Ustekinumab
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From MedlinePlus, U.S. National Library of Medicine
Interleukin-12 Antagonist, Interleukin-23 Antagonist
Dosing in kidney impairment
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Preparation and administration
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General Considerations for Administration STELARA is intended for use under the guidance and supervision of a healthcare provider. STELARA should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider. The appropriate dose should be determined by a healthcare provider using the patient's current weight at the time of dosing.
In pediatric patients, it is recommended that STELARA be administered by a healthcare provider. If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use [see Instructions for Use] .
The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex. It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated.
When using the vial, a 1 mL syringe with a 27 gauge, ½ inch needle is recommended. Prior to administration, visually inspect STELARA for particulate matter and discoloration. STELARA is a colorless to light yellow solution and may contain a few small translucent or white particles. Do not use STELARA if it is discolored or cloudy, or if other particulate matter is present.
STELARA does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.
Preparation and Administration of STELARA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis) STELARA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. Calculate the dose and the number of STELARA vials needed based on patient weight (see Table 4 , Table 5 , Table 6 , and Table 7 above).
Obtain the appropriate infusion solution (Table 8). Withdraw and discard a volume of the infusion solution equal to the volume of STELARA solution to be added: [See table below.] Adult All weights 0.45% or 0.9% Sodium Chloride Injection 250 mL Add the volume of STELARA solution equal to the calculated dose of STELARA to the infusion solution and gently mix.
Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completely administered within the storage time (see Storage below) . Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Do not infuse STELARA concomitantly in the same intravenous line with other agents. STELARA does not contain preservatives. Each vial is for a one-time use in only one patient. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements. Discard any unused portion of the infusion solution.
Storage Do not freeze. Storage time at room temperature begins once the diluted solution has been prepared. 100 mL infusion bag : If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 3 hours. The infusion should be completed within 4 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period). 250 mL infusion bag : If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 7 hours.
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).
| Body Weight (kg) at the Time of Dosing | Dose (mg) | Volume of Injection (mL) |
|---|---|---|
| 15 | 11.3 | 0.12 |
| 16 | 12 | 0.13 |
| 17 | 12.8 | 0.14 |
| 18 | 13.5 | 0.15 |
| 19 | 14.3 | 0.16 |
| 20 | 15 | 0.17 |
| 21 | 15.8 | 0.17 |
| 22 | 16.5 | 0.18 |
| 23 | 17.3 | 0.19 |
| 24 | 18 | 0.20 |
| 25 | 18.8 | 0.21 |
| 26 | 19.5 | 0.22 |
| 27 | 20.3 | 0.22 |
| 28 | 21 | 0.23 |
| 29 | 21.8 | 0.24 |
| 30 | 22.5 | 0.25 |
| 31 | 23.3 | 0.26 |
| 32 | 24 | 0.27 |
| 33 | 24.8 | 0.27 |
| 34 | 25.5 | 0.28 |
| 35 | 26.3 | 0.29 |
| 36 | 27 | 0.3 |
| 37 | 27.8 | 0.31 |
| 38 | 28.5 | 0.32 |
| 39 | 29.3 | 0.32 |
| 40 | 30 | 0.33 |
| 41 | 30.8 | 0.34 |
| 42 | 31.5 | 0.35 |
| 43 | 32.3 | 0.36 |
| 44 | 33 | 0.37 |
| 45 | 33.8 | 0.37 |
| 46 | 34.5 | 0.38 |
| 47 | 35.3 | 0.39 |
| 48 | 36 | 0.4 |
| 49 | 36.8 | 0.41 |
| 50 | 37.5 | 0.42 |
| 51 | 38.3 | 0.42 |
| 52 | 39 | 0.43 |
| 53 | 39.8 | 0.44 |
| 54 | 40.5 | 0.45 |
| 55 | 41.3 | 0.46 |
| 56 | 42 | 0.46 |
| 57 | 42.8 | 0.47 |
| 58 | 43.5 | 0.48 |
| 59 | 44.3 | 0.49 |
| Body Weight of Patient at the Time of Dosing | Recommended Dose |
|---|---|
| less than 60 kgFor pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial. | 0.75 mg/kg |
| 60 kg or more | 45 mg |
| greater than 100 kg with co-existent moderate-to-severe plaque psoriasis | 90 mg |
| Patient Population | Body Weight of Patient at the Time of Dosing | Infusion Solution | Final Volume in the Infusion Bag |
|---|---|---|---|
| Pediatric | 10 kg to 25 kg | 0.9% Sodium Chloride Injection | 100 mLRemove a volume of infusion solution equal to the volume of STELARA solution to be added to obtain the final volume. |
| Greater than 25 kg | 0.9% Sodium Chloride Injection | 250 mL | |
| Adult | All weights | 0.45% or 0.9% Sodium Chloride Injection | 250 mL |
Drug interactions
Check ustekinumab against a medication listLabel text (6 paragraphs)
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.
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 STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of STELARA 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 STELARA has not been evaluated in patients who have undergone allergy immunotherapy. STELARA 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.
Contraindications
4 CONTRAINDICATIONS STELARA is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA. ( 4 )
Pregnancy and lactation
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.
In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, STELARA may be present in infants exposed in utero .
The potential clinical impact of ustekinumab exposure in infants exposed in utero should be considered. Data Human Data An observational pregnancy registry conducted by (OTIS)/MotherToBaby in the U.S. and Canada (enrollment between 2013 and 2019) assessed the risk of major birth defects, pattern of major and minor anomalies in live-born infants, miscarriage, and adverse infant outcomes in women with STELARA exposure. In the registry study, there were 101 participants and 107 pregnancies with exposure to STELARA (88 prospective; 19 retrospective). Most participants had a primary indication of CD (65.4%) or psoriasis (30.8%).
The pregnancy registry did not identify a STELARA-associated risk of major birth defects, pattern of major or minor anomalies, increased risk of miscarriage or adverse infant outcomes. Methodological limitations of the registry include small sample size, lack of an internal comparison group, a mix of prospective and retrospective reports, and unmeasured confounders. The…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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