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Treatment Name: IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone)

IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone) is a Chemotherapy Regimen for Multiple Myeloma (MM)

How does IRd chemotherapy work?
Each of the medications in the IRd chemo regimen are designed to kill or slow the growth of multiple myeloma cells.

I – Ixazomib (Ninlaro®)
R – Revlimid® (lenalidomide)
d - dexamethasone

Goals of therapy:
IRd is given to slow the progression and decrease symptoms of multiple myeloma and is not commonly given with the goal of cure.

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Schedule

Common IRd starting doses:

  • Ixazomib (Ninlaro®) 4 mg oral capsule by mouth on Days 1, 8, and 15
    • Take on empty stomach (at least one hour before food or two hours after) at approximately the same time of day each week
    • Ixazomib is taken once weekly for three weeks, then no dose for the fourth week
  • Lenalidomide (Revlimid®) 25 mg oral capsule by mouth once daily for 21 consecutive days, followed by 7 days off (no doses)
    • For patients with kidney problems, lenalidomide may be lowered to 10 mg once daily for 21 consecutive days, followed by 7 days off (no doses)
  • Dexamethasone 40 mg (ten 4 mg tablets) by mouth once daily on Days 1, 8, 15, and 22
    • Take with food to lessen chance of experiencing stomach upset

Lenalidomide is a human teratogen. In order to decrease the risk of embryo-fetal (pregnancy) exposure, lenalidomide is available only through a restricted distribution program (Revlimid® REMS).

Ixazomib, lenalidomide, and dexamethasone are all usually taken at home. Ixazomib and dexamethasone should not be taken at the same time because ixazomib should be taken on an empty stomach and dexamethasone should be taken with food.

IRd is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

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Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects of IRd are shown here:

  • Diarrhea (45%)
  • Rash (36%)
  • Constipation (35%)
  • Low white blood cells [neutropenia] (33%)
  • Low platelets [thrombocytopenia, increased bleeding risk] (31%)
  • Low red blood cells [anemia] (29%)
  • Fatigue (29%)
  • Nausea (29%)
  • Swelling in arms or legs (28%)
  • Pain or tingling feeling in fingers or toes (27%)
  • Back pain (24%)
  • Vomiting (23%)
  • Sinus infection (23%)
  • Sore throat (22%)
  • Trouble sleeping (20%)
  • Muscle spasms (18%)
  • Abnormal heart rhythm (16%)
  • Blood clot (8%)
  • Decreased liver function (7%)
  • Increased blood pressure [HYPERtension] (6%)
  • Decreased blood pressure [HYPOtension] (6%)

On average, 17% of patients discontinue treatment due to unacceptable side effects.

  • In the clinical study, roughly 1 in 5 patients taking IRd received antidiarrheal medications (primarily loperamide) to help manage loose stools, and 1 in 5 patients received medications used to prevent or treat nausea

  • In the clinical study, roughly 1 in 12 patients taking IRd received a platelet transfusion to prevent bleeding. The platelet count usually reaches its lowest level between Days 14 and 21 of each Cycle

  • Patients who develop a rash from IRd usually experienced the rash within the first 3 months, which then would often go away on its own. If treatment was needed patients used cetirizine (Zyrtec®), a topical steroid cream such as hydrocortisone, or a dose adjustment of the IRd drugs

Side effect videos Side Effect Videos
DiarrheaDiarrheaConstipationConstipationBleedingBleedingAnemiaAnemiaFatigue Fatigue Nausea and VomitingNausea and VomitingPainPainBlood ClotsBlood Clots

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), common multiple myeloma labs, plus any others your doctor may order. The platelet count (found in a CBC) is usually measured monthly, or more often during the first three cycles as needed.

How often is imaging needed?
Imaging may be checked before treatment and then periodically during treatment to assess how the chemotherapy is working. Imaging may include: bone surveys, X-rays, computerized tomography (CT) scans, magnetic resonance imaging (MRI), or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results of blood tests, rash, or presence of other side effects, your doctor may advise to:  continue IRd as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy. Your doctor may delay treatment and adjust the dose of ixazomib to decrease the risk of bleeding if the platelet count drops too low. 

