ManufacturerPHOKHAM 2 PHARMACEUTICAL,Laos PDR
Ixazomib trade name Phoixaz4,Ninlaro is a drug for the treatment of multiple myeloma, a type of white blood cell cancer, in combination with other drugs. It is taken by mouth in the form of capsules.
Common side effects include diarrhea, constipation and low platelet count. Like the older bortezomib (which can only be given by injection), it acts as a proteasome inhibitor, has orphan drug status in the US and Europe, and is a boronic acid derivative.
The drug was developed by Takeda. In the US, it is approved since November 2015, and in the EU since November 2016.
Ixazomib is used in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adults after at least one prior therapy. There are no experiences with children and youths under 18 years of age.
The study relevant for approval included 722 people. In this study, ixazomib increased the median time of progression-free survival from 14.7 months (in the placebo+lenalidomide+dexamethasone study arm including 362 people) to 20.6 months (under ixazomib+lenalidomide+dexamethasone, 360 people), which was a statistically significant effect (p = 0.012). 11.7% of patients in the ixazomib group had a complete response to the treatment, versus 6.6% in the placebo group. Overall response rate (complete plus partial) was 78.3% versus 71.5%.
A phase 3 study demonstrated a significant improvement in progression-free survival (PFS) with ixazomib-lenalidomide-dexamethasone (IRd) compared with placebo. High-risk cytogenetic abnormalities were defined as del(17p), t(4;14), and/or t(14;16); additionally, patients were assessed for 1q21 amplification. Of 722 randomized patients, 552 had cytogenetic results; 137 (25%) had high-risk cytogenetic abnormalities and 172 (32%) had 1q21 amplification alone. PFS was improved with IRd versus placebo in both high-risk and standard-risk cytogenetics subgroups: in high-risk patients, with median PFS of 21.4 versus 9.7 months; in standard-risk patients, with median PFS of 20.6 versus 15.6 months. This PFS benefit was consistent across subgroups with individual high-risk cytogenetic abnormalities, including patients with del(17p). PFS was also longer with IRd versus placebo- in patients with 1q21 amplification, and in the "expanded high-risk" group, defined as those with high-risk cytogenetic abnormalities and/or 1q21 amplification. IRd demonstrated substantial benefit compared with placebo in relapsed/refractory multiple myeloma patients with high-risk and standard-risk cytogenetics, and improves the poor PFS associated with high-risk cytogenetic abnormalities.
Why is this medication prescribed?
Ixazomib is used in combination with lenalidomide (Revlimid) and dexamethasone to treat multiple myeloma (cancer of the plasma cells in the bone marrow) that has worsened after treatment with other chemotherapy medications. Ixazomib is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells.
How should this medicine be used?
Ixazomib comes as a capsule to take by mouth. It is usually taken with water on an empty stomach, at least 1 hour before or 2 hours after eating. It is taken on days 1,8, and 15 of a 28 day treatment cycle. Take ixazomib at around the same time on every day that you take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ixazomib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not take ixazomib and dexamethasone at the same time because you should take dexamethasone with food.
Swallow the capsules whole; do not split, chew, or crush them.
Be careful when handling ixazomib capsules. Do not allow your skin, eyes, mouth, or nose to come into contact with broken or crushed ixazomib capsules. If such contact occurs, wash your skin well with soap and water or rinse your eyes well with plain water.
If you vomit after taking ixazomib, do not repeat the dose. Take your next dose of ixazomib on the next scheduled day that you are supposed to take it.
Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of ixazomib, or of the other medications that you are taking, depending on the side effects that you experience. Be sure to talk to your doctor about how you are feeling during your treatment. Do not stop taking ixazomib without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What side effects can this medication cause?
Ixazomib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
new or worsening rash
unusual swelling of your arms or legs
weight gain due to swelling