There are some important precautions to follow when treating alopecia areata with litfullo. These precautions ensure that patients achieve the best treatment effect during medication use and minimize possible side effects. Hereinafter, we will detail the precautions for Ritlecitinib to help patients use this medication correctly and ensure safe and effective treatment. Be sure to consult your doctor before use and follow your doctor's advice and guidance.

Things to note about Ritlecitinib

It is reported that severe infections have occurred in patients treated with Ritlecitinib. The most common severe infections are appendicitis, COVID-19 infections (including pneumonia), and sepsis. In opportunistic infections, multiple dermal shingles are reported in Ritlecitinib.

Severe infection

Avoid using Ritlecitinib in patients with active and severe infections. Consider the risks and benefits of treatment before patients start using Ritlecitinib:

1) Suffering from chronic or recurrent infections;

2) People who have been exposed to tuberculosis;

3) Have a history of serious infection or opportunistic infection;

4) Have lived or traveled in areas endemic to tuberculosis or fungal diseases or have underlying diseases that may lead to infection.

During and after treatment of Ritlecitinib, closely monitor the development of infection signs and symptoms of the patient. If the patient develops a serious or opportunistic infection, interrupt Ritlecitinib.

Patients who experience new infections during Ritlecitinib treatment should receive timely and complete diagnostic tests suitable for patients with immunocompromised dysfunction, appropriate antibacterial treatment should be initiated, and patients should be monitored closely. Once the infection is controlled, Ritlecitinib treatment can be restored.

Pulmonary tuberculosis

Search the patient for tuberculosis (TB) before starting treatment. Ritlecitinib should not be administered to patients with active tuberculosis.

For patients with newly diagnosed latent tuberculosis or previously untreated latent tuberculosis, anti-tuberculosis treatment should be initiated before starting treatment with Ritlecitinib.

For patients who test negative for latent tuberculosis, anti-tuberculosis treatment should be considered before starting treatment with Ritlecitinib for high-risk patients, and screening high-risk patients with TB during treatment with Ritlecitinib.

Virus reactivation

If the patient develops shingles during Ritlecitinib, consider discontinuing treatment until the symptoms disappear.

Viral hepatitis screening should be performed in accordance with clinical guidelines before starting Ritlecitinib treatment. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.

Mortality rate

In a large, randomized, post-market safety study, it was observed that patients treated with JAK inhibitors had higher all-cause mortality, including sudden cardiovascular death, compared with TNF blockers. Therefore, consider the benefits and risks for individual patients before starting or continuing with Ritlecitinib treatment.

Malignant tumors and lymphoproliferative diseases

Malignant tumors, including non-melanoma skin cancer (NMSC), were observed in Ritlecitinib clinical trials.

For patients with known malignant tumors (except for successful non-melanoma skin or cervical cancer), the risks and benefits of Ritlecitinib treatment should be considered before initiating or continuing the treatment.

For patients with high risk of skin cancer, it is recommended to undergo regular skin examinations.

Major adverse cardiovascular events (MACE)

Before starting or continuing with Ritlecitinib treatment, consider the benefits and risks for individual patients, especially current or previous smokers and patients with other cardiovascular risk factors. Patients should be informed of the symptoms of serious cardiovascular events and the measures they should take when they occur. Patients who have experienced myocardial infarction or stroke should stop taking Ritlecitinib.

Thromboembolism events

Pulmonary embolism (PE) event occurred in patients treated with Ritlecitinib. Avoid Ritlecitinib for patients with a possible increased risk of thrombosis. If thrombosis or embolism occurs, the patient should interrupt Ritlecitinib and receive timely evaluation and appropriate treatment.

Allergic reactions

Severe reactions such as allergic reactions, urticaria and rash were observed in patients treated with Ritlecitinib. If a clinically severe allergic reaction occurs, discontinue Ritlecitinib and start appropriate treatment.

Laboratory abnormalities

The use of Ritlecitinib may cause lymphocytes and thrombocytopenia, and lymphocytes and platelet counts are performed before starting treatment. After initiating treatment with Ritlecitinib, treatment interruption or termination is recommended based on abnormal lymphocyte and platelet counts.

Ritlecitinib treatment is related to the increased incidence of liver enzymes. If elevations of Ritlecitinib or alanine aminotransferase are observed and suspected of being drug-induced liver damage, Ritlecitinib is interrupted until the diagnosis is ruled out.

Ritlecitinib treatment may lead to an increase in creatine phosphokinase (CPK).

Vaccination

There are currently no data on vaccination responses to patients receiving Ritlecitinib. Live attenuated vaccines should be avoided during or shortly before starting treatment. Before starting Ritlecitinib, patients are advised to follow current immunization guidelines for all the latest immunizations, including preventive shingles vaccination.