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Guselkumab Injection

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Why is this medication prescribed?

Guselkumab injection is used to treat moderate to severe plaque psoriasis in individuals whose psoriasis is too severe to be treated by topical drugs alone (a skin condition in which red, scaly patches develop on specific areas of the body). Adults with psoriatic arthritis, a disorder that causes joint discomfort, swelling, and skin scales, can take it either by itself or in conjunction with other drugs. Monoclonal antibodies are a class of drugs that includes gluselkumab injection. It functions by preventing specific bodily cells from acting in a way that results in the psoriasis symptoms.

How should this medicine be used?

Guselkumab injection is available as a solution (liquid) to be injected subcutaneously (under the skin) in a prefilled automatic injection device and syringe. Typically, it is injected once every 4 weeks for the first two doses and once every 8 weeks after that. Follow the guselkumab injection instructions precisely. Never inject more, less, or more frequently than your doctor has instructed.

Your doctor’s office will be where you get your first guselkumab injection. After that, your doctor might let you administer guselkumab injections by yourself or with the help of a caregiver. Ask your doctor or pharmacist to demonstrate how to inject guselkumab for you or the person administering the injections. Read the enclosed written instructions before administering guselkumab injection for the first time.

Only use one syringe or automatic injection device per solution, and inject the entire contents of the syringe. Even if there is still medication inside, dispose of the discarded syringe or device. Use a container that won’t puncture to dispose of spent syringes or tools. Regarding how to get rid of the puncture-resistant container, see your physician or pharmacist.

When you are prepared to administer the medication, take the prefilled syringe or automatic injection device out of the refrigerator, set it on a flat surface, and let it warm to room temperature for 30 minutes. Do not remove the needle cover or device cap from the syringe during this time. Never attempt to warm the drug by heating it in a microwave, submerging it in hot water, exposing it to sunshine, or by any other means.

A prefilled syringe or automatic injection tool containing guselkumab shouldn’t be shaken. If the guselkumab prefilled syringe is dropped, do not use it; it contains glass and needs to be handled with care.

Before injecting guselkumab, always check the solution. Verify that the liquid is clear, colorless to light yellow, and that the expiration date has not passed. There might be a few discernible particles in the liquid. If the device or prefilled syringe is broken, frozen, expired, or the liquid is hazy, discolored, or includes big particles, do not use it.

Within five minutes of removing the needle cap or device cap, administer the guselkumab injection. Replace the device cap or needle cover as soon as possible to avoid harm or damage to the needle. After removing the device cap, never utilize an automatic injection device that has been dropped.

Except for your navel and the region 2 inches (5 centimeters) around it, you can inject guselkumab injection anyplace on the front of your legs (upper leg), back of your upper outside arms, or abdomen (stomach). Use a different place for each injection to lessen the possibility of discomfort or redness. Never inject into skin that is irritated, bruised, red, or rigid.

When you start therapy with guselkumab injection, your doctor or pharmacist will provide you the medication guide (patient information sheet) from the manufacturer. If you have any questions, thoroughly read the material, then consult your physician or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website, as well as on the manufacturer’s website, which also hosts the Instructions for Use.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using guselkumab injection,

  • If you have an allergy to guselkumab injection, any other drugs, or any of the ingredients in guselkumab injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you get pregnant while taking guselkumab injection.
  • To find out if you require any immunizations, consult your doctor. Before starting guselkumab injectable therapy, it’s crucial to have had all recommended vaccinations for your age. Avoid getting any shots while you are receiving therapy without first consulting your doctor. Additionally, if anyone living in your home needs a vaccination while you are receiving guselkumab injectable treatment, discuss this with your doctor.
  • You should be aware that guselkumab injection may reduce your resistance to infection from bacteria, viruses, and fungi and raise your chance of developing a serious or lethal infection. Inform your doctor if you frequently contract any kind of infection or if you already have or suspect you may have any kind of infection. Included in this are fresh or developing skin lesions, mild infections (like cuts or sores that are still open), transient infections (like cold sores), and persistent infections that persist over time. Call your doctor right away if you suffer any of the following signs or symptoms during or soon after receiving guselkumab injectable therapy: Sweating, chills, muscular pains, cough, shortness of breath, fever, weight loss, excessive fatigue, flu-like symptoms, vomiting, sore throat, runny, stuffy nose, or sneezing, warm, red, or painful skin, painful or frequent urination, diarrhea, stomach discomfort, or other infection-related symptoms.
  • You should be aware that using guselkumab injection increases your risk of contracting tuberculosis (TB; a dangerous lung infection), particularly if you already have tuberculosis but do not now exhibit any symptoms of the illness. Inform your doctor if you have TB, have ever had TB, have lived in a country where TB is prevalent, or have come into contact with someone who has TB. To determine whether you have a dormant TB infection, your doctor will conduct a skin test. Before you begin using guselkumab injection, your doctor may prescribe medication to treat this infection if necessary. Call your doctor right away if you experience any of the following TB symptoms, or if any of them arise during your treatment: a cough, chest pain, coughing up blood or mucus, weakness or exhaustion, weight loss, lack of appetite, chills, fever, or night sweats.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Once you remember to take the missed dosage, proceed with your regular dosing regimen. To make up for a missing dose, do not take a second one. If you are unsure of your dose regimen, call your doctor.

What side effects can this medication cause?

The injection of glutelkumab may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • At the injection site, redness, itching, swelling, discomfort, discoloration, or irritation may occur
  • Joints hurt
  • 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 dizzy or ill at ease
  • Enlargement of the tongue, throat, mouth, eyes, lips, or face
  • Having trouble breathing
  • Throat or chest constriction

Other adverse effects from guselkumab injection are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Guselkumab injection should not be frozen; instead, store it in the refrigerator. To protect them from light, keep the prefilled syringes or automatic injection tools in their original cartons.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).

In case of emergency/overdose

Call 1-800-222-1222 to reach the poison control hotline in the event of an overdose. You can get information online at https://www.poisonhelp.org/help. Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

What other information should I know?

Keep all of your doctor’s appointments.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Tremfya®
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