Ninlaro is a brand-name prescription medication that's used to treat multiple myeloma in adults. This condition is a rare type of cancer that affects certain white blood cells called plasma cells. With multiple myeloma, normal plasma cells become cancerous and are called myeloma cells.
Ninlaro is approved for use in people who've already tried at least one other treatment for their multiple myeloma. This treatment could be a medication or a procedure.
Ninlaro belongs to a class of drugs called proteasome inhibitors. It's a targeted treatment for multiple myeloma. Ninlaro targets (works on) a specific protein inside myeloma cells. It creates a buildup of protein in the myeloma cells, which causes those cells to die.
Ninlaro comes as capsules that are taken by mouth. You'll take Ninlaro with two other multiple myeloma medications: lenalidomide (Revlimid) and dexamethasone (Decadron).
During studies, Ninlaro increased the length of time that some people with multiple myeloma lived without their disease progressing (getting worse). This length of time is called progression-free survival.
One clinical study looked at people with multiple myeloma who had already used one other treatment for their disease. The people were divided into two groups. The first group was given Ninlaro with both lenalidomide and dexamethasone. The second group was given a placebo (treatment with no active drug) with both lenalidomide and dexamethasone.
People who took the Ninlaro combination lived for an average of 20.6 months before their multiple myeloma progressed. People taking the placebo combination lived an average of 14.7 months before their multiple myeloma progressed.
Of people who took the Ninlaro combination, 78% responded to treatment. This means they had at least a 50% improvement in their lab tests that looked for myeloma cells. In those who took the placebo combination, 72% of people had the same response to treatment.
Ninlaro is available only as a brand-name medication. It's not currently available in generic form.
Ninlaro contains one active drug ingredient: ixazomib.
Ninlaro can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Ninlaro. These lists do not include all possible side effects.
For more information on the possible side effects of Ninlaro, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.
Common side effects
The more common side effects of Ninlaro can include:
- back pain
- blurred vision
- dry eyes
- conjunctivitis (also called pink eye)
- shingles (herpes zoster virus), which causes a painful rash
- neutropenia (low white blood cell level), which can increase your risk of infections
Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects can also be common with Ninlaro. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.
Serious side effects and their symptoms can include the following:
- Peripheral neuropathy (damage to your nerves). Symptoms can include:
- tingling or burning sensation
- weakness in your arms or legs
- Severe skin reactions. Symptoms can include:
- skin rash with bumps that are red to purple in color (called Sweet's syndrome)
- skin rash with areas of peeling and sores inside your mouth (called Stevens-Johnson syndrome)
- Peripheral edema (swelling). Symptoms can include:
- swollen ankles, feet, legs, arms, or hands
- weight gain
- Liver damage. Symptoms can include:
- jaundice (yellowing of your skin or the whites of your eyes)
- pain in the right side of your upper abdomen (belly)
Other serious side effects, which are described more in the "Side effect details" section below, can include:
- thrombocytopenia (low platelet levels)
- digestive problems such as diarrhea, constipation, nausea, and vomiting
Side effect details
You may wonder how often certain side effects occur with this drug. Here's some detail on some of the side effects this drug may cause.
You may have thrombocytopenia (low platelet level) while you're taking Ninlaro. This was the most common side effect of Ninlaro during clinical studies.
During studies, the people were divided into two groups. The first group was given Ninlaro with both lenalidomide and dexamethasone. The second group was given a placebo (treatment with no active drug) with both lenalidomide and dexamethasone.
Of those taking the Ninlaro combination, 78% of people had low platelet levels. Of those who took the placebo combination, 54% had low platelet levels.
In the studies, some people needed a platelet transfusion to treat their thrombocytopenia. With a platelet transfusion, you receive platelets from a donor or from your own body (if the platelets were collected previously). Of people taking the Ninlaro combination, 6% needed a platelet transfusion. Of people taking the placebo combination, 5% needed a platelet transfusion.
Platelets work in your body to stop bleeding by helping to form blood clots. If your platelet level becomes too low, you may have serious bleeding. While you're taking Ninlaro, you'll need to have blood tests regularly to check your platelet levels.
