Version May 2024
Note: Screen for tuberculosis (TB) prior to initiating treatment. Avoid use in patients with TB disease (active TB) or other clinically significant active infection; initiate treatment of TB infection (latent TB) prior to initiating deucravacitinib.
Plaque psoriasis, moderate to severe: Oral: 6 mg once daily.
No dosage adjustment necessary.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Avoid use.
Refer to adult dosing.
Deucravacitinib may increase the risk of infection. Commonly reported infections in clinical trials include pneumonia and upper respiratory tract infection. Other reported infections include tuberculosis disease, herpes simplex infection, herpes zoster infection, and multidermatomal herpes zoster. Reactivation of herpes virus (herpes simplex and herpes zoster) has also been reported. While the majority of infections reported in clinical trials were mild to moderate in severity, serious infection has been reported rarely.
Risk factors:
• History of recurrent or chronic infections (including serious or opportunistic infections)
• Exposure to tuberculosis
• Underlying conditions that may predispose a patient to infection
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Infection: Infection (29%, including pneumonia; serious infection: <1%) (table 1)
|
Drug (Deucravacitinib) |
Placebo |
Number of Patients (Deucravacitinib) |
Number of Patients (Placebo) |
|---|---|---|---|
|
0.6% |
0.5% |
840 |
419 |
Respiratory: Upper respiratory tract infection (19%)
1% to 10%:
Dermatologic: Acne vulgaris (1%), folliculitis (2%)
Gastrointestinal: Oral mucosa ulcer (2%)
Hepatic: Increased serum alanine aminotransferase (1%), increased serum aspartate aminotransferase (2%)
Infection: Herpes simplex infection (2%, including reactivation of herpes simplex) (table 2)
|
Drug (Deucravacitinib) |
Placebo |
Number of Patients (Deucravacitinib) |
Number of Patients (Placebo) |
|---|---|---|---|
|
2% |
0.2% |
840 |
419 |
Neuromuscular & skeletal: Increase creatinine phosphokinase in blood specimen (3%)
<1%:
Hematologic & oncologic: Malignant neoplasm (including hepatocellular carcinoma, malignant lymphoma, and malignant neoplasm of breast)
Infection: Herpes zoster infection (including multidermatomal herpes zoster and reactivation of herpes zoster)
Renal: Mean glomerular filtration rate decreased
Respiratory: Tuberculosis disease
Frequency not defined:
Endocrine & metabolic: Increased serum triglycerides
Neuromuscular & skeletal: Rhabdomyolysis
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including angioedema)
Hypersensitivity to deucravacitinib or any component of the formulation.
Concerns related to adverse effects:
• Cardiac effects: Another Janus-associated kinase (JAK) inhibitor has increased the risk of major adverse cardiac effects, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (deucravacitinib is not approved for the treatment of rheumatoid arthritis).
• Hepatic effects: Elevations in LFTs (eg, serum transaminases ≥3 times the ULN) have been observed in patients receiving deucravacitinib. If elevations in LFTs occur during therapy, evaluate for drug-induced liver injury (DILI); if DILI is suspected, interrupt therapy until a diagnosis of DILI is excluded.
• Rhabdomyolysis/elevated creatine phosphokinase: Increased incidences of asymptomatic elevations of creatine phosphokinase (CPK) and rhabdomyolysis have been observed. Instruct patients to report unexplained muscle pain or weakness, especially if it occurs with fever or malaise; discontinue therapy if marked CPK elevations occur or if myopathy is diagnosed or suspected.
• Thrombosis: Another JAK inhibitor has increased the risk of thrombosis (eg, deep venous thrombosis, pulmonary embolism, arterial thrombosis) in patients with rheumatoid arthritis (deucravacitinib is not approved for the treatment of rheumatoid arthritis).
Disease-related concerns:
• Malignancy: An increased risk of malignancies, including lymphoma, has been observed in clinical trials. Use with caution in patients with a history of malignancy (except for successfully treated nonmelanoma skin cancer) or in those who develop a new malignancy.
• Tuberculosis: Safety has not been established in patients who are tuberculosis-positive.
Concurrent drug therapy issues:
• Immunizations: Avoid use of live vaccines in patients treated with deucravacitinib. Patients were excluded from the clinical trial if they received a live vaccine within 60 days of enrollment or planned to receive a live vaccine during or within 60 days of completing the trial (Armstrong 2022).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sotyktu: 6 mg
No
Tablets (Sotyktu Oral)
6 mg (per each): $261.37
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sotyktu: 6 mg
Oral: Administer with or without food. Swallow tablets whole; do not crush, split, or chew.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Sotyktu: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214958s000lbl.pdf#page=19
Plaque psoriasis, moderate to severe: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of use: Not recommended for use in combination with other potent immunosuppressants.
Substrate of BCRP/ABCG2, CYP1A2 (minor), CYP2B6 (minor), CYP2D6 (minor), OCT1, P-glycoprotein/ABCB1 (minor), UGT1A9; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Corticosteroids (Systemic): Deucravacitinib may enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): Deucravacitinib may enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): Deucravacitinib may enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): Deucravacitinib may enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Methotrexate: Deucravacitinib may enhance the immunosuppressive effect of Methotrexate. Risk X: Avoid combination
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
In general, patients who may become pregnant should use effective contraception while using biologic therapy for the treatment of psoriasis (Smith 2020; Yeung 2020).
Adverse events were not observed in animal reproduction studies.
Pregnant patients were excluded from the initial studies (Armstrong 2022; Papp 2018); outcome data following inadvertent exposure to deucravacitinib during pregnancy are limited (Armstrong 2022).
Data collection to monitor pregnancy and infant outcomes following exposure to deucravacitinib is ongoing. Health care providers are encouraged to report patients exposed to deucravacitinib during pregnancy to the Bristol-Myers Squibb Company's Adverse Event reporting line (1-800-721-5072).
It is not known if deucravacitinib is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs and symptoms of hypersensitivity (eg, angioedema); triglycerides; LFTs; signs and symptoms of rhabdomyolysis (eg, muscle pain or weakness, elevated creatine phosphokinase, dark urine, fever); signs and symptoms of infection (including tuberculosis) during and after therapy; viral hepatitis (prior to initiating therapy in accordance with clinical guidelines); malignancy screening (in accordance with clinical guidelines).
Deucravacitinib inhibits tyrosine kinase 2, a member of the Janus kinase (JAK) family, which prevents downstream activation of signal transducers and activators of transcription and subsequent cytokine pathways. The exact role of deucravacitinib in moderate to severe plaque psoriasis is unknown.
Distribution: 140 L.
Protein binding: 82% to 90%.
Metabolism: Hepatic, primarily via CYP1A2 to active metabolite BMT-153261 (comparable potency to parent drug and accounts for 20% of activity).
Bioavailability: 99%.
Half-life elimination: 10 hours.
Time to peak: 2 to 3 hours (median).
Excretion: ~13% and ~26% as unchanged drug in urine and feces, respectively; ~ 12% excreted as BMT-153261 (active metabolite) in urine and feces, respectively.
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