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Ninlaro

Ninlaro

ixazomib

Manufacturer:

Takeda

Distributor:

Takeda
Concise Prescribing Info
Contents
Ixazomib
Indications/Uses
In combination w/ lenalidomide & dexamethasone for adults w/ multiple myeloma who have received at least 1 prior therapy.
Dosage/Direction for Use
In combination w/ lenalidomide & dexamethasone: Recommended initial ixazomib dose: 4 mg once wkly on days 1, 8 & 15 of a 28-day treatment cycle. Recommended initial lenalidomide dose: 25 mg daily on days 1-21 of a 28-day treatment cycle. Recommended initial dexamethasone dose: 40 mg on days 1, 8, 15 & 22 of a 28-day treatment cycle. Moderate or severe hepatic impairment, severe renal impairment or ESRD requiring dialysis Initial dose: 3 mg. In the event that Ninlaro dose is delayed or missed, the dose should be taken only if the next scheduled dose is ≥72 hrs away. A missed dose should not be taken w/ in 72 hrs of the next scheduled dose. A double dose should not be taken to make up for a missed dose. If a patient vomits after taking a dose, the patient should not repeat the dose but should resume dosing at the time of the next scheduled dose.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after food. Swallow whole w/ water, do not crush/chew/open.
Contraindications
Hypersensitivity.
Special Precautions
ANC should be ≥1,000/mm3, platelet count should be ≥75,000/mm3 & non-hematologic toxicities should generally be recovered to patient's baseline condition or grade ≤1 prior to initiation of new therapy cycle. Adjust dosing for grade 3 or 4 peripheral edema & GI symptoms. Monitor platelet counts at least mthly during treatment; consider more frequent monitoring during 1st 3 cycles. Monitor hepatic enzymes regularly & adjust dosing for grade 3 or 4 symptoms. Consider antiviral prophylaxis to decrease the risk of herpes zoster reactivation. Monitor for neuropathic symptoms; dose modification may be required for patients experiencing new or worsening peripheral neuropathy. Modify dose or discontinue treatment if grade ≥2 rash occurs. Discontinue use if diagnosis for thrombocytopenic purpura/haemolytic uremic syndrome is suspected. Do not drive or operate machines if fatigue or dizziness is experienced. Use 2 effective contraceptive measures during & for 90 days following treatment among males & females of child-bearing potential; consider risk for reduced efficacy of OC due to combination therapy w/ dexamethasone; women on oral hormonal contraceptives should also use a barrier method of contraception. Can cause fetal harm when administered to a pregnant woman. Discontinue nursing during treatment. Childn <18 yr.
Adverse Reactions
Diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, back pain.
Drug Interactions
Not recommended to be co-administered w/ strong CYP3A inducers (eg, rifampin, phenytoin, carbamazepine, St. John's wort). Decreased AUC & Cmax, & delayed Tmax w/ high-fat meal. May reduce efficacy of OCs due to interaction w/ dexamethasone
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Ninlaro cap 3 mg
Packing/Price
((blister wallet)) 3 × 1's
Form
Ninlaro cap 4 mg
Packing/Price
((blister wallet)) 3 × 1's
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