Medicinal Products

BENDAMUSTINE ACCORD 25 mg / mL powder for solution to be diluted for infusion box of 5 vials of 10 ml

Levact Generic Drug
Therapeutic class: Oncology and hematology
active ingredients: Bendamustine
laboratory: Accord Healthcare France

Powder for solution to be diluted for infusion IV
All forms

Indication

First-line treatment of chronic lymphocytic leukemia (Binet B or C stage) in patients who do not use a combination chemotherapy with fludarabine.

Treatment in monotherapy of indolent non-Hodgkin's lymphoma in progression, during or within 6 months, in patients who have received rituximab alone or in combination.

First-line treatment of multiple myeloma (stage II progression or stage III Durie-Salmon classification) in combination with prednisone in patients over 65 who are not eligible for autologous stem cell transplantation and who present neuropathy at the time of diagnosis excluding the use of treatment with thalidomide or bortezomib.

Dosage BENDAMUSTINE ACCORD 25 mg / mL powder for solution to be diluted for infusion box of 5 vials of 10 ml

First-line treatment of chronic lymphocytic leukemia (Binet B or C stage) in patients who do not use a combination chemotherapy with fludarabine.

Treatment in monotherapy of indolent non-Hodgkin's lymphoma in progression, during or within 6 months, in patients who have received rituximab alone or in combination.

First-line treatment of multiple myeloma (stage II progression or stage III Durie-Salmon classification) in combination with prednisone in patients over 65 who are not eligible for autologous stem cell transplantation and who present neuropathy at the time of diagnosis excluding the use of treatment with thalidomide or bortezomib.

Against indications

Hypersensitivity to bendamustine hydrochloride or to any of the excipients (see section Composition );

Breastfeeding;

Severe hepatic insufficiency (serous bilirubin> 3.0 mg / dl);

IctÞre;

Severe myelosuppression and significant abnormality in blood count (white blood cell and / or platelet count <3, 000 / l or <75, 000 / l, respectively);

Heavy surgery less than 30 days before the start of treatment;

Infections, especially in case of leucopenia;

Vaccination against yellow fever.

Adverse effects Bendamustine Accord

The most common undesirable effects of bendamustine hydrochloride are haematological reactions (leukopenia, thrombopenia), dermatological toxicity (allergic reactions), general symptoms (fever) and gastrointestinal effects (nausea, vomiting).

The table below lists the data collected during clinical trials with bendamustine hydrochloride.

MedDRA
organ system class

very good
(≥1 / 10)

Frequent (≥1 / 100,
<1/10)

little frequent
(≥1 / 1000,
<1/100)

rare (≥1 / 10, 000,
<1/1000)

very rare
(<1 / 10, 000)

FrÚquence
indÚterminÚe
(can not be
estimated on the
basis of
donnÚes
available)

Infections and
infestations

Infection
SAP *

SepticÚmie

Primary atypical pneumonitis

You die
bÚnignes,
malignant

Tumor lysis syndrome

affections
hÚmatologique
s and
systÞme
lymphatic

LeucopÚnie
SAP *
thrombopÚnie

HÚmorragie,
anÚmie,
neutropÚnie

HÚmolyse

Affections of
systÞme
immune

SAP hypersensitivity reaction *

Anaphylactic reaction,
anaphylactoid reaction

Anaphylactic shock

Affections of
systÞme
nervous

Insomnia

Drowsiness,
aphonia

dysgeusia
paresthÚsie,
Peripheral sensory neuropathy,
anticholinergic syndrome,
neurological disorders,
ataxia,
encÚphalite

affections
heart

Heart problems, such as
palpitations,
angina pectoris,
arrhythmia

effusion
pÚricardique

tachycardia,
infarction
infarction,
insufficiency
cardiac

affections
vascular

hypotension,
hypertension

Acute circulatory insufficiency

PhlÚbite

affections
respiratory,
thoracic and
mÚdiastinales

Pulmonary insufficiency

Pulmonary fibrosis

affections
gastrointestinal
intestinal

NausÚes,
vomiting

DiarrhÚe,
constipation,
stomatitis

Esophageal hemorrhage,
gastrointestinal bleeding

Affections of
skin and
sub-fabric
cutanÚ

AlopÚcie,
SAP skin disorders *

ErythÞme,
dermatitis,
pruritus,
Maculopapular rash,
rash,
hyperhidrosis

Affections of
organs of
reproduction and
breast

AmÚnorrhÚe

InfertilitÚ

unrest
general and
anomalies at
site
'administration

Inflammation of the mucous membranes,
fatigue, fever

Pain, chills,
dÚshydratation,
anorexia

Multi-organ failure

investigations

Decrease in hemoglobin levels,
increased cretatin and urea

Increased ASAT / ALT, alkaline phosphatase, bilirubin, hypokalemia

* SAP: without further precision.

A small number of cases of Stevens-Johnson syndrome and toxic epidermal necrosis have been reported in patients treated with bendamustine in combination with allopurinol or in combination with allopurinol and rituximab.

The CD4 / CD8 ratio can be decreased. A decrease in the number of lymphocytes has been brought to light. In immunocompromised patients, the risk of infection may be increased (eg with shingles virus).

After accidental extra-vascular administration, isolated cases of necrosis have been reported, as well as toxic epidermal necrosis, tumor lysis syndrome and anaphylaxis.

Cases of secondary tumors have been reported including myelodysplastic syndrome, myeloproliferative diseases, acute myeloid leukemia and bronchial carcinoma. The relationship with treatment with bendamustine hydrochloride has not been determined.

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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