Tremfya
(guselkumab)Dosage & Administration
Recommended Dosage
Plaque Psoriasis
Psoriatic Arthritis
Ulcerative Colitis
Crohn's Disease
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Tremfya Prescribing Information
Plaque Psoriasis
TREMFYA is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis
TREMFYA is indicated for the treatment of adult patients with active psoriatic arthritis.
Ulcerative Colitis
TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Crohn’s Disease
TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
Recommended Evaluations and Immunizations Prior to Treatment Initiation
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.3)] .
- For the treatment of Crohn’s disease or ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.4)] .
- Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.5)] .
Recommended Dosage for Plaque Psoriasis
TREMFYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.
Recommended Dosage for Psoriatic Arthritis
TREMFYA is administered by subcutaneous injection. The recommended dosage 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 (e.g., methotrexate).
Recommended Dosage for Ulcerative Colitis
Induction:
The recommended induction dosage of TREMFYA is 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 [see Dosage and Administration (2.6)] .
Maintenance:
The recommended maintenance dosage of TREMFYA is:
- 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
- 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response.
Recommended Dosage for Crohn’s Disease
Induction:
The recommended induction dosage of TREMFYA is:
- 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 or
- 400 mg administered by subcutaneous injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4, and Week 8.
Maintenance:
The recommended maintenance dosage of TREMFYA is:
- 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
- 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response.
Preparation and Administration Instructions for Subcutaneous Injection
TREMFYA is available for subcutaneous use in the following presentations: prefilled pen (TREMFYA PEN), One-Press injector, and prefilled syringes [see Dosage Forms and Strengths (3)and How Supplied/Storage and Handling (16)] .
- Administer TREMFYA subcutaneously. Each prefilled pen, One-Press injector, or prefilled syringe is for one time use in one patient only. Instruct patients to inject the full amount: 100 mg or 200 mg of TREMFYA (1 mL or 2 mL, respectively).
- TREMFYA is intended for use under the guidance and supervision of a healthcare professional. TREMFYA may be administered by a healthcare professional, or a patient/caregiver after proper training on correct subcutaneous injection technique.
- Before injection, remove TREMFYA from the refrigerator and allow to reach room temperature (30 minutes) without removing the needle cap.
- Inject into the front of the thighs, the lower abdomen except for the 2 inches around the navel, or the back of the upper arms (healthcare professional or caregiver only).
- Do not inject TREMFYA into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis [see Instructions for Use].
- The TREMFYA Instructions for Use contains more detailed patient instructions on the preparation and administration of TREMFYA [see Instructions for Use] .
- If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
- 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 pen, One-Press injector, or prefilled syringe.
Preparation and Administration Instructions for Intravenous Infusion (Ulcerative Colitis and Crohn's Disease)
Preparation Instructions:
- Withdraw and then discard 20 mL of the 0.9% Sodium Chloride Injection from the 250 mL infusion bag which is equal to the volume of TREMFYA to be added.
- Withdraw 20 mL of TREMFYA from the vial and add it to the 250 mL intravenous infusion bag of 0.9% Sodium Chloride Injection for a final concentration of 0.8 mg/mL. Gently mix the diluted solution. Discard the vial with any remaining solution.
- Visually inspect the diluted solution for particulate matter and discoloration before infusion. Infuse the diluted solution over a period of at least one hour.
- Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein binding filter (pore size 0.2 micrometer).
- Do not infuse TREMFYA concomitantly in the same intravenous line with other medicinal products.
- Dispose any unused medicinal product in accordance with local requirements.
Administration Instructions:
- TREMFYA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. TREMFYA does not contain preservatives. Each vial is for one time use in one patient only.
- 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 is cloudy.
Storage of Diluted Solution:
- The diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 10 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 10 hours after the dilution in the infusion bag.
- Do not freeze.
- Discard any unused portion of the infusion solution.
TREMFYA is a clear and colorless to light yellow solution.
Subcutaneous Injection
- Injection: 100 mg/mL in a single-dose One-Press patient-controlled injector.
- Injection: 100 mg/mL in a single-dose prefilled pen (TREMFYA PEN).
- Injection: 200 mg/2 mL in a single-dose prefilled pen (TREMFYA PEN).
