Dosing & Administration for NINLARO® (ixazomib)
NINLARO is taken as part of a triplet oral therapy—an all-oral PI-based regimen.1
NINLARO (ixazomib) REGIMEN* DOSING SCHEDULE
An all-oral, PI-based regimen your patients can take at home1-3
Dosing Schedule1
A NINLARO (ixazomib) dose is administered orally on days 1, 8, and 15 of a 28-day cycle.
A lenalidomide dose is administered orally on days 1-21 of a 28-day cycle.
A dexamethasone dose is administered orally on days 1, 8, 15, and 22 of a 28-day cycle.
Please note that there is NO DOSING on days 23-28.
- Advise patients to take NINLARO once a week on the same day and at approximately the same time for the first 3 weeks of a 4-week cycle. The importance of carefully following all dosage instructions should be discussed with patients starting treatment. Advise patients to take the recommended dosage as directed because overdosage has led to deaths
- The recommended starting dose of NINLARO is 4 mg (one capsule) in combination with lenalidomide and dexamethasone1
- A 3 mg starting dose is recommended for patients with moderate or severe hepatic impairment and patients with severe renal impairment or ESRD requiring dialysis. A 2.3 mg dose is also available for subsequent dose reductions due to ARs1
*The NINLARO regimen includes NINLARO + lenalidomide + dexamethasone.1
AR=adverse reaction; ESRD=end-stage renal disease; PI=proteasome inhibitor.
Available NINLARO (ixazomib) strengths1
A 4 mg starting NINLARO (ixazomib) dose is recommended in combination with lenalidomide and dexamethasone. NINLARO is available in the following capsule strengths1*:
The recommended starting NINLARO (ixazomib) dose is 4 mg (one capsule).1
A 3 mg starting NINLARO (ixazomib) dose is recommended for patients with moderate or severe hepatic impairment and patients with severe renal impairment or ESRD requiring dialysis.1
A 2.3 mg NINLARO (ixazomib) dose is also available for subsequent dose reductions due to ARs.1
*Not actual capsule size.
ARs=adverse reactions; ESRD=end-stage renal disease.
NINLARO Packaging Instructions
- All 3 NINLARO capsules required for a 28-day cycle1 can be accessed in a single blister pack
- The single blister pack offers simplicity for patients when it is time to access their NINLARO dose
- The compact package size allows for efficent storage of the NINLARO treatment at home and at pharmacies
- The minimalistic design reduces packaging waste and decreases NINLARO's carbon footprint
Instructions for patients taking NINLARO on the go1
Share this helpful video with your patients so they can better understand how to take NINLARO at home or on the go.1
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Narration
Tips for taking NINLARO at home or on the go. Please see NINLARO important safety information at the end of this video.
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NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.
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NINLARO should not be used to treat the following people unless they are participants in a controlled clinical trial: People who are receiving maintenance treatment, or people who have been newly diagnosed with multiple myeloma. It is not known if NINLARO is safe and effective in children.
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NINLARO is available in three doses. Your healthcare provider will determine the right NINLARO dose for you. Contact your healthcare provider if you have any questions about dosing.
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Always keep the NINLARO package closed. This prevents the medication card from sliding out of the sleeve.
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Only open the package when you are ready to take your medication.
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Follow these simple steps when you are ready to take your medication. Make sure that the blister pack is pushed all the way into the sleeve to help with the release.
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Step 1. Press in on the package with your thumb and hold, to release the locking mechanism.
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Step 2. While pressing and holding the button with your thumb, pull out the blister pack using your free hand.
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To access the NINLARO capsule, gently press on the blue tab to puncture the foil and remove the capsule.
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Use the calendar reminder on the medication box to record when you have taken your NINLARO doses.
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Remember to read these important reminders for taking NINLARO which can be found on the underside of the flap of the medication box.
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Remember to also read the NINLARO package insert fully before taking your medication.
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NINLARO is taken in cycles. Each cycle lasts 4 weeks or 28 days.
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Take the NINLARO dose once per week for the first 3 weeks of a 4-week cycle. Take NINLARO on the same day each week at roughly the same time. Refer to the patient information in the package insert for more information on how to take NINLARO in combination with REVLIMID and dexamethasone.
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Missed a dose? If a dose is missed or you are delayed in taking a dose of NINLARO, you can take the missed dose as long as the next scheduled one is more than 3 days away. Do not take a missed dose of NINLARO if it is within 3 days or 72 hours of your next scheduled dose.
