Prab at 18:53, 12 October 2023

2023-10-12T18:53:45Z

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== '''What is Guselkumab?''' ==

Guselkumab (TREMFYA) is an '''interleukin-23 blocker''' used to treat severe [[Plaque-like psoriasis|plaque psoriasis]], [[psoriatic arthritis]] (PsA).

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== '''What are the uses of this medicine?''' ==

This medicine used to treat adults:
* with moderate to severe [[Plaque-like psoriasis|plaque psoriasis]] who may benefit from taking injections or pills (systemic therapy) or [[phototherapy]] (treatment using [[ultraviolet]] or UV light)
* with active [[psoriatic arthritis]] (PsA).

== '''How does this medicine work?''' ==

* Guselkumab (gue" sel koo' mab) is a '''human monoclonal [[immunoglobulin]] G1 antibody to [[interleukin]] (IL)-23''', a [[cytokine]] that is an important mediator of [[autoimmune]] reactions.
* IL-23 is found in the skin [[lesions]] of [[psoriasis]] and in the affected gastrointestinal mucosa of patients with [[inflammatory bowel disease]]. Although similar, '''guselkumab is directed to the p19 subunit of IL-23''' whereas ustekinumab is directed at the p40 subunit which is a component shared by both IL-23 and IL-12.
* As a consequence, guselkumab has a '''more restricted activity in the Th17 immune pathways''' which are considered to play a major role in autoimmune reactions.

== '''Who Should Not Use this medicine ?''' ==

This medicine cannot be used in patients with:
* a history of serious [[hypersensitivity]] reaction to guselkumab or to any of the excipients.

== '''What drug interactions can this medicine cause?''' ==

* Upon initiation of TREMFYA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment as needed.

== '''Is this medicine FDA approved?''' ==

* It was approved for use in the United States in 2017.

== '''How should this medicine be used?''' ==

'''Recommended Dosage:'''
'''Plaque Psoriasis'''
* The recommended dose is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.

'''Psoriatic Arthritis'''
* The recommended dose is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.
* TREMFYA may be administered alone or in combination with a conventional disease-modifying [[Antirheumatic drugs|antirheumatic drug]] (cDMARD) (e.g., [[methotrexate]]).

'''Administration'''
* Administer TREMFYA subcutaneously. Each prefilled syringe or One-Press injector is for single-dose only.
* Instruct patients to inject the full amount (1 mL), which provides 100 mg of TREMFYA.
* Do not inject TREMFYA into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
* TREMFYA is intended for use under the guidance and supervision of a physician.
* TREMFYA may be administered by a health care professional, or a patient may self-inject after proper training in subcutaneous injection technique.
* The TREMFYA Instructions for Use contains more detailed patient instructions on the preparation and administration of TREMFYA.
* Before injection, remove TREMFYA prefilled syringe or One-Press injector from the refrigerator and allow TREMFYA to reach room temperature (30 minutes) without removing the needle cap.
* Inspect TREMFYA visually for particulate matter and discoloration prior to administration.
* TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles.
* Do not use if the liquid contains large particles, is discolored or cloudy.
* TREMFYA does not contain preservatives; therefore, discard any unused product remaining in the prefilled syringe or One-Press injector.

== '''What are the dosage forms and brand names of this medicine?''' ==

This medicine is available in fallowing doasage form:
* '''As Injection:''' 100 mg/mL in a single-dose prefilled syringe or single-dose One-Press patient-controlled injector.

This medicine is available in fallowing brand namesː
*'''TREMFYA'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* [[Upper respiratory infection|upper respiratory infections]]
* joint pain ([[arthralgia]])
* fungal skin infections
* headache
* [[diarrhea]]
* [[herpes simplex]] infections
* injection site reactions
* stomach flu ([[gastroenteritis]])
* [[bronchitis]]

TREMFYA may cause serious side effects including:
* Serious allergic reactions
* Infections

==''' What special precautions should I follow?''' ==

* Serious [[hypersensitivity]] reactions, including [[anaphylaxis]], have been reported with postmarket use of TREMFYA.
* TREMFYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue TREMFYA until the infection resolves.
* Evaluate patients for [[tuberculosis]] (TB) infection prior to initiating treatment with TREMFYA. Initiate treatment of latent TB prior to administering TREMFYA.
* Prior to initiating therapy with TREMFYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of [[live vaccines]] in patients treated with TREMFYA.

== '''What to do in case of emergency/overdose?''' ==

'''management for overdosage:'''
* In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.

== '''Can this medicine be used in pregnancy?''' ==

* There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes.
* There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy.
* Patients should be encouraged to enroll by calling 1-877-311- 8972.

=='''Can this medicine be used in children?'''==

* The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established.

== '''What are the active and inactive ingredients in this medicine?''' ==

* '''Active ingredient:''' guselkumab
* '''Inactive ingredients:''' L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection

== '''Who manufactures and distributes this medicine?''' ==

* '''Manufactured by:''' Janssen Biotech, Inc., Horsham, PA 19044, U.S. License Number 1864.

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

* TREMFYA is sterile and preservative-free.
* Discard any unused portion.
* Store in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).
* Store in original carton until time of use.
* Protect from light until use.
* Do not freeze.
* Do not shake.
* Not made with natural rubber latex.
* Keep out of reach of children.

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[[Category:Monoclonal antibodies]]
[[Category:Johnson & Johnson brands]]

Guselkumab - Revision history

Prab at 18:53, 12 October 2023