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Important Safety Information Prescribing Information

Dosing

DOSING

NINLARO® (ixazomib) regimen* dosing

Consider an all-oral PI-based regimen your patients can take at home1,7,8
NINLARO� (ixazomib) Dosing Calendar
  • NINLARO is administered orally on days 1, 8, and 15 of a 28-day cycle.
  • Lenalidomide is administered orally on days 1-21 of a 28-day cycle.
  • Dexamethasone 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 dexamethasone
  • A 3-mg starting dose is recommended for patients with moderate or severe hepatic impairment and patients with severe renal impairment or end-stage renal disease requiring dialysis. A 2.3-mg dose is also available for subsequent dose reductions due to ARs
  • *The NINLARO regimen includes NINLARO+lenalidomide+dexamethasone.


Treatment should be continued until disease progression or unacceptable toxicity.

DOSING CONSIDERATIONS

  • 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 THERAPY

  • Absolute neutrophil count should be at least 1000/mm3
  • Platelet count should be at least 75,000/mm3. Monitor platelet counts at least monthly during treatment with NINLARO
  • Nonhematologic toxicities should, at the physician's discretion, generally be recovered to patient's baseline condition or grade 1 or lower

Please refer to the accompanying NINLARO full Prescribing Information for dose modification guidelines for hematologic and nonhematologic toxicities, as well as dose reduction instructions for patients with hepatic or renal impairment.

TO HELP YOUR PATIENTS STAY ON TRACK WITH THEIR TREATMENT SCHEDULE, DOWNLOAD THE TREATMENT CALENDAR.

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Dose modification guidelines

DOSE MODIFICATION GUIDELINES FOR THE NINLARO® (ixazomib) REGIMEN

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 NonHematologic 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.
  • †Grading based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.
  •  G-CSF=granulocyte-colony stimulating factor.

Storage and handling of NINLARO® (ixazomib)


Storage

  • 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 disposal

  • 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 the 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 is available in the following capsule strengths*:

NINLARO� (ixazomib) capsules: 2.3 mg, 3 mg, 4 mg
  • *Not actual capsule size.