Tremfya

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking while using Tremfya.

Tremfya is given as an injection under the skin. It comes as a single-dose, prefilled syringe.

The typical dose is 100 milligrams (mg) every eight weeks. But your first two "starter" doses will be four weeks apart.

You might be shown how to inject Tremfya at home.

Follow your doctor's instructions carefully when administering this medicine. Don't give yourself more or less Tremfya than is recommended.

Store your Tremfya syringes in a refrigerator, but don't freeze them. Before giving yourself an injection, take the syringe out of the refrigerator, and let it warm up to room temperature.

Never inject this medicine into a muscle or vein. Avoid areas of the skin that are bruised, red, hard, thick, scaly, tender, or affected by psoriasis.

Use each syringe only one time, and throw it away after use, even if there's medicine left in it.

Tremfya Overdose

Call your healthcare provider right away if you think you've injected more Tremfya than your doctor has prescribed.

If you suspect an overdose, contact a poison control center or emergency room immediately. You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Tremfya

If you miss a dose of Tremfya, inject it as soon as you remember. Then continue to follow your regular medication schedule.

Call your doctor for instructions if you aren't sure what to do after a missed dose.

Guselkumab is a monoclonal antibody that blocks a certain protein in the body that can cause inflammation and other immune responses.

Guselkumab is used to treat moderate to severe plaque psoriasis in adults.

Guselkumab may also be used for purposes not listed in this medication guide.

You should not use guselkumab if you are allergic to it.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Before you start treatment with guselkumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

To make sure guselkumab is safe for you, tell your doctor if you have:

• an active or chronic infection;

• active tuberculosis infection that is not being treated; or

• if you have recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start treatment with guselkumab.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether guselkumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Guselkumab is not approved for use by anyone younger than 18 years old.

Contraindications

None.1

Warnings/Precautions

Infections

Guselkumab may increase the risk of infection. In clinical trials, infections occurred in 23% of subjects in the guselkumab 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 guselkumab group than in the placebo group. The rate of serious infections for the guselkumab group and the placebo group was ≤0.2%. Treatment with guselkumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.1

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing guselkumab. 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 guselkumab until the infection resolves.1

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with guselkumab. Initiate treatment of latent TB prior to administering guselkumab. In clinical studies, 105 subjects with latent TB who were concurrently treated with guselkumab and appropriate TB prophylaxis did not develop active TB (during the mean follow-up of 43 weeks). Monitor patients for signs and symptoms of active TB during and after guselkumab treatment. Consider anti-TB therapy prior to initiating guselkumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer guselkumab to patients with active TB infection.1

Immunizations

Prior to initiating therapy with guselkumab, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with guselkumab. No data are available on the response to live or inactive vaccines.1

Specific Populations

Risk Summary: There are no available data on guselkumab use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus. 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 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6–30 times the MRHD. The clinical significance of these nonclinical findings is unknown.1

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated 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.1

Animal Data: In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison), and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). 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.1

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. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for guselkumab and any potential adverse effects on the breastfed infant from guselkumab or from the underlying maternal condition.1

The safety and efficacy of guselkumab in pediatric patients (less than 18 years of age) have not been established.1

Of the 1748 subjects with plaque psoriasis exposed to guselkumab, a total of 93 subjects were 65 years or older, and 4 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received guselkumab. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.1

Common Adverse Effects

Most common (≥1%) adverse reactions associated with guselkumab include upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.1

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Avoid use of live vaccines in patients treated with guselkumab.1

Guselkumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Plaque psoriasis is a skin disease with red patches and white scales that do not go away.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of guselkumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of guselkumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Alfentanil
• Aminophylline
• Artemether
• Astemizole
• Bacillus of Calmette and Guerin Vaccine, Live
• Carbamazepine
• Cholera Vaccine, Live
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Iloperidone
• Influenza Virus Vaccine, Live
• Lumefantrine
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Phenytoin
• Pimozide
• Poliovirus Vaccine, Live
• Quinidine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sirolimus
• Smallpox Vaccine
• Tacrolimus
• Terfenadine
• Theophylline
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection, or history of—Guselkumab is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Burning or stinging of the skin
• diarrhea
• itching in the genital or other skin areas
• loss of appetite
• nausea
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• scaling
• stomach pain

• White patches in the mouth or throat or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• difficulty in moving
• muscle pain or stiffness
• pain in the joints

• Headache, severe and throbbing
• hives or welts
• itching, skin rash
• redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to Tremfya (guselkumab) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have active TB (tuberculosis).

