Factor VII Deficiency

Hemophilia A

Hemorrhage

von Willebrand Diseases

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII.</p><p>AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes.</p><p>AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-dose vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below.</p><table width="85%"><caption><span>Table 4. Nominal Composition after Reconstitution with sWFI</span></caption><col align="left" valign="top" width="16%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><thead><tr class="First Last"><th align="left" class="Lrule Rrule">Ingredient</th><th align="center" class="Rrule">250 IU vial</th><th align="center" class="Rrule">500 IU vial</th><th align="center" class="Rrule">1000 IU vial</th><th align="center" class="Rrule">1500 IU vial</th><th align="center" class="Rrule">2000 IU vial</th><th align="center" class="Rrule">2500 IU vial</th><th align="center" class="Rrule">3000 IU vial</th></tr></thead><tbody><tr class="Botrule First"><td align="left" class="Lrule Rrule">rVIII-Single Chain</td><td align="center" class="Rrule">100 IU/mL</td><td align="center" class="Rrule">200 IU/mL</td><td align="center" class="Rrule">400 IU/mL</td><td align="center" class="Rrule">300 IU/mL</td><td align="center" class="Rrule">400 IU/mL</td><td align="center" class="Rrule">500 IU/mL</td><td align="center" class="Rrule">600 IU/mL</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">L-Histidine</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td><td align="center" class="Rrule">3.1 mg/mL</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Polysorbate 80</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td><td align="center" class="Rrule">0.2 mg/mL</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Calcium chloride</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td><td align="center" class="Rrule">0.4 mg/mL</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Sodium chloride</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td><td align="center" class="Rrule">16.4 mg/mL</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Sucrose</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td><td align="center" class="Rrule">6 mg/mL</td></tr><tr class="Last"><td align="left" class="Lrule Rrule">Water for Injection</td><td align="center" class="Rrule">2.5 mL</td><td align="center" class="Rrule">2.5 mL</td><td align="center" class="Rrule">2.5 mL</td><td align="center" class="Rrule">5 mL</td><td align="center" class="Rrule">5 mL</td><td align="center" class="Rrule">5 mL</td><td align="center" class="Rrule">5 mL</td></tr></tbody></table><p>The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).</p></section>

AFSTYLA

lonoctocog alfa

lonoctocog alfa 1 UNT Injection

Afstyla

lonoctocog alfa 1 UNT Injection [Afstyla]

factor VIII

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Instructions For Use: Antihemophilic Factor [Hemophilia A - Congenital Factor VIII Deficiency]