² infused over one hour, followed by cisplatin at a dosage of 75 mg / m² infusion. from 1 hour to D1, followed by 5 fluorouracil at a dosage of 750 mg / m² / day in continuous infusion over 5 days.

This pattern is repeated every 3 weeks for 4 cycles. After chemotherapy, patients should be treated with radiotherapy.

· Induction chemotherapy followed by chemoradiotherapy (TAX324)

In the induction treatment of patients with locally advanced squamous cell carcinoma of the upper aerodigestive tract (VADS) (unresectable technically, low probability of surgical curability or organ preservation), the recommended dose of docetaxel is 75 mg / day. m 2 intravenous infusion for 1 hour on D1, followed by cisplatin at the dosage of 100 mg / m 2 infusion 30 minutes to 3 hours, followed by 5-fluorouracil 1000 mg / m 2 / day continuous infusion from D1 to J4. This schedule is administered every 3 weeks at 3 cycles. After chemotherapy, patients should be treated with chemoradiotherapy.

For dosage adjustments of cisplatin and 5-fluorouracil, refer to the summary of the corresponding product characteristics.

Dosage adjustment:

Overview

Docetaxel should not be administered until the number of neutrophils is less than 1500 / mm 3 .

In patients who during treatment with docetaxel experienced febrile neutropenia, neutrophils <500 / mm 3 for more than 1 week, severe or repeated skin reactions or severe peripheral neuropathy, docetaxel must be reduced from 100 mg / m 2 to 75 mg / m 2 and / or from 75 to 60 mg / m 2 . If these reactions persist at 60 mg / m², treatment should be discontinued.

Adjuvant treatment of breast cancer

In the pivotal study, in patients who received adjuvant treatment for breast cancer and who had complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended that G -CSF prophylactically (ex: from 4th to 11th day) for all subsequent cycles. Patients who continued to have this effect should remain on G-CSF and the docetaxel dose should be decreased to 60 mg / m 2 .

However, in clinical practice, neutropenia may occur sooner. Therefore, the use of G CSF should be considered according to the neutropenic risk of the patient and the recommendations in force.

For patients with grade 3 or 4 stomatitis, the dose of docetaxel should be decreased to 60 mg / m 2 .

In combination with cisplatin

In patients who received an initial dose of docetaxel 75 mg / m 2 in combination with cisplatin, for whom the nadir in the number of platelets at the previous course of treatment was <25000 / mm 3, or with febrile neutropenia or severe toxicities non-haematological, the dose of docetaxel should be reduced to 65 mg / m² in subsequent cycles. For dosage adjustment of cisplatin, refer to the Summary of Product Characteristics.

In combination with capecitabine

· For dosage adjustment of capecitabine, see its summary of product characteristics.

· In patients with an initial appearance of Grade 2 toxicity, which persists until the next dose of docetaxel / capecitabine, delay treatment until returning to Grade 0-1, then continue at 100% initial dosages

· In patients with a second onset of Grade 2 toxicity or Grade 1 toxicity, regardless of the stage of the treatment cycle, delay treatment until returning to Grade 0-1, then resume therapy. treatment with 55 mg / m 2 of docetaxel.

· For any subsequent appearance of toxicity, or any Grade 4 toxicity, discontinue docetaxel therapy.

For dosage modifications of trastuzumab, see the Summary of Product Characteristics.

In combination with cisplatin and 5-fluorouracil

If an episode of complicated neutropenia (febrile, prolonged, or neutropenic) occurs despite the use of G-CSF, the dosage of docetaxel should be reduced from 75 to 60 mg / m².

If other episodes of complicated neutropenia occur, the dosage of docetaxel should be reduced from 60 to 45 mg / m².

In Grade 4 thrombocytopenia, the dose of docetaxel should be reduced from 75 to 60 mg / m².

The following administrations of docetaxel should be resumed only if the number of neutrophils is> 1500 / mm 3 and the number of platelets is> 100 000 / mm 3 . If these haematological toxicities persist treatment should be stopped (see Warnings and precautions for use ).

In case of toxicities, the dose adjustments of patients receiving docetaxel in combination with cisplatin and 5-fluorouracil (5-FU) are as follows:

Toxicity- grade

Dosage adjustments

Diarrhea - grade 3

1st episode: 20% reduction in the dose of 5-FU.

