Hemlibra SC Injection 105 mg/0.7 ml Introduction
Hemlibra SC Injection 105 mg/0.7 ml (Hembirel) is a novel monoclonal antibody (MAB) designed to treat and prevent bleeding episodes in people with hemophilia A (classic hemophilia). It is the first medicine of its kind that works by bringing together two different clotting molecules so the body can form a blood clot. The medicine is specifically designed to help those with hemophilia A who have developed inhibitors to Factor VIII (FVIII) because of the repeated administration of FVIII.
Uses for Hemlibra SC Injection 105 mg/0.7 ml
Hemlibra SC Injection 105 mg/0.7 ml is approved for the prevention and treatment of bleeding episodes and routine prophylaxis of bleeding episodes in adults and children (from 12 years of age and older) with hemophilia A (classic hemophilia) with factor VIII (FVIII) inhibitors. Hemlibra SC Injection 105 mg/0.7 ml is also approved for the prophylactic treatment of bleeding episodes in children from six weeks of age, and under 12 years of age with hemophilia A with or without FVIII inhibitors, when other treatments cannot be used.
Mechanism of action
Hemlibra SC Injection 105 mg/0.7 ml is a specific antibody which works by preventing excessive bleeding by bringing together two different clotting molecules. The medicine helps the body form a clot by binding to and activating clotting factors IXa and X, promoting clot formation and formation of a stable clot.
How long does it take to work?
Hemlibra SC Injection 105 mg/0.7 ml starts to work within hours of administration, although it may take a few days for the medicine to be completely effective.
Absorption
After subcutaneous administration, emicizumab is rapidly absorbed with an average time to peak concentration of 2 hours.
Route of Elimination
Hemlibra SC Injection 105 mg/0.7 ml is eliminated through the kidneys and liver. After metabolism by the liver, the majority of emicizumab is excreted in the urine as metabolites.
Dosage
Recommended loading dose is 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of:- 1.5 mg/kg once every week, or
- 3 mg/kg once every two weeks, or
- 6 mg/kg once every four weeks.
The recommended dosage for emicizumab is:
Administration
Hemlibra SC Injection 105 mg/0.7 ml is administered as a subcutaneous injection. Injections should be administered in the abdomen or thigh and following the directions in the patient information provided.
Side Effects
Common side effects of emicizumab include injection site reactions, headache, and nausea. Rare side effects include thrombotic microangiopathy, thrombocytopenia, and other serious blood disorders. Medical advice should be sought if any of these side effects occur.
Toxicity
Hemlibra SC Injection 105 mg/0.7 ml has not been shown to be toxic to humans. However, there are potential risks of thrombotic microangiopathy, thrombocytopenia, and other serious blood disorders, which could be related to the interaction between emicizumab and components of the clotting cascade.
Precaution
Patients taking emicizumab should always have their hemophilia monitored. Regular tests should be performed to check the clotting ability of the blood. In addition, patients should be alert for signs and symptoms such as headache, nausea, vomiting, excessive bleeding, or jaundice.
Interaction
Hemlibra SC Injection 105 mg/0.7 ml should not be used with other anticoagulants or blood thinners. Also, patients should avoid taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) while using emicizumab.
Disease Interaction
Hemlibra SC Injection 105 mg/0.7 ml has not been shown to interact with any other diseases or conditions. However, if you have any other medical problems, make sure to consult your healthcare provider prior to starting therapy.
Drug Interaction
Hemlibra SC Injection 105 mg/0.7 ml may interact with certain medications like aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Make sure to consult with your healthcare provider about your medications before starting therapy with emicizumab.
Food Interactions
Hemlibra SC Injection 105 mg/0.7 ml does not interact with food. Patients may eat normally while taking emicizumab.
Pregnancy Use
Hemlibra SC Injection 105 mg/0.7 ml has not been studied in pregnant women. Therefore, pregnant women should consult their healthcare provider prior to starting therapy.
Lactation Use
Hemlibra SC Injection 105 mg/0.7 ml has not been studied in lactating mothers. Therefore, lactating mothers should consult their healthcare provider prior to starting therapy.
Acute Overdose
If an overdose of emicizumab is suspected, seek medical advice. The symptoms of an overdose may include nausea, vomiting, and other gastrointestinal symptoms.
Contraindication
Hemlibra SC Injection 105 mg/0.7 ml is contraindicated in patients who are hypersensitive to the active ingredient, or any of the excipients of the product.
Use Direction
Hemlibra SC Injection 105 mg/0.7 ml is intended for subcutaneous injection. Injections should be administered following the directions in the patient information provided.
Storage Condition
Product should be stored in a refrigerator at a temperature of 2-8°C.
Volume of Distribution
The volume of distribution for emicizumab is 4 L.
Half Life
The half-life of emicizumab is approximately 22 days.
Clearance
The clearance of emicizumab is approximately 91 mL/day.
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