恩莱瑞Ninlaro(ixazomib)

恩莱瑞Ninlaro(ixazomib)

Drug name: Ninlaro (ixazomib)
Drug alias: ixazomib
English name: ixazomib
R&D company: Takeda
Indications: Second-line treatment of multiple myeloma
Model specifications: 4mg, 3mg, and 2.3mg

Drug details:

Indications and Uses
Ninlaro is a proteomic inhibitor indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Dosage Form and Specifications
Capsules: 4mg, 3mg, and 2.3mg.

Dosage and Administration
⑴ The recommended starting dose is 4mg orally on days 1, 8, and 15 of a 28-day course of treatment.
⑵ The dose should be taken at least one hour before or at least 2 hours after food.

Warnings and Precautions
⑴ Thrombocytopenia: Monitor platelet counts at least monthly during treatment and adjust when necessary.
⑵ Gastrointestinal toxicity: For severe diarrhea, constipation, nausea, and vomiting, adjust dosing as needed.
⑶ Peripheral neuropathy: Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.
⑷ Peripheral edema: Monitor for fluid retention. Investigate potential causes, when appropriate. Adjust dosing as needed.
⑸ Skin reactions: Monitor patients for rash and adjust dosing as needed.
⑹ Hepatotoxicity: Monitor liver enzymes during treatment.
⑺ Embryofetal toxicity: Ninlaro may cause fetal harm. Advise females of reproductive potential and use effective contraception.

Adverse reactions
The most common adverse reactions (≥20%) are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.

Drug interactions
Strong CYP3A inducers: Avoid concomitant use with Ninlaro.

Use in special populations
⑴ Hepatic impairment
Reduce the starting dose of Ninlaro to 3 mg in patients with moderate or severe hepatic impairment.

⑵ Renal impairment
Reduce the starting dose of Ninlaro to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis.

⑶ Breastfeeding
Discontinue breastfeeding.

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