Ninlaro
Ninlaro (ixazomib) is an oral anticancer treatment option for multiple myeloma. It’s taken by mouth once a week during the first 3 weeks of a 4-week treatment cycle. This medication is typically taken as a triplet therapy along with lenalidomide (Revlimid) and dexamethasone. But this treatment is only prescribed for people who've already tried other medication options for multiple myeloma. Ninlaro (ixazomib) can cause stomach problems, like nausea, diarrhea, and constipation), which can be serious.
What is Ninlaro (ixazomib)?
What is Ninlaro (ixazomib) used for?
- Multiple myeloma in people whose cancer came back after receiving anticancer treatments
How Ninlaro (ixazomib) works
Ninlaro (ixazomib) is a type of targeted therapy known as a proteasome inhibitor. It works by blocking a group of proteins, called proteasomes, inside cancer cells. Typically, proteasomes help cells break down proteins that they no longer need. When Ninlaro (ixazomib) blocks proteasomes from working, cell waste builds up, which causes cancer cells to die.
Drug facts
Side effects of Ninlaro (ixazomib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low platelet count (85%)
- Low white blood cell count (74%)
- Diarrhea (52%)
- Constipation (35%)
- Nausea (32%)
- Nerve pain (peripheral neuropathy) (32%)
- Back pain (27%)
- Sore throat, runny nose, and other symptoms of sinus or throat infections (27%)
- Rash (27%)
- Swelling of arms and legs (27%)
- Vomiting (26%)
Please note: The side effects above were reported by people in clinical trials who also took lenalidomide (Revlimid) and dexamethasone.
Less Common Side Effects
- Cough, trouble breathing, and other symptoms of bronchitis
- Clouding of the lens of the eye (cataract)
- Pink eye (conjunctivitis)
- Blurred vision
- Dry eye
- Shingles (herpes zoster infection)
Ninlaro (ixazomib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe loss of fluids and electrolytes: dizziness, confusion, fainting, feeling tired, feeling thirsty, dry skin, vomiting or diarrhea that’s difficult to stop, not making much urine
- Serious blood clots in small arteries: tiredness, nausea, vomiting, bruising, rash-like patches on the skin, nosebleeds, blood in the urine, pale skin
- Serious liver problems: tiredness, loss of appetite, nausea or vomiting, dark urine, stomach pain, yellowing of the eyes or skin
- Serious skin reactions: new or worsening rash, severe blistering or peeling of your skin, mouth sores
The following Ninlaro (ixazomib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, or sore throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Pain, tingling, or numbness in the hands or feet
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Swelling of the ankles, hands, or feet
- TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Cough
- Diarrhea
- Nausea
- Vomiting
Pros and cons of Ninlaro (ixazomib)
Pros
- Possible treatment option for multiple myeloma, in combination with other anticancer medications
- Taken by mouth, so good for people who don't like needles
- Only taken once a week during the first 3 weeks of a 4-week treatment cycle
Cons
- Must be taken on an empty stomach
- Not recommended during pregnancy
- Commonly causes stomach problems, like diarrhea and nausea
Pharmacist tips for Ninlaro (ixazomib)
- Make sure to take Ninlaro (ixazomib) on an empty stomach (e.g., at least 1 hour before or 2 hours after food)
- Swallow the Ninlaro (ixazomib) capsule whole with water. Don’t crush, chew, or open the capsule.
- Don’t touch the contents inside the Ninlaro (ixazomib) capsule. If the capsule breaks open and your skin comes in contact with the contents inside, wash that area of skin with soap and water right away. If you get the contents in your eye, make sure to flush your eye with water.
- It can be helpful for you to use a calendar to help keep track of when to take Ninlaro (ixazomib). This medication is typically taken along with lenalidomide (Revlimid) and dexamethasone for the treatment of multiple myeloma. But you don’t necessarily take each medication at the same time or on the same days. Ask your provider to help you plan out when you need to take what medication.
- If you miss a dose of Ninlaro (ixazomib) and your next dose is at least 3 days away, you can take your missed dose. If your next dose is less than 3 days away, just wait and take your next dose at the normally scheduled time.
- Don't take more Ninlaro (ixazomib) than what your provider prescribed. Taking too much Ninlaro (ixazomib) can cause serious side effects, such as severe nausea, vomiting, or diarrhea. In rare cases, these side effects can be life-threatening. If you think you took too much medication and are experiencing severe stomach problems, go to the emergency room right away. If you can, take your medication bottle with you so that your healthcare team can know what you've taken and how to treat your symptoms.
- Ninlaro (ixazomib) can cause flare ups in shingles (herpes zoster). To prevent this, your provider might prescribe you an antiviral medication, like acyclovir (Zovirax), to take before you start treatment with Ninlaro (ixazomib).
- Ask your provider or pharmacist about the best way to handle and throw away Ninlaro (ixazomib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Common questions about Ninlaro (ixazomib)
You should take Ninlaro (ixazomib) as instructed by your provider. This medication is usually given on certain days during each cancer treatment cycle, so it’s important to follow the schedule your provider gives you. How long you receive Ninlaro (ixazomib) treatment depends on several factors, including how well the medication is working to treat your cancer, your specific anticancer regimen, and how well you tolerate it. Don’t stop taking Ninlaro (ixazomib) without first discussing it with your provider.
There are currently 3 FDA-approved proteasome inhibitors to treat multiple myeloma: Ninlaro (ixazomib), bortezomib (Velcade), and Kyprolis (carfilzomib). All 3 medications are typically given in combination with other medications for multiple myeloma. But there are some differences between them. One main difference is that Ninlaro (ixazomib) is taken by mouth, while Kyprolis (carfilzomib) and bortezomib (Velcade) are given as injections. Your provider might choose one proteasome inhibitors over another for you based on certain factors, such as what other treatments you've already received and what other health issues you might have. Talk with your provider if you want to discuss the the options most appropriate for you.
