IMULDOSA 130 mg/26mL
ustekinumab-srlf · INJECTION · Accord BioPharma Inc.
IMULDOSA is a injection containing ustekinumab-srlf at 130 mg/26mL, taken intravenous. Manufactured by Accord BioPharma Inc..
Key Facts
- Brand Name
- IMULDOSA
- Generic Name
- ustekinumab-srlf
- NDC Code (Product)
69448-019- Manufacturer
- Accord BioPharma Inc.
- Strength
- 130 mg/26mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761364
- Marketing Start
- 10/18/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1) active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2) moderately to severely active Crohn’s disease in adult patients. (1.3) moderately to severely active ulcerative colitis in adult patients. (1.4) 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn’s Disease (CD) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis (UC) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage (2.1) : Weight Range (kilograms) Recommended 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. Weight Range (kilograms) Recommended Dose 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage (2.2) : The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 1…
Contraindications
4 CONTRAINDICATIONS IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to Ustekinumab products or to any of the excipients in IMULDOSA [ see Warnings and Precautions ( 5.5 ) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA
Drug 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. 7.2 CYP450 Substrates The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of IMULDOSA in patients who are receiving concomitant CYP450 substrates, particularly those with a na…
Adverse Reactions
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 in Adults induction (≥3%): vomiting. (6.1) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. (6.1) Ulcerative colitis in Adults induction (≥3%): nasopharyngitis (6.1) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical tr…
Frequently Asked Questions
What is IMULDOSA used for?
IMULDOSA contains ustekinumab-srlf. It is a injection taken intravenous. Consult your doctor for specific uses.
Is IMULDOSA a controlled substance?
IMULDOSA is not classified as a controlled substance by the DEA.
What is the generic name for IMULDOSA?
The generic name for IMULDOSA is ustekinumab-srlf. There are no other listed brand versions of ustekinumab-srlf.
What is the NDC code for IMULDOSA 130 mg/26mL?
The NDC (National Drug Code) for IMULDOSA 130 mg/26mL is 69448-019, listed by Accord BioPharma Inc..
Other IMULDOSA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)