Call your doctor right away if you have any of these symptoms of low platelet levels:
- bruising easily
- bleeding more often than usual (such as having nosebleeds or bleeding from your gums)
If your platelet level becomes too low, your doctor may decrease your dosage of Ninlaro or recommend a platelet transfusion. They may even ask you to stop taking Ninlaro for a while.
You may experience problems with your stomach or bowels while you're taking Ninlaro. During clinical studies of the drug, people commonly had digestive problems.
In studies, the people were divided into two groups. The first group was given Ninlaro with both lenalidomide and dexamethasone. The second group was given a placebo (treatment with no active drug) with both lenalidomide and dexamethasone. The following side effects were reported in studies:
- diarrhea, which occurred in 42% of people taking the Ninlaro combination (and in 36% of people taking the placebo combination)
- constipation, which occurred in 34% of people taking the Ninlaro combination (and in 25% of people taking the placebo combination)
- nausea, which occurred in 26% of people taking the Ninlaro combination (and in 21% of people taking the placebo combination)
- vomiting, which occurred in 22% of people taking the Ninlaro combination (and in 11% of people taking the placebo combination)
Managing digestive problems
It's important to talk to your doctor about how to manage these problems. Otherwise, they can become serious.
Nausea and vomiting can usually be prevented or treated by taking certain medications. Besides taking medication, there are other things you can do if you're feeling nauseous. Sometimes it's helpful to eat small amounts of food more often, instead of eating three big meals each day. The American Cancer Society provides several other tips to help relieve nausea.
Diarrhea can also be treated with certain medications, such as loperamide (Imodium). And if you have diarrhea, make sure that you're drinking plenty of fluids. This will help you avoid getting dehydrated (when your body has low fluid amounts).
You can help prevent constipation by drinking plenty of fluids, eating high-fiber foods, and doing gentle exercise (such as walking).
If your digestive problems become severe, your doctor may decrease your dosage of Ninlaro. They may even ask you to stop taking the drug for a while.
You may have an increased risk of developing shingles (herpes zoster) while you're taking Ninlaro. Shingles is a skin rash that causes burning pain and blistering sores. It was reported in people taking Ninlaro during clinical studies.
Participants were divided into two groups. The first group was given Ninlaro with both lenalidomide and dexamethasone. The second group was given a placebo (treatment with no active drug) with both lenalidomide and dexamethasone.
During the studies, shingles was reported in 4% of people taking the Ninlaro combination. Of those taking the placebo combination, 2% of people had shingles.
You can develop shingles if you've had chickenpox in the past. Shingles occurs when the virus that causes chickenpox reactivates (flares up) inside your body. This flare-up can occur if your immune system isn't working as well as it normally does, which commonly happens in people with multiple myeloma.
If you've had chickenpox in the past and are using Ninlaro, your doctor may prescribe an antiviral medication for you to take while you're using Ninlaro. The antiviral medication will help to prevent shingles from developing in your body.
The Ninlaro dosage your doctor prescribes will depend on several factors. These include:
- how well your liver and kidneys are functioning
- if you have certain side effects from your Ninlaro treatment
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
Drug forms and strengths
Ninlaro comes as oral capsules that are available in three strengths: 2.3 mg, 3 mg, and 4 mg.
Dosage for multiple myeloma
The typical starting dosage of Ninlaro is one 4-mg capsule taken once a week for three weeks. This is followed by one week of not taking the drug. You'll repeat this four-week cycle as many times as your doctor recommends.
During treatment, you should take a Ninlaro capsule on the same day each week. It's best to take Ninlaro at around the same time of day for each dose. You should take Ninlaro on an empty stomach, at least one hour before you eat or at least two hours after you've eaten.
You'll take Ninlaro in combination with two other multiple myeloma medications: lenalidomide (Revlimid) and dexamethasone (Decadron). These drugs have different schedules for dosing than Ninlaro does. Be sure to follow the dosage instructions given by your doctor for each of these drugs.
It's best to have your dosage schedule written down on a chart or calendar. This helps you to know all the drugs you need to take and exactly when you need to take them. It's a good idea to check off each dose after you take it.
If you have problems with your liver or kidneys, your doctor may recommend that you take a lower dosage of Ninlaro. Your doctor may also lower your dosage or ask you to take a break from treatment if you get certain side effects from the drug (such as a low platelet level). Always take Ninlaro exactly as your doctor prescribes.