2nd episode: 20% reduction in the dose of docetaxel.

Diarrhea - grade 4

1st episode: 20% reduction in the dose of docetaxel and 5-FU.

2nd episode: discontinuation of treatment.

Stomatitis / mucositis -

1st episode: 20% reduction in the dose of 5-FU.

grade 3

2nd episode: definitive cessation of 5-FU only.

3rd episode: 20% reduction of the dose of docetaxel.

Stomatitis / mucositis -

1st episode: final stop of 5-FU only.

grade 4

2nd episode: 20% reduction in the dose of docetaxel.

For dosage adjustments for 5-fluorouracil and cisplatin, refer to the summary of product characteristics.

In pivotal studies in patients treated with induction chemotherapy for

VADS, and with complicated neutropenia (including prolonged neutropenia, febrile neutropenia or infection), G-CSF prophylaxis (eg, 6 th to 15 th day) was recommended for subsequent cycles.

Populations at risk:

Patients with hepatic insufficiency:

Based on the pharmacokinetic data for docetaxel 100 mg / m 2 monotherapy, the recommended dose of docetaxel in patients with transaminases (ALT and / or ASAT) greater than 1.5 times ULN and alkaline phosphatase greater than 2.5 times the ULN, is 75 mg / m 2 (see sections Warnings and Precautions for Use and Pharmacokinetic Properties ). In patients with bilirubinemia> ULN and / or ASAT and ALT 3.5 times ULN and alkaline phosphatase> 6x ULN, no dose reduction may be recommended and docetaxel should not be used. administered unless strictly indicated.

In the treatment of gastric adenocarcinoma, in combination with cisplatin and 5-fluorouracil, the pivotal study excluded patients with transaminase levels (ASAT and / or ALT)> 1.5 times the ULN associated with alkaline phosphatase> 2.5 times ULN and bilirubin> 1 times ULN: therefore, for these patients, no dose reduction may be recommended and docetaxel should not be administered unless strictly indicated.

There is no data on hepatic impairment treated with docetaxel in combination with other indications.

Children and adolescents:

Use in children is rare.

Elderly

In view of the population pharmacokinetic data, no special precautions are to be taken in the elderly.

In combination with capecitabine, it is recommended that the initial dose of capecitabine be reduced to 75% in subjects 60 years of age or older (see summary of capecitabine product characteristics).

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Docetaxel should not be used in patients with an initial neutrophil count <1500 / mm 3 .

Docetaxel should not be given to pregnant or breastfeeding women.

In the absence of available data, docetaxel should not be administered to patients with severe hepatic impairment (see sections Posology and method of administration and Warnings and precautions for use ).

Also take into account the contraindications of the specialties associated with docetaxel.

Adverse effects Docetaxel Actavis 20 MG / ML

Adverse reactions believed to be possibly or probably related to the administration of docetaxel have been reported in:

· 1312 and 121 patients receiving 100 mg / m² and 75 mg / m² of docetaxel monotherapy, respectively.

· 258 patients who received docetaxel in combination with doxorubicin.

· 406 patients who received docetaxel in combination with cisplatin.

· 92 patients who received docetaxel in combination with trastuzumab.

· 255 patients who received docetaxel in combination with capecitabine.

· 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important and treatment-related adverse events are presented).

· 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically relevant and treatment-related adverse events are presented below).

· 300 patients with gastric adenocarcinoma (221 patients in phase III and 79 patients in phase II) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically relevant and treatment-related adverse events are presented below).

· 174 and 251 patients with upper aerodigestive tract cancer treated with docetaxel in combination with cisplatin and 5-fluorouracil (clinically relevant and treatment-related adverse events are presented below).

These events have been described using the NCI Common Criteria for Toxicity (grade 3 = G3, grade 3-4 = G3 / 4, grade 4 = G4) and COSTART terms. Frequencies are defined as: very common (≥1 / 10), frequent (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100); rare (≥1 / 10, 000, <1/1000); very rare (<1/10000).

Within each frequency group, adverse effects should be presented in order of decreasing severity.

The most commonly observed adverse events when using docetaxel monotherapy are: neutropenia (reversible and non-cumulative, median nadir onset and median duration of severe neutropenia (<500 / mm 3 ) were 7 days), anemia, alopecia, nausea, vomiting, stomatitis, diarrhea and asthenia.

