Icotrokinra

FDA Drug Information • Also known as: Icotyde

Brand Names: Icotyde
Dosage Form: POWDER
Product Type: BULK INGREDIENT

Description

11 DESCRIPTION Icotrokinra is an IL-23 receptor antagonist, in the form of a hydrochloride salt. Icotrokinra is a 13-amino acid peptide. The molecular formula for icotrokinra is C 90 H 120 N 20 O 22 S 2 and its molecular weight is 1898.17. The chemical name for icotrokinra is (4S)-4-[([4-[(2S)-2-[(2S)-2-[([(4R,7S,10S,13S,16S,19R)-19-acetamido-7-(4-acetamidobutyl)-16-(2-amino-2-oxoethyl)-13-[(1R)-1-hydroxyethyl]-3,3,20,20-tetramethyl-10-[(7-methyl-1H-indol-3-yl)methyl]6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl)amino]-3-[4-(2-aminoethoxy)phenyl]propanamido]-3-(2-naphthyl)propanamido]tetrahydro-2H-pyran-4-yl]carbonyl)amino]-5-[[(2S)-4-amino-1-[[(2S)-1-[(2-amino-2-oxoethyl)(methyl)amino]-1-oxo-3-(pyridin-3-yl)propan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-5-oxopentanoic acid. The structural formula for icotrokinra hydrochloride is: Icotrokinra hydrochloride is a white to almost white powder. It is freely soluble below pH 2, very slightly soluble at pH 5, practically insoluble at pH 9, and freely soluble above pH 11. The isoelectric point (pI) of the compound is 7.15. ICOTYDE™ (icotrokinra) tablets are supplied as 200 mg film-coated tablets for oral administration. Each tablet of ICOTYDE contains 200 mg icotrokinra (equivalent to 201.6–202.8 mg of icotrokinra hydrochloride) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The film coating contains the following inactive ingredients: glyceryl monocaprylocaprate, iron oxide yellow, macrogol polyvinyl alcohol graft polymer, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide. Chemical Structure

What Is Icotrokinra Used For?

1 INDICATIONS AND USAGE ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION See the full prescribing information for recommended evaluation and immunizations prior to treatment. ( 2.1 ) Recommended dosage is 200 mg orally once daily. ( 2.2 ) Administer ICOTYDE on an empty stomach with water upon waking. ( 2.2 ) Wait at least 30 minutes after taking ICOTYDE before eating food. ( 2.2 ) For patients who have difficulty swallowing tablets, ICOTYDE can be dispersed in water. ( 2.3 ) 2.1 Recommended Evaluation and Immunizations Prior to Treatment Initiation Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment [see Warnings and Precautions (5.2) ] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage and Administration Instructions The recommended dosage of ICOTYDE is 200 mg administered orally once daily. Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food. Swallow ICOTYDE whole. Do not crush, split, or chew tablets [see Clinical Pharmacology (12.3) ] . If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day. 2.3 Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions: Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water. It may take a few minutes for the tablet to disperse. The tablet may not completely disperse. The mixture may look yellow, milky, or cloudy, and small pieces may be seen in the water which are safe to swallow. Gently swirl the cup before drinking and swallowing the full mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow the contents to make sure the whole dose is taken. Complete administration of ICOTYDE within 15 minutes of dispersion in water.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS Most common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) [see Clinical Studies (14) ] . A total of 2367 adults and pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis received ICOTYDE 200 mg orally once daily. Of these, 648 subjects were treated with ICOTYDE for at least one year. Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions. Adverse Reactions ICOTYDE N=1296 n (%) Placebo N=568 n (%) Headache 51 (4.1) 19 (3.3) Nausea 15 (1.2) 3 (0.5) Cough 15 (1.2) 1 (0.2) Fungal Infection Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), laryngitis fungal (n=1). Two subjects experienced more than 1 event. 14 (1.1) 0 (0) Fatigue 15 (1.0) 3 (0.5) Adverse reactions that occurred in < 1% of subjects in the ICOTYDE group and at a higher rate than in the placebo group through Week 16 in Trials PSO-1, PSO-2, PSO-3, and PSO-4 were: gastritis, abdominal discomfort, and one fatal case involving upper gastrointestinal bleeding in a subject with underlying risk factors. A relationship of this event to ICOTYDE is not established. Adverse Reactions in Pediatric Subjects 12 Years of Age and Older The safety of ICOTYDE was evaluated in pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4). A total of 72 pediatric subjects were treated with ICOTYDE 200 mg orally once daily. Of these, 45 subjects were treated with ICOTYDE for at least one year. The adverse reactions observed in pediatric subjects were consistent with the most common adverse reactions (≥ 1%) observed in the overall population.

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. 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. There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day. No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison). In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison). No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison). In a pre- and post-natal...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ICOTYDE™ (icotrokinra) tablets: 200 mg, yellowish orange to yellowish brown, oval, film-coated tablets debossed with '200' on one side and 'JNJ' on the other side. ICOTYDE is supplied in bottles of 30 tablets (NDC Number: 57894-201-30), with a silica gel desiccant and a child-resistant closure. Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Store in original package to protect from moisture. Do not discard desiccant.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.