Odomzo Dosage

Important Safety Information

Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO.

Recommended Dosage

The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity.

Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients.

If a dose of ODOMZO is missed, resume dosing with the next scheduled dose.

Dosage Modifications for Adverse Reactions

Interrupt ODOMZO for

• Severe or intolerable musculoskeletal adverse reactions.
• First occurrence of serum CK elevation between 2.5 and 10 times upper limit of normal (ULN).
• Recurrent serum CK elevation between 2.5 and 5 times ULN.

Resume ODOMZO at 200 mg daily upon resolution of clinical signs and symptoms.

Permanently discontinue ODOMZO for

• Serum CK elevation greater than 2.5 times ULN with worsening renal function.
• Serum CK elevation greater than 10 times ULN.
• Recurrent serum CK elevation greater than 5 times ULN.
• Recurrent severe or intolerable musculoskeletal adverse reactions.