Stelara
(ustekinumab)Dosage & Administration
Psoriasis Adult Subcutaneous Recommended Dosage ( 2.1) :
| Weight Range (kilograms) | Dose |
|---|---|
| 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 |
Psoriasis Pediatric Patients (6 to 17 years old) 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) | Dose |
|---|---|
| less than 60 kg | 0.75 mg/kg |
| 60 kg to 100 kg | 45 mg |
| greater than 100 kg | 90 mg |
Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2):
Psoriatic Arthritis Pediatric (6 to 17 years old) Subcutaneous Recommended Dosage ( 2.2): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.
| Weight Range (kilograms) | Dose |
|---|---|
| less than 60 kg | 0.75 mg/kg |
| 60 kg or more | 45 mg |
| greater than 100 kg with co-existent moderate-to-severe plaque psoriasis | 90 mg |
Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dosage ( 2.3) :
A single intravenous infusion using weight-based dosing:
| Weight Range (kilograms) | Recommended Dosage |
|---|---|
| up to 55 kg | 260 mg (2 vials) |
| greater than 55 kg to 85 kg | 390 mg (3 vials) |
| greater than 85 kg | 520 mg (4 vials) |
Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage ( 2.3) :
A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
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Stelara Prescribing Information
Plaque Psoriasis (PsO)
STELARA ®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.
Psoriatic Arthritis (PsA)
STELARA ®is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
Crohn's Disease (CD)
STELARA ®is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
Ulcerative Colitis
STELARA ®is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Recommended Dosage in Plaque Psoriasis
Subcutaneous Adult Dosage Regimen
- For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14)] .
Subcutaneous Pediatric Dosage Regimen
Administer STELARA ®subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
The recommended dose of STELARA ®for pediatric patients (6–17 years old) with plaque psoriasis based on body weight is shown below (Table 1).
| Body Weight of Patient at the Time of Dosing | Recommended Dose |
|---|---|
| less than 60 kg | 0.75 mg/kg |
| 60 kg to 100 kg | 45 mg |
| more than 100 kg | 90 mg |
For 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 single-dose vial.
| Body Weight (kg) at the time of dosing | Dose (mg) | Volume of injection (mL) |
|---|---|---|
| ||
| 15 | 11.3 | 0.12 |
| 16 | 12.0 | 0.13 |
| 17 | 12.8 | 0.14 |
| 18 | 13.5 | 0.15 |
| 19 | 14.3 | 0.16 |
| 20 | 15.0 | 0.17 |
| 21 | 15.8 | 0.17 |
| 22 | 16.5 | 0.18 |
| 23 | 17.3 | 0.19 |
| 24 | 18.0 | 0.20 |
| 25 | 18.8 | 0.21 |
| 26 | 19.5 | 0.22 |
| 27 | 20.3 | 0.22 |
| 28 | 21.0 | 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 |
Recommended Dosage in Psoriatic Arthritis
Subcutaneous Adult Dosage Regimen
- The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
Subcutaneous Pediatric Dosage Regimen
Administer STELARA ®subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
The recommended dose of STELARA ®for pediatric patients (6 to 17 years old) with psoriatic arthritis, based on body weight, is shown below (Table 3).
| Body Weight of Patient at the Time of Dosing | Recommended Dose |
|---|---|
| |
| less than 60 kg * | 0.75 mg/kg |
| 60 kg or more | 45 mg |
| greater than 100 kg with co-existent moderate-to-severe plaque psoriasis | 90 mg |
Recommended Dosage in Crohn's Disease and Ulcerative Colitis
Intravenous Induction Adult Dosage Regimen
A single intravenous infusion dose of STELARA ®using the weight-based dosage regimen specified in Table 4 [see Instructions for dilution of STELARA® 130 mg vial for intravenous infusion (2.6)] .
| Body Weight of Patient at the time of dosing | Dose | Number of 130 mg/26 mL (5 mg/mL) STELARA ®vials |
|---|---|---|
| 55 kg or less | 260 mg | 2 |
| more than 55 kg to 85 kg | 390 mg | 3 |
| more than 85 kg | 520 mg | 4 |
Subcutaneous Maintenance Adult Dosage Regimen
The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
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 Medication Guide [see Medication Guide] .
- 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 single-dose 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.
Instructions for Administration of STELARA ®Prefilled Syringes Equipped with Needle Safety Guard
Refer to the diagram below for the provided instructions.
To prevent premature activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.
- Hold the BODY and remove the NEEDLE COVER. Do not hold the PLUNGER or PLUNGER HEAD while removing the NEEDLE COVER or the PLUNGER may move. Do not use the prefilled syringe if it is dropped without the NEEDLE COVER in place.
- Inject STELARA ®subcutaneously as recommended [see Dosage and Administration (2.1, 2.2, 2.3)] .
- Inject all of the medication by pushing in the PLUNGER until the PLUNGER HEAD is completely between the needle guard wings. Injection of the entire prefilled syringe contents is necessary to activate the needle guard.
- After injection, maintain the pressure on the PLUNGER HEAD and remove the needle from the skin. Slowly take your thumb off the PLUNGER HEAD to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by the illustration below:
- Used syringes should be placed in a puncture-resistant container.
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 (Table 4). Each 26 mL vial of STELARA ®contains 130 mg of ustekinumab.
- Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of STELARA ®to be added (discard 26 mL sodium chloride for each vial of STELARA ®needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used.
- Withdraw 26 mL of STELARA ®from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. 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 eight hours of the dilution in the infusion bag.
- 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 single-dose only. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.
