Detailed instructions for ixazomib

1. Indications and Usage

Ixazomib is a proteasome inhibitor indicated for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received at least one prior therapy.

Restrictions on Use:Ixazomib(Ixazomib) is not recommended for use in combination with lenalidomide and dexamethasone for maintenance treatment in uncontrolled clinical trials or in newly diagnosed multiple myeloma.

2. Dosage and usage

Recommended starting dose of 4 mg orally on days 1, 8, and 15 of a 28 day cycle.

Dose should be taken at least one hour before or two hours after a meal.

Three. Dosage form and strength

Capsules: 4mg, 3mg and 2.3mg

Four. Contraindications

No.

Five. Warnings and Precautions

1.Thrombocytopenia:Monitor platelet count at least monthly during treatment and adjust dosage as necessary.

2.Gastrointestinal Toxicity:Adjust dosage as needed for severe diarrhea, constipation, nausea, and vomiting.

3.Peripheral Neuropathy:Monitor patients for symptoms of peripheral neuropathy and adjust dosage as needed.

4.Peripheral edema:Monitor for fluid retention. Investigate the root cause when appropriate. Adjust dosage as needed.

5.Skin Reactions:Monitor patients for rash and adjust dosage as needed.

6.Thrombotic microangiopathy:Monitor for signs and symptoms. If in doubt, discontinueixazomib.

7.Hepatotoxicity:Monitor liver enzymes during treatment.

8.Embryonic-Fetal Toxicity:Ixazomib can cause harm to the fetus. Inform patients of the potential risk to the fetus and use an effective non-hormonal method of contraception.

9.Increased mortality in patients receivingixazomibin the maintenance setting:The use ofixazomibin the maintenance setting is not recommended in the treatment of patients with multiple myeloma outside of controlled trials.

6. Adverse reactions

The most common adverse reactions (≥ 20%) are thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis.

7. Drug interactions

StrongCYP3AInducers:Avoid concurrent use withixazomib.

8. Use among specific groups of people

Hepatic Impairment: In patients with moderate or severe hepatic impairment, reduce the starting dose of ixazomib to 3 mg .

Renal Impairment:For patients with severe renal impairment or end-stage renal disease requiring dialysis, reduce theinitiating dose of ixazomib to3 mg.

Breastfeeding:Breastfeeding is not recommended.

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