What if I miss a dose?
If you forget to take a dose of Ninlaro, follow these instructions:
- If there are 72 or more hours until your next dose is due, take your missed dose right away. Then, take your next dose of Ninlaro at the usual time.
- If there are less than 72 hours until your next dose is due, just skip the missed dose. Take your next dose of Ninlaro at the usual time.
Never take more than one dose of Ninlaro to make up for a missed dose. Doing so can increase your risk of side effects.
To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful too.
Will I need to use this drug long term?
Ninlaro is meant to be used as a long-term treatment. If you and your doctor determine that Ninlaro is safe and effective for you, you'll likely take it long term.
Other drugs are available that can treat multiple myeloma. Some may be better suited for you than others. If you're interested in finding an alternative to Ninlaro, talk with your doctor. They can tell you about other medications that may work well for you.
Examples of other drugs that may be used to treat multiple myeloma include:
- certain chemotherapy drugs, such as:
- cyclophosphamide (Cytoxan)
- doxorubicin (Doxil)
- melphalan (Alkeran)
- certain corticosteroids, such as:
- dexamethasone (Decadron)
- certain immunomodulating therapies (drugs that work with your immune system), such as:
- lenalidomide (Revlimid)
- pomalidomide (Pomalyst)
- thalidomide (Thalomid)
- certain targeted therapies, such as:
- bortezomib (Velcade)
- carfilzomib (Kyprolis)
- daratumumab (Darzalex)
- elotuzumab (Empliciti)
- panobinostat (Farydak)
You may wonder how Ninlaro compares to other medications that are prescribed for similar uses. Here we look at how Ninlaro and Velcade are alike and different.
Ninlaro contains ixazomib, while Velcade contains bortezomib. These drugs are both targeted therapies for multiple myeloma. They belong to a class of drugs called proteasome inhibitors. Ninlaro and Velcade work the same way inside your body.
Ninlaro is FDA-approved to treat:
- multiple myeloma in adults who've already tried at least one other treatment for their disease. Ninlaro is used in combination with lenalidomide (Revlimid) and dexamethasone (Decadron).
Velcade is FDA-approved to treat:
- multiple myeloma in adults who:
- haven't had any other treatments for their disease; for these people, Velcade is used in combination with melphalan and prednisone
- have multiple myeloma that has relapsed (come back) after previous treatment
- mantle cell lymphoma (cancer of the lymph nodes) in adults
Drug forms and administration
Ninlaro comes as capsules that are taken by mouth. You'll usually take one capsule each week for three weeks. This is followed by one week without taking the drug. This four-week cycle is repeated as many times as your doctor recommends.
Velcade comes as a liquid solution that's given by injection. It's given as either an injection under your skin (a subcutaneous injection) or an injection into your vein (an intravenous injection). You'll receive these treatments at your doctor's office.
Your dosing schedule for Velcade will vary based on your situation:
- If your multiple myeloma hasn't been treated before, you'll likely use Velcade for about a year. You'll usually follow a three-week treatment cycle. You'll begin treatment by receiving Velcade twice a week for two weeks, followed by one week off of the drug. This pattern will be repeated for a total of 24 weeks. After 24 weeks, you'll receive Velcade once a week for two weeks, followed by one week off of the drug. This is repeated for a total of 30 weeks.
- If you're using Velcade because your multiple myeloma has come back after other treatments (with Velcade or other drugs), your dosage schedule may vary, depending on your treatment history.
Side effects and risks
Ninlaro and Velcade both contain drugs from the same class. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.
Common side effects
These lists contain examples of other common side effects that can occur with Ninlaro, with Velcade, or with both drugs (when taken individually).
- Can occur with Ninlaro:
- dry eyes
- Can occur with Velcade:
- nerve pain
- feeling weak or tired
- reduced appetite
- anemia (low red blood cell level)
- alopecia (hair loss)
- Can occur with both Ninlaro and Velcade:
Serious side effects
These lists contain examples of serious side effects that can occur with Ninlaro, with Velcade, or with both drugs (when taken individually). Most of these side effects occur often in people taking these drugs.
