Tremfya (Guselkumab)
Tremfya
Guselkumab
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Tremfya (Guselkumab)

What is Tremfya (Guselkumab)?

Tremfya (guselkumab) is a subcutaneously injected medication that is used for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. Tremfya is a biologic medication that is not available in a biosimilar form.

How is Tremfya Used?

Tremfya comes as a solution contained within a device called a One-Press injector that functions in the same manner as other prefilled syringes for medication. Tremfya needs to be injected subcutaneously as prescribed by the patient’s doctor. The initial two doses of Tremfya will be injected with a period of four weeks between each dose. After these first two doses have been administered, patients should inject the medication every eight weeks to continue treatment.

Storage

Due to its lack of preservatives, Tremfya should be stored in the refrigerator at temperatures ranging between 36°F (2°C) and 46°F (8°C) before use. This medication should not be frozen. It is recommended that Tremfya be stored in its original packaging to avoid exposing the medication to any light.

Keep this medication out of the reach of children at all times.

Any unused medication should be disposed of properly. Due to Tremfya being in a prefilled syringe or One-Press injector, it should not be thrown loosely into household trash or anywhere else that may expose another individual to a used needle. Syringes and other forms of injectors should be disposed of in sharps containers. Please consult with your local pharmacist or waste disposal company regarding the safe and appropriate method for disposing of your excess or expired Tremfya if your injection is being performed at home.

Uses

Tremfya is prescribed for the following conditions:

  • moderate to severe plaque psoriasis
  • psoriatic arthritis

It is available in a prefilled syringe as well as a One-Press injector. Tremfya needs to be subcutaneously injected under a patient’s skin in two initial doses that are four weeks apart, and the remaining doses during treatment should be administered with a period of eight weeks between each dose.

Tremfya should remain refrigerated until it is ready to be used. When it’s time for a patient to inject their regular dose of Tremfya, it should be removed from the refrigerator about 30 minutes before injection. This allows the medication to reach room temperature and reduces discomfort when injecting. Tremfya should not be heated using sunlight or hot water, and it should not be warmed in the microwave. It should also not be shaken.

When patients administer their dose of Tremfya, they should rotate injection sites. The most common areas on the body to safely inject Tremfya include the lower abdomen/belly, the backsides of the upper arms, and the thighs. Tremfya should not be injected into any skin that is inflamed, irritated, scaly, red, or affected by psoriasis. After injecting the medication, the prefilled syringe or One-Press injector should be safely disposed of to prevent injury.

How Does Tremfya Work?

Tremfya is a selective immunomodulating agent that is, more specifically, an interleukin-23 inhibitor. This means that Tremfya functions by inhibiting the action of the protein known as interleukin-23 within a patient’s body. This is the primary protein that is overproduced in individuals who struggle with psoriasis.

By blocking this protein, Tremfya is able to limit the spread and worsening of a patient’s psoriasis and alleviate their current symptoms.

Dosage

Tremfya is available in a strength of 100 mg, either in a prefilled syringe or a One-Press injector.

Patients using Tremfya for the treatment of plaque psoriasis will inject this 100 mg dose twice with a period of four weeks between the initial two doses, and all following doses will be injected eight weeks apart.

Patients using Tremfya for the treatment of psoriatic arthritis will follow the same injection schedule as patients who have plaque psoriasis. However, they may also use Tremfya alongside a conventional disease-modifying antirheumatic drug, known as a cDMARD, which assists in suppressing the immune system and further reducing the impact of certain inflammatory conditions.

Overdose

If a patient has somehow injected too much Tremfya and an overdose is suspected, they should seek medical attention right away, especially if they are presenting with severe side effects from the overdose.

If you suspect that you or someone else has taken more Tremfya than what has been prescribed, please contact your local Poison Control Center or the prescribing physician.