The severity of the undesirable effects of docetaxel may be increased when combined with other cytotoxics.

For association with trastuzumab, adverse effects (all grades) reported in at least 10% of cases are presented. An increase in the incidence of serious adverse events (40% vs. 31%) and Grade 4 adverse events (34% vs. 23%) was observed for the combination with trastuzumab compared with docetaxel monotherapy.

For the combination with capecitabine, the most commonly reported adverse events (≥5%) in a phase III trial in patients treated for breast cancer after failure of treatment with anthracycline are presented (see summary of characteristics of capecitabine).

The following side effects have been commonly observed with docetaxel:

Nervous system disorders:

The occurrence of severe peripheral neurotoxicity requires a dose reduction (see sections Posology and method of administration and Warnings and precautions for use ).

Mild to moderate neurosensory signs are characterized by paresthesia, dysesthesia or pain-like burning sensations. Neuromotor manifestations are mainly characterized by weakness.

Skin and subcutaneous tissue disorders:

Reversible skin reactions were observed and were generally considered mild to moderate. Reactions were characterized by rash with localized eruptions mainly in the feet and hands (including severe hand-foot syndromes) but also in the arms, face or chest, and frequently associated with pruritus. These eruptions usually occurred in the week following the infusion of docetaxel. Severe symptoms such as eruptions followed by desquamation, rarely leading to temporary or definitive discontinuation of docetaxel, have been reported less frequently (see section 4.2). Posology and method of administration and Warnings and Precautions employment ). Severe nail disorders are characterized by hypo or hyperpigmentation of the nails and sometimes pain and onycholysis.

General disorders and administration site defects:

Injection site reactions were generally minor and manifested by hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation, and swelling of the vein.

Fluid retention may result in peripheral edema and, less commonly, pleural effusion, pericardial effusion, ascites, and weight gain. Peripheral edema usually begins in the lower limbs and can be generalized with a weight gain of 3 kg or more. Fluid retention is cumulative in incidence and severity (see sections Warnings and Precautions for Use ).

Immune system disorders:

Hypersensitivity reactions usually occurred within minutes of starting a docetaxel infusion and were usually mild to moderate. The most commonly reported symptoms were flushes, rash with or without pruritus, chest tightness, low back pain, dyspnea and fever or chills. Intense reactions were characterized by hypotension and / or bronchospasm or general rash / erythema (see Warnings and Precautions section ).

DOCETAXEL ACTAVIS 100 mg / m² as monotherapy:

Side effects by

Very common

Frequent

Rare

class-organ system

10% of patients

1 to <10% of

0.1 to <1% of

patients

patients

investigations

Elevation of bilirubin (G3 / 4 <5%); Elevation of alkaline phosphatases (G3 / 4 <4%); Elevation of ASAT (G3 / 4 <3%);

Elevation of ALAT

(G3 / 4 <2%)

Heart conditions

Arrhythmia (G3 / 4: 0.7%)

Heart failure

affections

Neutropenia (G4:

Thrombocytopenia (G4:

hematological and

76.4%);

0.2%)

lymphatic system

Anemia (G3 / 4: 8.9%); Febrile neutropenia

System conditions

Sensory neuropathy

nervous

peripheral

(G3: 4.1%);

Motor neuropathy

peripheral (G3 / 4:

4%);

Dysgeusia (severe 0.07%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea (severe 2.7%)

Gastrointestinal disorders

Stomatitis (G3 / 4: 5.3%);

Constipation (severe:

Esophagitis (severe:

intestinal

Diarrhea (G3 / 4: 4%);

0.2%);

0.4%)

Nausea (G3 / 4: 4%);

Abdominal pain

Vomiting (G3 / 4:

(severe: 1%);

3%)

Gastrointestinal haemorrhage (severe: 0.3%)

Skin disorders and

Alopecia;

subcutaneous tissue

Skin reactions

(G3 / 4: 5.9%);

Alteration of the nails

(severe: 2.6%)

Musculoskeletal and systemic disorders

Myalgia (severe 1.4%)

arthralgia

Metabolism and nutrition disorders

Anorexia

Infections and infestations

Infections (G3 / 4: 5.7%, including sepsis and pneumonia, fatal in 1.7% of cases)

Infection associated with grade 4 neutropenia (G3 / 4: 4.6%)

Vascular disorders

Hypotension; Hypertension Hemorrhage

General disorders and

Water retention

Site reaction

site anomalies

(severe: 6.5%);

injection;

administration

Asthenia (severe:

Chest pain

11.2%);

of non-cardiac origin

pains

(severe: 0.4%)

Immune system disorders

Hypersensitivity (G3 / 4: 5.3%)

Hematological and lymphatic system disorders:

Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.

