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RX ITEM-Odomzo Sonidegib 200Mg Cap 30 By Sun Pharma

NDC 00078-0645-15 UPC/GTIN No.3-00780-64515-7 Mfg.Part No.45585BRAND: ODOMZO  NDC: 47335-0303-83,47335030383 UPC: 3-47335-30383-4,347335303834 ASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Odomzo Sonidegib 200Mg Cap 30 By Sun Pharma

$12072.00$10999.00

item No.:RX471300 NDC No.47335030383 UPC No.:347335303834 NDC No.47335-0303-83 47335-303-83 UPC/GTIN No. 3-47335-30383-4 MPN 30383 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx471300 Odomzo 200mg Cap 30 by Sun Pharma Item No.3471300 NDC No. 47335030383 4733530383 00078064515 UPC No. 347335-3038

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ODOMZO- sonidegib phosphate capsule
Novartis Pharmaceuticals Corporation
WARNING: EMBRYO-FETAL TOXICITY

ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].
Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].

1 INDICATIONS AND USAGE

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.
2 DOSAGE AND ADMINISTRATION
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.

3 DOSAGE FORMS AND STRENGTHS

200 mg opaque pink colored capsules with 'SONIDEGIB 200MG" printed on the body and 'NVR" printed on the cap in black ink (equivalent to 281 mg of diphosphate salt of sonidegib).
4 CONTRAINDICATIONS

None.
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-fetal Toxicity

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 [see Use in Specific Populations (8.1)].

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 [see Use in Specific Populations (8.3)].

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 [see Use in Specific Populations (8.3)].

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.

NDC 00078-0645-15 UPC/GTIN No.3-00780-64515-7 Mfg.Part No.45585
RX ITEM-Odomzo Sonidegib 200Mg Cap 30 By
NDC 00078-0645-15 UPC/GTIN No.3-00780-64515-7 Mfg.Part No.45585

BRAND: ODOMZO  NDC: 47335-0303-83,47335030383 UPC: 3-47335-30383-4,347335303834 ASD Specialty Healthcare-Special Order
Odomzo Sonidegib 200Mg Cap 30 By Sun Pha
BRAND: ODOMZO NDC: 47335-0303-83,47335030383 UPC: 3-47335-30383-4,347335303834 ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
SONIDEGIB PHOSPHATE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.