- Can occur with Ninlaro:
- severe skin reactions, including Sweet's syndrome and Stevens-Johnson syndrome
- Can occur with Velcade:
- low blood pressure (may cause dizziness or fainting)
- heart problems, such as heart failure or abnormal heart rhythm
- lung problems, such as respiratory distress syndrome, pneumonia, or inflammation in your lungs
- Can occur with both Ninlaro and Velcade:
- peripheral edema (swelling in your ankles, feet, legs, arms, or hands)
- thrombocytopenia (low platelet level)
- stomach or bowel problems, such as diarrhea, constipation, nausea, or vomiting
- nerve problems, such as tingling or burning feelings, numbness, pain, or weakness in your arms or legs
- neutropenia (low white blood cell level), which can increase your risk of getting infections
- liver damage
Ninlaro and Velcade have different FDA-approved uses, but they're both used to treat multiple myeloma in adults.
These drugs haven't been directly compared in clinical studies. However, studies have found that both Ninlaro and Velcade are effective in delaying the progression (worsening) of multiple myeloma. Both drugs are recommended by current treatment guidelines for use in people with multiple myeloma.
For certain people, treatment guidelines recommend using a Velcade-based regimen over using the combination of Ninlaro with lenalidomide (Revlimid) and dexamethasone (Decadron). This recommendation includes people with active multiple myeloma who are being treated for the first time. Active multiple myeloma means that a person has symptoms of the disease, such as kidney problems, bone damage, anemia, or other issues.
For people whose multiple myeloma has come back after other treatments, the guidelines recommend treatment with either Ninlaro or Velcade, in combination with other drugs.
Ninlaro and Velcade are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.
According to estimates on WellRx.com, Velcade generally costs more than Ninlaro. The actual price you'll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.
As with all medications, the cost of Ninlaro can vary. To find current prices for Ninlaro in your area, check out WellRx.com.
The cost you find on WellRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.
Financial and insurance assistance
If you need financial support to pay for Ninlaro, or if you need assistance understanding your insurance coverage, help is available.
Takeda Pharmaceutical Company Limited, the manufacturer of Ninlaro, offers a program called Takeda Oncology 1Point. This program offers assistance and may be able to help lower the cost of your treatment. For more information and to find out if you're eligible for support, call 844-817-6468 (844-T1POINT) or visit the program website.
The Food and Drug Administration (FDA) approves prescription drugs such as Ninlaro to treat certain conditions. Ninlaro may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.
Ninlaro for multiple myeloma
Ninlaro is FDA-approved to treat multiple myeloma in adults who've already tried at least one other treatment for the condition. This treatment could be a medication or a procedure. Ninlaro is approved for use in combination with two other drugs: lenalidomide (Revlimid) and dexamethasone (Decadron).
Multiple myeloma is a rare type of cancer that develops in your plasma cells. These cells are a type of white blood cell. They're made by your bone marrow, which is a spongy material found inside your bones. Your bone marrow makes all your blood cells.
Sometimes plasma cells become abnormal and start multiplying (making more plasma cells) uncontrollably. These abnormal, cancerous plasma cells are called myeloma cells.
Myeloma cells can develop in multiple (several) areas of your bone marrow and in multiple different bones. This is why the condition is called multiple myeloma.
The myeloma cells take up a lot of space in your bone marrow. This makes it difficult for your bone marrow to make enough healthy blood cells. The myeloma cells can also damage your bones, making them weak.
Effectiveness for multiple myeloma
In a clinical study, Ninlaro was effective in treating multiple myeloma. The study looked at 722 people with multiple myeloma who had already had at least one other treatment for the condition. In these people, their multiple myeloma had either stopped responding (getting better) to other treatments, or it had come back after first improving with other treatments.
In this study, people were divided into two groups. The first group was given Ninlaro with two other multiple myeloma medications: lenalidomide and dexamethasone. The second group was given a placebo (treatment with no active drug) with lenalidomide and dexamethasone.
People who took the Ninlaro combination lived for an average of 20.6 months before their multiple myeloma progressed. People taking the placebo combination lived an average of 14.7 months before their disease progressed.
Seventy-eight percent of people who took the Ninlaro combination responded to treatment. This means they had at least a 50% improvement in their lab tests that looked for myeloma cells. In those who took the placebo combination, 72% of people had the same response to treatment.
