Ustekinumab
Generic Name: ustekinumab
Brand Names:
Stelara, Stelara
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn's disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) .
Dosage
2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight Range (kilograms) Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease, induction (≥3%): vomiting.
Interactions
7 DRUG INTERACTIONS 7.1 Concomitant Therapies In trials in subjects with plaque psoriasis the safety of STELARA in combination with immunosuppressive agents or phototherapy has not been evaluated . In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In trials in subjects with Crohn's disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA.
Warnings
5 WARNINGS AND PRECAUTIONS Infections : Serious infections have occurred. Avoid starting STELARA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue STELARA until the infection resolves. ( 5.1 ) Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with STELARA. Initiate treatment of latent TB before administering STELARA. ( 5.3 ) Malignancies : STELARA may increase risk of malignancy. 4 CONTRAINDICATIONS STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby STELARA Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy.
Storage
Storage If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 7 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period). Do not freeze.
Frequently Asked Questions
What is Ustekinumab used for?▼
1 INDICATIONS AND USAGE STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn's disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) .
What are the side effects of Ustekinumab?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease, induction (≥3%): vomiting.
Can I take Ustekinumab during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby STELARA Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy.
What are the important warnings for Ustekinumab?▼
5 WARNINGS AND PRECAUTIONS Infections : Serious infections have occurred. Avoid starting STELARA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue STELARA until the infection resolves. ( 5.1 ) Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. ( 5.2 ) Tuberculosis (TB) : Evaluate patients for TB prior to initiating treatment with STELARA. Initiate treatment of latent TB before administering STELARA. ( 5.3 ) Malignancies : STELARA may increase risk of malignancy. 4 CONTRAINDICATIONS STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.