Guselkumab Injection

What is this medication?

GUSELKUMAB (goo SELK ue mab) treats autoimmune conditions, such as psoriasis, arthritis, Crohn disease, and ulcerative colitis. It works by slowing down an overactive immune system.  It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tremfya, Tremfya PEN

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Have tuberculosis (TB) or have been in close contact with someone who does
• Infection that does not go away or keeps coming back
• Liver disease
• Recent or upcoming vaccine
• An unusual or allergic reaction to guselkumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is usually given by a care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at a hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. Then continue your normal schedule. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines

This medication may also interact with the following:

• Amoxapine
• Certain medications for depression, anxiety, or mental health conditions, such as amitriptyline, clomipramine, desipramine, doxepin, imipramine, maprotiline, nortriptyline, protriptyline, trimipramine
• Codeine
• Inactivated vaccines
• Methadone
• Pimozide
• Thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medication. If your care team prescribes any medication for TB, you should start taking the TB medication before starting this medication. Make sure to finish the full course of TB medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Joint pain
• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in the refrigerator. Do not freeze. Keep it in the original container until you are ready to use. Protect from light. Do not shake. Remove the dose from the refrigerator about 30 minutes prior to use. Get rid of any unused medication after the expiration date on the label.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.