Tremfya One-press

The usual dose of Tremfya One-Press (Guselkumab) is 100 mg injected under the skin. After the first dose, the second dose is given in 4 weeks, and then every 8 weeks for subsequent doses.

Many things can affect the dose of 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 taking the medication without consulting your doctor.

Most people using Tremfya One-Press (Guselkumab) can be taught by a health care professional to give themselves the injection. Tremfya One-Press (Guselkumab) 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 Tremfya One-Press (Guselkumab) on your own until you completely understand how to inject a dose.

Before using Tremfya One-Press (Guselkumab), remove it from the refrigerator and allow it to warm to room temperature, with the cap on. This takes approximately 30 minutes. Do not shake Tremfya One-Press (Guselkumab). Shaking causes the medication to become less effective.

Follow the instructions from your doctor or pharmacist when administering the medication. The solution should be clear to slightly yellow and may contain tiny white or clear particles. Do not use the injection if it appears cloudy or discoloured, or if it has large particles floating in it.

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

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take 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 Tremfya One-Press (Guselkumab) in the refrigerator, protect it from freezing, and keep it out of the reach of children.

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 diarrhea; it may cause joint pain; it could make you more prone to respiratory infections; it may cause redness and swelling at the injection site. 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.

Pre-filled syringe

Each mL of sterile, clear-to-slightly-yellow solution for injection in a prefilled syringe contains 100 mg of Tremfya One-Press (Guselkumab). Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sucrose, polysorbate 80, and water for injection.

Patient-controlled injector

Each mL of sterile, clear-to-slightly-yellow solution for injection in a patient-controlled injector contains 100 mg of Tremfya One-Press (Guselkumab). Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sucrose, polysorbate 80, and water for injection.

Do not take Tremfya One-Press (Guselkumab) if you are allergic to Tremfya One-Press (Guselkumab) or any ingredients of the medication.

There may be an interaction between Tremfya One-Press (Guselkumab) and any of the following:

• Baricitinib
• BCG
• Belimumab
• Cladribine
• Denosumab
• echinacea
• Fingolimod
• Infliximab
• Leflunomide
• Natalizumab
• Nivolumab
• Ocrelizumab
• Pimecrolimus
• Roflumilast
• siponimod
• Tacrolimus
• Tofacitinib
• 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 Tremfya One-Press (Guselkumab). 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 Tremfya One-Press (Guselkumab).

Infections: Tremfya One-Press (Guselkumab) can increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and Tuberculosis. Before starting Tremfya One-Press (Guselkumab) treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. Tremfya One-Press (Guselkumab) should also not be started while you have an active infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections such as Diabetes. While you are taking Tremfya One-Press (Guselkumab), your doctor will monitor you for signs of infection.

Vaccinations: Vaccines that are given during treatment with Tremfya One-Press (Guselkumab) may not be as effective as expected. Also, people taking Tremfya One-Press (Guselkumab) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Tremfya One-Press (Guselkumab).

Pregnancy: Tremfya One-Press (Guselkumab) should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant should use effective birth control while taking Tremfya One-Press (Guselkumab) and for at least 12 weeks after the last dose of Tremfya One-Press (Guselkumab). If you become pregnant while taking Tremfya One-Press (Guselkumab), contact your doctor immediately.

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

Children: The safety and effectiveness of using Tremfya One-Press (Guselkumab) have not been established for children.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. If you forget a dose, contact your pharmacist.