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Nifev (Nintedanib) also known as Ofev and Vargatef is used to treat certain lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease).

Nifev is the alternative & generic version of Ofev / Vargatef by Boehringer Ingelheim. Nifev is manufactured by UniMed UniHealth Ltd Bangladesh which is the biggest pharmaceutical company in Bangladesh.

Nifev | Nintedanib also known as Ofev and Vargatef is used to treat certain types of lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease). Both types of lung disease scar and stiffen your lungs, making it hard to breathe. Nintedanib may help slow down the worsening of your lung disease.

Pregnancy:

Based on findings from animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women; counsel patients on pregnancy prevention and planning

Verify pregnancy status of females of reproductive potential prior to treatment and during treatment as appropriate

Animal data

• In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib/Ofev caused embryofetal deaths and structural abnormalities at less than (rats) and ~5 times (rabbits) the maximum recommended human dose

Contraception

• Advise females of reproductive potential to avoid becoming pregnant while receiving nintedanib

• Use effective contraception during treatment, and for at least 3 months after taking the last dose

• Drug does not change exposure to oral contraceptive containing ethinylestradiol and levonorgestrel in patients with SSc-ILD; however, efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea or other conditions where drug absorption may be reduced

Infertility

• Based on animal data, may reduce fertility in females of reproductive potential

Lactation:

There is no information on the presence of nintedanib in human milk, the effects on the breast-fed infant or the effects on milk production

Nintedanib/ Ofev and/or its metabolites are present in the milk of lactating rats

Because of the potential for serious adverse effects in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

Pharmacology:

Mechanism of Action

Tyrosine kinase inhibitor; targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis (eg, vascular endothelial growth factor receptor [VEGFR], fibroblast growth factor receptor [FGFR], platelet-derived growth factor receptor [PDGF])

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

Absorption:

Bioavailability: 4.7%; undergoes substantial first-pass metabolism

Peak plasma concentration: 2-4 hr

Food increases systemic exposure by ~20% and delays peak level to ~4 hr

Distribution:

Protein bound: 97.8%

Vd: 1050 L

Metabolism:

Hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202 is the prevalent metabolic pathway (~25%); BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide

Only a minor extent of the biotransformation consists of CYP pathways (~5%), with CYP3A4 being the predominant enzyme involved

Elimination:

Excretion: 93.4% feces/biliary; 0.65% urine

Administration:

Take with food

Swallow capsule whole with liquid; do not chew or crush (bitter taste); effect of crushing on the pharmacokinetics is unknown

Missed dose: Take next dose at next scheduled time; advise patient to not make up for a missed dose

Storage:

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

Protect from exposure to high humidity and avoid excessive heat

If repackaged, use USP tight.