Medicinal Products

ABRAXANE 5 mg / ml powder for suspension for injection for infusion box of 1 vial of 100 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Paclitaxel
laboratory: Celgene Europe Limited

Powder for injectable IV suspension for infusion
All forms

Indication

Abraxane is indicated as monotherapy in the treatment of metastatic breast cancer, in adult patients who have failed first-line treatment of metastatic cancer, and for whom standard treatment including an anthracycline is not indicated (see section 4.4). precautions for use ).

Abraxane in combination with gemcitabine is indicated for the first line treatment of adenocarcinoma of the metastatic pancreas in adult patients.

Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and / or radiotherapy.

Dosage ABRAXANE 5 mg / ml powder for suspension for injection for infusion box of 1 vial of 100 mg

Abraxane is indicated as monotherapy in the treatment of metastatic breast cancer, in adult patients who have failed first-line treatment of metastatic cancer, and for whom standard treatment including an anthracycline is not indicated (see section 4.4). precautions for use ).

Abraxane in combination with gemcitabine is indicated for the first line treatment of adenocarcinoma of the metastatic pancreas in adult patients.

Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and / or radiotherapy.

Against indications

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

Breastfeeding (see Pregnancy and lactation ).

Patients with pre-treatment neutrophil count <1500 / mm 3 .

Abraxane side effects

Summary of the security profile

The most common clinically significant adverse events associated with Abraxane were neutropenia, peripheral neuropathy, arthralgia / myalgia, and gastrointestinal disease.

The frequencies of adverse events associated with Abraxane treatment are presented in Table 6 (Abraxane monotherapy), Table 7 (Abraxane in combination with gemcitabine) and Table 9 (Abraxane in combination with carboplatin).

Frequencies are defined as follows: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000). Within each frequency group, adverse effects are presented in descending order of severity.

Breast cancer (Abraxane monotherapy)

Tabulated list of adverse effects

Table 6 lists the adverse events associated with the administration of Abraxane to patients in studies in which Abraxane was administered as monotherapy, all doses and indications combined (N = 789).

Table 6: Adverse Events Reported with Abraxane Monotherapy, Regardless of Dose in Clinical Studies

Infections and infestations

Common: infection, urinary tract infection, folliculitis, upper respiratory infection, candidiasis, sinusitis

Uncommon: oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter placement infection, fungal infection, shingles, infection of the injection site, sepsis 2,

seven icemia on neutropenia 2

Benign, malignant and non-malignant neoplasms

specified (including

cysts and polyps)

Uncommon: metastatic pain, tumor necrosis

affections

hematologic and lymphatic system

Very common: neutropenia, anemia, leukopenia, thrombocytopenia,

lymphopenia, medullary aplasia

Frequent: febrile neutropenia

Rare: pancytopenia

Immune system disorders

Uncommon 1 : hypersensitivity

Rare: severe hypersensitivity

Disorders of

metabolism and the

nutrition

Very common: anorexia

Frequent: dehydration, decreased appetite, hypokalemia

Uncommon: hypophosphatemia, fluid retention, hypoalbuminemia, polydipsia, hyperglycemia, hypocalcemia, hypoglycemia, hyponatremia

affections

psychiatric

Frequent: insomnia, depression, anxiety

Uncommon: agitation

Nervous system disorders

Very common: peripheral neuropathy, neuropathy, hypoaesthesia, paresthesia

Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbances, somnolence

Uncommon: polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, loss of sensation, syncope, postural vertigo, neuropathic pain, tremors

Eye disorders

Common: increased lacrimal secretion, blurred vision,

dry eye, keratoconjunctivitis sicca, madarosis

Uncommon: eye irritation, eye pain, abnormal vision,

decreased visual acuity, conjunctivitis, blurred vision, eye pruritus, keratitis

Rare : cystoid macular edema 2

Affections of the ear and labyrinth

Common: vertigo

Uncommon: ear pain, tinnitus

Heart conditions

Common: tachycardia, arrhythmias, supraventricular tachycardia

Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block 2

Vascular disorders

Common: redness, flushing, hypertension, lymphoedema

Uncommon: hypotension, peripheral cooling, orthostatic hypotension

Rare: thrombosis

Respiratory, thoracic and mediastinal disorders

Frequent: interstitial lung disease 3, dyspnea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhea

