|
NINLARO (ixazomib) capsules
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO.
NINLARO ® (ixazomib) capsules, for oral use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. (1)
DOSAGE AND ADMINISTRATION
-
Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. (2.1)
-
Dose should be taken at least one hour before or at least two hours after food. (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: 4 mg, 3 mg, and 2.3 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
-
Thrombocytopenia: Monitor platelet counts at least monthly during treatment and adjust dosing, as needed. (2.2, 5.1)
-
Gastrointestinal Toxicities: Adjust dosing for severe diarrhea, constipation, nausea, and vomiting, as needed. (2.2, 5.2)
-
Peripheral Neuropathy: Monitor patients for symptoms of peripheral neuropathy and adjust dosing, as needed. (2.2, 5.3)
-
Peripheral Edema: Monitor for fluid retention. Investigate for underlying causes, when appropriate. Adjust dosing, as needed. (2.2, 5.4)
-
Cutaneous Reactions: Monitor patients for rash and adjust dosing, as needed. (2.2, 5.5)
-
Hepatotoxicity: Monitor hepatic enzymes during treatment. (5.6)
-
Embryo-Fetal Toxicity: NINLARO can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.7, 8.1)
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-844-617-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Strong CYP3A inducers: Avoid concomitant use with NINLARO. (7.1, 12.3)
USE IN SPECIFIC POPULATIONS
-
Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. (2.3, 8.6)
-
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, 8.7)
-
Lactation: Discontinue nursing. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 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.
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.
2.2 Dose Modification Guidelines
The NINLARO dose reduction steps are presented in Table 2 and the dose modification guidelines are provided in Table 3.
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.
|
|