Off-label uses for Ninlaro
In addition to the use listed above, Ninlaro may be used off-label for other uses. Off-label drug use is when a drug that's approved for one use is used to treat a different one that's not approved.
Ninlaro for multiple myeloma in other situations
Ninlaro is FDA-approved for use with lenalidomide and dexamethasone to treat multiple myeloma in people who've previously had other treatments. It's being studied as a treatment option for other situations involving multiple myeloma.
Research is being done to see how Ninlaro could be used off-label in the following situations:
- to treat different stages of multiple myeloma
- in combination with drugs other than lenalidomide and dexamethasone to treat multiple myeloma
You might be prescribed Ninlaro off-label in one of these ways.
Ninlaro for systemic light chain amyloidosis
Ninlaro isn't FDA-approved to treat systemic light chain amyloidosis. However, sometimes it's used off-label to treat this condition.
This rare condition affects the way your plasma cells (found in your bone marrow) produce certain proteins called light chain proteins. Abnormal copies of these proteins enter your bloodstream and can build up in tissues and organs throughout your body. As the proteins build up, they form amyloids (clusters of protein), which can damage certain organs such as your heart or kidneys.
Ninlaro was included in treatment guidelines for systemic light chain amyloidosis, after a study found that it was effective in treating this condition. Ninlaro is a treatment option for people whose amyloidosis has stopped responding to an approved first-choice treatment for the condition. It's also a treatment option for people whose amyloidosis has come back after it improved with an approved first-choice treatment.
Ninlaro is used either on its own or in combination with dexamethasone when used to treat this disease.
You'll usually take Ninlaro in combination with other drugs that each work in different ways to treat your multiple myeloma.
Ninlaro is approved for use with lenalidomide (Revlimid) and dexamethasone (Decadron). During clinical studies, treatment with Ninlaro in combination with these drugs was more effective than using just lenalidomide and dexamethasone.
Your doctor may also recommend that you take Ninlaro with certain other multiple myeloma drugs. This is an off-label way of using Ninlaro. Off-label drug use is when a drug that's approved for one use is used to treat a different one that's not approved.
Ninlaro with lenalidomide (Revlimid)
Lenalidomide (Revlimid) is an immunomodulatory drug. This type of drug works by helping your immune system kill myeloma cells.
Revlimid comes as capsules that are taken by mouth in combination with Ninlaro. You'll take Revlimid once daily for three weeks, followed by one week of not taking the drug.
You can take Revlimid with or without food.
Ninlaro with dexamethasone (Decadron)
Dexamethasone (Decadron) is a type of drug called a corticosteroid. These drugs are used mainly to reduce inflammation (swelling) in your body. However, when given in low doses for multiple myeloma treatment, dexamethasone helps Ninlaro and Revlimid to kill myeloma cells.
Dexamethasone comes as tablets that are taken by mouth in combination with Ninlaro. You'll take dexamethasone once a week, on the same day of the week that you take Ninlaro. You'll take dexamethasone every week, including the week you don't take Ninlaro.
Don't take your dexamethasone dose at the same time of day as you take your Ninlaro dose. It's best to take these drugs at different times of day. This is because dexamethasone needs to be taken with food, while Ninlaro should be taken on an empty stomach.
Alcohol isn't known to affect how Ninlaro works in your body. However, if you're having certain side effects from Ninlaro (such as nausea or diarrhea), drinking alcohol could make these side effects worse.
If you drink alcohol, talk with your doctor about how much alcohol is safe for you while you're using Ninlaro.
Ninlaro can interact with several other medications. It can also interact with certain supplements.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Ninlaro and other medications
Below are lists of medications that can interact with Ninlaro. These lists do not contain all the drugs that may interact with Ninlaro.
