Ninlaro Capsules (Hard Gelatin)
Ixazomib
3mg
TAKEDA PHARMA A/S
| Pack size | 3's (1's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | DENMARK |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 46336.00 AED |
Available as:
Indications
Ninlaro Capsules (Hard Gelatin) is used for:
Multiple Myeloma
Indicated in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy
Adult Dose
Multiple Myeloma
Indicated in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy
Treatment should be continued until disease progression or unacceptable toxicity
Starting doses
Ixazomib: 4 mg PO on days 1, 8, and 15 of a 28-day cycle; take 1 hr ac or 2 hr pc
Lenalidomide: 25 mg PO on days 1-21 of a 28-day cycle; take with or without food
Dexamethasone: 40 mg PO in morning on days 1, 8, 15, and 22 of a 28-day cycle
Hepatic impairment
Mild: No dosage adjustment required
Moderate (TB >1.5-3 x ULN) or severe (TB >3 ULN): Decrease starting dose to 3 mg
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate: No dosage adjustment required
Severe (CrCl <30 mL/min) or ESRD requiring dialysis: Decrease starting dose to 3 mg; ixazomib is not dialyzable and therefore can be administered without regard to the timing of dialysis
Administration
Oral Administration
Take once a week on the same day and at approximately the same time for the first 3 weeks of a 4-week cycle
Taken at least 1 hr before or at least 2 hr after food
Swallow capsule whole with water; do not crush, chew, or open
Contra Indications
Hypersensitivity
Precautions
Cutaneous reactions reported, the most common types being maculopapular and macular rash; manage with supportive care or with dose modification if ≥grade 2
Rare occurrence of drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic, and hepatotoxicity reported; monitor hepatic enzymes regularly and adjust dosing for grade 3 or 4 symptoms
Can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals
Thrombocytopenia reported with platelet nadirs typically occurring between days 14 and 21 of each 28-day cycle and recovery to baseline by the start of the next cycle; monitor platelet counts at least monthly during treatment; consider more frequent monitoring during the first 3 cycles
Diarrhea, constipation, nausea, and vomiting reported, occasionally requiring use of antidiarrheals, antiemetics, and supportive care
Peripheral neuropathy was reported (majority grade 1); the most commonly reported reaction was peripheral sensory neuropathy; monitor for symptoms; new or worsening peripheral neuropathy may require dose modification
Peripheral edema reported; adjust dosing of dexamethasone per its prescribing information or ixazomib for grade 3 or 4 symptoms
Lactation
No data are available in human milk; effects of drug on breast fed infant, or effects of drug on milk production; because potential for serious adverse reactions from drug in breastfed infants is unknown, advise nursing women not to breastfeed during treatment and for 90 days after last dose
Pregnancy-Lactation
Pregnancy
Can cause fetal harm when administered to a pregnant woman
There are no human data available regarding the potential effect of ixazomib on pregnancy or development of the embryo or fetus
Animal studies
Ixazomib caused embryofetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose
Increases in fetal skeletal variations/abnormalities (fused caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) in rabbit studies
Decrease fetal weights, a trend towards decreased fetal viability, and increased postimplantation losses were observed in rat studies
Contraception
Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated
Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following the final dose
Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters; because drug is administered with dexamethasone, consider risk for reduced efficacy of contraceptives; advise women using hormonal contraceptives to also use a barrier method of contraception
Lactation
No data are available in human milk; effects of drug on breast fed infant, or effects of drug on milk production; because potential for serious adverse reactions from drug in breastfed infants is unknown, advise nursing women not to breastfeed during treatment and for 90 days after last dose
Interactions
Adverse Effects
Side effects of Ixazomib :
>10%
Thrombocytopenia (78%)
Neutropenia (67%)
Diarrhea (42%)
Constipation (34%)
Peripheral neuropathies (28%)
Nausea (26%)
Thrombocytopenia, grade 3-4 (26%)
Neutropenia, grade 3-4 (26%)
Peripheral edema (25%)
Vomiting (22%)
Back pain (21%)
Upper respiratory tract infection (19%)
Rash (19%)
1-10%
Diarrhea, grade 3 (6%)
Blurred vision (6%)
Conjunctivitis (6%)
Dry eye (5%)
Herpes zoster, without antiviral prophylaxis (4%)
Rash, grade 3 (3%)
Peripheral edema (2%)
Peripheral neuropathies, grade 3 (2%)
Nausea, grade 3 (2%)
Vomiting, grade 3 (1%)
<1%
Herpes zoster, with antiviral prophylaxis
Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic, and hepatotoxicity
Upper respiratory tract infection, grade 3
Constipation, grade 3
Back pain, grade 3
Acute febrile neutrophilic dermatosis (Sweet syndrome)
Stevens-Johnson syndrome
Transverse myelitis
Posterior reversible encephalopathy syndrome
Tumor lysis syndrome
Thrombotic thrombocytopenic purpura
Mechanism of Action
Reversible proteasome inhibitor; preferentially binds and inhibits the chymotrypsinlike activity of the beta 5 subunit of the 20S proteasome
Note
Ninlaro 3mg Capsules (Hard Gelatin) manufactured by TAKEDA PHARMA A/S. Its generic name is Ixazomib. Ninlaro is availble in United Arab Emirates.
Farmaco UAE drug index information on Ninlaro Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.