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RX ITEM-Ofev 100Mg Cap 60 By Boehringer Ingelheim

Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name:
NINTEDANIB
Description:
OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA
NDC:
00597-0143-60  upc 305970143604 00597014360   
BRAND: OFEV  NDC: 00597-0143-60,597014360 UPC: 305970-143604,305970143604 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.Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name:
NINTEDANIB
Description:
OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA
NDC:
00597-0143-60  upc 305970143604 00597014360

RX ITEM-Ofev 100Mg Cap 60 By Boehringer Ingelheim

$10990.00$9799.00

item No.:RX00597-0143-60 NDC No.597014360 UPC No.:305970143604 NDC No.00597-0143-60 00597-143-60 UPC/GTIN No.3-05970-14360-4 MPN 43745 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.Rx354973 Ofev 100mg Cap 60 by Healthcare Item No.00597-0143-60 NDC No.00597014360 0059714360 UPC No.305970143604 3059

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OFEV- nintedanib capsule
Boehringer Ingelheim Pharmaceuticals, Inc. (10368.00, 9969)

1  INDICATIONS AND USAGE

OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

2  DOSAGE AND ADMINISTRATION

2.1 Testing Prior to OFEV Administration
Conduct liver function tests and a pregnancy test prior to initiating treatment with OFEV [see Warnings and Precautions (5.2, 5.4)].

2.2 Recommended Dosage


The recommended dosage of OFEV is 150 mg twice daily administered approximately 12 hours apart.

OFEV capsules should be taken with food [see Clinical Pharmacology (12.3)] and swallowed whole with liquid. OFEV capsules should not be chewed or crushed because of a bitter taste. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known.

If a dose of OFEV is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.

In patients with mild hepatic impairment (Child Pugh A), the recommended dosage of OFEV is 100 mg twice daily approximately 12 hours apart taken with food.

2.3 Dosage Modification due to Adverse Reactions
In addition to symptomatic treatment, if applicable, the management of adverse reactions of OFEV may require dose reduction or temporary interruption until the specific adverse reaction resolves to levels that allow continuation of therapy. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If a patient does not tolerate 100 mg twice daily, discontinue treatment with OFEV [see Warnings and Precautions (5.2, 5.3, 5.5, 5.7) and Adverse Reactions (6.1)].

DOSAGE FORMS AND STRENGTHS

150 mg capsules: brown, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and "150″.

100 mg capsules: peach, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and "100″.
DESCRIPTION

OFEV capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H -Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-,methyl ester, (3Z)-, ethanesulfonate (1:1).

Its structural formula is:
Chemical Structure

Nintedanib esylate is a bright yellow powder with an empirical formula of C31 H33 N5 O4 ĚC2 H6 O3 S and a molecular weight of 649.76 g/mol.

OFEV capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib ethanesulfonate, respectively). The inactive ingredients of OFEV are the following: Fill Material: triglycerides, hard fat, lecithin. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink.

12  CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, and Fms-like tyrosine kinase-3 (FLT3). Among them, FGFR, PDGFR, and VEGFR have been implicated in IPF pathogenesis. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signaling which is crucial for the proliferation, migration, and transformation of fibroblasts representing essential mechanisms of the IPF pathology. In addition, nintedanib inhibits the following nRTKs: Lck, Lyn and Src kinases. The contribution of FLT3 and nRTK inhibition to IPF efficacy is unknown.

Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name:
NINTEDANIB
Description:
OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA
NDC:
00597-0143-60  upc 305970143604 00597014360
Ofev 100mg Cap 60
Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name: NINTEDANIB Description: OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA NDC: 00597-0143-60 upc 305970143604 00597014360

BRAND: OFEV  NDC: 00597-0143-60,597014360 UPC: 305970-143604,305970143604 Specialty Healthcare-Special Order
Ofev 100Mg Cap 60 By Boehringer Ingelhei
BRAND: OFEV NDC: 00597-0143-60,597014360 UPC: 305970-143604,305970143604 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
Ofev 100mg Cap 60
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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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com

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

Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name:
NINTEDANIB
Description:
OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA
NDC:
00597-0143-60  upc 305970143604 00597014360
RX ITEM-Ofev 100Mg Cap 60 By Boehringer
Ofev 100mg Cap 60 by Boehringer Ingelheim Generic Name: NINTEDANIB Description: OFEV, 100MG, (6000 MG), CAPSULES, 1X60 EA NDC: 00597-0143-60 upc 305970143604 00597014360