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Store your NINLARO medication at room temperature. Do not store your medication above 86 degrees Fahrenheit or 30 degrees Celsius, and do not freeze.
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Keep your NINLARO medication out of the reach of children, and ask your pharmacist or healthcare team how to dispose of any unused medication.
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Always store NINLARO medication in its original packaging, and do not put your NINLARO medication in a pill box.
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The NINLARO capsule should be taken by mouth on an empty stomach at least 1 hour before, or 2 hours after ingesting food.
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Swallow the capsule whole with water. And wash your hands with soap and water after you have taken your medication.
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Do not crush, chew, or open the capsule. Also remember not to remove the capsule from its original packaging until time of consumption. If you accidentally get powder from the NINLARO capsule on your skin, wash the area well with soap and water. If you accidentally get powder from the NINLARO capsule in your eyes, flush your eyes well with water.
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NINLARO may cause serious side effects. For more information, see the important safety information for NINLARO at the end of this video. If you experience any side effects, make sure to report these to your healthcare provider straight away.
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Refer to the patient information in the package insert for more information on how to take NINLARO in combination with REVLIMID and dexamethasone. You can also speak to your healthcare provider for more information.
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NINLARO is a treatment that allows lifestyle flexibility.
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The NINLARO regimen offers the convenience and simplicity of an all-oral regimen and offers flexibility to fit in with everyday life.
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"It's just the freedom to be able to conduct your life more independently and on your own. If I want to go somewhere today, I can go there and I can take this oral pill with me if I hadn't taken it yet." A quote from Joe, a real patient taking the all-oral NINLARO regimen.
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With the NINLARO regimen you can take your treatment without disrupting your daily activities.
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At home, or on the go.
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Narration
What is NINLARO? NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma. NINLARO should not be used to treat the following people, unless they are participants in a controlled clinical trial. People who are receiving maintenance treatment, or people who have been newly diagnosed with multiple myeloma. It is not known if NINLARO is safe and effective in children.
Important safety information for NINLARO (ixazomib). NINLARO may cause serious side effects, including: Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising. Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms.
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Nerve problems are common with NINLARO and may also be severe. Tell your healthcare provider if you get any new or worsening Symptoms including: tingling, numbness, pain, a burning feeling in your feet or hands, or weakness in your arms or legs. Swelling is common with NINLARO and can sometimes be severe. Tell your healthcare provider if you develop swelling in your face, arms, hands, legs, ankles, or feet, or if you gain weight from swelling. Skin reactions. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores. Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination. Liver problems. Tell your healthcare provider if you get these signs of a liver problem: yellowing of your skin or the whites of your eyes; pain in your right upper stomach-area (abdomen).
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Other common side effects of NINLARO include low white blood cell counts (neutropenia) and bronchitis. Tell your healthcare provider if you get new or worsening signs or symptoms of the following during treatment with NINLARO: skin rash and pain (shingles) due to reactivation of the chicken pox virus, (herpes zoster); blurred vision or other changes in your vision, dry eye, and pink eye (conjunctivitis).
These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to Takeda at 1-844-217-6468; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Before taking NINLARO, tell your healthcare provider about all your medical conditions, including if you: have liver problems; have kidney problems or are on dialysis; are pregnant or plan to become pregnant. NINLARO can harm your unborn baby. Females who are able to become pregnant: Avoid becoming pregnant during treatment with NINLARO; Your healthcare provider will do a pregnancy test before you start treatment with NINLARO; You should use effective non-hormonal birth control during treatment and for 90 days after your last dose of
NINLARO. If using hormonal contraceptives (for example, birth control pills), you should also use an additional barrier method of contraception (for example, diaphragm or condom). Talk to your healthcare provider about birth control methods that may be right for you during this time; Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with NINLARO.
Males with female partners who are able to become pregnant: You should use effective birth control during treatment and for 90 days after your last dose of NINLARO; Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant while you are being treated with NINLARO. Are breastfeeding or plan to breastfeed. It is not known if NINLARO passes into breast milk, if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with NINLARO and for 90 days after your last dose of NINLARO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before starting any new medicines during treatment with NINLARO. Taking too much NINLARO (overdose) can cause serious side effects, including death. If you take more NINLARO than instructed by your healthcare provider, call your healthcare provider right away or go to the nearest hospital emergency room right away. Take your medicine pack with you. Please see Patient Information in the NINLARO (ixazomib) full prescribing information.
