ALPROLIX Injection
Factor IX Complex
1000 IU
SWEDISH ORPHAN BIOVITRUM AB (publ)
| Pack size | 1 Glass Vial+ 1 Pre-Filled Syringe (5 ml Solvent) + 1 Plunger Rod + 1 Vial Adapter + 1 Infusion Set + 2 Swabs + 2 Plasters + 1 Gauze |
|---|---|
| Dispensing mode | POM |
| Source | SWEDEN |
| Agent | GULF DRUG LLC |
| Retail Price | 5567.00 AED |
Indications
ALPROLIX Injection is used for:
Hemophilia B or Christmas disease
Adult Dose
Hemophilia B
Management of bleeding
Typical initial doses suggested below; usually two-thirds of initial dose given for maintenance
Minor: Single dose of 25-35 IU/kg IV x 1 dose; may repeat dose after 24 hr
Moderate: 40-55 IU/kg/day IV x 2 days or until adequate wound healing
Major: 60-70 IU/kg/day IV x 2-3 days or until adequate wound healing
Management of surgical procedures
Minor: 50-60 IU/kg IV on day of surgery, decrease to 25-55 IU/kg/day during initial postop period (ie, 1st to 2nd week)
Major: 70-95 IU/kg IV on day of surgery, decrease to 35-70 IU/kg/day during initial postop period (ie, 1st to 2nd week), THEN 25-35 IU/kg/day late postop period (ie, 3rd week onwards)
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Contra Indications
Hypersensitivity to mouse or hamster protein.
Precautions
Caution when used in patients at risk of thromboembolism or disseminated intravascular coagulation. May cause increased risk of intravascular coagulation and thrombosis in patients with hepatic impairment. Risk of viral infection transmission as factor IX complex is a plasma-derived product. Vaccination against hepatitis A and B are recommended in haemophilic patients. Safety and efficacy have not been demostrated in patients < 16 yr. Pregnancy.
Lactation: Unknown if distributed in human breast milk
Pregnancy-Lactation
Pregnancy Category: C
Lactation: Unknown if distributed in human breast milk
Interactions
Adverse Effects
Side effects of Factor IX Complex :
>10%
Headache (10.8%)
1-10%
Dizziness (7.7%), Rash (1.6-7.7%), Injection site pain (6.2%), Nausea (6.2%), Urticaria (3.1-4.8%), Rhinitis (4.6%), Altered taste sense (4.6%), Dyspnea (3.2%), Fever (3.1%), Flushing (3.1%), Allergic reaction (1.5%)
Frequency Not Defined
Lethargy, Altered blood pressure (too rapid infusion), Thrombosis (large dose), Myocardial infarction (large dose), DIC (large dose), Chills, Tingling, Vomiting, Human-derived products: viral infection, Stinging at infusion site (large dose), Hives, Anaphylaxis
Mechanism of Action
Factor IX is used as replacement therapy in patients with haemophilia B whereby there is a genetic deficiency of factor IX.
Note
ALPROLIX 1000 IU Injection manufactured by SWEDISH ORPHAN BIOVITRUM AB (publ). Its generic name is Factor IX Complex. ALPROLIX is availble in United Arab Emirates.
Farmaco UAE drug index information on ALPROLIX Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.