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Important Safety Information Prescribing Information



Setting expectations for your patients

Current multiple myeloma strategies are moving toward a long-term treatment approach11-14

  • Although multiple myeloma is not curable, it is treatable15
  • Multiple myeloma is a complex disease characterized by periods of remission and relapse16
  • Extending the remission period/delaying the disease from progressing is an important treatment goal11,17

When speaking with your patients, identify factors that may play an important role in selecting treatment

Some considerations are:

Treatment considerations: patient/disease characteristics and lifestyle factors

Help set expectations with your patients

  • Establish and reinforce treatment and lifestyle goals
  • Explain potential adverse reactions at the start
  • Emphasize the need to take their medicines as prescribed

Managing patients receiving treatment with NINLARO® (ixazomib)

NINLARO is an effective,* sustainable therapy for your patients' long-term treatment plan9

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

Before patients begin treatment with NINLARO, identify any medical conditions, including whether or not the patients:

  • Have hepatic impairment
  • Have renal impairment or are on dialysis
  • Are pregnant or plan to become pregnant. Patients should use effective birth control during treatment and for 90 days after the final dose of NINLARO. If patients are using hormonal contraceptives (for example, the pill), an additional barrier method of contraception (for example, diaphragm or condom) must be used
  • Are breastfeeding or plan to breastfeed. It is not known if NINLARO passes into breast milk. Patients should not breastfeed during treatment with NINLARO and for 90 days after their final dose of NINLARO

Ask your patients about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure that patients speak with their healthcare provider before starting any new medicines during treatment with NINLARO.

For more information on managing patients receiving NINLARO, see dose modifications.

  • *Median PFS: 20.6 months with the NINLARO regimen vs 14.7 months with the placebo regimen; HR=0.74 (95% CI, 0.59-0.94); P=0.012.1,2
  • Discontinuation rates of the placebo regimen and the NINLARO regimen were 11% and 13%, respectively; 80% of patients continued at the starting dose of NINLARO without dose reduction.9
  • Defined as treatment to disease progression or unacceptable toxicity.

Use the following patient-friendly information to educate your patients about side effects with NINLARO

  • Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. Consider platelet transfusions if counts are too low. Speak with patients about the low platelet counts, including bleeding and easy bruisings
  • Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Ask patients to call you if they get any of these symptoms and these symptoms do not go away during treatment with NINLARO. Tell your patients that you may prescribe medicine to help treat their symptoms
  • Nerve problems are common with NINLARO and may also be severe. Ask patients to tell you if they get any new or worsening symptoms including: tingling, numbness, pain, a burning feeling in their feet or hands, or weakness in their arms or legs
  • Swelling is common with NINLARO and can sometimes be severe. Ask patients to tell you if they develop swelling in their arms, hands, legs, ankles, or feet, or if they gain weight from swelling
  • Skin reactions. Ask patients to tell you if they get a new or worsening rash
  • Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your patients' kidneys, brain, and other organs, and may lead to death. Tell your patients to get medical help right away if they get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination
  • Liver problems. Ask patients to tell you if they get these signs of a liver problem: yellowing of their skin or the whites of their eyes; pain in their right upper-stomach area

Other common side effects have occurred. Ask your patients to inform you if they get a new or worsening back pain, skin rash and pain (shingles) as a result of reactivation of the chicken pox virus (herpes zoster), lowered white blood cells (neutropenia) that may increase the risk of infection, or vision conditions including blurred vision, dry eye, and pink eye (conjunctivitis).

These are not all the possible side effects of NINLARO. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at 1-800-FDA-1088.

Help manage patients if a side effect occurs with NINLARO treatment

  1. IDENTIFY AND REPORT: Identify the adverse reaction, determine if it's a result of the treatment or the disease, and report as required
  2. ASSESS: Use appropriate diagnostic and physical evaluations to monitor the severity of the symptom
  3. MANAGE: Implement the appropriate pharmacologic or nonpharmacologic intervention

For information on dose modification guidelines for thrombocytopenia, neutropenia, PN, rash, and other nonhematologic toxicities, click here.

Speaking with your patients about NINLARO® (ixazomib) administration

Counsel patients on how to take NINLARO

How to take NINLARO® (ixazomib): Dos and Don'ts

Per the clinical trial for NINLARO, talk to your patients about the importance of remaining on therapy until disease progression or unacceptable toxicity

Factors that may impact patient adherence include19,20:

  • Poor communication between patient and healthcare team
  • Patient belief that the drugs were not needed or not working
  • Side effects