Side Effects

Tremfya is associated with a number of potential side effects. The most common side effects of taking Tremfya are as follows:

  • cold symptoms (sore throat, sneezing, stuffy nose)
  • diarrhea
  • headache
  • indigestion
  • irritation, swelling, or itching at the injection site
  • joint pain
  • minor fungal infections (skin-related)
  • nausea
  • shortness of breath
  • sinus infections
  • skin infections
  • stomach pain

Some of the following side effects may occur due to lowered immunity and a higher risk of infection occurring or worsening when using Tremfya and should be discussed with your doctor immediately:

  • cough
  • chills
  • dizziness
  • fever
  • headache
  • persistent sore throat
  • severe diarrhea
  • stiff neck
  • weight loss

There are additional conditions that may develop after using Tremfya as well. Please discuss any new development or returning symptoms of any of the following conditions:

  • herpes simplex virus (i.e., genital herpes, cold sores)
  • infection symptoms
  • migraines
  • rashes
  • yeast infections

Please contact your doctor or seek medical attention if you experience any of the following symptoms of an allergic reaction after using this medication:

  • difficulty breathing
  • itching
  • rash
  • severe dizziness
  • swelling of the throat, tongue, or face

Warnings & Precautions

Tremfya is a medication that impacts a patient’s immune system; therefore, it also includes a number of precautions to prevent serious infection and other concerns for the duration of treatment.

Infections

Patients using Tremfya are at a heightened risk of developing infections, some of which may be serious (e.g., tuberculosis, pneumonia, sepsis). When using Tremfya, the patient’s doctor will likely perform tests to determine whether they have tuberculosis before beginning treatment. If the patient is experiencing any active infections, treatment with Tremfya should not be initiated until the infections are resolved.

Patients that experience any symptoms of infection while using Tremfya should report these symptoms to their physician immediately. Those with conditions such as diabetes that may be at a higher risk of infection or those who have a history of recurring infections will be monitored more closely during treatment.

Pregnancy and Breastfeeding

Tremfya is not recommended for use during pregnancy unless a doctor determines that the benefits of the medication will outweigh the risks for the pregnant patient. If a patient is currently using Tremfya to manage their psoriasis, they should take extra precautions to avoid becoming pregnant and should avoid trying to conceive for a minimum of 12 weeks after having received their last dose of the medication. If a patient is actively using Tremfya and becomes pregnant, they should contact their doctor as soon as possible.

It has not been determined if Tremfya is passed into breast milk, so the risk to any infants receiving such breastmilk is uncertain. Patients desiring to breastfeed while using Tremfya should discuss the potential risks with their physician before proceeding.

Vaccinations

Due to Tremfya’s effect on a patient’s immune system, those that receive vaccinations while using this medication may have those vaccinations be less effective. Certain vaccines, such as live vaccines, are not recommended with using Tremfya. Patients that wish or need to receive any vaccinations should discuss the risks and efficacy of those immunizations while using Tremfya for treatment.

Drug Interactions

Speak to your doctor about any medications or herbal supplements you are currently taking before beginning treatment with Tremfya. Discuss any concerns you may have with your doctor or a trusted pharmacist.

Drugs That Are Known to Interact with Tremfya

The following medications are known to interact with Tremfya:

  • baricitinib
  • BCG
  • belimumab
  • cladribine
  • denosumab
  • echinacea
  • fingolimod
  • infliximab
  • leflunomide
  • natalizumab
  • nivolumab
  • ocrelizumab
  • pimecrolimus
  • roflumilast
  • siponimod
  • tacrolimus
  • tofacitinib
  • upadacitinib

Other Substances That May Interact with Tremfya

In addition to the interactions that may occur between certain medications and Tremfya, patients should also be advised of the increased risk of side effects as well as decreased efficacy when receiving any vaccines while taking this medication.

Patients should not receive any of the following live vaccines while using Tremfya:

  • MMR (measles, mumps, rubella)
  • nasal flu vaccine (influenza)
  • rotavirus
  • typhoid
  • varicella (chickenpox)
  • yellow fever
  • zoster (shingles)

Alternative Medications

For patients who are unable to take Tremfya or experiencing significant adverse side effects, alternative medications may be used to treat some of the associated conditions for which this medication is commonly prescribed:

  • adalimumab (Humira)
  • ixekizumab (Taltz)
  • secukinumab (Cosentyx)
  • tildrakizumab-asmn (Ilumya)
  • ustekinumab (Stelara)

Frequently Asked Questions

Tremfya and Humira are two very different medications. Despite the similarities they share, Tremfya is used for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis, whereas Humira may also be used for the treatment of Crohn’s disease, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis.

