ixazomib

Contraindicated in:

Maintenance setting (may ↑ risk of mortality);
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Moderate or severe hepatic impairment (↓ dose);
Severe renal impairment or end stage renal disease (↓ dose);
Rep: Women and men of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema

Derm: rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

EENT: blurred vision, conjunctivitis, dry eye

GI: constipation, diarrhea, nausea, vomiting, HEPATOTOXICITY

Hemat: HEMOLYTIC UREMIC SYNDROME, NEUTROPENIA, THROMBOCYTOPENIA, THROMBOTIC MICROANGIOPATHY, THROMBOTIC THROMBOCYTOPENIC PURPURA

MS: back pain

Neuro: peripheral neuropathy

Misc: herpes zoster infection

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inducers, including carbamazepine, phenytoin, and rifampin, may ↓ levels and effectiveness; avoid concurrent use.

Drug-Natural Products:

St. John's wort may ↓ levels and effectiveness; avoid concurrent use.

Availability ⬆ ⬇

Capsules: 2.3 mg; 3 mg; 4 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 4 mg on Days 1, 8, and 15 of a 28-day treatment cycle.

Hepatic Impairment

(Adults ): Moderate or severe hepatic impairment (total bilirubin >1.5× upper limit of normal): 3 mg on Days 1, 8, and 15 of a 28-day treatment cycle.

Renal Impairment

(Adults ): CCr <30 mL/min or requiring dialysis: 3 mg on Days 1, 8, and 15 of a 28-day treatment cycle.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a proteasome inhibitor by binding to sites on the 20s proteasome. Has antiproliferative and proapoptotic activity.

Therapeutic effects:

Delayed progression of multiple myeloma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: proteasome inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: 58% absorbed following oral administration; bioavailability ↓ by high-fat foods.

Distribution: Extensively distributed to tissues.

Protein Binding: 99%.

Metabolism/Excretion: Metabolized by multiple CYP450 enzymes (including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4). 62% excreted in urine (<3.5% as unchanged drug), 22% excreted in feces.

Half-Life: 9.5 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take ixazomib as directed and to avoid contact with capsule contents. Take delayed or missed doses only if next scheduled dose is ≥72 hr away. Do not take within 72 hr of next scheduled dose, and do not double doses. If vomiting occurs after taking dose, omit dose and resume dosing at time of next scheduled dose. Advise patient to read Patient Information sheet prior to starting therapy and with each Rx refill in case of changes.
Caution patient to avoid direct contact with capsule contents. If powder accidentally gets on skin, wash area well with soap and water. If in eyes, flush eyes well with water.
Advise patient to notify health care professional if signs and symptoms of thrombocytopenia (bleeding, easy bruising); thrombotic microangiopathy; GI problems (diarrhea, constipation, nausea, vomiting); peripheral neuropathy (tingling, numbness, pain, burning in feet or hands, weakness in arms or legs); liver problems (yellowing of skin or whites of eyes, pain in right upper abdomen); swelling in arms, hands, legs, ankles, or feet; weight gain from swelling; new or worsening rash; or back pain occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
Rep: May cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential to use effective nonhormonal contraception during and for 90 days after last dose and to avoid breastfeeding during and for 90 days after last dose. Advise patient to notify health care professional immediately if pregnancy is suspected.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

63020- Takeda Pharmaceuticals America, Inc.
- 63020-230- NINLARO
  - 63020-230-01- 1 CAPSULE in 1 BLISTER PACK (63020-230-01)

63020- Takeda Pharmaceuticals America, Inc.
- 63020-230- NINLARO
  - 63020-230-02- 1 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03)

63020- Takeda Pharmaceuticals America, Inc.
- 63020-390- NINLARO
  - 63020-390-01- 1 CAPSULE in 1 BLISTER PACK (63020-390-01)

63020- Takeda Pharmaceuticals America, Inc.
- 63020-390- NINLARO
  - 63020-390-02- 1 BLISTER PACK in 1 CARTON (63020-390-02) / 3 CAPSULE in 1 BLISTER PACK (63020-390-03)

63020- Takeda Pharmaceuticals America, Inc.
- 63020-400- NINLARO
  - 63020-400-01- 1 CAPSULE in 1 BLISTER PACK (63020-400-01)

63020- Takeda Pharmaceuticals America, Inc.
- 63020-400- NINLARO
  - 63020-400-02- 1 BLISTER PACK in 1 CARTON (63020-400-02) / 3 CAPSULE in 1 BLISTER PACK (63020-400-03)

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Indications ⬇

Contraind./Precautions ⬆ ⬇