Buy Tremfya (guselkumab)

What is Tremfya (guselkumab) for?

Tremfya (guselkumab) is a Interleukin 23 antagonist indicated for the treatment of adult patients with:^[1]

• Moderate-to-severe plaque psoriasis who are candidates for systemic therapy or light therapy
• Active psoriatic arthritis (PsA)

It is available as a single-dose syringe containing 100 mg guselkumab.^[1]

How does Tremfya (guselkumab) work?

Psoriasis is a chronic autoimmune condition, characterized by raised areas of inflamed skin. Psoriatic arthritis is a type of chronic inflammatory arthritis that presents with painful inflammation of the joints and surrounding connective tissue.^[2]

The cytokine interleukin 23 (IL-23) is found to be very important in the development of psoriasis. Cytokines play a role in signaling in a cell. IL-23 signaling can increase the risk of developing inflammation in the body, which causes the onset of psoriasis.^[2]

Guselkumab is a human monoclonal antibody, a type of protein, that binds to the IL-23. Hereby, it will block its action, and thereby slow down inflammation in patients.^[1]

Where has Tremfya (guselkumab) been approved?

Tremfya (guselkumab) was approved by:

• The Food and Drug Administration (FDA), US:
  • July 13, 2017 for the treatment of adult patients with moderate to severe plaque psoriasis.^[3]
  • July 14, 2020 for the treatment of adult patients with active PsA.^[4]
• The European Medicines Agency (EMA), Europe:
  • November 10, 2017 for the treatment of adults with moderate to severe psoriasis.^[5]
• Health Canada, Canada:
  • November 15, 2017 for the treatment of adults with moderate to severe plaque psoriasis.^[6]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan:
  • April 7, 2018 for the treatment of three types of psoriasis (plaque, pustular, and erythrodermic) and PsA in patients with moderate-to-severe disease.^[4,7]
• The Therapeutic Goods Administration (TGA), Australia:

• February 1, 2019 for the treatment of severe chronic plaque psoriasis.^[8]

Tremfya (guselkumab) is the first and only approved medication that selectively blocks only IL-23.^[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tremfya (guselkumab) taken?

The standard dosage is:^[1]

• 100 mg of guselkumab, administered by subcutaneous injection.

Tremfya (guselkumab) is administered at week 0, week 4, and every 8 weeks thereafter.

It is intended for use under the guidance and supervision of a healthcare professional. The patient may self-inject after proper training in how to inject subcutaneously.

Patients should be tested for tuberculosis (TB) infection before starting with Tremfya (guselkumab) therapy.

Complete information about Tremfya (guselkumab) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known adverse reactions or side effects of Tremfya (guselkumab)?

Common adverse reactions

The most common adverse effects (≥1% of patients) listed in the prescribing information include:^[1]

• Upper respiratory infections
• Headache
• Injection site reactions
• Arthralgia
• Diarrhea
• Gastroenteritis
• Tinea infections
• Herpes simplex infections

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Risk of infections: please seek medical help if signs or symptoms of acute or chronic infection occur.

Use in a specific population

Tremfya (guselkumab) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please read the full prescribing information.

References

1. Summary of Product Characteristics [FDA]: Tremfya (guselkumab) [PDF] Janssen, July 2017

2. Targeting IL-23 in psoriasis: current perspectives
Fotiadou C, Psoriasis (Auckl.), Jan 4, 2018

3. Janssen Announces US FDA Approval of TREMFYA™ (guselkumab) For The Treatment Of Moderate To Severe Plaque Psoriasis
Janssen press release, July 13, 2017

4. TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
Janssen press release, July 14, 2020

5. MorphoSys’ licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis
News article, last checked on Sept 1, 2020

6. Tremfya (guselkumab)
European Medicines Agency (EMA) information, last checked on Sept 2, 2020

7. Medicines for the treatment of psoriasis listed on the PBS
Therapeutic Goods Administration (TGA) information, Jan 25, 2019