Guselkumab Injection

WHY is this medicine prescribed?

Guselkumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults whose psoriasis is too severe to be treated by topical medications alone. It is also used alone or in combination with other medications to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Guselkumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of psoriasis.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Guselkumab injection comes as a solution (liquid) in a prefilled syringe and a prefilled automatic injection device to inject subcutaneously (under the skin). It is usually injected once every 4 weeks for the first two doses and then continued once every 8 weeks. Use guselkumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You will receive your first dose of guselkumab injection in your doctor's office. After that, your doctor may allow you to inject guselkumab yourself or have a caregiver give the injections. Ask your doctor or pharmacist to show you or the person who will be giving the injections how to inject guselkumab. Before you use guselkumab injection yourself the first time, read the written instructions that come with it.

Use each syringe or automatic injection device only once and inject all the solution in the syringe. Discard the used syringe or device even if there is still some medication left in it. Dispose of used syringes or devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Remove the prefilled syringe or automatic injection device from the refrigerator, place the syringe on a flat surface without removing the needle cover or device cap, and allow it warm to room temperature for 30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.

Do not shake a prefilled syringe or automatic injection device that contains guselkumab. Do not use guselkumab prefilled syringe if it is dropped; it has glass parts and should be handled carefully.

Always look at guselkumab solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to light yellow solution. The liquid may contain a few visible particles. Do not use the prefilled syringe or device if it is damaged, expired, frozen, or if the liquid is cloudy, discolored, or contains large particles.

Inject guselkumab injection within 5 minutes of removing the needle cover or device cap. Do not replace the needle cover or device cap as this can damage the needle or cause injury. Do not use an automatic injection device that has been dropped after removal of the device cap.

You can inject guselkumab injection anywhere on the front of your thighs (upper leg), back of upper outer arms, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with guselkumab injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide, or the manufacturer's website to obtain the Medication Guide and the Instructions for Use.

What SPECIAL PRECAUTIONS should I follow?

Before using guselkumab injection,

• tell your doctor and pharmacist if you are allergic to guselkumab injection, any other medications, or any of the ingredients in guselkumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using guselkumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with guselkumab injection. Do not have any vaccinations during your treatment without talking to your doctor. Also talk to your doctor if anyone in your household needs to receive a vaccine during your treatment with guselkumab injection.

• you should know that guselkumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes new or changing skin lesions, minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with guselkumab injection, call your doctor immediately: sweating; chills; muscle aches; cough; shortness of breath; fever; weight loss; extreme tiredness; flu-like symptoms; vomiting; sore throat; runny, stuffed nose, or sneezing; warm, red, or painful skin; painful or frequent urination; diarrhea; stomach pain; or other signs of infection.

• you should know that using guselkumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using guselkumab injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one. Call your doctor if you are unclear about your dosing schedule.

What SIDE EFFECTS can this medicine cause?

Guselkumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• redness, itching, swelling, pain, discoloration, or irritation at the injection site
• joint pain
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, stop using guselkumab injection and call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• feeling faint or lightheaded
• swelling of the face, eyes, lips, mouth, throat, or tongue
• difficulty breathing
• chest or throat tightness

Guselkumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Store guselkumab injection in the refrigerator, but do not freeze. Keep the prefilled syringes or automatic injection devices in their original cartons to protect them from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.