Before taking Ninlaro, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Ninlaro and certain drugs for tuberculosis
Taking certain tuberculosis medications with Ninlaro can lower the level of Ninlaro in your body. This could make Ninlaro less effective for you. You should avoid taking the following drugs with Ninlaro:
- rifabutin (Mycobutin)
- rifampin (Rifadin)
- rifapentine (Priftin)
Ninlaro and certain drugs for seizures
Taking certain seizure medications with Ninlaro can lower the level of Ninlaro in your body. This could make Ninlaro less effective for you. You should avoid taking the following drugs with Ninlaro:
- carbamazepine (Carbatrol, Equetro, Tegretol)
- fosphenytoin (Cerebyx)
- oxcarbazepine (Trileptal)
- phenytoin (Dilantin, Phenytek)
- primidone (Mysoline)
Ninlaro and herbs and supplements
Ninlaro may interact with certain herbs and supplements, including St. John's wort. Make sure to discuss any supplements you're taking with your doctor before you start using Ninlaro.
Ninlaro and St. John's wort
Taking St. John's wort with Ninlaro can lower the level of Ninlaro in your body and make it less effective for you. Avoid taking this herbal supplement (also called Hypericum perforatum) while you're using Ninlaro.
You should take Ninlaro according to your doctor or healthcare provider's instructions.
When to take
Unless your doctor tells you otherwise, take your dose of Ninlaro once a week, on the same day each week. It's best to take your doses at around the same time of day.
You'll take Ninlaro once each week for three weeks. Then you'll have a week off of the drug. You'll repeat this four-week cycle as many times as your doctor recommends.
To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
Taking Ninlaro with food
You shouldn't take Ninlaro with food. It should be taken on an empty stomach because food can reduce the amount of Ninlaro that your body absorbs. This could make Ninlaro less effective for you. Take each dose of Ninlaro at least one hour before you eat or at least two hours after you've eaten.
Can Ninlaro be crushed, split, or chewed?
No, you shouldn't crush, break open, split, or chew Ninlaro capsules. The capsules are meant to be swallowed whole with a drink of water.
If a Ninlaro capsule accidentally breaks open, avoid touching the powder that's inside the capsule. If any powder gets on your skin, wash it off right away with soap and water. If any powder gets into your eyes, flush it out with water right away.
Ninlaro is approved to treat multiple myeloma. It's given with two other drugs (lenalidomide and dexamethasone) that help it to work inside your body.
What happens in multiple myeloma
In the center of your bones, there is a spongy material called bone marrow. This is where your blood cells are made, including your white blood cells. White blood cells fight off infections.
There are lots of different types of white blood cells. One type is called plasma cells. Plasma cells make antibodies, which are proteins that help your body recognize and attack germs, such as viruses and bacteria.
With multiple myeloma, abnormal plasma cells are made in your bone marrow. They start to multiply (make more plasma cells) uncontrollably. These abnormal, cancerous plasma cells are called myeloma cells.
Myeloma cells take up too much space in your bone marrow, which means there is less space for healthy blood cells to be made. The myeloma cells also damage your bones. This causes your bones to release calcium into your blood, which makes your bones weak.
What Ninlaro does
Ninlaro works by reducing the amount of myeloma cells in your bone marrow. The drug targets a specific protein, called a proteasome, inside the myeloma cells.
Proteasomes break down other proteins that cells no longer need, as well as proteins that are damaged. Ninlaro attaches to the proteasomes and stops them from working properly. This leads to a buildup of damaged and unneeded proteins in the myeloma cells, which causes the myeloma cells to die.
How long does it take to work?
Ninlaro starts working inside your body as soon as you start taking it. But it will take a while to build up effects that can be noticed, such as improvements in your symptoms or lab test results.
In a clinical study, people with multiple myeloma took Ninlaro (in combination with lenalidomide and dexamethasone). Half of these people saw an improvement in their condition within about a month of when they started taking Ninlaro.
Ninlaro hasn't been studied in pregnant women. However, the way Ninlaro works inside your body is expected to be harmful to a developing pregnancy.
In animal studies, the drug caused harm to fetuses when given to pregnant animals. While animal studies don't always predict what will happen in humans, these studies suggest that the drug may harm a human pregnancy.
If you're pregnant, or may become pregnant, talk with your doctor the risks and benefits of taking Ninlaro.
Because Ninlaro could harm a developing pregnancy, it's important to use birth control while you're taking this drug.
Birth control for women
If you're a female who's able to become pregnant, you should use effective birth control while you're taking Ninlaro. You should continue using birth control for at least 90 days after you've stopped taking Ninlaro.
