Odomzo
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
History
There is currently no drug history available for this drug.
Other Information
ODOMZO (sonidegib) is a Smoothened (Smo) antagonist which inhibits the Hedgehog (Hh) signaling pathway.
The molecular formula for sonidegib phosphate is C26H26 F3N3O3• 2H3PO4. The molecular weight is 681.49 daltons. The chemical name is N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-biphenyl]-3-carboxamide diphosphate.
The molecular structure is shown below:
Sonidegib phosphate is a white to off-white powder. Sonidegib freebase is practically insoluble.
Each ODOMZO capsule for oral use contains 200 mg of sonidegib as the freebase and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer and sodium lauryl sulfate. The opaque pink hard gelatin capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.
Sources
Odomzo Manufacturers
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Novartis Pharmaceuticals Corporation
![Odomzo (Sonidegib) Capsule [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Odomzo | Novartis Pharmaceuticals Corporation
2.1 Recommended DosingThe 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 ModificationsInterrupt 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.
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