Posted on February 11th, 2016 by
Class: Biological Therapy
Generic Name: Ixazomib
Trade Name: Ninlaro®
For which conditions is this drug approved? Ninlaro is approved for use in combination with the medicines Revlimid® (lenalidomide) and dexamethasone to treat people with multiple myeloma who have received at least one prior treatment.
What is the mechanism of action? Ninlaro is a type of drug known as a proteasome inhibitor. It works by blocking enzymes from multiple myeloma cells to make it difficult for them to grow and survive.
How is Ninlaro typically given (administered)? You will take Ninlaro by mouth (orally) during 28-day periods, or “cycles.” Your doctor will give you a schedule for taking Ninlaro and tell you how many cycles you need to take. Your doctor will also tell you how to take Revlimid® and dexamethasone while you are taking Ninlaro.
How are patients typically monitored?
Your healthcare provider will do blood tests during treatment with Ninlaro to check for low platelet counts (thrombocytopenia) and to check your liver function. Your doctor will also monitor you for gastrointestinal complications (severe diarrhea, constipation, nausea, and vomiting), peripheral neuropathy (weakness, numbness, and pain, usually in the hands and feet), peripheral edema (accumulation of fluid causing swelling), and skin reactions.
What are the common (occur in 30% or more of patients) side effects of treatment with Ninlaro?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Ninlaro?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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