Description
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 also used to treat moderate to severe active ulcerative colitis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of guselkumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- 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
This medicine is available in 4 forms: vial, One-Press® injector, prefilled pen, and prefilled syringe.
Vial: A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed in one of your veins to treat ulcerative colitis. It must be given slowly, so the IV catheter will have to remain in place for at least 1 hour.
One-Press® injector, prefilled pen, and prefilled syringe: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
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, affected by psoriasis, or areas with scars or stretch marks.
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 pen, 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.
To use the One-Press® injector:
- Wash your hands with soap and water before and after using this medicine.
- Pull off the bottom cap. Inject within 5 minutes of removing the cap. Do not put the cap back on.
- Place straight on the skin. Push the handle all the way down until the teal body is not visible. You will hear a click when the injection begins. Once complete, you may see the yellow band which indicates that the needle guard is locked.
To use the prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Pull the cap straight off. Inject the pen within 5 minutes of removing the cap. Do not put the cap back on.
- Place the pen straight onto the injection site with the yellow needle guard against the skin and the viewing window facing you. Press down on the pen and keep holding it down against the skin. You will hear the first click.
- Firmly hold the pen or about 10 seconds to hear a second click. Once complete, the plunger rod stops moving and fills the viewing window. Lift the pen straight up.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Remove the needle cover when you are ready to inject. Inject within 5 minutes of removing the needle cover. Do not put the needle cover back on.
- Pinch the skin and insert the needle at about a 45 degree angle with a quick dart-like motion. Slowly press the plunger all the way down until it stops. Slowly release pressure from the plunger.
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 1 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 pen, 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.
- For ulcerative colitis:
- Adults—The first 3 doses are given by a doctor through an IV catheter placed into one of your veins at Weeks 0, 4, and 8. A maintenance dose of 200 milligrams (mg) injected under your skin is given starting at Week 12 and every 4 weeks after, or 100 mg injected under your skin is given starting at Week 16 and every 8 weeks after.
- Children—Use and dose must be determined by your doctor.
- For plaque psoriasis or psoriatic arthritis:
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
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, which can be life-threatening and require immediate medical attention. 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 or been exposed to tuberculosis.
Your body's ability to fight infection may be reduced while you are being treated with guselkumab. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.
While you are being treated with guselkumab and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Guselkumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, talk to your doctor.
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
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
- joint pain
- muscle pain or stiffness
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.
CON-XXXXXXXX
