Medicinal Products

ADVATE 2000 UI

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Factor VIII
laboratory: Baxter

Powder and solvent for solution for injection
set of 1 vial of powder + 5 ml solvent bottle (+ disp prey)
All forms

Indication

Treatment and prophylaxis of hemorrhagic episodes in patients with hemophilia A (congenital factor VIII deficiency). ADVATE is indicated in all age groups.

Posology ADVATE 2000 IU powder and solvent for solution for injection 1 vial of powder + vial of solvent (+ disp prey) 5 ml

Treatment and prophylaxis of hemorrhagic episodes in patients with hemophilia A (congenital factor VIII deficiency). ADVATE is indicated in all age groups.

Against indications

Hypersensitivity to the active substance, to any of the excipients listed under Composition, or to hamster or mouse proteins.

Advate side effects

Summary of the safety profile

ADVATE clinical trials included 418 subjects with at least one exposure to ADVATE; a total of 93 adverse events have been reported. The most common adverse events observed were the development of neutralizing antibodies to factor VIII (inhibitors), headache and fever.

Hypersensitivity or allergic reactions (which may include: angioedema, burning and injection site sting, chills, redness, generalized urticaria, headache, urticaria, hypotension, lethargy, nausea, agitation, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been rarely observed and may, in some cases, progress to severe anaphylaxis (including shock).

The appearance of antibodies directed against mouse and / or hamster proteins can be observed in connection with hypersensitivity reactions.

Patients with hemophilia A may develop neutralizing antibodies (inhibitors) of factor VIII. The appearance of inhibitors is manifested by an insufficient clinical response. In this case, it is recommended to contact a specialized hemophilia center.

Summary Table of Adverse Reactions

Table 2 below shows the frequency of adverse reactions from clinical studies and spontaneous reports. This chart is presented in accordance with the MedDRA Organ System Classification. (CSO and recommended term).

Frequency was defined according to the following criteria: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1 000) and very rare (<1 / 10, 000), not known (can not be estimated from the available data). In each frequency group, adverse effects are presented in order of decreasing severity.

Table 2: Frequency of Adverse Events from Clinical Studies and Spontaneous Reporting

MedDRA standard

Classes of organ systems

Side effects

Frequency of adverse effects a

Infections and infestations

Influenza

Rare

Laryngitis

Rare

Blood and lymphatic system disorders

Inhibition of factor VIII

Frequent

lymphangitis

Rare

Immune system disorders

Anaphylactic reaction

Not known frequency

Hypersensitivity c

Not known frequency

Affection of the nervous system

Headache

Frequent

Dizziness

Rare

Memory problems

Rare

Syncope

Rare

tremors

Rare

Migraine

Rare

dysgeusia

Rare

Eye disorders

Inflammation of the eyes

Rare

Heart conditions

palpitations

Rare

Vascular disorders

hematoma

Rare

Hot flashes

Rare

Pallor

Rare

Respiratory, thoracic and mediastinal disorders

dyspnoea

Rare

Gastrointestinal disorders

diarrhea

Rare

Abdominal pain

Rare

nausea

Rare

vomiting

Rare

Skin and subcutaneous tissue disorders

itching

Rare

rash

Rare

Hyperhidrosis

Rare

Urticaria

Rare

General disorders and administration site conditions

pyrexia

Frequent

Peripheral edema

Rare

Chest pain

Rare

Chest discomfort

Rare

Chills

Rare

Abnormal condition

Rare

Hematoma at the site of vascular puncture

Rare

Tired

Not known frequency

Reaction at the injection site

Not known frequency

Discomfort

Not known frequency

investigations

Increase in the number of
monocytes

Rare

Decrease in coagulation factor VIII b

Rare

Decreased hematocrit

Rare

Abnormal biological test

Rare

Injury, poisoning and procedural complications

Post-procedure complication

Rare

Post-procedure hemorrhage

Rare

Reaction on the site of the intervention

Rare

a) Calculated on the basis of the total number of patients who received ADVATE (418).

b) The unexpected decrease in plasma factor VIII coagulant activity occurred in a patient on continuous ADVATE infusion after surgery (10-14 postoperative days). Hemostasis was maintained at all times during this period. Factor VIII activity and clearance returned to normal at D15. Factor VIII inhibitor investigations performed at the end of continuous infusion and at the end of the study were negative.

c) Adverse effect explained in the section below.

Description of some adverse effects

Inhibitor development

The development of inhibitors has been reported in previously treated patients (PTPs) and in previously untreated patients (PUPs). For further details, refer to the sections Pharmacodynamic properties ( Pharmacological properties) and Warnings and precautions for use (Special warnings and precautions for use).

Residual effects specific to residues in the manufacturing process

Of the 229 treated patients, for whom antibody levels against Chinese hamster ovary (CHO) proteins were assessed, 3 cases of statistically significant increase in titre, 4 cases of prolonged peaks were observed. or temporary and a patient who presented both at the same time but without any clinical symptoms. Of the 229 patients treated, for whom antibodies to murine IgG were evaluated, 10 cases of statistically significant increases in antibodies to murine antigens, 2 cases of prolonged or temporary peaks, and one patient were observed. who presented both at once. In four of these patients, isolated cases of urticaria, pruritus, rash and mildly elevated eosinophil counts were observed during repeated exposures to the product during the study.

hypersensitivity

Allergic-type reactions include anaphylaxis and have occurred in the form of dizziness, paresthesia, rash, flushing, facial swelling, urticaria and pruritus.

Pediatric population

In addition to the development of inhibitors in previously untreated pediatric patients (PUPs) and catheter-related complications, no differences in age-related adverse events were observed in clinical studies.

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 through the national reporting system listed in Annex V.

Popular Posts

Category Medicinal Products, Next Article