Nervous system disorders:

Reversibility data are available for 35.3% of patients with neurotoxic manifestations following docetaxel monotherapy at 100 mg / m². These effects were spontaneously reversible within 3 months.

Skin and subcutaneous tissue disorders:

Very rare: 1 case of non-reversible alopecia at the end of the study. 73% of the skin reactions were reversible within 21 days.

General disorders and administration site defects:

For fluid retention, the median cumulative dose at discontinuation was greater than 1000 mg / m² and the median reversal time was 16.4 weeks (range 0 to 42 weeks).

The occurrence of moderate to severe fluid retention is delayed (median cumulative dose: 818.9 mg / m²) in premedicated patients compared to patients who did not receive premedication (median cumulative dose: 489.7 mg / m²); however, this event has been reported in some patients during the first cycles of treatment.

DOCETAXEL ACTAVIS 75 mg / m² monotherapy:

Side effects by system

Very common

Frequent

Organ Class

10% of patients

1 to <10% of patients

investigations

Elevation of bilirubin (G3 / 4 <2%)

Heart conditions

Arrhythmia (never severe)

Blood and lymphatic system disorders

Neutropenia (G4: 54.2%); Anemia (G3 / 4: 10.8%);

Febrile neutropenia

Thrombocytopenia (G4: 1.7%)

Nervous system disorders

Peripheral sensory neuropathy (G3 / 4: 0.8%)

Peripheral motor neuropathy (G3 / 4: 2.5%)

Gastrointestinal disorders

Nausea (G3 / 4: 3.3%);

Constipation

Stomatitis (G3 / 4: 1.7%);

Vomiting (G3 / 4: 0.8%);

Diarrhea (G3 / 4: 1.7%)

Skin and tissue disorders

Alopecia;

Alteration of the nails

subcutaneous

Cutaneous reactions (G3 / 4: 0.8%)

(severe: 0.8%)

Musculoskeletal and systemic disorders

myalgia

Metabolism and nutrition disorders

Anorexia

Infections and infestations

Infections (G3 / 4: 5%)

Vascular disorders

hypotension

General disorders and abnormalities

Asthenia (severe: 12.4%);

at the administration site

Fluid retention (severe:

0.8%);

pains

Immune system disorders

Hypersensitivity (never severe)

DOCETAXEL ACTAVIS 75 mg / m² in combination with doxorubicin

Side effects by

Very common

Frequent

Rare

class-organ system

10% of patients

1 to <10% of

0.1 to <1% of

patients

patients

investigations

Increase of the

Increase in

bilirubin (G3 / 4 <2.5%);

ASAT (G3 / 4 <1%);

Increase in

Increase in

alkaline phosphatase

ALAT (G3 / 4 <1%)

(G3 / 4 <2.5%)

Heart conditions

Heart failure ;

Arrhythmia (never severe)

affections

Neutropenia (G4:

hematological and

91.7%); Anemia (G3 / 4:

lymphatic system

9.4%);

Febrile neutropenia;

Thrombocytopenia (G4:

0.8%)

Nervous system disorders

Peripheral sensory neuropathy (G3: 0.4%)

Peripheral motor neuropathy (G3 / 4: 0.4%)

Gastrointestinal disorders

Nausea (G3 / 4: 5%); Stomatitis (G3 / 4: 7.8%); Diarrhea (G3 / 4: 6.2%);

Vomiting (G3 / 4:

5%); Constipation

Skin disorders and

Alopecia;

subcutaneous tissue

Alteration of the nails

(severe: 0.4%);

Skin reactions

(never severe)

Musculoskeletal and systemic disorders

myalgia

Metabolism and nutrition disorders

Anorexia

Infections and infestations

Infection (G3 / 4: 7.8%)

