Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SOTYKTU™ (deucravacitinib) tablets are available as listed in the table below: Tablet Strength Tablet Color/Shape Tablet Markings Package Size NDC Code 6 mg Pink, round, biconvex, film-coated tablet Laser printed with “BMS 895” and “6 mg” on one side Bottles of 30 with child-resistant closure 0003-0895-11 16.2 Storage and Handling Store SOTYKTU tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0003-0895-11 30 Tablets SOTYKTU TM (deucravacitinib) tablets 6 mg Rx only Bristol Myers Squibb deucravacitinib-principal-display-panel-label.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SOTYKTU™ (deucravacitinib) tablets are available as listed in the table below: Tablet Strength Tablet Color/Shape Tablet Markings Package Size NDC Code 6 mg Pink, round, biconvex, film-coated tablet Laser printed with “BMS 895” and “6 mg” on one side Bottles of 30 with child-resistant closure 0003-0895-11 16.2 Storage and Handling Store SOTYKTU tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0003-0895-11 30 Tablets SOTYKTU TM (deucravacitinib) tablets 6 mg Rx only Bristol Myers Squibb deucravacitinib-principal-display-panel-label.jpg
Overview
Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor and is described chemically as: 6-(cyclopropanecarbonylamido)-4-[2-methoxy-3-(1-methyl-1,2,4-triazol-3-yl)anilino]-N-(trideuteriomethyl)pyridazine-3-carboxamide. The molecular formula is C 20 H 19 D 3 N 8 O 3 and the molecular weight of the free base is 425.47. Deucravacitinib has the structural formula: Deucravacitinib is a white to yellow powder. The solubility of deucravacitinib is pH dependent. Solubility decreases with increasing pH. SOTYKTU (deucravacitinib) tablets are supplied in 6 mg strength for oral administration. Each tablet contains deucravacitinib as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide. In addition, the film coating Opadry ® II Pink contains the following inactive ingredients: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. chem-structure
Indications & Usage
SOTYKTU™ is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use : SOTYKTU is not recommended for use in combination with other potent immunosuppressants. SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants.
Dosage & Administration
• For recommended evaluation prior to SOTYKTU initiation, see Full Prescribing Information. (2.1) • Recommended dosage is 6 mg orally once daily, with or without food. (2.2) 2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for active and latent tuberculosis (TB) infection prior to initiating treatment with SOTYKTU. If positive, start treatment for TB prior to SOTYKTU use [see Warnings and Precautions (5.3) ]. Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.7) ] . 2.2 Recommended Dosage The recommended dosage of SOTYKTU is 6 mg taken orally once daily, with or without food. Do not crush, cut, or chew the tablets. 2.3 Recommended Dosage in Patients with Hepatic Impairment SOTYKTU is not recommended in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. No dosage adjustment is needed for patients with mild to moderate hepatic impairment.
