Sotyktu

SOTYKTU™ is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

• •For recommended evaluation prior to SOTYKTU initiation, see Full Prescribing Information.
  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)]

  .
• •Recommended dosage is 6 mg orally once daily, with or without food.
  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.

Tablets: 6 mg, pink, round, biconvex, laser printed with “BMS 895” and “6 mg” on one side with no content on the other side.

• •
  Hypersensitivity:
  Hypersensitivity reactions such as angioedema have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs.
  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)].
• •
  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 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.
• •
  Tuberculosis:
  Evaluate for TB prior to initiating treatment with SOTYKTU.
  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.
• •
  Malignancy:
  Malignancies including lymphomas were observed in clinical trials with SOTYKTU
  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.
• •
  Rhabdomyolysis and elevated CPK.
  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)].
• •
  Laboratory Abnormalities:
  Periodically evaluate serum triglycerides. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease.
  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)].
• •
  Immunizations:
  Avoid use with live vaccines.
  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.
• •
  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 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.