Complement Inhibitor

Complement Inhibitors

Hemoglobinuria, Paroxysmal

Atypical Hemolytic Uremic Syndrome

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Ravulizumab-cwvz, a complement inhibitor, is a humanized monoclonal antibody (mAb) produced in Chinese hamster ovary (CHO) cells. Ravulizumab-cwvz consists of 2 identical 448 amino acid heavy chains and 2 identical 214 amino acid light chains and has a molecular weight of approximately 148 kDa. The constant regions of ravulizumab-cwvz include the human kappa light chain constant region, and the protein engineered "IgG2/4" heavy chain constant region.</p><p>The heavy chain CH1 domain, hinge region, and the first 5 amino acids of the CH2 domain match the human IgG2 amino acid sequence, residues 6 to 36 in the CH2 region (common to both human IgG2 and IgG4 amino acid sequences), while the remainder of the CH2 domain and the CH3 domain match the human IgG4 amino acid sequence. The heavy and light chain variable regions that form the human C5 binding site consist of human framework regions grafted to murine complementarity-determining regions.</p><div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><p></p><p class="First"><span class="Underline">ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials)</span></p><p>ULTOMIRIS (ravulizumab-cwvz) injection 100 mg/mL is a sterile, translucent, clear to yellowish color, preservative-free solution for intravenous use. Each single-dose vial contains 300 mg or 1,100 mg ravulizumab-cwvz at a concentration of 100 mg/mL with a pH of 7.4. Each mL also contains L-arginine (4.33 mg), polysorbate 80 (0.5 mg) (vegetable origin), sodium phosphate dibasic (4.42 mg), sodium phosphate monobasic (4.57 mg), sucrose (50 mg), and Water for Injection, USP.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-9.2"></a><p></p><p class="First"><span class="Underline">ULTOMIRIS 10 mg/mL (30 mL vial)</span></p><p>ULTOMIRIS (ravulizumab-cwvz) injection 10 mg/mL is a sterile, clear to translucent, slight whitish color, preservative-free solution for intravenous use. Each single-dose vial contains 300 mg ravulizumab-cwvz at a concentration of 10 mg/mL with a pH of 7.0. Each mL also contains polysorbate 80 (0.2 mg) (vegetable origin), sodium chloride (8.77 mg), sodium phosphate dibasic (1.78 mg), sodium phosphate monobasic (0.46 mg), and Water for Injection, USP.</p></div></section>

Ultomiris

ravulizumab

ravulizumab-cwvz

30 ML ravulizumab-cwvz 10 MG/ML Injection

30 ML ravulizumab-cwvz 10 MG/ML Injection [Ultomiris]

11 ML ravulizumab-cwvz 100 MG/ML Injection

11 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]

3 ML ravulizumab-cwvz 100 MG/ML Injection

3 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]

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Billing & Coding Guide: Generalized Myasthenia Gravis (gMG)

Billing & Coding Guide: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

Billing & Coding Guide: Atypical Hemolytic Uremic Syndrome (aHUS)

Billing & Coding Guide: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Coverage Authorization Request

Coverage Authorization Appeals: Generalized Myasthenia Gravis (gMG)

Letter of Medical Necessity: Generalized Myasthenia Gravis (gMG)

PA Criteria: Generalized Myasthenia Gravis (gMG)

Letter of Medical Necessity: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

Letter of Medical Necessity: Atypical Hemolytic Uremic Syndrome (aHUS)

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Other HCP Resources: Atypical Hemolytic Uremic Syndrome (aHUS)

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Receiving Ultomiris: Atypical Hemolytic Uremic Syndrome (aHUS)

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About Ultomiris: Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Starting Ultomiris: Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Instructions For Use: Atypical Hemolytic Uremic Syndrome (aHUS)

Instructions For Use: Paroxysmal Nocturnal Hemoglobinuria (PNH)