Guselkumab

Tremfya

Tremfya (guselkumab), an FDA-approved biologic medication, treats psoriatic arthritis and moderate to severe plaque psoriasis. It works by blocking a specific inflammatory protein with Guselkumab. Administered every eight weeks via prefilled syringes or autoinjectors at 100 mg/ml, it’s for adults unresponsive to other psoriasis treatments. Common side effects include headache, upper respiratory infections, injection site reactions, and diarrhea. Severe allergic reactions or infections require immediate medical attention. Precautions apply to patients with tuberculosis or other diseases. Missed doses should be taken promptly unless within four weeks of the next scheduled dose. Storage requires refrigeration between 36°F and 46°F, avoiding freezing. Patients should be aware of infection risks and report symptoms promptly to their healthcare provider.

Product Overview

Tremfya is an FDA-approved biologic medication for treating psoriatic arthritis and moderate to severe plaque psoriasis in adults. Its active ingredient, Guselkumab, targets a specific protein in the body that plays a vital role in the inflammation associated with psoriasis. By blocking this protein, Tremfya helps reduce psoriasis symptoms, including the thick, red patches of skin and the accompanying discomfort.

Tremfya has a 100 mg/ml strength and is available in prefilled syringes or autoinjectors. It is typically administered as a subcutaneous injection every eight weeks after an initial loading dose. Tremfya is suitable for adults who have not adequately responded to other systemic psoriasis therapies. Common side effects of Tremfya may include headache, upper respiratory infections, injection site reactions, and diarrhea. Patients are advised to seek medical attention if they experience signs of a severe allergic reaction or infections. 

Precautions should be taken in patients with a history of tuberculosis or other infections. If a dose is missed, it should be taken as soon as remembered unless it is within four weeks of the next scheduled dose. Storage guidelines recommend keeping Tremfya refrigerated between 36°F to 46°F until use, avoiding freezing. Patients should be cautioned about the risk of infections and advised to report any symptoms to their healthcare provider promptly.

Uses of Tremfya

It is used for treating:

• Psoriatic arthritis
• Moderate to severe plaque psoriasis

How to Use Tremfya?

Dosage

Strengths and Form

Form: It comes as a solution and is given as a subcutaneous injection.

Strength: 100 mg/ml

Recommended Dosage for Different Patients

For Adults with Psoriatic Arthritis:

• A subcutaneous dose of 100 mg should be given at Week 0, Week 4, and every eight weeks after that.

For Adults with Plaque Psoriasis:

• A subcutaneous dose of 100 mg should be given at Week 0, Week 4, and every eight weeks after that.

[Note: These Tremfya dosage recommendations may differ from individual to individual. Discuss it with your healthcare professional, and they’ll decide your dosage accordingly.]

How to Take It?

Here is a step-by-step guide for administering Tremfya injection:

Step 1. Wash hands thoroughly with soap and water.

Step 2. Choose an injection site, typically the abdomen or thigh, and clean the area with an alcohol swab.

Step 3. Remove the cap from the prefilled syringe or autoinjector.

Step 4. Pinch a fold of skin at the chosen injection site.

Step 5. Insert the needle at a 45 to 90-degree angle into the skin fold.

Step 6. Press the plunger or activate the autoinjector to administer the medication.

Step 7. Once the injection is complete, remove the needle and dispose of the syringe or autoinjector properly according to local regulations.

Step 8. Apply gentle pressure to the injection site with a cotton ball or gauze pad if needed.

Step 9. Record the date and location of the injection for future reference.

[Note: Your doctor will decide the right amount of Tremfya for you based on your condition, following guidelines and studies on the drug. They’ll adjust your Tremfya dosage as needed over time.]

How Does Tremfya Work?

Tremfya targets a specific protein in the body known as interleukin-23 (IL-23), which plays a crucial role in the inflammatory process associated with psoriasis. The active ingredient in Tremfya, Guselkumab, binds to IL-23, preventing it from signalling other cells to produce inflammatory molecules. By blocking this pathway, Tremfya helps reduce the inflammation that leads to psoriatic symptoms, such as thick, red patches of skin. This targeted approach helps alleviate moderate to severe plaque psoriasis symptoms in adults who have not responded adequately to other systemic therapies.

Important Safety Information

Side Effects

Common side effects of Tremfya may include:

• Headache
• Upper respiratory infections
• Injection site reactions
• Diarrhea

Mild side effects of Tremfya may include:

• Common cold
• Stomach flu
• Joint pain
• Herpes
• Headaches
• Fungal skin or nail infections
• Diarrhea
• Bronchitis
• Redness or itching at the injection site
• Minor flu-like symptoms such as fever or fatigue

Adverse side effects of Tremfya may include:

• Severe allergic reactions (e.g., redness, irritation, swelling of the face, tongue, or throat, difficulty breathing)
• Serious infections (e.g., tuberculosis, bacterial, fungal, or viral infections)
• Reactivation of latent tuberculosis
• Inflammatory bowel disease exacerbation
• Liver enzyme abnormalities

[Note: This list may not cover all possible Tremfya side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

Infections: Tremfya can increase the risk of serious diseases, including tuberculosis (TB) and bacterial, fungal, and viral infections. Before starting treatment with Tremfya, healthcare providers will assess patients for infections and may perform tests for latent TB. Patients should report any signs of illness to their healthcare provider promptly.

Allergic Reactions: Some individuals may experience allergic reactions to Tremfya. Signs of an allergic reaction include rash, swelling, itching, dizziness, or difficulty breathing. Patients experiencing these symptoms should seek medical attention immediately.

Hypersensitivity Reactions: In addition to allergic reactions, Tremfya may cause hypersensitivity reactions. Patients should inform their healthcare provider if they experience symptoms such as chest tightness, trouble breathing, or swelling of the face, lips, or tongue.

