STARJEMZA™ has the same dosing schedule and dosing recommendations as Stelara®1,2,3

This site is intended for US residents only.

Dosage form and strengths¹

STARJEMZA™ is a clear, colorless to light yellow solution.

Subcutaneous Injection (SC); shot given under the skin

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 (IV); performed at doctor’s office

Intravenous Infusion (IV); performed at doctor’s office

Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial

Starting treatment with STARJEMZA™ 1

Starting treatment1

Patients who have never used Stelara® and are just beginning their treatment for their disease can start their treatment with STARJEMZA™ as prescribed by their healthcare provider.

Your healthcare provider will discuss the dosing schedule of STARJEMZA™ with you.
For patients with Crohn’s disease or ulcerative colitis, you will first receive a starting dose that is given through an IV infusion. All subsequent doses will be given as a shot under the skin every 3 months.

Switching treatment

If you have been treated with Stelara® previously and are switching to STARJEMZA™, the dosing schedule will remain identical, so there should not be any differences in how or when you get your treatment.

Dosing and administration 1

Adult

recommended dosage

>18 years

weight

<100 kg (220 lbs)

Dosage

45 mg

Schedule

Week 0

Week 4

Every 12 weeks

>100 kg (220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Pediatric

recommended dosage

6 – 17 years

weight

<60 kg (132 lbs)

Dosage

0.75 mg/kg

Schedule

Week 0

Week 4

Every 12 weeks

60-100 kg (132-220lbs)

45 mg

Week 0

Week 4

Every 12 weeks

>100 kg (220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

Adult

recommended dosage

>18 years

weight

<100 kg (220 lbs)

Dosage

45 mg

Schedule

Week 0

Week 4

Every 12 weeks

>100 kg (220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Pediatric

recommended dosage

6 – 17 years

weight

<60 kg (132 lbs)

Dosage

0.75 mg/kg

Schedule

Week 0

Week 4

Every 12 weeks

60-100 kg (132-220lbs)

45 mg

Week 0

Week 4

Every 12 weeks

>100 kg (220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

For patients with CD or UC that are just starting STARJEMZA™, a starting dose that is given intravenously at the doctor’s office is necessary.
For those patients who have already received the starting dose of Stelara® and are switching to STARJEMZA™, this starting dose does not need to be repeated.

Initiation Dose Given by IV infusion over 1 hour:

weight

≤55 kg (≤121 pounds)

Dosage

260 mg (2 vials of 130 mg/26 mL solution)

>55 kg to <85 kg (≤121 to 187 pounds)

390 mg (3 vials of 130 mg/26 mL solution)

>85 kg (>187 pounds)

520 mg (4 vials of 130 mg/26 mL solution)

For all patients regardless of weight, 8 weeks after initial IV dose and every 8 weeks thereafter.

The recommended dose is 90 mg given as a shot under the skin (SC injection)

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

For patients with CD or UC that are just starting STARJEMZA™, a starting dose that is given intravenously at the doctor’s office is necessary.
For those patients who have already received the starting dose of Stelara® and are switching to STARJEMZA™, this starting dose does not need to be repeated.

Initiation Dose Given by IV infusion over 1 hour:

weight

≤55 kg (≤121 pounds)

Dosage

260 mg (2 vials of 130 mg/26 mL solution)

>55 kg to <85 kg (≤121 to 187 pounds)

390 mg (3 vials of 130 mg/26 mL solution)

>85 kg (>187 pounds)

520 mg (4 vials of 130 mg/26 mL solution)

For all patients regardless of weight, 8 weeks after initial IV dose and every 8 weeks thereafter.

