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리틀레시티닙토실산염

Ritlecitinib Tosylate

원료 코드 M284857 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D001836

🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기

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  • 🤰 임부금기 2등급 -임부에 대한 안전성 미확립. 랫트 및 토끼에서 태자 체중감소와 내장기형, 골격기형 및 변형, 모체독성(체중감소)이 발생하였고, 출생 후 생존율 감소 및 두 성별 모두에서 성적 성숙지연과 상관관계 있음(경질캡슐제, 산제)

이 성분만 든 제품 (단일제 1)

리트풀로캡슐50밀리그램(리틀레시티닙토실산염) 사진 리트풀로캡슐50밀리그램(리틀레시티닙토실산염) 한국화이자제약(주)· 모발용제(발모, 탈모, 염모, 양모제)· 2024년 허가 전문

🌐 해외(미국) 정보 — 리틀레시티닙토실산염

미국 FDA·NLM 자료 · 2026-10-06 기준

이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. ( 1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. • Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ). Monitor all patients for signs and symptoms of infection during and after treatment with LITFULO. ( 5.1 ) • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LITFULO is not approved for use in RA patients. ( 5.2 ) • Malignancies were reported in patients treated with LITFULO ( 5.3 ). Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ). • Thrombosis has occurred in patients …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

• Hypersensitivity : Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. ( 5.6 ) • Hypoglycemia in Patients with Diabetes : Consider increased monitoring of blood glucose; advise diabetic patients to notify their healthcare provider if they develop signs and symptoms of hypoglycemia. ( 5.7 ) • Laboratory Abnormalities : Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. ( 5.8 ) • Vaccinations : Avoid use of live vaccines during or shortly prior to LITFULO treatment. ( 5.9 ) 5.1 Serious Infections Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis [see Adverse Reactions (6.1) ] . Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO. Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of serious infection or an opportunistic infection • who have resided or traveled in areas of endemic TB or mycoses, or • 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 LITFULO. …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Pregnancy Exposure Registry If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940. Risk Summary Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal …

미국 제품명 Litfulo

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 1,862건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.

  1. 1 약효 없음drug ineffective332
  2. 2 치료제 효과 불완전therapeutic product effect incomplete134
  3. 3 증상 악화condition aggravated116
  4. 4 적응증 외 사용off label use109
  5. 5 두통headache87
  6. 6 원형 탈모alopecia61
  7. 7 설사diarrhoea61
  8. 8 제품 용량 누락 문제product dose omission issue51
  9. 9 URTICARIA51
  10. 10 소양증pruritus47
  11. 11 ACNE43
  12. 12 피로fatigue43

미국 리콜 기록

FDA 리콜 기록이 없습니다.

출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.