Medicinal Products

AFINITOR 25 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Everolimus
laboratory: Novartis Pharma SA

Compressed
box of 3 blister packs of 10
All forms

Indication

Advanced breast cancer with positive hormone receptors
Afinitor is indicated for the treatment of advanced hormone receptor-positive breast cancer, HER2 / neu-negative, in combination with exemestane, in postmenopausal women without symptomatic visceral involvement following recurrence or progression of the disease and previously treated with a non-inhibitory inhibitor. -stheroidal aromatase.

Neuroendocrine tumors of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic pancreatic neuroendocrine tumors that are well or moderately differentiated with progression of the disease in adults.

Kidney cancer
Afinitor is indicated for the treatment of advanced kidney cancer in patients who have progressed under or after targeted anti-VEGF therapy.

Dosage AFINITOR 25 mg tablet box of 3 blister packs of 10

Advanced breast cancer with positive hormone receptors
Afinitor is indicated for the treatment of advanced hormone receptor-positive breast cancer, HER2 / neu-negative, in combination with exemestane, in postmenopausal women without symptomatic visceral involvement following recurrence or progression of the disease and previously treated with a non-inhibitory inhibitor. -stheroidal aromatase.

Neuroendocrine tumors of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic pancreatic neuroendocrine tumors that are well or moderately differentiated with progression of the disease in adults.

Kidney cancer
Afinitor is indicated for the treatment of advanced kidney cancer in patients who have progressed under or after targeted anti-VEGF therapy.

Against indications

Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients listed under Composition .

Adverse effects Afinitor

Tolerance Profile Summary

The safety profile is derived from the pooled data of 2, 470 Afinitor-treated patients in nine clinical studies, including four randomized, double-blind, placebo-controlled phase III and five phase I and phase II open-label studies. approved indications.

The most common adverse events (incidence ≥ 1/10) from pooled safety data were (in descending order): stomatitis, rash, fatigue, diarrhea, infections, nausea, decreased appetite, anemia, dysgeusia, pneumonitis, hyperglycemia, decreased weight, pruritus, asthenia, peripheral edema, hypercholesterolemia, epistaxis, and headache.

The most common adverse reactions of Grades 3-4 (frequency ≥ 1/100 to <1/10) were: stomatitis, anemia, hyperglycemia, fatigue, infections, pneumonia, diarrhea, asthenia, thrombocytopenia, neutropenia, dyspnoea, lymphopenia, Proteinuria, hemorrhage, hypophosphatemia, rash, hypertension, increase of aspartate aminotransferase (ASAT), increase of alanine aminotransferase (ALT) and pneumonia. Grades follow the CTCAE version 3.0 classification.

List of adverse reactions in tabular form

Table 3 shows the adverse event frequency categories reported in the pooled analyzes taken into account for pooled tolerance. Adverse effects are presented according to MedDRA organ classes and frequency categories. Frequency categories are defined according to the following convention: 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 should be presented in order of decreasing severity.

Table 3 Adverse Reactions Reported in Clinical Studies

Infections and infestations

Very common

Infections a *

Blood and lymphatic system disorders

Very common

Anemia

Frequent

Thrombocytopenia, neutropenia, leukopenia, lymphopenia

Rare

pancytopenia

Rare

Pure red cell aplasia

Immune system disorders

Rare

hypersensitivity

Metabolism and nutrition disorders

Very common

Decreased appetite, hyperglycemia, hypercholesterolemia

Frequent

Hypertriglyceridemia, hypophosphatemia, diabetes mellitus, hyperlipidemia,

hypokalemia, dehydration, hypocalcemia

Psychiatric disorders

Frequent

Insomnia

Nervous system disorders

Very common

Dysgeusia, headache

Rare

ageusia

Eye disorders

Frequent

Edema of the eyelid

Rare

Conjunctivitis

Heart conditions

Rare

Congestive heart failure

Vascular disorders

Frequent

Haemorrhage b, hypertension

Rare

Flushing, deep vein thrombosis

Respiratory, thoracic and mediastinal disorders

Very common

Pneumopathy c, epistaxis

Frequent

Cough dyspnea

Rare

Hemoptysis, pulmonary embolism

Rare

Acute Respiratory Distress Syndrome

Gastrointestinal disorders

Very common

Stomatitis, diarrhea, nausea

Frequent

Vomiting, dry mouth, abdominal pain, mucositis, oral pain, dyspepsia, dysphagia

Hepatobiliary disorders

Frequent

Increased aspartate aminotransferase, increased alanine aminotransferase

Affections of the

skin and subcutaneous tissue

Very common

Rash, itching

Frequent

Skin dryness, nail alteration, mild alopecia, acne, erythema, onychoclasia, hand-foot syndrome, exfoliation, skin lesion

Rare

Angioedema

Musculoskeletal and systemic disorders

Frequent

arthralgia

Renal and urinary disorders

Frequent

Proteinuria *, increased creatinine, renal failure *

Rare

Increased diurnal urination, acute renal failure *

Disorders of reproductive organs and breast

Frequent

Irregular menstruation

Rare

Amenorrhea e

General disorders and administration site conditions

Very common

Fatigue, asthenia, peripheral edema

Frequent

pyrexia

Rare

Non-cardiac chest pain

Rare

Alteration of wound healing

investigations

Very common

Weightloss

* See also the sub-section "Description of certain adverse effects"

a Includes all effects of organ class "infections and infestations" including (frequent) pneumonia and (infrequent) herpes zoster, sepsis and isolated cases of opportunistic infections (eg, aspergillosis, candidiasis, pneumocystis pneumoniae pneumoniae, carinii) (PPJ, CPP) and hepatitis B (see also Warnings and precautions for use )]

b Includes different haemorrhagic events not listed individually

c Includes (frequent) pulmonary interstitial lung disease, pulmonary infiltration and (rare) pulmonary alveolar hemorrhage, pulmonary toxicity and alveolitis

d Includes (very common) stomatitis, (common) canker sores, oral ulcer and tongue and (uncommon) glossodynia, glossitis

e Frequency based on the number of women aged 10 to 55 from pooled data

Description of some adverse effects

In cases reported during clinical studies and spontaneously after marketing, everolimus has been associated with severe cases of reactivation of hepatitis B, including a case of fatal outcome. The reactivation of infections is an expected effect during the immunosuppression phases.

In clinical studies and pharmacovigilance reports for spontaneous notification, everolimus has been associated with reports of renal failure (including fatal outcomes) and proteinuria. Monitoring of renal function is recommended (see section Warnings and precautions for use ).

In cases reported during clinical studies and spontaneously after marketing, everolimus has been associated with amenorrhea (secondary amenorrhea and other menstrual irregularities).

In clinical studies and in post-marketing reports, everolimus has been associated with pneumocystis jirovecii (carinii) pneumonia (PPJ, PPC), some with fatal outcome (see section 4.4). employment ).

In clinical studies and in post-marketing reports, angioedema has been reported with and without concomitant use of ACE inhibitors (see Warnings and Precautions ).

The elderly

When pooling tolerance data, 35% of Afinitor-treated patients were 65 years of age or older. The number of patients with an adverse event that led to discontinuation was higher in patients 65 years and older (19% vs. 13%). The most common adverse events leading to discontinuation were pneumopathies (including interstitial pneumonitis), stomatitis, fatigue and dyspnoea.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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