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ChemoExperts Tips

  • Ixazomib and dexamethasone should NOT be taken together because dexamethasone should be taken with food and ixazomib should be taken without food (water is acceptable)
  • A medication to prevent blood clots is usually recommended for everyone receiving the IRd regimen. The exact medicine to prevent blood clots may differ from patient to patient and will be chosen by your doctor
  • Swelling is common when taking ixazomib. Tell your doctor if you develop swelling in your hands, legs, or feet, or if you gain weight as a result of swelling
  • Ixazomib can cause reactivation of herpes simplex virus (HSV) or varicella zoster virus (VZV). Prophylactic (preventative) anti-viral medications such as acyclovir (Zovirax®), valacyclovir (Valtrex®), or famciclovir (Famvir®) should be taken during treatment
  • Additional medications that may be prescribed include Bactrim® (Sulfamethoxazole/Trimethoprim; unless you have a sulfa allergy) to prevent Pneumocystis Pneumonia and omeprazole (Prilosec®, or a similar medication) to prevent ulcers from dexamethasone
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately. If you have unused ixazomib, talk to your pharmacist to find out the best way to dispose of it
  • Clinical trials may exist for multiple myeloma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone). Depending upon your income, they may be able to help cover the cost of:

  • Ixazomib
  • Lenalidomide
  • Dexamethasone

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with IRd (Ixazomib + Revlimid® (lena­lidomide) + dexametha­sone)

Individual Drug Label Information

Ixazomib (Ninlaro®)

  • Is an oral capsule available in blister packs containing 4 mg, 3 mg, or 2.3 mg capsules
  • Is usually taken without food (at least one hour before food or two hours after). Swallow capsules whole and do not crush, chew, or open
  • Food decreases absorption so it is best to take on an empty stomach to avoid a possible decrease in effectiveness
  • If you miss a dose, the dose can be taken if the next scheduled dose is more than three days (72 hours) away. Do not double a dose to make up for a missed dose. If you vomit after a dose, do not repeat the dose. Resume ixazomib when the next scheduled dose is due
  • Store ixazomib at room temperature (68°F to 77°F). Do not take out of original packaging until immediately before taking a dose
  • Dosage adjustments may be required for decreased liver function, decreased kidney function, low blood counts, rash, nerve pain, or other significant side effects
  • May interact with certain antifungal, antibacterial, seizure, or antiviral medications 
  • May interact with grapefruit and grapefruit juice, pomegranate, star fruit, or seville oranges (in marmalade) causing increased blood levels of ixazomib. This could increase your risk of experiencing side effects. Avoid eating or drinking these foods during treatment
  • May cause fetal harm if taken while pregnant. Men and women taking ixazomib should use an effective method of contraception during treatment and for 90 days after the last dose of ixazomib. If using hormonal contraception, it is recommended to use a barrier method of contraception as well to avoid becoming pregnant while taking ixazomib
General side effects from ixazomib (Ninlaro®)
  • Diarrhea or constipation
  • Rash
  • Low white blood cells, red blood cells, or platelets
  • Fatigue
  • Nausea or vomiting
  • Swelling in arms or legs
  • Tingling feeling in fingers or toes
  • Infection
  • Trouble sleeping
  • Blood clot
  • Liver injury
  • Eye problems, such as blurred vision or dry eye
  • Click on the ixazomib (Ninlaro®) package insert below for reported side effects, possible drug interactions, and other ixazomib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Lenalidomide (Revlimid®)

  • Lenalidomide is a capsule
  • Is not to be used during pregnancy; it may cause human embryo toxicity and birth defects. Females must avoid pregnancy while taking this and for 4 weeks after finishing therapy 
  • Is only available through the R.E.M.S. program, which is Risk Evaluation and Mitigation Strategy http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm 
  • Women should not breast feed while on this drug
  • Can cause severe low white blood cells and platelet cell counts. Patients who have “del 5q myelodysplastic syndromes” should have complete blood counts (CBC) monitored every week for the first eight weeks of treatment
  • Patients may require dose decreases and periodic stopping of doses for low blood cell counts, poor kidney function, or other reasons
  • Some patients may require growth factors to help stimulate blood cell production
  • Patients are at increased risk of blood clots in limbs (DVT- deep vein thrombosis) or lungs (PE- pulmonary embolism), as well as risk for heart attack and stroke.  A "blood thinner" such as aspirin or warfarin may be prescribed to decrease risk of clots
  • Is swallowed whole with or without food and with a large glass of water; take at the same time every day
  • If you miss a dose and it’s less than 12 hours late, take the dose.  If it’s more than 12 hours late skip the dose.  Do not take two doses at the same time
  • This capsule contains lactose.  Patients should advise their physician if they are lactose intolerant
  • Do not open capsules.  If powder from capsule touches skin, wash immediately with soap and water
  • Should be stored at controlled room temperature
  • May interact with digoxin, estrogen containing therapies, and erythropoietin
  • Has been linked to the development of other cancers in a small number of people
  • Do not donate blood during therapy and for one one month after completion of therapy
General Lenalidomide (Revlimid) Side Effects
  • Low while blood cells
  • Low platelet cells
  • Blood clots
  • Bleeding
  • Diarrhea
  • Constipation
  • Itching
  • Cough or shortness of breath
  • Skin rash
  • Pain
  • Nausea
  • Fatigue, dizziness
  • Muscle cramps
  • Low red blood cells
  • Swelling of arms and legs
  • Liver toxicity
  • Allergic reactions
  • Tumor Lysis Syndrome (TLS)
  • Click on the lenalidomide (Revlimid) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

