Iclusig is also approved for the treatment of cancer cells in adults who have a genetic mutation called T315I mutation (abnormality of genes, permanent changes). This CML is called T315I positive CML.
In addition, Iclusig is approved for the treatment of adult cancer called acute lymphoblastic leukemia (ALL). The drug is used to treat Philadelphia chromosomes (Ph) with certain genetic mutations. This kind of ALL is called Ph + ALL. Iclusig is used to treat ALL in adults who cannot take other TKIs.
ICLUSIG has a variety of dosage strength prescriptions to meet your personalized treatment needs. The starting dose is usually 45 mg or 30 mg. Your health care provider will start your dose at the dosage that suits you. If you respond well to ICLUSIG, your health care provider may decide to lower your dose.
Effectiveness
Clinical studies have shown that Iclusig can effectively treat certain types of CML.
This clinical study is aimed at patients with chronic CML who have been previously diagnosed but not recently diagnosed. (The chronic phase is the first stage of CML.) These people cannot take other TKI drugs, but take Iclusig. The reason why they cannot take other TKI drugs is because the drugs do not work for them, or because they cannot tolerate side effects.
Iclusig Universal
Iclusig can only be used as a brand drug. It is currently not available in a general form.
Generic drugs are exact copies of branded drugs. The price of generic drugs is often lower than brand-name drugs.
Iclusig contains an active pharmaceutical ingredient: ponatinib. This means that ponatinib is the ingredient that makes Iclusig work.
Indications and usage of Iclusig
Iclusig (ponatinib) is a kinase inhibitor suitable for:
There is no treatment for adult patients with chronic myeloid leukemia (CML) or Ph + ALL treated with other tyrosine kinase inhibitors (TKI) in the chronic phase, accelerated phase or germ phase.
Treatment of adult patients with T315I positive CML (chronic phase, accelerated phase or blast cell phase) or T315I positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL).
Iclusig dosage and administration
Recommended dose
The optimal dose of Iclusig has not been determined. In clinical trials, the starting dose of Iclusig is 45 mg orally once a day. However, in the phase 2 trial, 68% of patients needed to reduce the dose to 30 mg or 15 mg per day during treatment.
Start with a daily dose of 45 mg. For patients with chronic phase (CP) CML and accelerated phase (AP) CML who have reached the main cytogenetic response, consider reducing the Iclusig dose.
If no reaction occurs within 3 months (90 days), please consider discontinuing Iclusig.
Iclusig can be taken with or without food. The tablets should be swallowed whole.
Dose modification of bone marrow suppression
Table 1 summarizes the dosage recommendations for neutropenia (ANC * less than 1.0 × 109 / L) and thrombocytopenia (platelets less than 50 × 109 / L) that are not related to leukemia.
Dose modification for non-hematological adverse reactions
If serious non-hematological adverse reactions occur, adjust the dose, interrupt treatment, or consider discontinuation. Patients with arterial or venous occlusion reactions should not restart Iclusig unless the potential benefits outweigh the risk of recurrent arterial or venous occlusion, and the patient has no other treatment options.
Common side effects
More common side effects of Iclusig include:
- Pain in the abdomen, muscles, legs or arms
- Pain in bones, joints or back
- Mouth pain or blisters
- Nausea or vomiting
- Constipation or diarrhea
- Loss of appetite
- lose weight
- Red, dry or itchy skin or rash
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