Stelara 45mg Prefilled Syringe

Ustekinumab is a human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit of human interleukins (IL)-12 and -23. By binding to the p40 subunit, ustekinumab prevents IL-12 and IL-23 from binding to their common receptor, IL-12Rβ1, expressed on the surface of immune cells. IL-12 and IL-23 are naturally occurring cytokines involved in immune and inflammatory responses, and their dysregulation is implicated in the pathogenesis of immune-mediated inflammatory diseases like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Warm, red, or painful skin or sores on the body
Flushing
Severe dizziness or fainting
Weight loss
Muscle aches
Skin lump or growth
Vaginal itching or discharge
Posterior reversible encephalopathy syndrome (PRES), a rare but serious brain condition, characterized by symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headache
Pneumonia, which can be serious and require hospitalization, marked by symptoms such as cough, fever, chest pain, shortness of breath, or difficulty breathing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Feeling tired or weak
Headache
Diarrhea, stomach pain, upset stomach, or vomiting
Nose or throat irritation
Signs of a common cold
Back, muscle, or joint pain
* Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have received the BCG vaccine within the past year.
If you currently have an infection.
If you have been diagnosed with tuberculosis (TB).

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, be sure to discuss this with your doctor.

Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication. Be aware that drugs like this one, which suppress the immune system, may increase the risk of cancer. Your doctor will closely monitor you for signs of cancer, particularly if you are 60 years or older, have undergone light therapy, or have been taking immunosuppressive medications for an extended period. If you have any questions or concerns, do not hesitate to discuss them with your doctor.

Regular skin checks are also important. Notify your doctor immediately if you notice any skin changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of a mole.

As this medication may increase your risk of infection, it is crucial to take preventive measures. Wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and ensure you are up to date with all recommended vaccinations before starting treatment with this medication.

Before receiving any vaccinations while taking this medication or after stopping it, consult with your doctor. The use of vaccines with this medication may either increase the risk of infection or reduce the vaccine's effectiveness. Additionally, do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Discuss any concerns with your doctor.

A tuberculosis (TB) test is required before initiating treatment with this medication. If you experience any weight changes, inform your doctor, as your dosage may need to be adjusted.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you took this medication during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccinations for your child.

• Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) during ustekinumab treatment and for at least 3 months after discontinuation.

• Immunosuppressants (e.g., cyclosporine, methotrexate, azathioprine, 6-mercaptopurine): Increased risk of immunosuppression and infection when used concomitantly. Use with caution.

• Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin lesions, diarrhea, abdominal pain, painful urination)
• Symptoms of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing or swallowing, dizziness, faintness)
• New or worsening skin lesions (for potential malignancy)
• Unexplained weight loss, night sweats, persistent fatigue (for potential malignancy)
• New or worsening neurological symptoms (e.g., numbness, tingling, weakness, vision changes, dizziness)

Ustekinumab is an IgG1 antibody and is known to cross the placental barrier, especially during the third trimester. Limited data from pregnancy registries and postmarketing reports suggest no increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, animal studies have shown some evidence of developmental toxicity at high doses. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Ustekinumab is present in human milk at low levels. The effects of local gastrointestinal exposure and systemic exposure in a breastfed infant are unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ustekinumab and any potential adverse effects on the breastfed infant from ustekinumab or from the underlying maternal condition. Generally considered compatible with breastfeeding with caution.

Approved for pediatric patients 6 years and older with moderate to severe plaque psoriasis and 12 years and older with Crohn's disease. Dosing is weight-based for psoriasis. Safety and efficacy in pediatric patients younger than 6 years with psoriasis or younger than 12 years with Crohn's disease have not been established. Increased risk of serious infections and malignancies should be considered.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor for increased risk of infections and malignancies, which may be higher in the elderly population.

• Stelara is a biologic agent administered via subcutaneous injection for maintenance therapy, often following an initial intravenous induction dose for Crohn's or ulcerative colitis.
• Patients should be thoroughly screened for tuberculosis and hepatitis B/C prior to initiation due to the risk of reactivation.
• Live vaccines are contraindicated during treatment and for a period after discontinuation. Ensure patients are up-to-date on non-live vaccines prior to starting therapy.
• Educate patients on the signs and symptoms of infection and malignancy, and to report them promptly.
• The long half-life of ustekinumab means that its effects (and potential side effects) can persist for several months after the last dose.
• Proper injection technique is crucial for subcutaneous administration; patients should be trained or receive injections from a healthcare professional.

• Other biologics for psoriasis/psoriatic arthritis (e.g., TNF inhibitors like adalimumab, etanercept, infliximab; IL-17 inhibitors like secukinumab, ixekizumab; IL-23 inhibitors like guselkumab, risankizumab; JAK inhibitors like tofacitinib).
• Other biologics for Crohn's/ulcerative colitis (e.g., TNF inhibitors like adalimumab, infliximab; integrin inhibitors like vedolizumab; JAK inhibitors like tofacitinib).
• Systemic non-biologic therapies (e.g., methotrexate, cyclosporine, acitretin for psoriasis/PsA; corticosteroids, immunomodulators like azathioprine, 6-mercaptopurine for IBD).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.