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sonidegib

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Overview

What is Odomzo?

ODOMZO (sonidegib) is a Smoothened (Smo) antagonist which inhibits the Hedgehog (Hh) signaling pathway.

The molecular formula for sonidegib phosphate is CH FNO• 2HPO. 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 (equivalent to 281 mg of diphosphate salt of sonidegib) 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.



What does Odomzo look like?



What are the available doses of Odomzo?

200 mg capsules (equivalent to 281 mg of diphosphate salt of sonidegib) ()

What should I talk to my health care provider before I take Odomzo?

How should I use Odomzo?

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.

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 .

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 .

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


What interacts with Odomzo?

Sorry No Records found


What are the warnings of Odomzo?

Sorry No Records found


What are the precautions of Odomzo?

Sorry No Records found


What are the side effects of Odomzo?

Sorry No records found


What should I look out for while using Odomzo?

None.


What might happen if I take too much Odomzo?

There are no recommendations regarding management of overdosage.


How should I store and handle Odomzo?

Each ODOMZO capsule has an opaque pink color with ‘SONIDEGIB 200MG’ printed on the capsule body and ‘NVR’ printed on the cap in black ink. ODOMZO capsules are supplied as follows:Bottle of 30 capsules               NDC 47335-303-83Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Each ODOMZO capsule has an opaque pink color with ‘SONIDEGIB 200MG’ printed on the capsule body and ‘NVR’ printed on the cap in black ink. ODOMZO capsules are supplied as follows:Bottle of 30 capsules               NDC 47335-303-83Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Each ODOMZO capsule has an opaque pink color with ‘SONIDEGIB 200MG’ printed on the capsule body and ‘NVR’ printed on the cap in black ink. ODOMZO capsules are supplied as follows:Bottle of 30 capsules               NDC 47335-303-83Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Sonidegib is an inhibitor of the Hedgehog pathway. Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Non-Clinical Toxicology
None.

See Table 1 for clinically significant drug interactions with naproxen.

Table 1: Clinically Significant Drug Interactions with naproxen

Drug/Laboratory Test Interactions

ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, sonidegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures below the recommended human dose of 200 mg. Advise pregnant women of the potential risk to a fetus .

Females of Reproductive Potential

Verify pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment. Advise females to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose .

Males

Advise male patients with female partners to use condoms, even after a vasectomy, during treatment with ODOMZO and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential .

Blood Donation

Advise patients not to donate blood or blood products while taking ODOMZO and for at least 20 months after the last dose of ODOMZO because their blood or blood products might be given to a female of reproductive potential.

The following serious adverse reactions are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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