Adult Dosing
Moderate-severe plaque psoriasis
100 kg- Initial dose: 45 mg SC initially and 4 wks later, followed by 45 mg SC every 12 wks
- >100 kg
- Initial dose: 90 mg SC initially and 4 wks later, followed by 90 mg SC every 12 wks
Psoriatic arthritis
- Initial dose: 45 mg SC initially and 4 wks later, followed by 45 mg SC every 12 wks
- >100 kg: 90 mg SC initially and 4 wks later, followed by 90 mg SC every 12 wks
Notes:- At physician's discretion, patient may self inject with ustekinumab after receiving proper training in SC injection technique
- Safety and efficacy of ustekinumab have not been evaluated beyond two years
- For administration procedure refer package insert
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Increased risk of infections, reactivation of latent infections, serious bacterial, fungal, and viral infections have been reported with ustekinumab. Avoid therapy in case of active infection. If a serious infection develops, stop therapy until the infection resolves and seek medical advice
- Use therapy cautiously in patients with a chronic infection or a history of recurrent infection
- Serious infections such as cellulitis, diverticulitis, osteomyelitis, viral infections, gastroenteritis, pneumonia, and urinary tract infections requiring hospitalization have occurred during psoriasis development program
- 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 dictated by clinical circumstances
- Evaluate patients for TB infection before starting therapy
- Avoid administration of drug in patients with active tuberculosis; initiate treatment of latent TB before administering ustekinumab
- Anti-tuberculosis therapy should be considered before starting with therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed; closely monitor the patient for signs and symptoms of active tuberculosis during and after treatment
- Therapy may increase risk of malignancy. Safety of ustekinumab in patients with a history of or a known malignancy has not been evaluated
- Anaphylaxis or serious allergic reactions may occur with ustekinumab, discontinue ustekinumab if such reactions occur and institute appropriate therapy
- Rare cases of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) have occurred with the use of ustekinumab; if RPLS is suspected, treat patient promptly and discontinue the treatment
- Patients should receive all immunizations appropriate for age as recommended by current immunization guidelines before initiating therapy. Avoid administrating live vaccines, BCG vaccines during treatment with ustekinumab, for one year before starting treatment, or one year following discontinuation of treatment
- Use cautiously when administering live vaccines to household contacts of patients receiving ustekinumab. Administration of non-live vaccinations received during use of therapy may not elicit an immune response sufficient to prevent disease
Caution: Use cautiously in
- Chronic or recurrent infection
- Latent tuberculosis
Supplemental Patient Information
- Instruct patients to read the medication guide before starting treatment with ustekinumab
- Advise patients to report if they develop any symptoms of infection
- Counsel patients about the risk of malignancies while receiving ustekinumab
Pregnancy Category:B
Breastfeeding: IgG is excreted in human milk, so it is expected that ustekinumab will be present in human milk; however information suggests that antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts. Manufacturer advises caution.
