Ustekinumab

Ustekinumab is a prescription medicine used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

• Ustekinumab is available under the following different brand names: Stelara

Adult and pediatric dosage

Injectable solution for SC

• 45mg/0.5mL (prefilled syringe or single-dose vial)
• 90mg/mL (prefilled syringe)
• Injectable solution for IV infusion
• 130mg/26mL (5mg/mL) single-dose vial

Plaque Psoriasis

Adult dosage

• Adult weighing less than 100 kg: 45 mg SC at Weeks 0 and 4, then every 12 weeks thereafter
• Adult weighing more than 100 kg: 90 mg SC at Weeks 0 and 4, then every 12 weeks thereafter

Pediatric dosage

• Children below 6 years: Safety and efficacy not established
• Children above 6 years: 
  • Weighing less than 60 kg: 0.75 mg/kg SC at Weeks 0 and 4, then every 12 weeks thereafter
  • 60-100 kg: 45 mg SC at Weeks 0 and 4, then every 12 weeks thereafter
  • More than 100 kg: 90 mg SC at Weeks 0 and 4, then every 12 weeks thereafter

Psoriatic arthritis

Adult dosage

• 45 mg SC at Weeks 0 and 4, then every 12 weeks thereafter
• For patients weighing more than100 kg with co-existent moderate-to-severe plaque psoriasis, increase the dose to 90 mg SC at Weeks 0 and 4, then every 12 weeks thereafter

Crohn’s Disease

Adult dosage

• Initial weight-based IV dose
• Single IV dose infused over 1 hour 
• Patients weighing less than 55 kg: 260 mg IV
• Patients weighing between 55-85 kg: 390 mg IV
• Patients weighing more than 85 kg: 520 mg IV

Maintenance SC dose

• Begin 90 mg SC 8 weeks after the initial IV infusion, then every 8 weeks thereafter

Ulcerative Colitis

Adult dosage

• Initial weight-based IV dose
• Single IV dose infused over 1 hour 
• Patients weighing less than 55 kg: 260 mg IV
• Patients weighing between 55-85 kg: 390 mg IV
• Patients weighing more than 85 kg: 520 mg IV

Maintenance SC dose

• Begin 90 mg SC 8 weeks after the initial IV infusion, then every 8 weeks thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ustekinumab include:

• nasal congestion, 
• sore throat, 
• runny nose
• upper respiratory infections,
• fever,
• headache,
• tiredness,
• itching,
• nausea, 
• vomiting,
• redness at the injection site,
• vaginal yeast infections,
• urinary tract infections,
• sinus infection,
• bronchitis,
• diarrhea, and
• stomach pain.

Serious side effects of Ustekinumab include:

• lung inflammation-shortness of breath and cough, and
• serious allergic reactions- feeling faint, swelling of the face, eyelids, tongue or throat, chest tightness, and skin rash.

Rare side effects of Ustekinumab include:

• severe infection,
• malignancy, and 
• reversible posterior leukoencephalopathy syndrome.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ustekinumab has severe interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine quadrivalent, intranasal
  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, adjuvanted
  • influenza virus vaccine trivalent, recombinant
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Ustekinumab has serious interactions with at least 49 other drugs.
• Ustekinumab has moderate interactions with at least 69 other drugs.
• Ustekinumab has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Active serious infection
• Concomitant live vaccines

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ustekinumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ustekinumab?”

Cautions

• Use caution in patients genetically deficient in IL-12/IL-23
• Reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 case); cases reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease; if RPLS is suspected, administer appropriate therapy and discontinue treatment
• Provide age-appropriate immunization before initiating therapy
• Hypersensitivity reactions reported, including anaphylaxis and angioedema
• Infections
  • Do not administer treatment to patients with active tuberculosis infection; initiate treatment of latent tuberculosis (TB) before administering ustekinumab; closely monitor for signs and symptoms of active tuberculosis during and after treatment
  • May increase risk of infections and reactivation of latent infections; serious bacterial, fungal, mycobacterial, and viral infections observed with treatment; evaluate for TB infection before initiating drug
  • Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported; if the diagnosis is confirmed, discontinue therapy and institute appropriate treatment
  • Other serious infections requiring hospitalization reported include diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, and UTIs
  • Do not initiate in patients with any clinically important active infection until the infection resolves or is adequately treated; consider risks and benefits of treatment before initiating therapy 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 and consider discontinuing therapy for serious or clinically significant infections until infection resolves or is adequately treated
  • Infections observed by disease treated
  • Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following
  • 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
• Malignancies
  • Increased risk of malignancy
  • Reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients with pre-existing risk factors for developing nonmelanoma skin cancer; monitor all patients for nonmelanoma skin cancer
• Drug interactions overview
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation; ustekinumab (IL-12 and IL-23 antagonist) may normalize the formation of CYP450 enzyme; monitor therapeutic effects (eg, warfarin) or concentration (eg, cyclosporine) with concomitant CYP450 substrates use (especially narrow therapeutic index drugs)
  • In psoriasis studies, the safety of ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated; in psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy
  • May decrease the protective effect of allergen immunotherapy
  • Avoid the use of live vaccines with ustekinumab
  • BCG vaccines should not be given during treatment or for one year before initiating treatment or one year following discontinuation of treatment; use caution when administering live vaccines to household contacts of patients receiving treatment due to the potential risk for shedding from the household contact and transmission to the patient.

Pregnancy and Lactation

• Pregnancy registry (1-877-311-8972) available that monitors pregnancy outcomes in women exposed to ustekinumab during pregnancy
• Limited data on ustekinumab use in pregnant women to inform a drug-associated risk
• In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximum recommended human subcutaneous dose (MRHD)

Lactation

• Data are not available on the presence of ustekinumab in human milk, effects on the breastfed infant, or effects on milk production
• Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ustekinumab and any potential adverse effects on the breastfed child from ustekinumab or the underlying maternal condition