Vascular disorders

hypotension

General disorders and

Asthenia (severe:

Feedback to the site

site anomalies

8.1%);

injection

administration

Water retention

(severe: 1.2%);

pains

Immune system disorders

Hypersensitivity (G3 / 4: 1.2%)

DOCETAXEL ACTAVIS 75 mg / m² in combination with cisplatin

Side effects by

Very common

Frequent

Rare

class-organ system

10% of patients

1 to <10% of

0.1 to <1% of

patients

patients

investigations

Increase of the

Increase in

bilirubin (G3 / 4: 2.1%);

ASAT (G3 / 4: 0.5%);

Increase in

Increase in

ALAT (G3 / 4: 1.3%)

alkaline phosphatase (G3 / 4: 0.3%)

Heart conditions

Arrhythmia (G3 / 4: 0.7%)

Heart failure

affections

Neutropenia (G4:

Febrile neutropenia

hematological and

51.5%); Anemia (G3 / 4

lymphatic system

6.9%);

thrombocytopenia

(G4: 0.5%)

System conditions

Sensory neuropathy

nervous

peripheral (G3:

3.7%);

Peripheral motor neuropathy (G3 / 4: 2%)

affections

Nausea (G3 / 4: 9.6%);

Constipation

Gastrointestinal

Vomiting (G3 / 4:

7.6%); Diarrhea (G3 / 4:

6.4%);

Stomatitis (G3 / 4: 2%)

Skin disorders and

Alopecia;

subcutaneous tissue

Alteration of the nails

(severe: 0.7%);

Skin reactions (G3 / 4: 0.2%)

Musculoskeletal and systemic disorders

Myalgia (severe: 0.5%)

Metabolism and nutrition disorders

Anorexia

Infections and infestations

Infection (G3 / 4: 5.7%)

Vascular disorders

Hypotension (G3 / 4: 0.7%)

General disorders and

Asthenia (severe:

Feedback to the site

site anomalies

9.9%);

injection;

administration

Water retention

pains

(severe: 0.7%);

Fever (G3 / 4: 1.2%)

Immune system disorders

Hypersensitivity (G3 / 4: 2.5%)

DOCETAXEL ACTAVIS 100 mg / m² in combination with trastuzumab

Side effects by system

Very common

Frequent

Organ Class

10% of patients

1 to <10% of patients

investigations

Increase in weight

Heart conditions

Heart failure

Hematologic disorders and

Neutropenia (G3 / 4: 32%);

lymphatic system

Febrile neutropenia (including neutropenia associated with fever and antibiotic use) or neutropenia with sepsis

Nervous system disorders

Paresthesia Headache;

Dysgeusia; Hypoaesthesia

Eye disorders

Increased tearing Conjunctivitis

Respiratory disorders,

Epistaxis; pains

thoracic and mediastinal

pharyngolaryngeal;

Rhinopharyngitis;

Dyspnoea;

Cough; rhinorrhea

Gastrointestinal disorders

Nausea; Diarrhea;

Vomiting; Constipation;

Stomatitis; Dyspepsia; pains

abdominal

Skin and tissue disorders

Alopecia; Erythema; Rash;

subcutaneous

Alteration of the nails

Musculoskeletal disorders

Myalgia; Arthralgia; pains

and systemic

ends; pains

Bones, Back pain

Metabolism and nutrition disorders

Anorexia

Vascular disorders

lymphedema

General disorders and abnormalities

Asthenia; Peripheral edema;

Lethargy

at the administration site

Fever; Tired ; Inflammation

mucous membranes; Pain;

flu-like syndrome;

Chest pain; Chills

Psychiatric disorders

Insomnia

Heart conditions:

Symptomatic heart failure was reported in 2.2% of patients receiving docetaxel plus trastuzumab, compared to 0% of patients receiving docetaxel alone.

In the docetaxel arm associated with trastuzumab, 64% of patients had previously received anthracycline as adjunctive therapy, compared to 55% in the docetaxel arm alone.

