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