Warnings & Precautions
• Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs. (5.1) • Infections: SOTYKTU may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue SOTYKTU until the infection resolves. (5.2) • Tuberculosis: Evaluate for TB prior to initiating treatment with SOTYKTU. (5.3) • Malignancy: Malignancies including lymphomas were observed in clinical trials with SOTYKTU (5.4) • Rhabdomyolysis and elevated CPK. (5.5) • Laboratory Abnormalities: Periodically evaluate serum triglycerides. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease. (5.6) • Immunizations: Avoid use with live vaccines. (5.7) • Potential Risks Related to JAK Inhibition: It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients. SOTYKTU is not approved for use in RA. (5.8) 5.1 Hypersensitivity Hypersensitivity reactions such as angioedema have been reported in subjects receiving SOTYKTU. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU [see Adverse Reactions (6.1) ]. 5.2 Infections SOTYKTU may increase the risk of infections. Serious infections have been reported in subjects with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19 [see Adverse Reactions (6.1) ] . Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SOTYKTU. A patient who develops a new infection during treatment with SOTYKTU should undergo prompt and complete diagnostic testing; appropriate antimicrobial therapy should be initiated; and the patient should be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated. Viral Reactivation Herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical trials with SOTYKTU. In the 16‑week placebo-controlled period, herpes simplex infections were reported in 17 subjects (6.8 per 100 patient‑years) treated with SOTYKTU, and 1 subject (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent subject who received SOTYKTU. During PSO-1, PSO-2, and the open-label extension trial in which subjects who completed the controlled trials could enroll, the majority of subjects who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Subjects with positive screening tests for hepatitis B or C, or chronic hepatitis B, or untreated hepatitis C were excluded from clinical trials. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C. 5.3 Tuberculosis In clinical trials, of 4 subjects with latent tuberculosis (TB) who were treated with SOTYKTU and received appropriate TB prophylaxis, no subjects developed active TB (during the mean follow-up of 34 weeks). One subject, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients receiving SOTYKTU for signs and symptoms of active TB during treatment. 5.4 Malignancy including Lymphomas Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU [see Adverse Reactions (6.1) ] . Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU. 5.5 Rhabdomyolysis and Elevated CPK Cases of rhabdomyolysis were reported in subjects treated with SOTYKTU resulting in interruption or discontinuation of SOTYKTU dosing. Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to treatment with placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever [see Adverse Reactions (6.1) ]. 5.6 Laboratory Abnormalities Triglyceride Elevations - Treatment with SOTYKTU was associated with increases in triglyceride levels. The effect of this elevated parameter on cardiovascular morbidity and mortality has not been determined. Periodically evaluate serum triglycerides according to the clinical guidelines for hyperlipidemia while patients are receiving treatment with SOTYKTU. Manage patients according to clinical guidelines for the management of hyperlipidemia [see Adverse Reactions (6.1) ] . Liver Enzyme Elevations - Treatment with SOTYKTU was associated with an increase in the incidence of liver enzyme elevation compared to treatment with placebo. Liver serum transaminase elevations ≥ 3 times the ULN were reported in subjects treated with SOTYKTU. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded [see Adverse Reactions (6.1) ]. 5.7 Immunizations Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated. 5.8 Potential Risks Related to JAK Inhibition It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
Contraindications
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU [see Warnings and Precautions (5.1) ] . Known hypersensitivity to deucravacitinib or any of the excipients in SOTYKTU. ( 4 , 5.1 )
