Interleukin-12 Antagonist

Interleukin-12 Antagonists

Interleukin-23 Antagonist

Interleukin-23 Antagonists

Crohn Disease

Psoriatic Arthritis

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.</p><p>STELARA<span class="Sup">®</span> (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7– 6.3.</p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Underline">STELARA<span class="Sup">®</span> for Subcutaneous Use</span></p><p>Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex).</p><p>Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg).</p><p>Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg).</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a><p></p><p class="First"><span class="Underline">STELARA<span class="Sup">®</span> for Intravenous Infusion</span></p><p>Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.</p><p>Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2210 mg).</p></div></section>

STELARA

0.5 ML ustekinumab 90 MG/ML Injection

0.5 ML ustekinumab 90 MG/ML Injection [Stelara]

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]

1 ML ustekinumab 90 MG/ML Prefilled Syringe

1 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]

26 ML ustekinumab 5 MG/ML Injection

26 ML ustekinumab 5 MG/ML Injection [Stelara]

Stelara

ustekinumab

Midwest Biologics, Inc.

Actemra

Enbrel

Entyvio

Ilumya

Ocrevus

Rituxan

Soliris

Stelara | Midwest Biologics, Inc. | limited distribution

Does Stelara have a limited distribution partnership with Midwest Biologics, Inc.?

Does Midwest Biologics, Inc. work closely with Stelara and Janssen Biotech, Inc.?

Does Midwest Biologics, Inc. offer services for Stelara patients?

What conditions does Midwest Biologics, Inc. support?

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