ALHEMO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALHEMO (ALHEMO).
Antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein; replaces missing factor VIII in hemophilia A, providing hemostasis via activation of factor X to Xa and conversion of prothrombin to thrombin.
| Metabolism | Degraded by proteases; not metabolized by CYP450 enzymes. |
| Excretion | ALHEMO (efanesoctocog alfa) is cleared primarily via catabolism; renal excretion is minimal (<5%). No biliary or fecal data available. |
| Half-life | Terminal elimination half-life is 47 hours (range 39–56 hours) in adults, enabling prophylactic dosing every 4 days for hemophilia A. |
| Protein binding | ~98% bound to von Willebrand factor (VWF) via covalent linker; no other significant protein binding. |
| Volume of Distribution | Vd is approximately 0.04 L/kg (plasma volume), indicating primarily intravascular distribution with minimal extravascular penetration. |
| Bioavailability | 100% after intravenous administration; no other routes available. |
| Onset of Action | IV infusion: immediate rise in factor VIII activity; peak levels at end of infusion. |
| Duration of Action | Therapeutic effect lasts up to 4 days for prophylaxis; hemostatic effect for major surgery lasts ~48–72 hours per dose. |
30 mcg/kg intravenously on alternating days (e.g., Monday/Wednesday/Friday) for patients <40 kg; 30 mcg/kg intravenously twice weekly (e.g., Monday/Thursday) for patients ≥40 kg.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment. ALHEMO is not significantly renally excreted. |
| Liver impairment | No dose adjustment recommended for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Not studied in severe (Child-Pugh C) impairment; use with caution. |
| Pediatric use | Weight-based dosing same as adults: 30 mcg/kg intravenously on alternating days for patients <40 kg; 30 mcg/kg intravenously twice weekly for patients ≥40 kg. Safety and efficacy established in pediatric patients aged ≥12 years. |
| Geriatric use | No specific dose adjustment recommended for elderly patients (>65 years). Clinical studies included limited numbers of geriatric patients; no overall differences in safety or efficacy observed. Monitor for bleeding events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALHEMO (ALHEMO).
| Breastfeeding | Not known if excreted in human milk; M/P ratio not available. Caution advised; weigh benefits against potential risk of bleeding in infant. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; insufficient human data. Risk cannot be excluded (Pregnancy Category C). Fetal risk during organogenesis is unknown; late pregnancy may increase hemorrhage risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Severe hypersensitivity to the drug or its components"]
| Precautions | ["Hypersensitivity reactions","Thromboembolic events (especially in patients with risk factors)","Inhibitor formation (neutralizing antibodies to factor VIII)","Monitoring for signs of bleeding or thrombosis"] |
| Food/Dietary | No significant food interactions have been reported. Alhemo may be taken without regard to meals. |
| Clinical Pearls | Alhemo (concizumab) is a monoclonal antibody that targets tissue factor pathway inhibitor (TFPI) to restore thrombin generation in hemophilia A or B with inhibitors. Administer subcutaneously once daily for prophylaxis. Monitor for thrombotic events, especially in patients with other thrombotic risk factors. Dosing is weight-based; no dose adjustment needed for mild hepatic impairment. Efficacy endpoints include annualized bleeding rate (ABR); reduce ABR by 80% vs on-demand bypassing agents. |
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| Monitor maternal coagulation parameters, signs of thrombosis or bleeding. Fetal ultrasound for growth and anatomy; assess for hemorrhage if maternal bleeding occurs. |
| Fertility Effects | No known effects on fertility in animal studies; no human data. |
| Patient Advice | Inject Alhemo subcutaneously every day at the same time. Rotate injection sites. · Do not stop Alhemo without consulting your doctor, even if you feel well. · Report any signs of blood clots: sudden chest pain, shortness of breath, leg swelling, severe headache. · Alhemo is for prophylaxis; it does not treat acute bleeds. Use a bypassing agent for breakthrough bleeds. · Keep Alhemo in the refrigerator at 2°C to 8°C. Do not freeze. Protect from light. |