Generic name: SONIDEGIB PHOSPHATE 200mg
Dosage form: capsule
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2.1 Recommended Dosing
The recommended dose 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 [see Clinical Pharmacology (12.3)].
Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO. Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)].
If a dose of ODOMZO is missed, resume dosing with the next scheduled dose.
2.2 Dose Modifications
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.