Medicinal Products

BENLYSTA 120 mg

Generic drug of the therapeutic class: Immunology
active ingredients: Bélimumab
laboratory: Glaxo Group Ltd

Powder for concentrate for solution for infusion IV
Box of 1 vial of 120 mg
All forms

Indication

Benlysta, in combination with usual therapy, is indicated in adult patients with active systemic lupus with autoantibodies and elevated disease activity (eg defined by the presence of anti-native DNA antibodies and a low complement). ) despite standard treatment (see section 5.1 Pharmacodynamic properties ).

Dosage BENLYSTA 120 mg Powder for concentrate for solution for infusion IV Box of 1 vial of 120 mg

Benlysta treatment should be initiated and monitored by a physician experienced in the diagnosis and treatment of systemic lupus. Benlysta infusions should be administered by a qualified healthcare professional trained in the administration of infusion therapy. Administration of Benlysta may cause hypersensitivity reactions and infusion-related reactions that are severe or life-threatening. The occurrence of symptoms of acute hypersensitivity has been reported in patients several hours after administration of the infusion. A reappearance of clinically significant reactions after appropriate initial symptomatic treatment has also been observed (see Warnings and Precautions and Adverse Reactions sections). Therefore, Benlysta must be administered in an environment with the necessary means to deal with this type of reaction immediately. Patients should remain under medical supervision for a prolonged period (several hours), after the first 2 infusions at least considering the possibility of a delayed reaction.

Patients taking Benlysta should be informed of the potential risk of severe or life-threatening hypersensitivity and the possibility of delayed onset or recurrence of symptoms. The package leaflet should be provided to the patient at each Benlysta administration (see Warnings and Precautions section ).

There is virtually no data available on the effects of Benlysta in patients with systemic lupus with active and severe lupus nephropathy or with active and severe manifestations of the central nervous system (CNS). Benlysta can not therefore be recommended for treating these forms of systemic lupus (see Warnings and Precautions ).

Dosage

Premedication with an antihistamine, with or without antipyretic, may be given prior to Benlysta infusion (see Warnings and Precautions ).

The recommended dosage of Benlysta is 10 mg / kg on days 0, 14 and 28 of treatment followed by every 4 weeks.

The condition of the patient should be regularly evaluated. Stopping treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment with Benlysta.

Special Populations

Elderly (> 65 years old)

The efficacy and safety of Benlysta have not been established in the elderly. Data for subjects over 65 years old represent less than 1.6% of the study population. The use of Benlysta in elderly patients is therefore not recommended unless the expected benefits outweigh the risks. If administration of Benlysta to elderly patients is deemed necessary, no dose adjustment is required (see section 5.2 ).

Renal failure

Belimumab has been evaluated in a limited number of patients with systemic lupus with renal impairment.

Based on the available information, no dose adjustment is required in patients with mild, moderate or severe renal impairment. However, caution is advised in patients with severe renal impairment due to the lack of data in this population (see section 5.2 ).

Hepatic insufficiency

No specific studies have been conducted with Benlysta in patients with hepatic impairment. Dose adjustment is unlikely to be necessary in these patients (see section Pharmacokinetic properties ).

Pediatric population

Tolerance and efficacy of Benlysta in children (under 18 years of age) have not been evaluated. No data available.

Administration mode

Benlysta is given as an intravenous infusion and should be reconstituted and diluted prior to administration. For reconstitution, dilution and storage instructions prior to administration, see section Instructions for use, handling and disposal .

Benlysta must be administered by infusion for 1 hour.

Benlysta should not be administered by intravenous bolus injection.

The infusion rate may be slowed or the infusion interrupted if the patient develops an infusion reaction. The infusion should be discontinued immediately if the patient experiences a life-threatening adverse event (see Warnings and Precautions and Adverse Reactions sections).

Against indications

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

Benlysta side effects

Tolerance Profile Summary

The safety of Benlysta in patients with systemic lupus was assessed in 3 placebo-controlled studies.

