Guselkumab

What is guselkumab?

Guselkumab is a prescription medicine that is used to treat plaque psoriasis.

Description

Guselkumab, an interleukin-23 blocker, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology.

TREMFYA (guselkumab) injection is a sterile, preservative free, clear, colorless to light yellow solution that may contain small translucent particles. TREMFYA is supplied as a single-dose solution in a 1 mL glass syringe with a 27G, half inch fixed needle assembled in a passive needle guard delivery system or One-Press patient-controlled injector for subcutaneous use.

Each TREMFYA 1 mL prefilled syringe or One-Press patient-controlled injector contains 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8.

Mechanism of Action

Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.

Before taking guselkumab, tell your doctor:

• If you are allergic to guselkumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you have active TB (tuberculosis).

This is not a list of all drugs or health problems that interact with guselkumab.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take guselkumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take guselkumab?

• Tell all of your health care providers that you take guselkumab. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You will need a TB (tuberculosis) test before starting guselkumab.
• Talk with your doctor before getting any vaccines. Use of some vaccines with guselkumab may either raise the chance of an infection or make the vaccine not work as well.
• Make sure you are up to date with all your vaccines before treatment with guselkumab.
• Allergic reactions have happened with guselkumab. Sometimes, these have been very bad and people have had to go to the hospital. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is guselkumab best taken?

Use guselkumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• Before using guselkumab, take it out of the refrigerator and leave it at room temperature for 30 minutes.
• Do not heat or microwave.
• Do not shake.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not give into skin that is affected by psoriasis.
• This product may contain small white particles. Do not use if the solution is cloudy, leaking, or has large lumps, flakes, or other particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Each prefilled pen or syringe is for one use only.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of guselkumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like 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 like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Red, painful, or itchy skin that is hot to touch.
• Shortness of breath.
• Cough with or without phlegm or blood.
• Weight loss.
• Passing urine more often.
• Stomach pain or diarrhea.
• Sweating a lot.
• Muscle pain.
• Passing out.

What are some other side effects of guselkumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Signs of a common cold.
• Headache.
• Irritation where the shot is given.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out guselkumab?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.