- Injection: 100 mg/mL in a single-dose prefilled syringe.
- Injection: 200 mg/2 mL (100 mg/mL) in a single-dose prefilled syringe.
Intravenous Infusion
- Injection: 200 mg/20 mL (10 mg/mL) solution in a single-dose vial.
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu.
Risk Summary
Available data from literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) to the 400 mg dose given subcutaneously. Neonatal deaths in monkeys were observed at 4 to 18 times the exposure (AUC) in humans administered 200 mg intravenously and 4 to 16 times the exposure (AUC) to the 400 mg dose given subcutaneously (see Data) . The clinical significance of these nonclinical findings is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-associated Maternal and Embryo/Fetal Risk
Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Fetal/Neonatal Adverse Reactions
Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, it is expected that TREMFYA may be present in infants exposed in utero. The potential clinical impact of guselkumab exposure in infants exposed in utero should be considered.
Data
Animal Data
In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab from the beginning of organogenesis to parturition at a dose (50 mg/kg) resulting in exposures (AUC) 18 times the exposure in humans administered 200 mg intravenously and 16 times the human exposure at 400 mg given subcutaneously. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (4 times the exposure (AUC) in humans administered 200 mg intravenously or 400 mg given subcutaneously) and three monkeys administered guselkumab at 50 mg/kg/week (18 times the exposure (AUC) in humans administered 200 mg intravenously and 16 times the exposure (AUC) following a 400 mg subcutaneous dose). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.
Lactation
Risk Summary
There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production. Guselkumab was not detected in the milk of lactating cynomolgus monkeys. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local gastrointestinal exposure and the extent of systemic exposure in the breastfed infant to guselkumab are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TREMFYA and any potential adverse effects on the breastfed infant from TREMFYA or from the underlying maternal condition.
Pediatric Use
The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established.
Geriatric Use
Of the 5392 subjects with plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn’s disease exposed to TREMFYA, a total of 285 subjects were 65 years or older, and 28 subjects were 75 years or older. Clinical studies of TREMFYA, within each indication, did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
No clinically meaningful differences in the pharmacokinetics of guselkumab were observed based on age [see Clinical Pharmacology (12.3)] .
TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1)] .
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with post market use of TREMFYA. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA and initiate appropriate therapy.
Infections
TREMFYA may increase the risk of infection. In clinical trials in subjects with plaque psoriasis, infections occurred in 23% of subjects in the TREMFYA group versus 21% of subjects in the placebo group through 16 weeks of treatment. Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections occurred more frequently in the TREMFYA group than in the placebo group [see Adverse Reactions (6.1)] . The rate of serious infections for the TREMFYA group and the placebo group was ≤ 0.2%. A similar risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis, ulcerative colitis, and Crohn's disease. Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing TREMFYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TREMFYA until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating TREMFYA treatment. Do not administer TREMFYA to patients with active TB infection. Initiate treatment of latent TB prior to administering TREMFYA. Consider anti-TB therapy prior to initiating TREMFYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor all patients for signs and symptoms of active TB during and after TREMFYA treatment.
In clinical trials, 105 subjects with plaque psoriasis, 71 subjects with psoriatic arthritis, 31 subjects with ulcerative colitis, and 36 subjects with Crohn’s disease with latent TB who were concurrently treated with TREMFYA, and appropriate TB prophylaxis did not develop active TB. In clinical trials of TREMFYA in subjects with Crohn’s disease, active TB was reported in 2 subjects during treatment with TREMFYA [see Adverse Reactions (6.1)] .
Hepatotoxicity
A serious adverse reaction of drug-induced liver injury was reported in a clinical trial subject with Crohn’s disease following three doses of a higher than the recommended induction regimen. This subject had peak alanine aminotransferase (ALT) of 18x the upper limit of normal (ULN), aspartate aminotransferase (AST) of 11x ULN, and total bilirubin of 2.4x ULN. TREMFYA was subsequently discontinued, and the liver test abnormalities resolved following administration of corticosteroids.
In patients with Crohn’s disease or ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management.
Consider other treatment options in patients with evidence of acute liver disease or cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Avoid use of live vaccines in patients treated with TREMFYA. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with TREMFYA, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.