The data below describe exposure to Benlysta at 10 mg / kg in 674 patients with systemic lupus, of whom 472 were exposed for at least 52 weeks. Tolerance data presented cover periods of up to 52 weeks in some patients. Benlysta was administered to these patients by intravenous infusion for 1 hour, at 10 mg / kg, on days 0, 14 and 28, then every 28 days for 52 weeks.

The majority of patients also received one or more concomitant treatments for systemic lupus such as: steroids, immunosuppressants, antimalarials, nonsteroidal anti-inflammatory drugs.

Adverse events were reported in 93% of patients treated with Benlysta and 92% of patients on placebo. The most commonly reported adverse events (incidence of at least 10% in patients with systemic lupus treated with Benlysta in combination with standard treatments and at least 1% greater than the placebo arm) were nausea, diarrhea, and fever. The proportion of patients who discontinued treatment due to adverse events was 7% for both Benlysta and placebo treated patients.

Tabulated summary of adverse effects

Adverse effects are presented below according to the MedDRA system organ classification and frequency. The frequency categories used are:

Very common> 1/10

Frequent ≥ 1/100 to <1/10

Uncommon ≥ 1/1000 to <1/100
Rare ≥ 1/10 000 to <1/1000

In each frequency group, adverse effects are presented in order of decreasing severity.

Organ system

Frequency

Side effects)

Infections and infestations

Very common

Bacterial infections, for example, bronchitis, cystitis.

Frequent

Viral gastroenteritis, pharyngitis, nasopharyngitis

Blood and lymphatic system disorders

Frequent

leukopenia

Immune system disorders

Frequent

Hypersensitivity reactions *

Rare
Rare

Anaphylactic reaction, angioedema

Delayed non-acute hypersensitivity reactions

Psychiatric disorders

Frequent

Depression, insomnia

Nervous system disorders

Frequent

Migraine

Gastrointestinal disorders

Very common

Diarrhea, nausea

Skin and subcutaneous tissue disorders

Rare

Urticaria, rash

Musculoskeletal disorders and connective tissue diseases

Frequent

Pain at the extremities

General disorders and administration site conditions

Frequent

Infusion-related reactions *, fever

* 'Hypersensitivity reactions' include a set of terms including anaphylaxis, and may be manifested by various symptoms such as: hypotension, angioedema, urticaria or other rash, pruritus and dyspnea.

'Infusion-related reactions' include a set of terms that can be manifested by various symptoms such as: bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, vertigo and arthralgia.

Because of the similarity of signs and symptoms, it is not always possible to differentiate hypersensitivity reactions from infusion-related reactions.

Description of some adverse effects

Infusion Reactions and Hypersensitivity Reactions: The incidence of infusion-related reactions and hypersensitivity reactions occurring on the day of infusion or during infusion was 17% in the Benlysta group and 15% in the the placebo group, and 1% and 0.3% respectively, required a definitive cessation of treatment. These reactions have generally been observed on the day of the infusion, but acute hypersensitivity reactions may also occur the following day. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk for reactions.

Infections: The overall incidence of infections was 70% in the Benlysta group and 67% in the placebo group. Infections occurring in at least 3% of patients receiving Benlysta and at an incidence greater than 1% greater than incidence in the placebo arm were: nasopharyngitis, bronchitis, pharyngitis, cystitis, and viral gastroenteritis. Five percent of patients receiving Benlysta or placebo had serious infections. Infections leading to discontinuation occurred in 0.6% of patients receiving Benlysta and 1% of those receiving placebo. Opportunistic infections have been reported in patients treated with Benlysta.

Leukopenia: The reported incidence of leukopenia as an adverse event was 4% in the Benlysta group and 2% in the placebo group.

Psychiatric disorders: Insomnia occurred in 7% of patients treated with Benlysta and 5% in those receiving placebo. Depression was reported in 5% of patients treated with Benlysta and 4% in those receiving placebo.

Gastrointestinal Disorders: Overweight patients (BMI> 30 kg / m 2 ) treated with Benlysta were more likely to experience nausea, vomiting, and diarrhea than those treated with placebo compared to normal weight patients (BMI ≥ 18.5 at ≤ 30 kg / m 2 ). None of the gastrointestinal disorders that occurred in overweight patients was serious.

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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