The recommended dose is 90 mg given as a shot under the skin (SC injection)

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

Dosing and administration1

Moderate to severe Plaque Psoriasis (PsO)

Adult

recommended dosage (>18 years)

weight

<100 kg
(220 lbs)

Dosage

45 mg

Schedule

Week 0

Week 4

Every 12 weeks

>100 kg
(220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Pediatric

recommended dosage (6-17 years)

weight

<60 kg
(132 lbs)

Dosage

0.75 mg/kg

Schedule

Week 0

Week 4

Every 12 weeks

60-100 kg
(132-220lbs)

45 mg

Week 0

Week 4

Every 12 weeks

>100 kg
(220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

Active Psoriatic Arthritis (PsA)

Adult

recommended dosage (>18 years)

weight

<100 kg
(220 lbs)

Dosage

45 mg

Schedule

Week 0

Week 4

Every 12 weeks

>100 kg
(220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Pediatric

recommended dosage (6-17 years)

weight

<60 kg
(132 lbs)

Dosage

0.75 mg/kg

Schedule

Week 0

Week 4

Every 12 weeks

60-100 kg
(132-220lbs)

45 mg

Week 0

Week 4

Every 12 weeks

>100 kg
(220 lbs)

90 mg

Week 0

Week 4

Every 12 weeks

Administer STARJEMZA™ by shot under the skin (SC injection) at Weeks 0 and 4, then every 12 weeks thereafter.

Moderate to severe Crohn’s Disease (CD)

For patients with CD or UC that are just starting STARJEMZA™, a starting dose that is given intravenously at the doctor’s office is necessary.
For those patients who have already received the starting dose of Stelara® and are switching to STARJEMZA™, this starting dose does not need to be repeated.

Initiation Dose Given by IV infusion over 1 hour:

weight

≤55 kg (≤121 pounds)

Dosage

260 mL
(2 vials of 130 mg/26 ml solution)

>55 kg to <85 kg (≤121 to 187 pounds)

390 mL
(3 vials of 130 mg/26 ml solution)

>85 kg (>187 pounds)

520 mL
(4 vials of 130 mg/26 ml solution)

Moderate to severe Ulcerative Colitis (UC)

For patients with CD or UC that are just starting STARJEMZA™, a starting dose that is given intravenously at the doctor’s office is necessary.
For those patients who have already received the starting dose of Stelara® and are switching to STARJEMZA™, this starting dose does not need to be repeated.

Initiation Dose Given by IV infusion over 1 hour:

weight

≤55 kg (≤121 pounds)

Dosage

260 mL
(2 vials of 130 mg/26 ml solution)

>55 kg to <85 kg (≤121 to 187 pounds)

390 mL
(3 vials of 130 mg/26 ml solution)

>85 kg (>187 pounds)

520 mL
(4 vials of 130 mg/26 ml solution)

Instructions for use1

STEP 1

Prepare the injection

Wash your hands and place supplies on a clean surface. Clean the injection site (stomach, thigh, or buttocks) with an antiseptic wipe. A caregiver may also use the upper arm. Let it dry.

STEP 2

Prepare the medicine

Take off the needle cover, and don’t touch the plunger or the needle. Hold the syringe body and pull the cover straight off. Throw the cover away.

STEP 3

Inject the medicine

Use your thumb to push the plunger all the way in until it’s fully between the needle guard wings.

STEP 4

Remove the needle

Once the syringe is empty, pull the needle out and let go of the skin. If there’s a little bleeding, press a cotton ball on the area, and apply a bandage if needed.

Download the official Medication Guide for more info about how to take STARJEMZA™

The Medication Guide gives you everything you need to feel informed and supported as you begin treatment.

Download medication guide

Still have questions about STARJEMZA™?

Read more about how you can get started with STARJEMZA™

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™.

References: 1. Starjemza™ Prescribing information. Hikma ; October 2024. 2. Jeremias S. FDA approves Starjemza™ as new Stelara® biosimilar. The Center for Biosimilars. May 27, 2025. Accessed July 28, 2025. https://www.centerforbiosimilars.com/view/fda-approves-starjemza-as-new-stelara-biosimilar 3. STELARA®. Prescribing information. Janssen Biotech, Inc.; November 2024.