Hemlibra Injection
Emicizumab
105mg
F. Hoffmann-La Roche Ltd.
| Pack size | 1 Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 38149.50 AED |
Available as:
Indications
Hemlibra Injection is used for:
Hemophilia A
Adult Dose
Hemophilia A
Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A with or without factor VIII inhibitors
Loading dose: 3 mg/kg SC qWeek for the first 4 weeks
Maintenance dose
1.5 mg/kg SC qWeek, OR
3 mg/kg SC q2Weeks, OR
6 mg/kg SC q4Weeks
Hepatic impairment
Mild-to-moderate (total bilirubin 1X to ?3X ULN and any AST): Pharmacokinetics are not affected
Child Dose
Hemophilia A
Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients aged newborn and older with hemophilia A with or without factor VIII inhibitors
Loading dose: 3 mg/kg SC qWeek for the first 4 weeks
Maintenance dose
1.5 mg/kg SC qWeek, OR
3 mg/kg SC q2Weeks, OR
6 mg/kg SC q4Weeks
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30-89 mL/min): Pharmacokinetics are not affected
Administration
SC Preparation
Visually inspect vial for particulate matter and discoloration prior to administration; solution appears colorless to slightly yellow; do not use if particulate matter is visible or product is discolored
Do not use different vials of different concentrations when combining vials to administer prescribed dose
SC administration
SC use only
Administer doses of up to 1 mL with a 1-mL syringe (graduation 0.01 mL)
Administer doses >1 mL to ?2 mL with a 2-mL or 3-mL syringe (graduation 0.1 mL)
Contra Indications
Precautions
Cases of TMA reported from clinical trials; improvement was seen within 1 week following discontinuation of aPCC
Thrombotic events reported from clinical trials when on average a cumulative amount of >100 U/kg/24 hr of aPCC was administered for >24 hr to patients receiving emicizumab-kxwh prophylaxis; no thrombotic event required anticoagulation therapy; evidence of improvement or resolution seen within one month following discontinuation of aPCC; consider benefits and risks of emicizumab-kxwh if aPCC must be used in patients receiving the drug or resuming prophylaxis following complete resolution of thrombotic event; monitor for development of thromboembolism when administering aPCC
Pregnancy-Lactation
Pregnancy
No data are available regarding use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
Unknown whether treatment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity
Should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus
Women of childbearing potential should use contraception during treatment
Lactation
No information is available regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production
Human IgG is known to be present in human milk
Interactions
Adverse Effects
Side effects of Emicizumab :
>10%
Injection site reaction (22%)
Headache (15%)
Arthralgia (15%)
Injection site erythema (11%)
1-10%
Pyrexia (6%)
Diarrhea (6%)
Injection site pruritus (4%)
Injection site pain (4%)
<1%
Rhabdomyolysis
Mechanism of Action
Bispecific factor IXa- and factor X-directed antibody that bridges activated factor IX and factor X in order to restore the function of missing activated factor VIII necessary for effective hemostasis
Note
Hemlibra 105mg Injection manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Emicizumab. Hemlibra is availble in United Arab Emirates.
Farmaco UAE drug index information on Hemlibra Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.