Fibroz Capsule

Introduction

Fibroz Capsule 100 mg is an oral tyrosine kinase inhibitor, which is used to treat idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is thought to work by inhibiting the tyrosine kinase activity of certain proteins involved in the development and progression of these diseases.

Uses

Fibroz Capsule 100 mg is used to treat idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Brand Name	Fibroz
Type	Capsule
Weight	100 mg
Generic	Nintedanib
Manufacturer	Beacon Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Fibroz Capsule 100 mg is thought to work by inhibiting the tyrosine kinase activity of certain proteins involved in the development and progression of IPF and SSc-ILD. By blocking these proteins, nintedanib is thought to help slow the progression of these lung diseases.

How Long Does It Take to Work?

The length of time it takes for nintedanib to work varies from patient to patient, but some improvements may be seen within the first few weeks of treatment. It typically takes around three months for patients to start to experience their maximum benefit from the drug.

Absorption

Fibroz Capsule 100 mg is rapidly absorbed after oral administration, with peak concentrations observed within 1-2 hours.

Route of Elimination

Fibroz Capsule 100 mg is metabolized in the liver via multiple pathways and is excreted in the urine and feces.

Dosage

Treatment with Nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF.

Posology: The recommended dose is 150 mg Nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.

For NSCLC:

The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Nintedanib must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.
Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Nintedanib should be discontinued.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).

The recommended dosage of nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF) is 150 mg taken by mouth twice daily with food. The recommended dosage for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) is 300 mg by mouth twice daily with food. It is important to take nintedanib exactly as prescribed by your doctor.

Administration

Fibroz Capsule 100 mg should always be taken with food. It is important to take nintedanib exactly as prescribed by your doctor.

Side Effect

The most common side effects of nintedanib include diarrhea, abdominal pain, headache, nausea, vomiting, rash, fatigue, decreased appetite, and alveolitis. Other potential side effects include flatulence, elevated liver enzymes, and increased blood pressure.

Toxicity

Fibroz Capsule 100 mg has a low toxicity profile and is generally well-tolerated. However, overdosage of nintedanib may potentially cause serious side effects, including nausea, vomiting, and abdominal pain.

Precaution

Fibroz Capsule 100 mg should be used with caution in patients with impaired hepatic function or moderate to severe renal function. Fibroz Capsule 100 mg should not be used in pregnant women or nursing mothers. Patients should talk to their doctor before taking nintedanib if they have any pre-existing medical conditions, such as liver or kidney disease, or if they are taking any other medications, especially drugs that affect the liver or kidneys.

Interaction

Fibroz Capsule 100 mg may interact with other drugs, including drugs that affect the liver or kidneys, and drugs that increase the risk of bleeding. Patients should talk to their doctor before taking nintedanib if they are taking any other medications.

Disease Interaction

Fibroz Capsule 100 mg may be used to treat idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Fibroz Capsule 100 mg should not be used to treat any other diseases.

Drug Interaction

Fibroz Capsule 100 mg may interact with other drugs, including anticoagulants (e.g. warfarin), anticonvulsants (e.g. carbamazepine), drugs that affect kidney or liver function (e.g. leflunomide), and drugs that increase the risk of bleeding (e.g. aspirin). Patients should tell their doctor about all medications they are taking before starting nintedanib.

Food Interaction

Fibroz Capsule 100 mg should be taken with food. Patients should not take nintedanib with grapefruit juice, as this may increase the amount of nintedanib in their system.

Pregnancy Use

Fibroz Capsule 100 mg should not be used during pregnancy, as it can cause harm to an unborn baby. Any woman who is pregnant or planning to become pregnant should talk to her doctor before taking nintedanib.

Lactation Use

Fibroz Capsule 100 mg has not been studied in nursing mothers, so it is not known if it is safe to take while breastfeeding. Women should talk to their doctor before taking nintedanib while breastfeeding.

Acute Overdose

An acute overdose of nintedanib may cause nausea, vomiting, and abdominal pain. Patients should seek immediate medical attention if they experience any of these symptoms.

Contraindication

Fibroz Capsule 100 mg should not be used in patients with moderate to severe hepatic impairment, or in combination with bosentan, as this may increase the risk of severe side effects.

Use Direction

Fibroz Capsule 100 mg should be taken exactly as prescribed by your doctor. It should always be taken with food. If you miss a dose, take it as soon as you remember. Do not double up on your dose.

Storage Condition

Fibroz Capsule 100 mg should be stored at room temperature and away from direct sunlight. It should also be kept in a dry place and out of the reach of children and pets.