Immunosuppression: Tremfya works by suppressing the immune system, which can increase the risk of infections and may decrease the body’s ability to fight infections.

Malignancies: There is a potential increased risk of malignancies (cancer) with the use of Tremfya. Patients should discuss the benefits and risks of treatment with their healthcare provider.

Latex Allergy: The needle cover of the Tremfya prefilled syringe contains latex, which may cause allergic reactions in individuals with latex sensitivity.

Vaccinations: Patients should avoid live vaccines while receiving Tremfya treatment. It’s essential to discuss vaccination schedules with healthcare providers.

Other Pre-existing Conditions: Patients with pre-existing conditions such as Crohn’s disease, ulcerative colitis, or a history of demyelinating disorders should use Tremfya cautiously, as it may exacerbate these conditions.

Precautions

• Get screened for TB before starting. Watch for signs of infection during and after treatment.
• Don’t use Tremfya or its components if you have a known allergy to them. Seek immediate help for any allergic symptoms.
• Be cautious if you have a history of chronic infections or immunosuppression. You might be more susceptible to infections.
• Discuss the risks, especially if you have a history of cancer or are immunocompromised.
• If you’re allergic to latex, inform your healthcare provider before starting Tremfya.
• Talk to your doctor about using Tremfya if you’re pregnant or breastfeeding.
• Tremfya has yet to be studied in children.
• Watch for signs of infection or other side effects. Your doctor will monitor your health throughout treatment.
• Tell your healthcare provider about all medications you’re taking to avoid potential interactions with Tremfya.

Tremfya Contraindications

• Tremfya is contraindicated in patients with a history of severe hypersensitivity reactions to Guselkumab or any of its excipients.
• Clinically significant active infections, such as active tuberculosis, are also a contraindication for using Tremfya.

Missed Dose

• Take the missed dose as soon as you remember.
• If you are following dose approaches, skip the missed one and resume your usual dosing schedule.
• Avoid taking a double dose to make up for the missed one.

[Note: If you have missed a Tremfya dose and are unsure when to take the next one, consult your doctor or pharmacist immediately.]

Overdose

Symptoms of a Tremfya overdose may include increased infection risk, allergic reactions, intensified side effects, skin reactions, gastrointestinal issues, liver dysfunction, and neurological symptoms.

[Note: If you consumed more than the recommended dose of Tremfya, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Store Tremfya in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep Tremfya in its original carton to protect it from light.
• Avoid shaking the Tremfya prefilled syringe.
• Keep Tremfya away from extreme temperatures. Do not expose it to temperatures above 77°F (25°C).
• Store Tremfya out of reach of children and pets.
• During transportation, keep Tremfya in a cooler with ice packs to maintain the required temperature range.

[Note: Discuss with your healthcare professional the proper disposal of unused Tremfya injection and any questions you may have regarding its storage.]

Tremfya Interactions

• Albuterol
• Amlodipine
• Atorvastatin
• Baclofen
• Bupropion
• Cosentyx (secukinumab)
• Cyclobenzaprine
• Cymbalta (duloxetine)
• Doxycycline
• Folic acid
• Gabapentin
• Humira (adalimumab)
• Hydrochlorothiazide
• Hydroxyzine
• Ibuprofen
• Levothyroxine
• Lisinopril
• Meloxicam
• Metformin
• Methotrexate
• Omeprazole
• Otezla (apremilast)
• Ozempic (semaglutide)
• Pantoprazole
• Prednisone
• Taltz (ixekizumab)
• Tramadol
• Trazodone
• Vitamin B12 (cyanocobalamin)
• Vitamin D3 (cholecalciferol)

[Note: This isn’t a complete list, and there could be other drugs that interact with Tremfya. Tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Tremfya Alternatives

• Otezla (apremilast)
• Taltz (ixekizumab)
• Stelara (ustekinumab)
• Cosentyx (secukinumab)
• Cimzia (certolizumab)

[Note: Your doctor will choose the best Tremfya alternative for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Can I take Tremfya during pregnancy?

Tremfya is not recommended during pregnancy due to limited data. Animal studies showed no adverse effects on fetal development, but the clinical significance remains uncertain. Human IgG antibodies can cross the placental barrier, potentially affecting the fetus. If you’re pregnant or planning to be, consult your doctor before using Tremfya. Always prioritize safety and discuss with your healthcare provider. 

How long does Tremfya take to work?

Tremfya (guselkumab) typically starts working in most people after about 16 weeks, corresponding to two Tremfya doses, each administered eight weeks apart. The drug is an interleukin-23 blocker used for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Its mechanism of action involves targeting the IL-23 subunit alpha, preventing it from binding to cell receptors. The half-life of Tremfya is approximately 15 to 18 days. Always consult your healthcare provider for personalized advice. 

How is Tremfya administered?

Tremfya (guselkumab) is administered by subcutaneous injection. The recommended dose is 100 mg at Week 0, Week 4, and every eight weeks afterward. Patients may self-inject with Tremfya after physician approval and proper training. In active psoriatic arthritis, Tremfya may be administered alone or with a conventional disease-modifying antirheumatic drug (cDMARD) such as methotrexate. Always follow your healthcare provider’s guidance for safe and effective administration. 

What are the signs of a severe allergic reaction to Tremfya?

Tremfya (guselkumab) may cause severe allergic reactions. If you experience any of the following symptoms, seek immediate medical attention:

• Fainting, dizziness, or feeling lightheaded (low blood pressure).
• Swelling of your eyelids, face, lips, tongue, mouth, or throat.
• Chest tightness.
• Trouble breathing or throat tightness.
• Skin rash or hives.

If you suspect a severe allergic reaction, call 911 or your local emergency number immediately. 

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