Ninlaro
(Ixazomib)Dosage & Administration
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Ninlaro Prescribing Information
Warnings and Precautions, Cutaneous Reactions (Rash was reported in 27% of patients in the NINLARO regimen and 16% of patients in the placebo regimen. The majority of the rash adverse reactions were Grade 1 (15% in the NINLARO regimen and 9% in the placebo regimen) or Grade 2 (9% in the NINLARO regimen and 4% in the placebo regimen) [see Adverse Reactions (6.1)] . Grade 3 rash was reported in 3% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Serious adverse reactions of rash were reported in <1% of patients in the NINLARO regimen. The most common type of rash reported in both regimens included maculo-papular and macular rash. Rash resulted in discontinuation of one or more of the three drugs in <1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher[see Dosage and Administration (2.2)] .Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported with NINLARO [see Adverse Reactions (6.1, 6.2)] . If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs, discontinue NINLARO and manage as clinically indicated. | 3/2024 |
NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. ()
2.1 Dosing and Administration GuidelinesNINLARO in combination with lenalidomide and dexamethasoneThe 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. The importance of carefully following all dosage instructions should be discussed with patients starting treatment. Instruct patients to take the recommended dosage as directed, because overdosage has led to deaths
[see Overdosage (10)].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)].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 healthcare provider'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.
Concomitant MedicationsConsider antiviral prophylaxis in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation
[see Adverse Reactions (6.1)]. - Dose should be taken at least one hour before or at least two hours after food. ()
2.1 Dosing and Administration GuidelinesNINLARO in combination with lenalidomide and dexamethasoneThe 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. The importance of carefully following all dosage instructions should be discussed with patients starting treatment. Instruct patients to take the recommended dosage as directed, because overdosage has led to deaths
[see Overdosage (10)].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)].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 healthcare provider'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.
Concomitant MedicationsConsider antiviral prophylaxis in patients being treated with NINLARO to decrease the risk of herpes zoster reactivation
[see Adverse Reactions (6.1)].
NINLARO is available in the following capsules:
- 4 mg ixazomib: Light orange gelatin capsule imprinted with "Takeda" on the cap and "4 mg" on the body in black ink.
- 3 mg ixazomib: Light grey gelatin capsule imprinted with "Takeda" on the cap and "3 mg" on the body in black ink.
- 2.3 mg ixazomib: Light pink gelatin capsule imprinted with "Takeda" on the cap and "2.3 mg" on the body in black ink.
- Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. (,
2.3 Dosage in Patients with Hepatic ImpairmentReduce 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)].)8.6 Hepatic ImpairmentIn patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment
[see Dosage and Administration (2.3), Clinical Pharmacology (12.3)]. - Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. (,
2.4 Dosage in Patients with Renal ImpairmentReduce 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.
)8.7 Renal ImpairmentIn patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis
[see Dosage and Administration (2.4), Clinical Pharmacology (12.3)]. - Lactation: Advise not to breastfeed. ()
8.2 LactationRisk SummaryThere are no data on the presence of ixazomib or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions from NINLARO in a breastfed infant, advise women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.
None.