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Prescribing information
Medication guide

Frequently asked questions

This site is intended for US residents only.

Why is the doctor prescribing this medication instead of Stelara®?

STARJEMZA™ is an FDA-approved prescription medicine that can be used instead of Stelara® for all the same uses. Your doctor is prescribing STARJEMZA™ as a cost-effective alternative to the higher cost originator product. Because of the rigorous analytic testing and the clinical trials that were required to show that there were no clinically meaningful differences, the FDA granted approval of STARJEMZA™ as an interchangeable biosimilar product to Stelara®.

A biosimilar is a medicinal product that has gone through extensive analysis and thorough testing to show that there are no clinically meaningful differences in terms of safety, purity, and potency compared to the originator product (in this case Stelara®). Because of the extensive testing and analysis performed, a biosimilar product can be readily used in place of the originator product.5,6

In short, Pharmacy Benefit Managers (PBMs) often push for higher list prices because it allows them to capture larger rebates. Other companies will use this rebate-driven model to limit competition and increase the cost of drug treatments. Hikma/STARJEMZA™ is taking a different approach. Hikma will use a low price approach to sell STARJEMZA™.

From a safety and efficacy standpoint, the results you see with STARJEMZA™ should be highly similar as to what to expect with Stelara®. The main benefit is that STARJEMZA™ is a more cost-effective option, thus saving money for patients and for health care systems.

Yes. Because STARJEMZA™ is an FDA-approved interchangeable biosimilar to Stelara®, the results you see with STARJEMZA™ should be highly similar as to what to expect with Stelara®, including both safety and efficacy.

STARJEMZA™ may cause serious side effects, including:
Serious allergic reactions. Serious allergic reactions can occur with STARJEMZA™. Stop using STARJEMZA™ and get medical help right away if you have any of the following symptoms of a serious allergic reaction:

  • feeling faint
  • swelling of your face, eyelids, tongue, or throat
  • chest tightness
  • skin rash

Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab products, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STARJEMZA™.

Common side effects of STARJEMZA™ include:

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

These are not all of the possible side effects of STARJEMZA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Hikma Pharmaceuticals USA Inc. at 1-877-845-0689.

STARJEMZA™ is taken the same way as Stelara®. It will depend on which condition you are being treated for and whether you are being treated for the first time or have been previously treated with Stelara®. For most patients and for most purposes, a self-administered auto-injector containing the appropriate dose of STARJEMZA™ is used to dispense the drug under your skin. (Please see section on Taking STARJEMZA™). 

Taking STARJEMZA™

Store STARJEMZA™ vials and prefilled syringes refrigerated between 2ºC to 8ºC (36ºF to 46ºF). Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

An individual 45 mg vial may be stored at room temperature, up to 25℃ (77°F), out of the original carton for up to 8 hours. After filling STARJEMZA™ into the syringe with attached needle, the filled syringe with needle can be stored at up to 25℃ (77°F) for up to 4 hours before injection. Once the prefilled syringe or the 45 mg vial has been stored at room temperature, do not return it to the refrigerator. Do not use STARJEMZA™ after the expiration date on the carton or on the prefilled syringe or on the 45 mg vial.

Download the medication guide for more information on how to use STARJEMZA™

Medication guide
Important Safety Information for STARJEMZA™ (ustekinumab-hmny) Injection

Contraindications

STARJEMZA™ is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA™.

Warnings & precautions

  • 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.  Avoid initiating treatment with STARJEMZA™ 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 STARJEMZA™ in patients with a chronic infection or a history of recurrent infection. 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.
  • 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.
  • Pre-treatment Evaluation for Tuberculosis – Evaluate patients for tuberculosis infection prior to initiating treatment with STARJEMZA™.  Avoid administering STARJEMZA™ to patients with active tuberculosis infection.
  • Malignancies – Ustekinumab products are immunosuppressants and may increase the risk of malignancy.  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.
  • Hypersensitivity Reactions – Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STARJEMZA™.
  • 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 STARJEMZA™ for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STARJEMZA™.
  • Immunizations – Prior to initiating therapy with STARJEMZA™, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STARJEMZA™ should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STARJEMZA™ 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 STARJEMZA™ because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STARJEMZA™ 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 ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STARJEMZA™ and institute appropriate treatment.

Adverse reactions

Serious adverse reactions associated with STARJEMZA™ include Infections, Malignancies, Hypersensitivity Reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and Noninfectious Pneumonia.

  • Immunogenicity – Approximately 6 to 12.4% of subjects treated with ustekinumab in plaque psoriasis and psoriatic arthritis clinical trials developed antibodies to ustekinumab, which were generally low-titer. In plaque psoriasis clinical trials, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In plaque psoriasis trials, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies. In Crohn’s disease and ulcerative colitis clinical trials, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen.
  • Postmarketing Experience – The following adverse reactions have been reported during post-approval use of ustekinumab products:
      • Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria).
      • Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis).
      • Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES).
      • Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia.
      • Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.

Drug interactions

  • Concomitant Therapies –  In plaque psoriasis trials the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis trials, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis induction trials, 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.
  • 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. A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease.
  • 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.

Indications and usage

STARJEMZA™ 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.
    • adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
    • adult patients with moderately to severely active Crohn’s disease.
    • adult patients with moderately to severely active ulcerative colitis.

For additional Important Safety Information, please refer to the Package Insert for full prescribing information, available on www.hikma.com.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:
Bio-Thera Solutions, Ltd.
155 Yaotianhe Street, Huangpu District,
Guangzhou, Guangdong, China 511356

Distributed By:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 USA

Important Safety Information for STARJEMZA™ (ustekinumab-hmny) Injection

Contraindications

STARJEMZA™ is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA™.