Medicinal Products

ELOCTA 1500 UI

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Factor VIII
laboratory: Biogen Idec Limited

Powder and solvent for solution for injection
box of 1 vial of powder + 3 ml solvent syringe
All forms

Indication

Treatment and prophylaxis of haemorrhagic episodes in patients with Haemophilia A (Factor VIII Congenital Deficiency).

ELOCTA is indicated in all age brackets.

Dosage ELOCTA 1500 IU powder and solvent for solution for injection 1 bottle of powder + 3 ml solvent syringe

Treatment and prophylaxis of haemorrhagic episodes in patients with Haemophilia A (Factor VIII Congenital Deficiency).

ELOCTA is indicated in all age brackets.

Against indications

Hypersensitivity to the active substance (recombinant human coagulation factor VIII and / or Fc fragment) or to any of the excipients listed under Composition .

Elocta side effects

Summary of the security profile

Hypersensitivity or allergic reactions (manifested by symptoms such as: swelling of the face, rash, hives, chest tightness and difficulty breathing, burning and stinging at the infusion site, chills flushing, generalized urticaria, headache, hypotension, lethargy, nausea, agitation, tachycardia) have been observed in rare cases and may, in some cases, progress to severe anaphylaxis (including shock).

Patients with hemophilia A may develop neutralizing antibodies (inhibitors) of factor VIII. The detection of inhibitors will be manifested by an insufficient clinical response. It is recommended to contact a specialized hemophilia center.

List of undesirable effects

The frequencies shown in Table 2 below were observed in a total of 233 patients with severe hemophilia A in Phase III clinical trials and one extension study. The total number of days of exposure was 34, 746, with a median of 129 (range: 1-326) days of exposure per subject.

Table 2 below presents the adverse effects according to the MedDRA system organ classification (organ system classes and recommended terms).

Frequencies are defined according to the following criteria: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1 / 10, 000, <1/1000), very rare (<1 / 10, 000), not known (can not be estimated from available data).

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

Table 2: Adverse Events Reported with ELOCTA in Clinical Trials

Classes of MedDRA Organ Systems

Side effects

Frequency

Nervous system disorders

headaches

Dizzying sensation Dysgueusie

Rare

Rare

Rare

Heart conditions

bradycardia

Rare

Vascular disorders

Hypertension

Hot flashes Angiopathie 1

Rare

Rare

Rare

Respiratory, thoracic and mediastinal disorders

Cough

Rare

Gastrointestinal disorders

Abdominal pain

low

Rare

Skin and subcutaneous tissue disorders

Skin rash

Rare

Musculoskeletal and systemic disorders

arthralgia

myalgia

Back pain

Joint swelling

Rare

Rare

Rare

Rare

General disorders and administration site conditions

Discomfort

Chest pain Sensation of cold Sensation of heat

Rare

Rare

Rare

Rare

investigations

Presence of anti-factor VIII antibodies

Rare

Injury, poisoning and procedural complications

Hypotension related to the procedure

Rare

1 Terms used by the investigator: vascular pain after injection of ELOCTA

2 An adult subject tested positive for anti-factor VIII antibodies, which coincided with a single measurement of neutralizing antibody titer of 0.73 Bethesda units / mL in week 14. The presence of Neutralizing antibody was not confirmed when the test was repeated 18 days later and the test was negative on subsequent visits. An increase in clearance (CL) was noted in week 14 but it returned to normal when continuing treatment with rFVIIIFc.

Post-marketing data

After commercialization, an appearance of FVIII inhibitors has been reported.

Pediatric population

Regarding adverse effects, there was no difference between pediatric and adult populations.

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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