Treatment with Tremfya has not been associated with any weight loss or weight gain in those who have used the medication. However, patients that experience weight gain while using Tremfya may have this occur as a side effect of an infection that has developed due to lowered immunity. Any significant weight changes that occur when using Tremfya should be reported to the patient’s prescribing physician.

Tremfya is only effective at managing psoriasis symptoms for the duration of its use. Many patients have used Tremfya for five years or longer with great success in their condition. If you are currently using Tremfya and do not want to continue using the medication, you should consult with your prescribing physician before stopping this medication.

Tremfya has not been linked to any actual liver injury in patients who have used the medication for treatment. However, it has been shown to result in elevations of a patient’s serum enzymes. This minor elevation is commonly asymptomatic and resolves after the medication has been stopped.

In a study to determine the efficacy of Tremfya at improving patients’ symptoms of active psoriatic arthritis, 50% of the patients in the study experienced a minimum of 20% improvement in swelling, stiffness, and joint pain after 24 weeks of treatment by comparison to those who only received a placebo.

Based on the clinical studies performed, Tremfya has been shown to entirely clear up or at least ease symptoms of psoriasis in 84%-85% of individuals taking the medication for 16 weeks. As of week 100, 53%-59% of patients using Tremfya were able to successfully achieve complete clearance of their skin.

Although alcohol does not directly interact with Tremfya, it does affect a person’s psoriatic arthritis and plaque psoriasis and may worsen both of these conditions. Additionally, alcohol may further impair a person’s immune system. Coupled with the immunity-related effects of Tremfya, this places an individual at a significantly higher risk of developing an infection.

Tremfya comes with a half-life ranging between 15 to 18 days. As it takes this medication about five half-lives to fully clear from a person’s body, this means it should stay in an individual’s system for 75 to 90 days.

As with most subcutaneous injections, the best locations on the body to inject Tremfya include the lower abdomen, the backside of the upper arms, and the thighs. Patients should not inject their dose of Tremfya into skin that is red, tender, hard, inflamed, scaly, thick, irritated, or currently affected by their psoriasis. The injection site should also be rotated each time another dose is administered.

Patients that are using Tremfya for the treatment of psoriatic arthritis typically see improvement in their condition and its associated symptoms within about six months. Those who use Tremfya for the treatment of plaque psoriasis will often notice an improvement in their skin’s condition within four months.

A small percentage of patients using Tremfya have developed basal cell carcinomas after multiple months of treatment with the medication. Prostate and breast cancer have developed in 0.6% of the patients using Tremfya in a study as well. Tremfya appears to mostly increase an individual’s risk of non-melanoma skin cancers, but researchers have stated that the increased cancer risk in those using Tremfya is no higher than the risk of those in the general population.

Tremfya should remain refrigerated at all times. This medication may be left out from refrigeration for no more than four hours, and this may only occur once and directly before it is used. If it has been left out otherwise, it should not be placed back into the refrigerator. If Tremfya is unable to be used within the four-hour period after it has been removed from refrigeration, it should be disposed of.

The active ingredient found in Tremfya is guselkumab. The inactive ingredients in this medication include the following: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water.

Tremfya helps with inflammation by decreasing the number of inflammatory cells within a patient’s psoriatic lesions. It also assists in repairing tissue damage and preventing the formation of plaque. Tremfya specifically targets IL-23, blocking its effects, and also regulates TNF-alpha and IL-17, all of which contribute to an individual experiencing inflammation.

Tremfya lowers a patient’s immune system and results in an increased risk of infection for those using the medication for treatment. The most common infections resulting from impaired immunity due to Tremfya are those that affect the upper respiratory tract. Patients that experience any symptoms of infection should immediately report these to their physician.

Although Tremfya itself is not associated with any hair loss occurring in those who have used the medication, hair loss is possible in those who have psoriasis present on their scalp. Irritation of the skin due to psoriasis may be a contributing factor to certain individuals experiencing hair loss.

Patients may be allowed to inject Tremfya at home if their doctor believes that the patient or an appropriate caregiver can successfully perform the injections. The individual that will be giving the injections should receive proper training and instruction from either the doctor, a nurse, or another qualified medical staff member of the health care team to ensure that the injection is performed correctly. Patients or any other individuals that may be caring for the patient using Tremfya should not inject the medication themselves without prior clearance and training by the prescribing physician and/or their medical staff.