DOSING

Convenient oral administration

Consider the advantages of an oral PI-based regimen* for your long-term treatment plan
NINLARO® (ixazomib) - Dosing Schedule
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  • 3-mg starting dose recommended for:
    • Patients with moderate or severe hepatic impairment
    • Severe renal impairment or end-stage renal disease requiring dialysis

Treatment should be continued until disease progression or unacceptable toxicity.


Prior to initiating a new cycle of therapy:

  • Do a complete blood count (CBC) and ensure:
    • Absolute neutrophil count (ANC) ≥1000/mm3
    • Platelet count ≥75,000/mm3
  • Nonhematologic toxicities are generally recovered to patient's baseline condition or grade 1 or lower

Patient Counseling information

  • Take NINLARO on the same day each week at approximately the same time
  • Take NINLARO on an empty stomach ≥1 hour before or ≥2 hours after food
    • NINLARO and dexamethasone should not be taken at the same time
  • The whole NINLARO capsule should be swallowed with water
    • The capsule 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 ≥72 hours away
    • A double dose should not be taken to make up for a missed dose
  • If vomiting occurs, the patient should not repeat the dose. The patient should resume dosing at the time of the next scheduled dose
Concomitant medications may be given for prophylaxis and/or management of symptoms
NINLARO® (ixazomib) - Concomitant Medications
Sample schedule of the NINLARO dosing regimen
NINLARO® (ixazomib) - Dosing Regimen
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone.
  • Defined as treatment to progression or unacceptable toxicity.
  • Dexamethasone is taken on days 1, 8, 15, and 22 of a 28-day treatment cycle.
  • §NINLARO is taken on days 1, 8, and 15 of a 28-day treatment cycle.
  • ||Lenalidomide is taken daily on days 1 through 21 of a 28-day treatment cycle.

Dose modification guidelines

DOSE MODIFICATION GUIDELINES FOR THE NINLARO® (ixazomib) REGIMEN

Thrombocytopenia

Platelet count less than 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 less than 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 less than 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 less than 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
  • *For additional occurrences, alternate dose modification of lenalidomide and NINLARO.
  • Grading based on National Cancer Institute Common Terminology Criteria 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
NINLARO® (ixazomib) - Packaging

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 strengths:

NINLARO® (ixazomib) - 2.3 mg Dose 3 mg Dose 4 mg Dose