Pronunciation:

gus-ELK-ue-mab

Brand Names:

• Tremfya

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Guselkumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Plaque psoriasis is a skin disease with red patches and white scales that do not go away.

Guselkumab injection is also used alone or with other medicines (eg, methotrexate) to treat active psoriatic arthritis, a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body. Psoriatic arthritis usually occurs with a skin condition called psoriasis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of guselkumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of guselkumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection, or history of—Guselkumab is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.

• Tuberculosis infection, inactive—Should be treated first before starting treatment with this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject the medicine into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.

Check the liquid in the prefilled syringe or One-Press® injector. It should be clear and colorless or slightly yellow and may contain small particles. Do not use this medicine if it is cloudy, discolored, or has large particles in it. Do not shake.

Inject the medicine within 5 minutes of removing the needle cover off the prefilled syringe or cap off the One-Press® injector. Do not put the cap or needle cover back on as this could damage the needle. Do not use it if it has been dropped after removing the cap.

You might not use all of the medicine in each prefilled syringe or One-Press® injector. Use each prefilled syringe or One-Press® injector only one time. Do not save an open syringe or One-Press® injector.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms (prefilled syringe or One-Press® injector):
  • For plaque psoriasis or psoriatic arthritis:
    • Adults—100 milligrams (mg) injected under your skin as a single dose at weeks 0 and 4, and every 8 weeks after.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton until you are ready to use it. Protect from light.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Guselkumab injection may cause serious allergic reactions, including anaphylaxis. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

It is important to check with your doctor if you have any symptoms of an infection, such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.

Do not have any live vaccines (immunizations) while you are being treated with guselkumab. Be sure to ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Less Common

Burning or stinging of the skin

diarrhea

itching in the genital or other skin areas

loss of appetite

nausea

painful cold sores or blisters on the lips, nose, eyes, or genitals

scaling

stomach pain

Rare

Headache, severe and throbbing

hives or welts, itching, skin rash

white patches in the mouth or throat or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty in moving

muscle pain or stiffness

pain in the joints

Rare

Redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.