Guselkumab injection

What is this medication?

GUSELKUMAB (goo ZELK ue mab) is used to treat plaque psoriasis and psoriatic arthritis.

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

COMMON BRAND NAME(S): Tremfya

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

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

• immune system problems
• infection (especially a virus infection such as chickenpox, cold sores, or herpes) or history of infections
• recently received or scheduled to receive a vaccine
• tuberculosis, a positive skin test for tuberculosis, or have recently been in close contact with someone who has tuberculosis
• an unusual or allergic reaction to guselkumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. It may be administered by a healthcare professional in a hospital or clinic setting or at home. If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used injectors, 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 healthcare provider to get one.

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 pediatrician regarding the use of this medicine 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?

It is important not to miss your dose. Call your doctor of health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. Then, take your next dose at your regular scheduled time.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may also interact with the following medications:

• amoxapine
• certain medicines for depression, anxiety, or psychotic disturbances like 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 medicine. Tell your doctor or healthcare professional 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 medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional if you get a cold or other infection while receiving this medicine. Do not treat yourself. This medicine may decrease your body's ability to fight infection.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or chest tightness
• dizziness, feeling faint or lightheaded
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

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

• diarrhea
• headache
• joint pain
• pain, redness, irritation at site where injected

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.

Store unopened syringes or injectors in a refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Keep in the original container until ready for use. Protect from light. Do not freeze. Do not shake. Prior to use, remove the syringe or injector from the refrigerator and use after 30 minutes at room temperature. Throw away any unused medicine after the expiration date on the label.

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.