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of labeling: • Infections [see Warnings and Precautions (5.2) ] • Malignancy including lymphomas [see Warnings and Precautions (5.4) ] • Laboratory Abnormalities [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥ 1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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 SOTYKTU was evaluated in two placebo- and active-controlled trials (PSO-1 and PSO-2) and an open-label extension trial in which subjects who completed PSO-1 or PSO-2 could enroll [see Clinical Studies (14) ]. In these clinical trials, a total of 1,519 subjects with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy received SOTYKTU 6 mg orally once daily. Of these, 1,141 subjects were exposed to SOTYKTU for at least one year. In trials PSO-1 and PSO-2, 1,681 subjects were randomized to receive SOTYKTU 6 mg (840 subjects), placebo (419 subjects), or apremilast 30 mg twice daily (422 subjects). All subjects randomized to placebo switched to SOTYKTU at Week 16. All other subjects remained in their original treatment group until Week 24, at which point subjects could have continued on the same treatment or be switched to SOTYKTU or placebo. The mean age of subjects was 47 years. The majority of subjects were White (87%) and male (67%). In the 16-week placebo-controlled period of the pooled clinical trials (PSO-1 and PSO-2), discontinuation of therapy due to adverse reactions in subjects who received SOTYKTU was 2.4%, compared to 3.8% for placebo. Table 1 summarizes the adverse reactions that occurred in at least 1% of subjects in the SOTYKTU group and at a higher rate than the placebo group during the 16-week controlled period. Table 1: Adverse Reactions that Occurred in ≥ 1% of Subjects with Plaque Psoriasis in the SOTYKTU Group and More Frequently than in the Placebo Group in Trials PSO-1 and PSO-2 through Week 16 a Includes upper respiratory tract infection (viral, bacterial, and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal, and unspecified), sinusitis (includes acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis, and tonsillitis (including bacterial, streptococcal) b Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection c Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis d Includes acne, acne cystic, and dermatitis acneiform Adverse Reaction SOTYKTU 6 mg once daily Placebo N=840 n (%) N=419 n (%) Upper respiratory infections a 161 (19.2) 62 (14.8) Blood creatine phosphokinase increased 23 (2.7) 5 (1.2) Herpes simplex b 17 (2.0) 1 (0.2) Mouth ulcers c 16 (1.9) 0 (0.0) Folliculitis 14 (1.7) 0 (0.0) Acne d 12 (1.4) 1 (0.2) Adverse reactions that occurred in < 1% of subjects in the SOTYKTU group were herpes zoster. Specific Adverse Reactions Exposure adjusted incidence rates are reported for all the adverse reactions presented below. Infections In the 16-week placebo-controlled period, infections occurred in 29% of the SOTYKTU group (116 events per 100 person-years) compared to 22% of the placebo group (83.7 events per 100 person-years). The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of SOTYKTU. In the 16-week placebo-controlled period, serious infections were reported in 5 subjects (2.0 per 100 patient-years) treated with SOTYKTU, and 2 subjects (1.6 per 100 patient-years) treated with placebo. The most common serious infections reported during the 52-week treatment period were pneumonia and COVID-19. Malignancies During the 0-to-52-week treatment period of the two clinical trials, PSO-1 and PSO-2 (total exposure of 986 patient-years with SOTYKTU), malignancies (excluding non-melanoma skin cancer) were reported in 3 subjects treated with SOTYKTU (0.3 per 100 patient-years), including single cases each of breast cancer, hepatocellular carcinoma, and lymphoma after 24, 32, and 25 weeks of treatment, respectively. During PSO-1, PSO-2, and the open-label extension trial in which subjects who completed the controlled trials could enroll, a total of 3 subjects (0.1 per 100 patient-years), developed lymphoma while receiving SOTYKTU after 25, 77, and 98 weeks of treatment. Laboratory Abnormalities Creatine Phosphokinase (CPK) In the 16-week placebo-controlled period, increased CPK (including Grade 4) was reported in 23 subjects (9.3 per 100 patient-years) treated with SOTYKTU, and 5 subjects (4.1 per 100 patient-years) treated with placebo. Liver Enzyme Elevations Events of increases in liver enzymes ≥3 times the ULN were observed in subjects treated with SOTYKTU [see Warnings and Precautions (5.5) ] . In the 16-week placebo-controlled period: • ALT elevations ≥3 times the ULN was reported in 9 subjects (3.6 per 100 patient- years) treated with SOTYKTU, and 2 subjects (1.6 per 100 patient-years) treated with placebo. • AST elevations ≥3 times the ULN was reported in 13 subjects (5.2 per 100 patient- years) treated with SOTYKTU, and 2 subjects (1.6 per 100 patient-years) treated with placebo. Decreased Glomerular Filtration Rate (GFR) In the 16-week placebo-controlled period in subjects who had moderate renal impairment (eGFR 30-59 mL/min) at baseline, decreased GFR was reported in 4 subjects (1.6 per 100 patient-years) treated with SOTYKTU, and 1 subject (0.8 per 100 patient-years) treated with placebo. Two of the deucravacitinib-treated subjects had worsening of baseline proteinuria. Lipid Elevations Mean triglycerides increased by 10.3 mg/dL during the 16-week treatment period in subjects treated with SOTYKTU and by 9.1 mg/dL during the 52-week treatment period. Safety Through Week 52 In PSO-1 and PSO-2, the exposure adjusted incidence rate of adverse reactions in subjects treated with SOTYKTU from Week 0 through Week 52 without switching treatment did not increase compared to the rate observed during the first 16 weeks of treatment.
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