Ixazomib

Ixazomib is a prescription medication indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

• Ixazomib is available under the following different brand names: Ninlaro

Common side effects of Ixazomib include:

• diarrhea
• constipation
• low levels of platelets in the blood (thrombocytopenia)
• low levels of white blood cells (neutropenia)
• weakness/numbness/pain in the hands and feet
• nausea
• swelling in the hands and feet
• vomiting
• back pain
• rash
• eye disorders including dry eye, blurred vision, and conjunctivitis

Serious side effects of Ixazomib include:

• thrombocytopenia
• diarrhea

Rare side effects of Ixazomib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 2.3 mg
• 3 mg
• 4 mg

Multiple Myeloma

Adult dosage

• Starting doses
  • Ixazomib: 4 mg orally on days 1, 8, and 15 of a 28-day cycle; take 1 hr before meals or 2 hr after meals.
  • Lenalidomide: 25 mg orally on days 1-21 of a 28-day cycle; take with or without food.
  • Dexamethasone: 40 mg orally in the morning on days 1, 8, 15, and 22 of a 28-day cycle

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ixazomib has severe interactions with no other drugs
• Ixazomib has serious interactions with at least 28 other drugs
• Ixazomib has moderate interactions with the following drugs:
  • belzutifan
  • cenobamate
  • elagolix
  • encorafenib
  • fedratinib
  • lenacapavir
  • lorlatinib
  • rucaparib
  • siponimod
  • stiripentol
  • tazemetostat
  • tecovirimat
• Ixazomib has minor interactions with at least 26 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ixazomib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ixazomib?”

Cautions

• Cases, sometimes fatal, of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), reported; monitor for signs and symptoms of TTP/HUS; if TTP/HUS is suspected, stop therapy, and evaluate; if TTP/HUS is excluded, consider restarting therapy; safety of reinitiating therapy in patients previously experiencing TTP/HUS not known
• Thrombocytopenia reported with platelet nadirs typically occurring between days 14 and 21 of each 28-day cycle and recovery to baseline by the start of the next cycle; monitor platelet counts at least monthly during treatment; consider more frequent monitoring during the first 3 cycles
• Diarrhea, constipation, nausea, and vomiting reported, occasionally requiring the use of antidiarrheals, antiemetics, and supportive care
• Peripheral neuropathy reported; monitor for symptoms; new or worsening peripheral neuropathy may require dose modification
• Peripheral edema reported; evaluate for underlying causes and provide supportive care, as necessary; adjust dosing of dexamethasone per its prescribing information or ixazomib for Grade 3 or 4 symptoms
• Cutaneous reactions reported, including maculopapular and macular rash; manage with supportive care or with dose modification if Grade ≥2; Stevens-Johnson syndrome, including a fatal case, reported; discontinue therapy if Stevens-Johnson syndrome occurs and manage as clinically indicated
• Rare occurrence of drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic, and hepatotoxicity reported; monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms
• Herpes zoster infection reported; consider antiviral prophylaxis during therapy to decrease the risk of herpes zoster reactivation
• Can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals
• Maintenance treatment for multiple myeloma in clinical trials resulted in increased deaths; therefore, not recommended for maintenance treatment outside of controlled trials
• Drug interaction overview
  • Substrate of CYP3A4
    • Strong CYP3A4 inducers
    • Avoid coadministration.
  • Rifampin (a strong CYP3A4 inducer) decreased ixazomib Cmax by 54% and AUC by 74%

Pregnancy and Lactation

• Can cause fetal harm when administered to a pregnant woman
• There are no human data available regarding the potential effect of ixazomib on pregnancy or the development of the embryo or fetus
• Contraception
  • Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated
  • Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following the final dose
  • Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters; because the drug is administered with dexamethasone, consider the risk for reduced efficacy of contraceptives; advise women using hormonal contraceptives to also use a barrier method of contraception
• Lactation
  • No data are available in human milk; the effects of the drug on breastfed infants, or on milk production; because the potential for serious adverse reactions from the drug in breastfed infants is unknown, advise nursing women not to breastfeed during treatment and for 90 days after last dose