Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Alpha1-antitrypsin
laboratory: Labo F. Fraction Biotechn
Powder and solvent for solution for injection
Box of 1 Bottle of powder (+ disp.transfer) + fl of solvent of 120 ml
This medicinal product is indicated for the substitution treatment of severe forms of primary alpha-1 antitrypsin deficiency in subjects with phenotype PiZZ or PiSZ with pulmonary emphysema.
Dosage ALFALASTIN 33.33 mg / mL Powder and solvent for solution for injection Box of 1 vial of powder (+ disptransfer) + fl of solvent of 120 ml
Treatment should be started as soon as possible when the first signs of emphysema appear.
This treatment is to be continued:
· Continuously, especially in cases of highly progressive emphysema,
· Either by discontinuous cures during bronchopulmonary infectious outbreaks.
Continuous or recurrent exposure to aerocontaminants that may increase intrapulmonary protease load is the only known factor in the development of emphysema. Stopping smoking is therefore imperative and protection of the subject against potential professional air contaminants is strongly recommended.
A dose of 60 mg / kg of ALFALASTIN injected once a week, intravenously, provides a plasma level of alpha-1 antitrypsin comparable to that of non-deficient subjects.
Alpha-1 antitrypsin assays should be performed on the patient once a month for the first six months of treatment and then every three to four months thereafter. The doses to be injected will eventually be corrected so as to maintain a minimum plasma level of 11 μM (0.50 g / l) at 15 μM (0.70 g / l).
Method and route of administration
ALFALASTIN is a powder to be reconstituted extemporaneously with water for injections, according to the procedures described in the section Instructions for use, handling and disposal .
ALFALASTIN should be injected intravenously, all at once, immediately after reconstitution, without exceeding a flow rate of 4 ml / min.
Hypersensitivity to one of the constituents of the preparation.
Alfalastin side effects
The frequency of adverse events was defined according to the following criteria: very common (≥1 / 10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10 000 to <1/1000) and very rare (<1/10 000), unknown (can not be calculated from the available data).
Unknown frequency: dyspnoea
Skin and subcutaneous tissue disorders
Unknown frequency: rash, hives.
Immune system disorders
Unknown frequency: Hypersensitivity
Nervous system disorders
Unknown frequency: headache, drowsiness
Musculoskeletal and systemic disorders
Unknown frequency: myalgia
Unknown frequency: hypotension, hypertension
General disorders and administration site conditions
Unknown frequency: Localized edema, generalized edema, pain at the injection site.
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 declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.