This is not a list of all drugs or health problems that interact with Tremfya.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Infections

Tremfya may increase the risk of infection. In clinical trials, 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%. 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.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Tremfya. Initiate treatment of latent TB prior to administering Tremfya. In clinical studies, 105 subjects with latent TB who were concurrently treated with Tremfya and appropriate TB prophylaxis did not develop active TB (during the mean follow-up of 43 weeks). Monitor patients for signs and symptoms of active TB during and after Tremfya treatment. 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. Do not administer Tremfya to patients with active TB infection.

Immunizations

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. No data are available on the response to live or inactive vaccines.

The following adverse reactions are discussed in greater detail in other sections of labeling:

• Infections [see Warnings and Precautions (5.1)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, a total of 1748 subjects with moderate-to-severe plaque psoriasis received Tremfya. Of these, 1393 subjects were exposed to Tremfya for at least 6 months and 728 subjects were exposed for at least 1 year.

Data from two placebo- and active-controlled trials (VOYAGE 1 and VOYAGE 2) in 1441 subjects (mean age 44 years; 70% males; 82% white) were pooled to evaluate the safety of Tremfya (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 8 weeks).

Weeks 0 to 16

In the 16-week placebo-controlled period of the pooled clinical trials (VOYAGE 1 and VOYAGE 2), adverse events occurred in 49% of subjects in the Tremfya group compared to 47% of subjects in the placebo group and 49% of subjects in the U.S. licensed adalimumab group. Serious adverse events occurred in 1.9% of the Tremfya group (6.3 events per 100 subject-years of follow-up) compared to 1.4% of the placebo group (4.7 events per 100 subject-years of follow-up), and in 2.6% of U.S. licensed adalimumab group (9.9 events per 100 subject-years of follow-up).

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Tremfya group than in the placebo group during the 16-week placebo-controlled period.

Adverse reactions that occurred in < 1% but > 0.1% of subjects in the Tremfya group and at a higher rate than in the placebo group through Week 16 in VOYAGE 1 and VOYAGE 2 were migraine, candida infections, and urticaria.

Specific Adverse Reactions

Infections

Infections occurred in 23% of the Tremfya group compared to 21% of the placebo group.

The most common (≥ 1%) infections were upper respiratory infections, gastroenteritis, tinea infections, and herpes simplex infections; all cases were mild to moderate in severity and did not lead to discontinuation of Tremfya.

Elevated Liver Enzymes

Elevated liver enzymes were reported more frequently in the Tremfya group (2.6%) than in the placebo group (1.9%). Of the 21 subjects who were reported to have elevated liver enzymes in the Tremfya group, all events except one were mild to moderate in severity and none of the events led to discontinuation of Tremfya.

Safety through Week 48

Through Week 48, no new adverse reactions were identified with Tremfya use and the frequency of the adverse reactions was similar to the safety profile observed during the first 16 weeks of treatment.

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity with Tremfya. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to guselkumab with the incidences of antibodies to other products may be misleading.

Up to Week 52, approximately 6% of subjects treated with Tremfya developed antidrug antibodies. Of the subjects who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing antibodies. Among the 46 subjects who developed antibodies to guselkumab and had evaluable data, 21 subjects exhibited lower trough levels of guselkumab, including one subject who experienced loss of efficacy after developing high antibody titers. However, antibodies to guselkumab were generally not associated with changes in clinical response or development of injection-site reactions.

Tremfya (guselkumab) is a monoclonal antibody that blocks a certain protein in the body that can cause inflammation and other immune responses.

Tremfya is used to treat moderate to severe plaque psoriasis in adults.

Tremfya may also be used for purposes not listed in this medication guide.

Other drugs may interact with guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.