Ninlaro (ixazomib) is only FDA-approved for people who've already tried at least one other anticancer treatment regimen for multiple myeloma. Ask your provider whether Ninlaro (ixazomib) is a possible option for you.
If you experience nausea or vomiting from Ninlaro (ixazomib), let your provider know. They can help you figure out the next steps, depending on your symptoms are and your personal preferences. For example, your provider can suggest ways to minimize nausea or vomiting through lifestyle changes, such as eating foods that are more bland or eating smaller meals more often throughout the day. Your provider can also prescribe anti-nausea medications for you if appropriate. If you're vomiting frequently and losing a lot of body fluid, they'll recommend that you drink enough water or fluids to stay hydrated and to minimize loss of important electrolytes. And in cases of severe vomiting, your provider might ask you to go to the hospital for more medical care.
It isn’t known if Ninlaro (ixazomib) can pass into breast milk, but there’s a risk of serious harm to nursing infants if it does. Because of this risk, you shouldn’t breastfeed during Ninlaro (ixazomib) treatment or for at least 3 months after your last dose. Talk with your provider if you have any questions about breastfeeding or other ways to feed your baby while receiving Ninlaro (ixazomib) or after treatment.
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Risks and warnings for Ninlaro (ixazomib)
Ninlaro (ixazomib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of bleeds (from low platelet counts)
Ninlaro (ixazomib) can lower your platelet levels and put you at higher risk of bleeding or bruising. Low platelet count is typically seen during week 2 to 3 of each 4-week treatment cycle. If your platelet level drops too low, you might need a platelet transfusion. Your provider will closely monitor your blood cell counts through routine lab work at least monthly while you’re receiving Ninlaro (ixazomib). Let your provider know as soon as possible if you experience bleeding and bruising that doesn’t stop or go away, because you might need your dose lowered or your next dose delayed.
Stomach problems
Ninlaro (ixazomib) can cause various stomach problems, like diarrhea, constipation, and nausea. These conditions can be serious because they can lead to dangerously low fluid or electrolyte levels (dehydration) and other medical problems. Let your provider know if you experience any of these problems. They might be able to prescribe anti-diarrhea or anti-nausea medications for you to ease your symptoms. If your problems are severe, your provider might need to stop your Ninlaro (ixazomib) treatment.
Nerve pain (peripheral neuropathy)
Ninlaro (ixazomib) can cause new or worsening nerve problems in your arms, hands, legs, and feet (peripheral neuropathy). These problems are typically mild. If you do experience symptoms of peripheral neuropathy, your provider might need to lower your dose of Ninlaro (ixazomib). Let your provider know if you experience numbness, pain, burning, a feeling of "pins and needles," or weakness in your arms or legs.
Swelling of arms and legs
Some people taking Ninlaro (ixazomib) experienced swelling of their arms and legs. While this side effect can become severe, it was typically mild for most people in clinical trials. Let your provider know if you experience swelling of your arms or legs, or weight gain due to swelling. They might lower your Ninlaro (ixazomib) dose or adjust your dose of steroid.
Skin reactions
Ninlaro (ixazomib) can cause rash in some people. Typically, the rashes aren’t severe. But there have been reports of very serious skin rash. Tell your provider right away if you experience a new or worsening rash, severe blistering or peeling of your skin, or mouth sores. If skin reactions occur, your provider might lower your dose of Ninlaro (ixazomib) or stop your treatment altogether, depending on how serious your skin reaction is.
Blood clots in small blood vessels (thrombotic microangiopathy)
Though rare, some people receiving Ninlaro (ixazomib) have experienced serious blood clots in the smallest blood vessels, including those in the kidney and brain. Let your provider know right away if you experience a fever, bruising, nose bleed, tiredness, or needing to urinate less often. You might have to stop treatment with Ninlaro (ixazomib) while your provider figures out the cause.
Liver damage
Rarely, Ninlaro (ixazomib) caused liver damage in people taking the medication. This can happen to anyone, but be sure to tell your provider if you have liver problems before starting this medication. Your provider will monitor your liver’s health through lab work while you’re taking Ninlaro (ixazomib) and might adjust your dose as needed. Let your provider know right away if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, stomach pain, or yellowing of the eyes or skin, as these can be signs of liver problems.
Harm to unborn baby
Ninlaro (ixazomib) hasn’t been studied in human pregnancies, but animal studies show that it can cause harm to an unborn baby. If you're a female of childbearing age taking Ninlaro (ixazomib), your provider might check to see if you’re pregnant before you start treatment. If you’re female who’s s able to become pregnant or a male with a female partner with childbearing potential, use non-hormonal birth control (e.g., condoms) while you’re receiving Ninlaro (ixazomib) and for at least 3 months after your last dose. Let your provider know right away if you become pregnant during this time.
Ninlaro (ixazomib) dosage
Typical dosage for Ninlaro (ixazomib)
Ninlaro (ixazomib) is typically taken along with lenalidomide (Revlimid) and dexamethasone.
The typical starting dose is to take 4 mg of Ninlaro (ixazomib) by mouth once a week during the first 3 weeks (on days 1, 8, and 15) of a 4-week treatment cycle.
Your dose of Ninlaro (ixazomib) might be different if you're taking other medications that might interact with Ninlaro (ixazomib), or have liver or kidney problems.
What are alternatives to Ninlaro (ixazomib)?
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