Ninlaro is taken in combination with lenalidomide and dexamethasone for multiple myeloma treatment. Dexamethasone can make hormonal birth control, including birth control pills, less effective to prevent pregnancy. If you're using hormonal birth control, you should also use a barrier contraceptive (such as condoms) as backup birth control.
Birth control for men
If you're a male who's sexually active with a female who could become pregnant, you should use effective birth control (such as condoms) while you're taking Ninlaro. This is important, even if your female partner is using contraception. You should continue using birth control for at least 90 days after your last dose of Ninlaro.
It's not known if Ninlaro passes into breast milk, or if it affects the way your body makes breast milk. You should avoid breastfeeding while you're taking Ninlaro. Don't breastfeed until at least 90 days after you've stopped taking Ninlaro.
Here are answers to some frequently asked questions about Ninlaro.
Is Ninlaro a type of chemotherapy?
No, Ninlaro isn't a type of chemotherapy. Chemotherapy works by killing cells in your body that are multiplying (making more cells) rapidly. This includes some healthy cells, as well as cancer cells. Because chemotherapy affects some of your healthy cells, it can have very serious side effects.
Ninlaro is a targeted therapy for multiple myeloma. Targeted therapies work on specific features in cancer cells that are different from those in healthy cells. Ninlaro targets certain proteins called proteasomes.
Proteasomes are involved in the normal growth and production of cells. These proteins are more active in cancer cells than in healthy cells. This means that when Ninlaro targets proteasomes, it affects myeloma cells more than it affects healthy cells.
Ninlaro can still affect healthy cells and can cause some serious side effects. However, in general, targeted therapies (such as Ninlaro) tend to cause fewer side effects than typical chemotherapy drugs.
Can I take Ninlaro before or after a stem cell transplant?
You might be able to. Ninlaro is approved for use in people who've had at least one other treatment for their multiple myeloma. This includes people who've had a stem cell transplant as treatment.
Stem cells are immature blood cells that are found in your blood and in your bone marrow. They can develop into all types of blood cells. A stem cell transplant is a treatment for multiple myeloma. It aims to replace the myeloma cells with healthy stem cells, which can then mature into healthy blood cells.
Current clinical guidelines include Ninlaro as a maintenance (long-term) treatment option to stop cancer cells from multiplying after you've had an autologous stem cell transplant. (In this procedure, your stem cells are collected from your own blood or bone marrow and given back to you in the transplant.) However, other drugs are preferred over Ninlaro in this case.
Current clinical guidelines also include Ninlaro as an option for the first drug treatment you have for your multiple myeloma, before you have a stem cell transplant. However, other drugs are also preferred over Ninlaro in this case. This would be an off-label use of Ninlaro. Off-label drug use is when a drug that's approved for one use is used to treat a different one that's not approved.
If I vomit after taking a dose, should I take another dose?
If you vomit after taking Ninlaro, don't take another dose of the drug that day. Just take your next dose when it's due on your dosing schedule.
If you frequently throw up while taking Ninlaro, talk with your doctor. They may prescribe medications to help reduce your nausea or give you tips on how to manage nausea during treatment.
Will I need lab tests while I'm taking Ninlaro?
Yes. While you're taking Ninlaro, you'll need to have blood tests regularly to monitor your blood cell levels and your liver function. During treatment, your doctor will check the following tests specifically:
- Platelet level. Ninlaro can lower your platelet level. If your level falls too low, you can have an increased risk of serious bleeding. Your doctor will check your platelet counts regularly, so that if problems are found, they can be addressed quickly. If your levels are low, your doctor may reduce your dosage of Ninlaro or have you stop taking Ninlaro until your platelets return to a safe level. Sometimes, you may need a transfusion to receive platelets.
- White blood cell level. One of the drugs (called Revlimid) that you'll take with Ninlaro can lower your level of white blood cells, which can increase your risk of getting infections. If you have low levels of these cells, your doctor may reduce your dosage of Revlimid and Ninlaro, or have you stop taking the drugs, until your white blood cells return to a safe level.
- Liver function tests. Ninlaro can sometimes damage your liver, causing liver enzymes to be released into your blood. Liver function tests check your blood for these enzymes. If the tests show that Ninlaro is affecting your liver, your doctor may lower your dosage of the drug.