Uncommon: productive cough, exercise dyspnea, sinus congestion, decreased respiratory noises, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, rales, pulmonary embolism, pulmonary thromboembolism

Gastrointestinal disorders

Very common: nausea, diarrhea, vomiting, constipation, stomatitis

Common: abdominal pain, abdominal distension, pain

abdominal high, dyspepsia, gastroesophageal reflux, hypoaesthesia

oral

Uncommon: dysphagia, flatulence, glossodynia, dry mouth, gum pain, loose stools, oesophagitis, low abdominal pain, mouth ulcer, oral pain, rectal hemorrhage

Hepatobiliary disorders

Uncommon: hepatomegaly

Skin disorders and

subcutaneous tissue

Very common: alopecia, rash

Frequent: nail disorders, pruritus, dry skin, erythema, dyeing / pigmentation of the nail, hyperpigmentation of the skin, onycholysis, nail changes

Uncommon: sensitivity of the nail bed, urticaria, painful skin,

photosensitivity reaction, pigmentation disorders, pruritic rashes, skin disorders, hyperhidrosis, onychomadesis, erythematous rash, generalized rash, dermatitis, night sweats, maculopapular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, rash macular, papula ire rash, cutaneous lesions,

facial edema

Very rare: Stevens-Johnson syndrome 2, Lyell syndrome 2

Musculoskeletal disorders

skeletal and systemic

Very common: arthralgia, myalgia

Common: extremity pain, bone pain, back pain, muscle cramps, limb pain

Uncommon: chest wall pain, muscle weakness, neck pain, groin pain, muscle spasms, muscular pain

skeletal, flank pain, limb discomfort, weakness

muscular

Renal and urinary disorders

Uncommon: dysuria, pollakiuria, hepatitis, nocturia, polyuria,

urinary incontinence

Disorders of reproductive organs and breast

Uncommon: painful breasts

General disorders and administration site conditions

Very common: fatigue, asthenia, pyrexia

Frequent: peripheral edema, inflammation of the mucosa, pain,

frizz sounds, edema, weakness, decrease in performance index, pain

thoracic, flu syndrome, malaise, lethargy, fever

Uncommon: chest discomfort, abnormal gait, swelling, reaction

at the injection site

Rare: extravasation

investigations

Frequent: weight loss, alanine aminotransferase (ALT) elevation, aspartate aminotransferase (AST) elevation, decreased hematocrit, decreased blood count

red, elevated temperature, increased levels of gamma-glutamyltransferases, elevated blood levels of alkaline phosphatase

Uncommon: elevation of blood pressure, weight gain, elevation

blood lactate dehydrogenase (LDH), elevated serum creatinine, blood glucose, phosphoremia, hypokalemia, hyperbilirubinemia

Injury, poisoning and procedural complications

Uncommon: bruise

Rare: skin reaction by reactivation of the previously irradiated area, radiation pneumonitis

MedDRA = Medical Dictionary for Regulatory Activities - Medical dictionary for regulatory activities.

SMQ = Standardized MedDRA Query - Standard MedDRA Dictionary Query; SMQs are groupings of several MedDRA preferred terms to define a medical concept.

1 The frequency of hypersensitivity reactions is calculated on the basis of a case with definite accountability in a population of 789 patients.

2 Reported as part of post-marketing surveillance of Abraxane.

3 The incidence of pneumonia was calculated from pooled data from 1310 patients included in clinical studies receiving Abraxane monotherapy for breast cancer and other indications, using the MedDRA "interstitial lung disease" SMQ. See Warnings and precautions for use .

Description of some adverse effects

The following adverse reactions are the most frequent and clinically relevant adverse events observed in 229 patients with metastatic breast cancer treated with Abraxane 260 mg / m 2 every three weeks in the Phase III pivotal clinical trial. .

Blood and lymphatic system disorders

Neutropenia was distinguished as

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