Medicinal Products

ARZERRA 1000 mg concentrate for solution for infusion box of 1 vial of 50 ml

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Ofatumumab
laboratory: Glaxosmithkline

Solution for solution for IV infusion
All forms

Indication

Chronic Leukemelymphoid (CLL) not previously treated:

Arzerra is indicated in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior treatment and who are not eligible for fludarabine therapy.

See section Pharmacodynamic properties for more information.

Refractory LLC:

Arzerra is indicated for the treatment of CLL in patients refractory to fludarabine and alemtuzumab.

Dosage ARZERRA 1000 mg concentrate for solution for infusion box of 1 vial of 50 ml

Chronic Leukemelymphoid (CLL) not previously treated:

Arzerra is indicated in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior treatment and who are not eligible for fludarabine therapy.

See section Pharmacodynamic properties for more information.

Refractory LLC:

Arzerra is indicated for the treatment of CLL in patients refractory to fludarabine and alemtuzumab.

Against indications

Hypersensitivity to ofatumumab or to any of the excipients listed under Composition .

Arzerra side effects

Summary of the security profile

The overall safety profile of ofatumumab in CLL (previously untreated, relapsed, or refractory) is based on data collected from 511 patients in clinical trials (see section 5.1 Pharmacodynamic properties ). Of these patients, 250 were treated with ofatumumab alone (patients with relapsed or refractory CLL) and 261 with ofatumumab in combination with an alkylating agent (patients with previously untreated CLL not eligible for fludarabine treatment). .

Tabulated summary of adverse effects

Adverse reactions reported with ofatumumab, alone or in combination with an alkylating agent, are listed by organ class (MedDRA classification) and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10 000) at <1/1000), very rare (<1 / 10, 000) and frequency not known (can not be estimated from the available data). Within each frequency group, adverse effects are presented in descending order of severity.

convention

MedDRA

Very common

Frequent

Rare

Rare

Infections and infestations

Infection of the lower respiratory tract, including pneumonia, upper respiratory tract infection

Sepsis, including neutropenic sepsis and septic shock, herpesvirus infection, urinary tract infection

HBV infection and reactivation of HBV

Blood and lymphatic system disorders

Neutropenia, anemia

Febrile neutropenia, thrombocytopenia, leukopenia

Agranulocytosis, disorders of coagulation, erythroblastopenia, lymphopenia

Immune system disorders

Anaphylactoid reactions *, hypersensitivity *

Anaphylactic shock*

Metabolism and nutrition disorders

Tumor lysis syndrome

Heart conditions

tachycardia *

bradycardia *

Vascular disorders

Hypotension *, hypertension *

Respiratory, thoracic and mediastinal disorders

Bronchospasm *, hypoxia *, dyspnea e *, chest discomfort *, pharyngolaryngeal pain *, cough *, nasal congestion *

Pulmonary edema *

Gastrointestinal disorders

Nausea *

Diarrhea*

Occlusion of the small intestine

Skin and subcutaneous tissue disorders

rash *

Urticaria *, pruritus *, redness *

Musculoskeletal and systemic disorders

Back pain *

General disorders and administration site conditions

Fever *

Cytokine release syndrome *, tremor *, chills *, hyperhidrosis *,
tired*

* These events may be attributable to ofatumumab as part of an infusion-related reaction, typically occurring after the start of the infusion and within 24 hours of completion of the infusion (see Warnings and Precautions section). employment ).

Description of some adverse effects

Infusion-related reactions

The most common adverse events observed in patients treated with ofatumumab in clinical trials were infusion-related reactions in 68% (348/511) of patients at any time during treatment. The majority of infusion-related reactions were grade 1 or grade 2. Eight percent of patients experienced a grade ≥3 infusion reaction at any time during treatment. Two percent of the infusion-related reactions required discontinuation of treatment. No reaction related to the perfusion of fatal outcome has been reported (see Warnings and Precautions ).

infections

Of the 511 patients treated with ofatumumab in clinical trials, 300 (59%) had an infection, including bacterial, viral, or fungal infections. One hundred and four (20%) of the 511 patients had grade ≥3 infections. Twenty-eight (5%) of the 511 patients had a life-threatening infection.

neutropenia

Of the 511 patients treated with ofatumumab in clinical trials, 139 (27%) experienced an adverse event associated with decreased neutrophils; 118 (23%) of the 511 patients experienced grade ≥3 adverse events associated with decreased neutrophils. Forty-two (8%) experienced a serious adverse event associated with decreased neutrophils.

In a pivotal study in patients with previously untreated CLL (OMB110911), prolonged neutropenia (defined as unresolved Grade 3 or 4 neutropenia between 24 and 42 days after the last dose) was reported in 41 patients ( 23 patients treated with ofatumumab in combination with chlorambucil, and 18 patients treated with chlorambucil alone). Late neutropenia, defined as grade 3 or 4 neutropenia occurring at least 42 days after the last dose, was reported in nine patients treated with ofatumumab in combination with chlorambucil, and three patients treated with chlorambucil alone.

Cardiovascular effects

The effect of multiple dose administration of Arzerra on the QTc interval was evaluated in a pooled analysis of three open-label clinical studies in patients with CLL (N = 85). In this pooled analysis, median / mean QT / QTc interval prolongations of more than 5 msec were observed. No significant changes in the mean QTc interval (ie> 20 milliseconds) were observed. No patients had QTc prolongation> 500 msec. No prolongation of the QTc dependent concentration was detected.

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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