Ninlaro

Ninlaro Dosage/Direction for Use

ixazomib

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
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. (See Table 3.)

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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 Pharmacology under Actions]. The whole 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 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.
Concomitant Medications: Consider antiviral prophylaxis in patients being treated with Ninlaro to decrease the risk of herpes zoster reactivation.
Dose Modification Guidelines: The Ninlaro dose reduction steps are presented in Table 4 and the dose modification guidelines are provided in Table 5. (See Table 4.)

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An alternating dose modification approach is recommended for Ninlaro and lenalidomide for thrombocytopenia, neutropenia, and rash as described in Table 5. Refer to the lenalidomide prescribing information if dose reduction is needed for lenalidomide. (See Table 5.)

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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 x ULN) or severe (total bilirubin greater than 3 x ULN) hepatic impairment [see Hepatic Impairment under Precautions and Pharmacology under Actions].
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 Renal Impairment under Precautions and Pharmacology under Actions].
Refer to the lenalidomide prescribing information for dosing recommendations in patients with renal impairment.
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