Taboo populations, foods, and restrictions for Regeneron Cemiplimab in the United States
Cemiplimab, as a PD-1 inhibitor, is contraindicated mainly in patients with specific immune states. The contraindicated foods include grapefruit, which affects the efficacy of the drug. The use restrictions should be combined with clinical evaluation and monitoring requirements.
1 Taboo population
(1) Patients with active autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, etc., may worsen their condition or induce immune related adverse reactions.
(2) Organ transplant recipients: The use of immunosuppressants may increase the risk of transplant rejection, and the benefit risk ratio needs to be rigorously evaluated.
(3) Patients with moderate to severe infections, including active tuberculosis and uncontrolled HIV, may experience exacerbation of infection due to immune activation.
(4) Pregnant women: Animal studies have shown embryotoxicity and contraception is required during treatment and within 4 months after the last dose.
2 Forbidden Foods
(1) Grapefruit and its products: may affect drug metabolism by inhibiting CYP3A4 enzyme, leading to abnormal increase in blood drug concentration.
(2) St. John's wort: induces CYP3A4 enzyme to accelerate drug clearance, reduces therapeutic efficacy, and should be avoided from simultaneous intake.
(3) High fat diet: may delay drug absorption, it is recommended to take on an empty stomach or at a fixed time to ensure drug stability.
3 Usage Restrictions
(1) Abnormal liver function: When ALT/AST>3 times ULN or bilirubin>1.5 times ULN, medication should be suspended and reduced after recovery.
(2) Renal insufficiency: Limited data on end-stage renal disease patients require close monitoring of creatinine levels and immune related nephritis symptoms.
(3) Elderly patients: Those aged 65 and above do not need to adjust the dosage, but those with multiple comorbidities need to strengthen adverse reaction monitoring.
(4) Pediatric patients: The safety of children under 12 years old has not been established, and the dosage should be adjusted according to body weight for children aged 12-18.
4 Other precautions
(1) Vaccination with live vaccines: Vaccination is prohibited during the treatment period and within 3 months after discontinuation, as it may cause vaccine related infections.
(2) Combination therapy: Combination therapy with immunosuppressants and other PD-1/PD-L1 inhibitors may increase toxicity and should be carefully evaluated.
(3) Infusion reaction: The first administration should be completed in a medical institution, equipped with emergency equipment to deal with possible hypersensitivity reactions.
Disclaimer：《Taboo populations, foods, and restrictions for Regeneron Cemiplimab in the United States》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！