What are the criteria for discontinuing selumetinib/coseutinib?

Selumetinib is a drug used to treat plexiform neurofibromas (PN) in neurofibromatosis type 1 (NF1). Although this drug generally shows good efficacy during treatment, in some cases, it may be necessary to discontinue the drug. The criteria for discontinuation mainly depend on changes in the patient's condition, drug side effects and clinical response.

1. Disease progression: If the patient's disease progresses during treatment with selumetinib, that is, the size of the plexiform neurofibromas increases or other related symptoms worsen, the doctor may consider discontinuing the drug or adjusting the treatment plan. Disease exacerbation usually refers to a patient's condition not being effectively controlled or the emergence of new tumors.

2. Unacceptable toxic reactions: Selumetinib may cause some side effects, such as upper respiratory tract infection, joint pain, rash, etc. In some cases, side effects may become too severe and affect the patient's daily life or health. When these side effects are unmanageable or pose significant health risks, doctors may recommend stopping the medication.

3. The patient's overall health condition: If the patient develops serious complications, such as liver and kidney failure, allergic reactions, or other life-threatening conditions, stopping the drug may be the best choice to avoid further health damage. The decision to discontinue medication is usually made after taking the patient's health into consideration.

4. Treatment period expires: In some cases, after the treatment period expires, the patient may enter the clinical remission stage, and the doctor may decide whether to continue or suspend treatment based on the patient's response. In stable disease, discontinuation of medication is sometimes part of the consideration, especially when the goals of treatment have been achieved.

After stopping the drug, patients need to continue to monitor their health, especially for changes in plexiform neurofibromas. The doctor will decide whether to resume treatment or adjust other treatments based on the patient's recovery.

Keyword tags: Selumetinib, Selumetinib, discontinuation criteria, drug side effects, treatment response, neurofibromatosis, drug adjustment

References：https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo