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Ninlaro Dosage

Generic name: ixazomib citrate 4mg
Dosage form: capsule

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Dosing and Administration Guidelines

NINLARO in combination with lenalidomide and dexamethasone

The recommended starting dose of NINLARO is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.

The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 through 21 of a 28-day treatment cycle.

The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.

Table 1: Dosing Schedule for NINLARO taken with Lenalidomide and Dexamethasone ✔ Take medicine
28-Day Cycle (a 4-week cycle)
Week 1 Week 2 Week 3 Week 4
Day 1 Days 2-7 Day 8 Days 9-14 Day 15 Days 16-21 Day 22 Days 23-28
NINLARO
Lenalidomide ✔ Daily ✔ Daily ✔ Daily
Dexamethasone

For additional information regarding lenalidomide and dexamethasone, refer to their prescribing information.

NINLARO should be taken once a week on the same day and at approximately the same time for the first three weeks of a four week cycle. NINLARO should be taken at least one hour before or at least two hours after food [see Clinical Pharmacology (12.3)]. The whole capsule should be swallowed with water. The capsule should not be crushed, chewed or opened [see How Supplied/Storage and Handling (16.3)].

If a NINLARO dose is delayed or missed, the dose should be taken only if the next scheduled dose is ≥ 72 hours away. A missed dose should not be taken within 72 hours of the next scheduled dose. 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.

Prior to initiating a new cycle of therapy:

  • Absolute neutrophil count should be at least 1,000/mm3
  • Platelet count should be at least 75,000/mm3
  • Non-hematologic toxicities should, at the physician's discretion, generally be recovered to patient's baseline condition or Grade 1 or lower

Treatment should be continued until disease progression or unacceptable toxicity.

Dose Modification Guidelines

The NINLARO dose reduction steps are presented in Table 2 and the dose modification guidelines are provided in Table 3.

Table 2: NINLARO Dose Reductions due to Adverse Reactions
*
Recommended starting dose of 3 mg in patients with moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease requiring dialysis [see Dosage and Administration (2.3, 2.4)].
Recommended starting dose* First reduction to Second reduction to Discontinue
  4 mg   3 mg   2.3 mg  

An alternating dose modification approach is recommended for NINLARO and lenalidomide for thrombocytopenia, neutropenia, and rash as described in Table 3. Refer to the lenalidomide prescribing information if dose reduction is needed for lenalidomide.

Table 3: Dose Modifications Guidelines for NINLARO in Combination with Lenalidomide and Dexamethasone
*
For additional occurrences, alternate dose modification of lenalidomide and NINLARO
Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03
Hematological Toxicities Recommended Actions
Thrombocytopenia (Platelet Count)
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)
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.*
Non-Hematological Toxicities Recommended Actions
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 Peripheral Neuropathy with Pain or Grade 2 Peripheral Neuropathy
  • 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 Peripheral Neuropathy with Pain or Grade 3 Peripheral Neuropathy
  • 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 Peripheral Neuropathy Discontinue treatment regimen.
Other Non-Hematological Toxicities
Other Grade 3 or 4 Non-Hematological Toxicities
  • 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.

Dosage in Patients with Hepatic Impairment

Reduce the starting dose of NINLARO to 3 mg in patients with moderate (total bilirubin greater than 1.5-3 × ULN) or severe (total bilirubin greater than 3 × ULN) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Dosage in Patients with Renal Impairment

Reduce the starting dose of NINLARO to 3 mg in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease (ESRD) requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Refer to the lenalidomide prescribing information for dosing recommendations in patients with renal impairment.

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