DOSAGE MODIFICATION GUIDELINES1
Thrombocytopenia
Platelet count <30,000/mm3
- Withhold NINLARO and lenalidomide until platelet count is at least 30,000/mm3
- Following recovery, resume lenalidomide at the next lower dose according to its Prescribing Information and resume NINLARO at its most recent dose
If platelet count falls to <30,000/mm3 again
- Withhold NINLARO and lenalidomide until platelet count is at least 30,000/mm3
- Following recovery, resume NINLARO at the next lower dose and resume lenalidomide at its most recent dose*
Neutropenia
Absolute neutrophil count <500/mm3
- Withhold NINLARO and lenalidomide until absolute neutrophil count is at least 500/mm3. Consider adding G-CSF as per clinical guidelines
- Following recovery, resume lenalidomide at the next lower dose according to its Prescribing Information and resume NINLARO at its most recent dose
If absolute neutrophil count falls to <500/mm3 again
- Withhold NINLARO and lenalidomide until absolute neutrophil count is at least 500/mm3
- Following recovery, resume NINLARO at the next lower dose and resume lenalidomide at its most recent dose*
Rash
Grade† 2 or 3
- Withhold lenalidomide until rash recovers to grade 1 or lower
- Following recovery, resume lenalidomide at the next lower dose according to its Prescribing Information
If grade 2 or 3 rash occurs again
- Withhold NINLARO and lenalidomide until rash recovers to grade 1 or lower
- Following recovery, resume NINLARO at the next lower dose and resume lenalidomide at its most recent dose*
Grade 4
- Discontinue treatment regimen
Peripheral Neuropathy
Grade 1 with pain or grade 2
- Withhold NINLARO until peripheral neuropathy recovers to grade 1 or lower without pain or patient's baseline
- Following recovery, resume NINLARO at its most recent dose
Grade 2 with pain or grade 3
- Withhold NINLARO. Toxicities should, at the physician's discretion, generally recover to patient's baseline condition or grade 1 or lower prior to resuming NINLARO
- Following recovery, resume NINLARO at the next lower dose
Grade 4
- Discontinue treatment regimen
Other non-hematologic toxicities
Grade 3 or 4
- Withhold NINLARO. Toxicities should, at the physician's discretion, generally recover to patient's baseline condition or grade 1 or lower prior to resuming NINLARO
- If attributable to NINLARO, resume NINLARO at the next lower dose following recovery
*For additional occurrences, alternate dose modification of lenalidomide and NINLARO.1
†Grading based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.1
G-CSF=granulocyte-colony stimulating factor.
NINLARO (ixazomib) DOSING1
- NINLARO should be taken once a week on the same day and at approximately the same time for the first 3 weeks of a 4-week cycle
- NINLARO should not be taken with food. Food may interfere with the absorption of NINLARO, which may lower levels of the medication in the blood and possibly reduce effectiveness
- NINLARO should be taken on an empty stomach or at least 1 hour before or at least 2 hours after food
- NINLARO should not be taken at the same time as dexamethasone because dexamethasone should be taken with food
- No body surface area dosing is required
- NINLARO should be swallowed whole with water and should not be crushed, chewed, or opened
- If a NINLARO dose is delayed or missed, the dose should be taken only if the next scheduled dose is at least 72 hours away. A double dose should not be taken to make up for the missed dose
- If vomiting occurs after taking a dose, the patient should not repeat the dose. The patient should resume dosing at the time of the next scheduled dose
Antiviral prophylaxis should be considered in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation.
CONSIDERATIONS PRIOR TO INITIATING A NEW CYCLE OF THERAPY1
- Absolute neutrophil count should be at least 1000/mm3
- Platelet count should be at least 75,000/mm3
- Nonhematologic toxicities should, at the healthcare provider’s discretion, generally be recovered to patient’s baseline condition or grade 1 or lower
Please refer to the NINLARO full Prescribing Information for dosage modification guidelines for hematologic and nonhematologic toxicities, as well as dose reduction instructions for patients with hepatic or renal impairment.
STORAGE AND HANDLING FOR NINLARO® (IXAZOMIB)
Storage1
- NINLARO may be stored at room temperature. Do not store above 30°C (86°F). Do not freeze
- Store capsules in original packaging until immediately prior to use
Handling and Disposal1
- NINLARO is cytotoxic. Capsules should not be opened or crushed. Direct contact with the capsule contents should be avoided
- In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes
- If contact occurs with the skin, wash thoroughly with soap and water
- If contact occurs with the eyes, flush thoroughly with water
- Any unused medicinal product or waste material should be disposed in accordance with local requirements
NINLARO patient management
Find resources and information to help you manage patients starting the NINLARO regimen.
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