- Other blood tests. You'll also have other blood tests to check how well your multiple myeloma is responding to treatment with Ninlaro.
Before taking Ninlaro, talk with your doctor about your health history. Ninlaro may not be right for you if you have certain medical conditions. These include:
- Kidney problems. If your kidney function is severely impaired, or if you're having hemodialysis treatments for kidney failure, your doctor will prescribe a lower dosage of Ninlaro for you.
- Liver problems. Ninlaro may cause liver problems. And if you have liver damage, taking Ninlaro may worsen your condition. If you have moderate to severe liver problems, your doctor will prescribe a lower dosage of Ninlaro for you.
- Pregnancy. If you're pregnant or may become pregnant, Ninlaro could be harmful to your pregnancy. If you or your partner are able to become pregnant, you should use birth control while taking Ninlaro. For more information, please see the "Ninlaro and pregnancy" and the "Ninlaro and birth control" sections above.
Note: For more information about the potential negative effects of Ninlaro, see the "Ninlaro side effects" section above.
Taking more than the recommended dosage of Ninlaro can lead to serious side effects. For a list of possible side effects caused by Ninlaro, please see the "Ninlaro side effects" section above.
Symptoms of an overdose may include an increase in any of the possible side effects of Ninlaro. For a list of possible side effects, please see the "Ninlaro side effects" section above.
What to do in case of overdose
If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
When you get Ninlaro from the pharmacy, the pharmacist will add an expiration date to the label on the medication package. This date is typically one year from the date they dispensed the medication. Don't take Ninlaro if the printed expiration date has passed.
The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.
How long a medication remains good can depend on many factors, including how and where you store the medication.
Ninlaro capsules should be kept in their original packaging. Store them at room temperature away from light. Ninlaro shouldn't be stored at a temperature higher than 86°F (30°C).
Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.
If you no longer need to take Ninlaro and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.
The following information is provided for clinicians and other healthcare professionals.
Ninlaro is approved to treat multiple myeloma, used in combination with lenalidomide and dexamethasone, in adults who have had at least one other treatment for the condition.
The safety and efficacy of Ninlaro have not been established in children.
Mechanism of action
Ninlaro contains ixazomib, a proteasome inhibitor. Proteasomes have a central role in breaking down proteins that are involved in cell cycle regulation, DNA repair, and apoptosis. Ixazomib binds to and inhibits the activity of the beta 5 subunit of the 20S core part of the 26S proteasome.
By disrupting proteasome activity, ixazomib causes a buildup of excess or damaged regulatory proteins inside the cell, resulting in cell death.
Proteasome activity is increased in malignant cells compared to healthy cells. Multiple myeloma cells are more susceptible to the effects of proteasome inhibitors than healthy cells.
Pharmacokinetics and metabolism
The mean bioavailability of ixazomib is 58% after oral administration. Bioavailability is reduced when the drug is taken with a high-fat meal. In this case, the area under the curve (AUC) of ixazomib is decreased by 28%, and its maximum concentration (Cmax) is decreased by 69%. Therefore, ixazomib should be administered on an empty stomach.
Ixazomib is 99% bound to plasma proteins.
Ixazomib is primarily cleared by hepatic metabolism involving multiple CYP enzymes and non-CYP proteins. The majority of its metabolites are excreted in the urine, with some excreted in the feces. Terminal half-life is 9.5 days.
Moderate to severe hepatic impairment increases mean ixazomib AUC by 20% more than the mean AUC that occurs with normal hepatic function.
Mean ixazomib AUC is increased by 39% in people with either severe renal impairment or end stage renal disease that requires dialysis. Ixazomib is not dialyzable.
Clearance is not significantly affected by age, sex, race, or body surface area. Studies of Ninlaro included people ages 23 to 91 years, and those with body surface areas ranging from 1.2 to 2.7 m².
There are no contraindications for Ninlaro. However, treatment-related toxicities such as neutropenia, thrombocytopenia, hepatic impairment, skin rash, or peripheral neuropathy may require interruption of treatment.
Ninlaro capsules should be stored in their original packaging at room temperature. They should not be stored at temperatures higher than 86°F (30°C).
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.