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. Discard any unused portion of the infusion solution.
STELARA ®(ustekinumab) is a colorless to light yellow solution and may contain a few small translucent or white particles.
Subcutaneous Injection
- Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe
- Injection: 45 mg/0.5 mL solution in a single-dose vial
Intravenous Infusion
- Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial
Pregnancy
Risk Summary
Limited data from observational studies, published case reports, and postmarketing surveillance on the use of STELARA ®during pregnancy are insufficient to inform a drug associated risk of major birth defects, miscarriage, and other adverse maternal or fetal outcomes . Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, STELARA ®may be transferred to the developing fetus [see Clinical Considerations]. 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).
The background risk of major birth defects and miscarriage for the indicated population(s) are unknown. 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
Fetal/Neonatal Adverse Reactions
Because ustekinumab may theoretically interfere with immune response to infections, consider risks and benefits prior to administering live vaccines to infants exposed to STELARA ®in utero.There are insufficient data regarding exposed infant serum levels of ustekinumab at birth and the duration of persistence of ustekinumab in infant serum after birth. Although a specific timeframe to delay administration of live attenuated vaccines in infants exposed in utero is unknown, consider the risks and benefits of delaying a minimum of 6 months after birth because of the clearance of the product.
Data
Animal Data
Ustekinumab was tested in two embryo-fetal development toxicity studies in cynomolgus monkeys. No teratogenic or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab subcutaneously twice weekly or intravenously weekly during the period of organogenesis. Serum concentrations of ustekinumab in pregnant monkeys were greater than 100 times the serum concentration in patients treated subcutaneously with 90 mg of ustekinumab weekly for 4 weeks.
In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly at exposures greater than 100 times the MRHD from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg. No ustekinumab-related-effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age.
Lactation
Risk Summary
Limited data from published literature suggests that ustekinumab is present in human breast milk. There are no available data on the effects of ustekinumab on milk production. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to ustekinumab are unknown. No adverse effects on the breastfed infant causally related to ustekinumab have been identified in the published literature or postmarketing experience.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for STELARA ®and any potential adverse effects on the breastfed child from STELARA ®or from the underlying maternal condition.
Pediatric Use
Plaque Psoriasis
The safety and effectiveness of STELARA ®have been established for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 to 17 years of age who are candidates for phototherapy or systemic therapy.
Use of STELARA ®in pediatric patients 12 to less than 17 years of age is supported by evidence from a multicenter, randomized, 60week trial (Ps STUDY 3) that included a 12week, double-blind, placebo-controlled, parallel group portion, in 110 pediatric subjects 12 years of age and older [see Adverse Reactions (6.1), Clinical Studies (14.2)] .
Use of STELARA ®in pediatric patients 6 to 11 years of age is supported by evidence from an open-label, single-arm, efficacy, safety, and pharmacokinetics trial (Ps STUDY 4) in 44 subjects [see Adverse Reactions (6.1), Pharmacokinetics (12.3)] .
The safety and effectiveness of STELARA ®have not been established in pediatric patients less than 6 years of age with plaque psoriasis.
Psoriatic Arthritis
The safety and effectiveness of STELARA ®have been established for treatment of psoriatic arthritis in pediatric patients 6 to 17 years old.
Use of STELARA ®in these age groups is supported by evidence from adequate and well controlled trials of STELARA ®in adults with psoriasis and PsA, pharmacokinetic data from adult subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and safety data from two clinical trials in 44 pediatric subjects 6 to 11 years old with psoriasis and 110 pediatric subjects 12 to 17 years old with psoriasis. The observed pre-dose (trough) concentrations are generally comparable between adult subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and the PK exposure is expected to be comparable between adult and pediatric subjects with PsA [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2, 14.3)].
The safety and effectiveness of STELARA ®have not been established in pediatric patients less than 6 years old with psoriatic arthritis.
Crohn's Disease and Ulcerative Colitis
The safety and effectiveness of STELARA ®have not been established in pediatric patients with Crohn's disease or ulcerative colitis.
Geriatric Use
Of the 6709 subjects exposed to STELARA ®, a total of 340 were 65 years of age or older (183 subjects with plaque psoriasis, 65 subjects with psoriatic arthritis, 58 subjects with Crohn's disease, and 34 subjects with ulcerative colitis), and 40 subjects were 75 years of age or older. Clinical trials of STELARA ®did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
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)].
Infections
STELARA ®may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving STELARA ®[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 STELARA ®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 STELARA ®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 STELARA ®and discontinue STELARA ®for serious or clinically significant infections until the infection resolves or is adequately treated.
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 STELARA ®may be susceptible to these types of infections. Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture, as dictated by clinical circumstances).
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA ®.
Avoid administering STELARA ®to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering STELARA ®. Consider anti-tuberculosis therapy prior to initiation of STELARA ®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 STELARA ®for signs and symptoms of active tuberculosis during and after treatment.
Malignancies
STELARA ®is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA ®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)] .
The safety of STELARA ®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 STELARA ®who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving STELARA ®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)] .
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA ®[see Adverse Reactions (6.1, 6.3)] . If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA ®.
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 initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
Monitor all patients treated with STELARA ®for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA ®.
Immunizations
Prior to initiating therapy with STELARA ®, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA ® should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STELARA ® 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 STELARA ® because of the potential risk for shedding from the household contact and transmission to patient.
Non-live vaccinations received during a course of STELARA ® may not elicit an immune response sufficient to prevent disease.
Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA ®. 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 STELARA ®and institute appropriate treatment [see Postmarketing Experience (6.3)] .