| Common Brands | Scemblix |
|---|---|
|
Drug Class |
Tyrosine Kinase Inhibitor |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
Lower-cost generic available |
|
Availability |
Prescription only |
Asciminib – a unique, targeted agent – is most commonly used for the therapy of chronic myeloid leukaemia (CML) which is a blood cancer that occurs in the bone marrow.
It is sold under the trade name Scemblix and developed by Bristol Meyers Squibb. Asciminib can be considered a tyrosine kinase inhibitors (TKI), however, mechanism of action of this compound varies from old TKIs, imatinib, dasatinib, and nilotinib, used in the treatment of CML for decades.
Asciminib inhibits ABL1 tyrosine kinase by binding to known allosteric site of BCR-ABL1 adapter-one protein that drives CML in a majority of patients.
It has been demonstrated in clinical practice to be effective in treating patients with chronic myeloid leukaemia (CML), targeting TKI resistant or intolerant patients including those with T315I mutational alteration, which is often associated with failure of other available TKIs.
Asciminib is an orally dosed agent in the tablet form, prescribed usually for once a day. The dosage and duration of treatment will differ from patient to patient based on their individual response to therapy, but standardly the initial dose in adult patients is 40 mg taken in one dose once every day.
Monitoring: While on asciminib therapy, the patients are required to have their blood counts assessed on a regular basis since the medication may alter the levels of the red blood cells, white blood cells, and platelets in circulation. In addition, liver function tests and other routine assessments may be advised.
Asciminib attaches to the bcrabl protein by precisely anchoring itself into its myristoyl pocket. A bcr-abl fusion protein is an aberration characterized by a translocation of parts of chromosome 9 and 22, known as the Philadelphia chromosome. This fusion protein exhibits enhanced tyrosine kinase activity that is responsible for the uncontrolled multiplication of neoplastic polymorphonuclear leukocytes in CML.
Most conventional tyrosine kinase inhibitors (TKIs), such as imatinib, dasatinib, and nilotinib work by inhibiting the ATP-Binding cleft of the BCR-ABL1 protein. In contrast, asciminib attaches to a unique cleft, the myristoyl pocket, which enables it to inhibit the BCR-ABL1 activity even in the presence of T315I mutation that is resistant to most other TKIs.
Owing to this novel mode of action, asciminib is not limited by the resistance presented by other TKIs which makes it helpful in cases where the patient has previously failed therapy with other drugs or when other agents are associated with intolerable side effects. It is considered second or third line in the management of chronic-phase CML.
As most medicines, asciminib has its side effects, however they are usually mild. The most common side effects and those that can be more serious with asciminib include:
Patients prescribed asciminib should be aware of the following warnings and precautions:
CYP3A4 Inhibitors and Inducers: Since asciminib is metabolized in large quantities by the CYP3A4 enzyme, any drug affecting this enzyme would alter the levels of asciminib in the body. Such CYP3A4 inhibitors, e.g., ketoconazole, ritonavir, clarithromycin, will increase the concentration of asciminib in the body, causing toxicity or side effects. On the other hand, CYP3A4 inducers, for example, rifampin, carbamazepine, and phenytoin, will tend to make the levels of asciminib lower in the body, making it less effective.
Other Tyrosine Kinase Inhibitors: Co-administration of Asciminib and other TKIs (for example imatinib, dasatinib and nilotinib) may increase the risk of adverse events such as cytopenias or QT interval prolongation. Strong monitoring is therefore needed for these adverse effects when these agents are given together.
Anticoagulants: Asciminib might have a minor effect on the function of platelets as well as on blood clotting. Thus, the combination of asciminib with anticoagulants, such as warfarin and dabigatran, may add a bleeding tendency which requires the close monitoring of coagulation parameters.
In most cases, the recommended initiation dose of asciminib in patients with chronic-phase CML is 40 mg per day. Furthermore, the patient tolerates the drug and patient response to treatment allows for the adjustment of the dose. The upper limit of the dose is 80 mg once a day.
Asciminib is classified as a prescription medication. Therefore it must be provided by a health care provider, often a hematologist or onco-hematologist who treats patients with bleeding disorders and cancers of the blood. Before prescribing asciminib, the physician will assess the patient’s condition, previous therapies as well as the presence of mutations (e.g. T315I) in determining the suitability of the drug for the patient.
Answer: Asciminib is a novel targeted therapy used primarily in the treatment of chronic myeloid leukemia (CML). It works as a selective inhibitor of the BCR-ABL1 protein, specifically targeting the “switch” pocket of the protein.
Answer: Asciminib specifically binds to the BCR-ABL1 protein in cancer cells, inhibiting its activity. This action prevents the proliferation of cancer cells and promotes their death, thereby leading to reduced disease progression.
Answer: Asciminib is mainly used to treat chronic myeloid leukemia (CML), particularly in patients who have shown resistance to other treatments like imatinib.
Answer: Asciminib is typically administered orally, in tablet form. Patients usually take it once daily, with or without food.
Answer: Common side effects include fatigue, nausea, diarrhea, musculoskeletal pain, and headache. Most side effects are mild to moderate in severity.
Answer: Yes, serious side effects can occur, though they are less common. These may include cardiovascular issues, liver function abnormalities, and severe allergic reactions.
Answer: Yes, Asciminib can be used in combination with other therapies for CML, particularly in cases of resistance or intolerance to prior treatments. However, combination therapy should be managed by a healthcare provider.
Answer: Asciminib is generally indicated for adults with Philadelphia chromosome-positive CML, particularly in chronic phase patients who are resistant or intolerant to other BCR-ABL inhibitors.
Answer: Yes, patients on Asciminib usually require regular monitoring of blood counts, liver function tests, and cardiovascular health to detect any potential side effects early.
Answer: Asciminib has shown efficacy in patients resistant to other therapies such as imatinib, dasatinib, or nilotinib. Its unique mechanism of action may offer benefits in specific patient populations.
Answer: Asciminib is contraindicated in patients with known hypersensitivity to the drug or its components. Discussion with a healthcare provider is essential before starting treatment.
Answer: If a dose is missed, it should be taken as soon as possible unless it’s close to the time of the next dose. Patients should not double up on doses; they should follow their healthcare provider’s instructions regarding missed doses.
Answer: Asciminib should be used with caution during pregnancy, as its effects on fetal development are unknown. It is also not recommended for breastfeeding without consulting a healthcare provider.
Answer: Duration of therapy with Asciminib varies based on individual patient response and tolerance. Continuous monitoring by a healthcare provider will help determine the appropriate length of treatment.
Answer: Yes, maintaining a healthy lifestyle, including a balanced diet, regular exercise, and avoiding smoking and excessive alcohol, can support treatment effectiveness and overall health.
Answer: Asciminib may not yet be available in all countries. Availability often depends on local regulations and approval status from health authorities.
Answer: The cost of Asciminib can vary widely depending on the healthcare system, insurance coverage, and country. Patients should consult with their healthcare provider and insurance company for specific pricing information.
Answer: Yes, ongoing clinical trials are exploring the efficacy of Asciminib in various patient populations and combination therapies. Interested patients can discuss potential participation with their healthcare providers.
Answer: Patients should inform their healthcare provider of their complete medical history, any other medications they are taking, and any existing health conditions, especially heart or liver issues.
Answer: Asciminib should be stored at room temperature, away from moisture and heat. It should be kept out of reach of children and disposed of properly when no longer needed.
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