Hematological and lymphatic system disorders:

Very common: Hematologic toxicity was higher in patients receiving trastuzumab and docetaxel than in those receiving docetaxel alone (G 3/4 neutropenia: 32% vs. 22%, based on NCI-CTC criteria). It is possible that these figures are underestimated since according to the nadir blood count, docetaxel monotherapy at the dose of 100 mg / m² is known to cause neutropenia in 97% of patients, 76% of grade 4. The The incidence of febrile neutropenia / neutropenia with sepsis was also increased in patients treated with trastuzumab in combination with docetaxel compared to those treated with docetaxel alone (23% vs. 17%).

DOCETAXEL ACTAVIS 75 mg / m² in combination with capecitabine

Side effects by system

Very common

Frequent

Organ Class

10% of patients

1 to <10% of patients

investigations

Decrease in weight Increased bilirubin (G3 / 4: 9%)

Hematologic disorders and

Neutropenia (G3 / 4: 63%);

Thrombocytopenia (G3 / 4: 3%)

lymphatic system

Anemia (G3 / 4: 10%)

Nervous system disorders

Dysgeusia (G3 / 4: <1%);

Dizziness;

Paresthesia (G3 / 4: <1%)

Headache (G3 / 4: <1%);

Peripheral neuropathy

Eye disorders

Increased tearing

Respiratory disorders,

Pharyngolaryngeal pain

Dyspnoea (G3 / 4: 1%);

thoracic and mediastinal

(G3 / 4: 2%)

Cough (G3 / 4: <1%);

Epistaxis (G3 / 4: <1%)

Gastrointestinal disorders

Stomatitis (G3 / 4: 18%)

Epigastric pain;

Diarrhea (G3 / 4: 14%);

Dryness of the mouth

Nausea (G3 / 4: 6%);

Vomiting (G3 / 4: 4%);

Constipation (G3 / 4: 1%);

Abdominal pain (G3 / 4:

2%); Dyspepsia

Skin and tissue disorders

Hand-foot syndrome (G3 / 4:

Dermatitis;

subcutaneous

24%);

Eruption erythematous (G3 / 4:

Alopecia (G3 / 4: 6%);

<1%); Discoloration of the nails;

Nail Alteration (G3 / 4:

Onycholysis (G3 / 4: 1%)

2%)

Musculoskeletal disorders

Myalgia (G3 / 4: 2%);

Pains of extremities (G3 / 4:

and systemic

Arthralgia (G3 / 4: 1%)

<1%);

Back pain (G3 / 4: 1%);

Metabolism disorders and

Anorexia (G3 / 4: 1%);

Dehydration (G3 / 4: 2%)

nutrition

Decreased appetite

Infections and infestations

Oral candidiasis (G3 / 4: <1%)

General disorders and abnormalities

Asthenia (G3 / 4: 3%);

Lethargy;

at the administration site

Fever (G3 / 4: 1%);

pains

Fatigue / weakness (G3 / 4: 5%);

Peripheral edema (G3 / 4: 1%);

DOCETAXEL ACTAVIS 75 mg / m² in combination with prednisone or prednisolone

Side effects by system

Very common

Frequent

Organ Class

10% of patients

1 to <10% of patients

Heart conditions

Decrease in left ventricular ejection fraction (G3 / 4: 0.3%)

Hematologic disorders and

Neutropenia (G3 / 4: 32%);

Thrombocytopenia; (G3 / 4: 0.6%);

lymphatic system

Anemia (G3 / 4: 4.9%)

Febrile neutropenia

Nervous system disorders

Peripheral sensory neuropathy (G3 / 4 1.2%);

Peripheral motor neuropathy (G3 / 4: 0%)

Dysgeusia (G3 / 4: 0%)

Respiratory disorders,

Increased tearing (G3 / 4: 0.6%)

Eye disorders

Epistaxis (G3 / 4: 0%);

thoracic and mediastinal

Dyspnoea (G3 / 4: 0.6%);

Cough (G3 / 4: 0%)

Gastrointestinal disorders

Nausea (G3 / 4: 2.4%);

Diarrhea (G3 / 4: 1.2%);

Stomatitis / Pharyngitis (G3 / 4:

0.9%);

Vomiting (G3 / 4: 1.2%)

Skin and tissue disorders

Alopecia;

Eruption with desquamation

subcutaneous

Altered nails (never

(G3 / 4: 0.3%)

severe)

Popular Posts

Category Medicinal Products, Next Article