Ninlaro Application Scope

Ninlaro is an oral, selectively acting proteasome inhibitor used in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy.

ninlaro

Characteristics

Ingredients: Ixazomib

Properties:
- Hard gelatin capsules in three strengths
  - 2.3 mg (light pink, size 4)
  - 3 mg (light grey, size 4)
  - 4 mg (light orange, size 3)
- Color-coded and marked “Takeda” with dosage amount
Packaging Specification: Sold in cartons with three wallet packs, each containing one blister (one capsule per blister)

Storage: Store at 20–25 °C (68–77 °F), protect from moisture, keep in original packaging, out of children’s reach
Expiry Date: Refer to the “EXP” date printed on blister/carton; dispose of expired medication safely
Executive Standard:

EMA marketing authorisation numbers:
- EU/1/16/1094/001 (2.3 mg),
- EU/1/16/1094/002 (3 mg),
- EU/1/16/1094/003 (4 mg)
Approval Number: U.S. FDA NDA 208462
Date of Revision:
- FDA label last revised July 2024
- EMA EU SmPC renewal September 2019

Manufacturer: Takeda Pharma A/S, Taastrup, Denmark

Guidelines for the Use of Ninlaro

Dosage and Administration:
- Oral dose of 4 mg once weekly on Days 1, 8, 15 in a 28-day cycle, combined with lenalidomide and dexamethasone
- Take capsule whole with water, at least 1 hour before or 2 hours after food
- Patients with moderate/severe hepatic or severe renal impairment: reduce to 3 mg weekly

Adverse Reactions:
- Prevalent (≥20%): thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, edema, rash, vomiting, bronchitis
- Lower-grade peripheral neuropathy: ~18–11%; grade 3: ~2%
Contraindications: None explicitly listed; caution in hepatic/renal impairment; pregnancy (fetal harm)
Precautions:
- Monitor: platelet & neutrophil counts, liver enzymes, signs of neuropathy and edema, gastrointestinal toxicity
- Advise contraception; avoid breastfeeding

Ninlaro Interactions

Drug Interactions: Avoid strong CYP3A inducers (e.g., rifampin, certain anticonvulsants)

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.