Dexamethasone (Decadron®)

  • Dexamethasone is supplied as an oral tablet or oral liquid
  • Dexamethasone may increase the risk of infection. Depending upon how much dexamethasone is taken, antibiotics may be prescribed to help prevent infection
  • Should be taken with food and with a large glass of water to avoid stomach irritation or ulcers
  • Should be taken before 6 p.m. when possible, to avoid trouble falling asleep
  • May decrease the response to vaccines; vaccines may need to be repeated at a later date to obtain maximal response
  • If taken daily for several days or weeks, the dose of dexamethasone may need to be gradually decreased (tapered) to avoid withdrawal symptoms
  • If you miss a dose, take the next dose as soon as possible
  • Should be stored at room temperature
General Dexamethasone (Decadron) Side Effects
  • May cause high blood sugar, weight gain, irritability, high blood pressure, difficulty sleeping, stomach ulcers, bone loss, muscle weakness
  • Click on the dexamethasone (Decadron) package insert below for reported side effects and potential drug Interactions
See DailyMed package insert.

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References

1) Moreau P, Masszi T, Grzasko N, et al. Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2016;374(17):1621-1634.

Created: July 27, 2017 Updated: November 14, 2017

What is Multiple Myeloma (MM)?

Multiple Myeloma is a disease of the white blood cells, called plasma cells, found in the blood or bone marrow. Plasma cells are a type of white blood cell known as a B-lymphocyte.

Sometimes plasma cells form collections on bone and weaken or destroy it. These are known as "lytic lesions". Multiple Myeloma is a rare condition with an unknown cause. The stage can vary at diagnosis and throughout treatment. Staging is based on the international staging system (ISS). The type and effectiveness of the treatment may depend upon the stage.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a teratogen?

A drug that is known to cause severe birth defects or fetal death. These drugs should NOT be used during pregnancy and patients should avoid becoming pregnant while taking these drugs.
  • Women, if taking a teratogenic medication, should abstain from heterosexual intercourse or use two forms of reliable contraception at least 4 weeks prior to, during, and for 4 weeks after treatment
  • Males (even after vasectomy), if taking a teratogenic medication, must use a latex or synthetic condom during any sexual contact with women of childbearing potential and must not donate sperm for up to 28 days following discontinuation of therapy.

What is the Revlimid REMS program?

REMS stands for Risk Evaluation and Mitigation Strategy. This program requires that all patients must sign a Patient-Physician agreement form acknowledging pregnancy risks before starting treatment. If you are female who can get pregnant, you must have 2 negative pregnancy tests before starting Revlimid® and will have pregnancy tests performed periodically throughout treatment. Revlimid® is only dispensed from certain pharmacies and the pharmacy will contact you before every prescription is dispensed. A confidential survey must also be taken every month before Revlimid® can be dispensed.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What labs are used to monitor multiple myeloma?

Commonly used labs to diagnose and monitor for treatment response in patients with multiple myeloma may include:

  • Serum Protein ElectroPhoresis (SPEP)
  • Serum Immunofixation Electrophoresis (IFE)
  • Lactate DeHydrogenase (LDH)
  • Serum Free Light Chains (FLC)
  • Quantitative immunoglobulins
  • Beta 2-microglobulin (B2M)
  • Cytogenetic analysis (karyotyping and FISH testing)

Note: Some labs may not apply. In addition, some labs are checked only at diagnosis, while others are used to assess response to treatment.