imuldosa
Pharmaranks rates Imuldosa 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Imuldosa (Ustekinumab-Srlf) is an interleukin-12 antagonist used to treat Ulcerative Colitis, Crohn Disease, Psoriasis, Psoriatic Arthritis.
Ustekinumab-Srlf · by Accord Biopharma Inc.
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ustekinumab-Srlf
- Drug class
- Interleukin-12 Antagonist
- Form
- Injectable
- Strength
- USTEKINUMAB-SRLF 130MG/26ML · USTEKINUMAB-SRLF 45MG/0.5ML · USTEKINUMAB-SRLF 90MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ulcerative colitis, crohn disease, psoriasis
- Manufacturer
- Accord Biopharma Inc.
- FDA application
- BLA761364
What is Imuldosa?
From the FDA label:Ustekinumab-srlf, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-srlf is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-srlf is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. IMULDOSA (ustekinumab-srlf) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution with pH of 5.7- 6.3. IMULDOSA for Subcutaneous Use Available as 45 mg of ustekinumab-srlf in 0.5 mL and 90 mg of ustekinumab-srlf in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed ½ inch needle. The syringe is fitted with a passive needle guard and a needle cover that does not contains latex. Each 0.5 mL prefilled syringe delivers 45 mg ustekinumab-srlf, histidine (2.23 mg) and L-histidine hydrochloride monohydrate (4.14 mg), polysorbate 80 (0.02 mg), and sucrose (25.9 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-srlf, histidine (4.46 mg) and L-histidine hydrochloride monohydrate (8.28 mg), polysorbate 80 (0.04 mg), and sucrose (51.8 mg). IMULDOSA for Intravenous Infusion Available as 130 mg of ustekinumab-srlf in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated…
How to use
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 12 weeks. Psoriatic Arthritis Pediatric Patients 6 Years of Age and Older Subcutaneous Recommended Dosage (2.2) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight…
Side effects
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 trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the…
Warnings
Important safety information
Infections : Serious infections have occurred. Avoid starting IMULDOSA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue IMULDOSA 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 IMULDOSA. Initiate treatment of latent TB before administering IMULDOSA. ( 5.3 ) Malignancies : Ustekinumab products may increase risk of malignancy. The safety of Ustekinumab products in patients with a history of or a known malignancy has not been evaluated. ( 5.4 ) Serious Hypersensitivity Reactions : If a severe or other clinically significant hypersensitivity reaction occurs, discontinue IMULDOSA immediately and initiate appropriate medical treatment. ( 5.5 ) Posterior Reversible Encephalopathy Syndrome (PRES) : If PRES is suspected, treat promptly and discontinue IMULDOSA. ( 5.6 ) Immunizations : Avoid use of live vaccines in patients during treatment with IMULDOSA. ( 5.7 ) Noninfectious Pneumonia : Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. If diagnosis is confirmed, discontinue IMULDOSA and institute appropriate treatment. ( 5.8 ) 5.1 Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving Ustekinumab products [see Adverse Reactions ( 6.1 , 6.3 )] . Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis : diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. Psoriatic arthritis : cholecystitis. Crohn’s disease : anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis : gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Avoid initiating treatment with IMULDOSA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of IMULDOSA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with IMULDOSA and discontinue IMULDOSA for serious or clinically significant infections until the infection resolves or is adequately treated. 5.2 Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). 5.3 Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with IMULDOSA. Avoid administering IMULDOSA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering IMULDOSA. Consider anti-tuberculosis therapy prior to initiation of IMULDOSA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving IMULDOSA for signs and symptoms of active tuberculosis during and after treatment. 5.4 Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received Ustekinumab in clinical trials [ see Adverse Reactions ( 6.1 ) ]. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [ see Nonclinical Toxicology ( 13.1 ) ]. The safety of Ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving IMULDOSA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment [see Adverse Reactions (6.1) ]. 5.5 Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of ustekinumab products [ see Adverse Reactions ( 6.1 , 6.3 )]. If a severe or clinically significant hypersensitivity reaction occurs, discontinue IMULDOSA immediately and initiate appropriate medical treatment [ see Contraindications ( 4 ) ]. 5.6 Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with IMULDOSA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment, and discontinue IMULDOSA. 5.7 Immunizations Prior to initiating therapy with IMULDOSA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with IMULDOSA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with IMULDOSA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving IMULDOSA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of IMULDOSA may not elicit an immune response sufficient to prevent disease. 5.8 Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue IMULDOSA and institute appropriate treatment [ see Postmarketing Experience…
Who should not take Imuldosa
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
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 narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates. A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease [see Clinical Pharmacology ( 12.3 )] . 7.3 Allergen Immunotherapy Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Drug class
May treat (source: NIH RxClass)
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Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Imuldosa treat?
- Imuldosa (Ustekinumab-Srlf) may be used to treat ulcerative colitis, crohn disease, psoriasis, psoriatic arthritis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Imuldosa rated?
- pharmaranks gives Imuldosa a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Imuldosa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Imuldosa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Imuldosa?
- Imuldosa is marketed by Accord Biopharma Inc.. You can see Accord Biopharma Inc.'s full profile, rating, and other products on pharmaranks.
- Is Imuldosa a brand-name or generic drug?
- Imuldosa is a brand-name product with the active ingredient Ustekinumab-Srlf.
- Is Imuldosa available over the counter?
- No. Imuldosa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Imuldosa come in?
- Imuldosa is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Imuldosa?
- Imuldosa is classified as interleukin-12 antagonist, interleukin-23 antagonist, per the FDA's Established Pharmacologic Class.
- Is Imuldosa FDA-registered?
- Imuldosa is on record with the U.S. FDA under application number BLA761364. You can verify this on its official FDA label.
- Has Imuldosa been recalled by the FDA?
- Yes. Imuldosa has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Imuldosa safe?
- There's no single safe-or-not verdict. pharmaranks gives Imuldosa a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Imuldosa?
- Imuldosa's side effects are taken directly from its FDA label. From the label: 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 (… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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imuldosa
70/100