Guselkumab

What is Guselkumab?

Guselkumab (TREMFYA) is an interleukin-23 blocker used to treat severe plaque psoriasis, psoriatic arthritis (PsA).

What are the uses of this medicine?

This medicine used to treat adults:

• with moderate to severe 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 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 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.

• Dailymed label info on Guselkumab
• FDA Guselkumab

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