Ustekinumab-auub
Generic Name: ustekinumab-auub
Brand Names:
Wezlana
11 DESCRIPTION Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa.
Overview
11 DESCRIPTION Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa.
Uses
1 INDICATIONS AND USAGE WEZLANA 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) ] 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 ustekinumab products 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 ustekinumab. 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 ustekinumab.
Warnings
5 WARNINGS AND PRECAUTIONS Infections: Serious infections have occurred. Avoid starting WEZLANA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue WEZLANA 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 WEZLANA. Initiate treatment of latent TB before administering WEZLANA. 4 CONTRAINDICATIONS WEZLANA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in WEZLANA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in WEZLANA. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab-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 and Stability Store WEZLANA vials and prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
Frequently Asked Questions
What is Ustekinumab-auub used for?▼
1 INDICATIONS AND USAGE WEZLANA 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-auub?▼
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) ] 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-auub during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab-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-auub?▼
5 WARNINGS AND PRECAUTIONS Infections: Serious infections have occurred. Avoid starting WEZLANA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue WEZLANA 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 WEZLANA. Initiate treatment of latent TB before administering WEZLANA. 4 CONTRAINDICATIONS WEZLANA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in WEZLANA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in WEZLANA. ( 4 )
Related Medications
Robinia Radix 6x
robinia radix 6x
For contitutional treatments based on homeopathic and anthroposophic indications or as directed by your physician.
Ensulizole, Titanium Dioxide
ensulizole, titanium dioxide
OTC sunscreen containing ensulizole and titanium dioxide that helps prevent sunburn and decreases the risk of skin cancer and early skin aging.
Passiflora Incarnata, Glandula Suprarenalis Suis, Thyroidinum (suis), Arnica Montana, Hypericum Perforatum, Lachesis Mutus, Muira Puama
passiflora incarnata, glandula suprarenalis suis, thyroidinum (suis), arnica montana, hypericum perforatum, lachesis mutus, muira puama
INDICATIONS: For temporary relief of numbness and tingling; stiffness in nape of the neck and shooting pains with tingling, and burning pain and numbness.
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.