NINLARO- ixazomib capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ixazomib citrate (UNII: 46CWK97Z3K) (ixazomib - UNII:71050168A2)

Διαθέσιμο από:

Takeda Pharmaceuticals America, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2, 14.3)] . None. Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)] and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a pregnant woman. There are no available data on NINLARO use in pregnant women to evaluate drug-associated risk. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose (see Data) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (fused caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg. Risk Summary There 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. NINLARO can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating NINLARO. Contraception Females Advise females of reproductive potential to use effective non-hormonal contraception during treatment with NINLARO and for 90 days after the last dose. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because NINLARO is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered [see Drug Interactions (7.1)] . Males Advise males with female partners of reproductive potential to use effective contraception during treatment with NINLARO and for 90 days after the last dose. Safety and effectiveness of NINLARO have not been established in pediatric patients. Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In 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)] . In 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)] .

Περίληψη προϊόντος:

How Supplied NINLARO is supplied as follows: Capsules are individually packaged in a PVC-Aluminum/Aluminum blister. Storage Store NINLARO at room temperature. Do not store above 30°C (86°F). Do not freeze. Store capsules in original packaging until immediately prior to use. Handling and Disposal NINLARO is a hazardous drug. Follow applicable special handling and disposal procedures1 . Do not open or crush capsules. Avoid direct contact with the capsule contents. In case of capsule breakage, avoid direct contact of capsule contents with the skin or 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.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

NINLARO- IXAZOMIB CAPSULE
TAKEDA PHARMACEUTICALS AMERICA, INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Cutaneous Reactions (5.5)
3/2024
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)
Limitations of Use: NINLARO is not recommended for use in the
maintenance setting or in newly
diagnosed multiple myeloma in combination with lenalidomide and
dexamethasone outside of controlled
clinical trials. (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)
Thrombotic Microangiopathy: Monitor for signs and symptoms.
Discontinue NINLARO if suspected. (5.6)
Hepatotoxicity: Monitor hepatic enzymes during treatment. (5.7)
Embryo-Fetal Toxicity: NINLARO can cause fetal harm. Advise patients
of the potential risk to a fetus
and to use effective non-hormonal con