Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Factor VIII
laboratory: Baxter
set of 1 vial of powder + vial of solvent (+ disp prey) of 2 ml
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 250 IU powder and solvent for solution for injection 1 vial of powder + vial of solvent (+ disp prea) 2 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 | 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.
