Stelara

To treat adults with either plaque psoriasis or psoriatic arthritis, the usual dose is 45 mg injected under the skin. The dose is repeated in 4 weeks, and then every 12 weeks thereafter. For people who weigh more than 100 kg, a dose of 90 mg may be used. When treating plaque psoriasis, some people may need to receive Stelara (Ustekinumab) every 8 weeks. The dose may be injected on top of the thigh or around the abdomen (about 2 inches away from the belly button).

For treating children and adolescents 6 to 17 years of age with plaque psoriasis, the dose is based on body weight.

For the treatment of Crohn's disease and ulcerative colitis, the first dose is given as an intravenous (into a vein) infusion and the dose is based on body weight. The dose is repeated as an injection under the skin 8 weeks after the first dose. The usual maintenance dose is 90 mg every 8 weeks. Under certain conditions, your doctor may decrease the frequency of your injections to once every 12 weeks.

Most people using Stelara (Ustekinumab) can be trained by a health care professional to give themselves the injection. Stelara (Ustekinumab) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Stelara (Ustekinumab) on your own until you completely understand how to inject a dose.

Follow the instructions from your doctor or pharmacist when administering the medication. The solution should be colourless or slightly yellow and may contain a few small clear or white particles of protein. Do not use the injection if it appears cloudy or discoloured, or if you see other particles floating in it. After taking the medication out of the refrigerator, preparing the syringe, and choosing the injection site, inject the dose under the skin as instructed by your health care provider.

Use a different site for each injection to decrease the risk of skin irritation. Dispose of your used needles in an appropriate sharps container.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Stelara (Ustekinumab) be given exactly as recommended by your doctor. If you miss a dose, contact your doctor for advice. Do not inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Stelara (Ustekinumab) in the refrigerator in its original carton, protect it from light, and keep it out of the reach of children. If necessary, pre-filled syringes may be kept at room temperature for up to 30 days. Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. Do not freeze or shake the medication.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause mood changes and, occasionally, may lead to depression; it may cause unusual tiredness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Subcutaneous solution
Each mL of sterile solution contains 90 mg of Stelara (Ustekinumab). It is available as a pre-filled syringe containing 45 mg (0.5 mL) or 90 mg (1.0 mL) of Stelara (Ustekinumab). Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Intravenous infusion
Each mL of sterile solution contains 5 mg of Stelara (Ustekinumab). It is available as a solution for intravenous infusion containing 130 mg per 26 mL. Nonmedicinal ingredients: sucrose, L-histidine and L-histidine hydrochloride monohydrate, polysorbate 80, L-methionine, and EDTA disodium salt dihydrate.

Do not use Stelara (Ustekinumab) if you:

• are allergic to Stelara (Ustekinumab) or any ingredients of Stelara (Ustekinumab), including latex
• have severe infections such as sepsis (bacterial infections that have spread throughout the body), Tuberculosis, and opportunistic infections (infections that can occur when people have weakened immune systems)

There may be an interaction between Stelara (Ustekinumab) and any of the following:

• BCG
• Baricitinib
• Belimumab
• Cladribine
• Denosumab
• echinacea
• Fingolimod
• Infliximab
• Leflunomide
• Natalizumab
• Nivolumab
• Ocrelizumab
• Pimecrolimus
• Roflumilast
• siponimod
• Tacrolimus
• Tofacitinib
• Trastuzumab
• upadacitinib
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Stelara (Ustekinumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Stelara (Ustekinumab).

Allergic reaction: In rare cases, some people may develop a serious allergic reaction to Stelara (Ustekinumab). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, seek immediate medical attention.

Allergy shots: Stelara (Ustekinumab) may affect allergy shots. If you are receiving or have received allergy shots, especially for severe allergic reactions, discuss with your doctor how Stelara (Ustekinumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stelara (Ustekinumab), and whether any special monitoring is needed.

Immune system and infections: Stelara (Ustekinumab) may lower your ability to fight infections and may increase the risk of infections and reactivate inactive infections. Your doctor may test for tuberculosis before starting Stelara (Ustekinumab).

Your doctor will do regular tests of immune system function while you are using Stelara (Ustekinumab). If you develop a severe infection, contact your doctor as soon as possible.

Latex: The needle cover on the pre-filled syringe contains dry natural rubber (a form of latex). If you are allergic to latex, talk to your doctor before using the pre-filled syringe.

Malignancies (cancer): Stelara (Ustekinumab) may increase the risk of cancer. If you have cancer or have had cancer in the past, discuss with your doctor how Stelara (Ustekinumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stelara (Ustekinumab), and whether any special monitoring is needed.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like Stelara (Ustekinumab). If you have had a previous episode of RPLS, Stelara (Ustekinumab) may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Serious infections: Stelara (Ustekinumab) can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking Stelara (Ustekinumab) with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how Stelara (Ustekinumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stelara (Ustekinumab), and whether any special monitoring is needed.

Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency of urination or burning while passing urine, redness or swelling of skin or joint, Cold Sores, tooth pain, or new or worsening pain in any part of the body.

If you have an active infection, you should not use Stelara (Ustekinumab) until the infection resolves.

Serious skin conditions: Some people receiving Stelara (Ustekinumab) have reported rare serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis). If you experience redness and shedding of skin over most of the body, contact your doctor immediately.

Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using Stelara (Ustekinumab). If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how Stelara (Ustekinumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stelara (Ustekinumab), and whether any special monitoring is needed.

Vaccinations: People taking Stelara (Ustekinumab) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Stelara (Ustekinumab).

Pregnancy: Stelara (Ustekinumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Stelara (Ustekinumab), contact your doctor immediately.

Breast-feeding: It is not known if Stelara (Ustekinumab) passes into breast milk. If you are breast-feeding and are taking Stelara (Ustekinumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Stelara (Ustekinumab) have not been established for children 6 years of age and younger with plaque psoriasis. The safety and effectiveness of using Stelara (Ustekinumab) have not been established for children less than 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Take this medication regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed.