INTRODUCTION

NINTIB 150 contains Nintedanib which belongs to the group of medicines called Kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is used in combination with docetaxel in adult patients for the treatment of locally advanced metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first line chemotherapy.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disorder in which the lungs become scarred and breathing becomes increasingly difficult. Symptoms include shortness of breath, persistent dry cough, tiredness, loss of appetite, weight loss, rounded and swollen fingertips (clubbed fingers).

Before taking NINTIB 150 inform your doctor if you have liver, heart or bleeding problems, history of blood clots or had a recent surgery in stomach. NINTIB 150 is not recommended for use in pregnant women unless advised by your doctor and it is not recommended for use in breastfeeding women as it may pass through breast milk. Before starting treatment with NINTIB 150, your doctor may want you to take several blood tests to understand your existing condition.

NINTIB 150 should be used with caution in elderly patients (aged 65 years and above). The most common side effects of taking NINTIB 150 are diarrhoea, nausea, vomiting, stomach pain, loss of appetite, headache, weight loss and high blood pressure. Consult your doctor if any of the symptom worsens.

USES OF NINTIB 150

• Treats idiopathic pulmonary fibrosis (IPF)
• Treats chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

HOW NINTIB 150 WORKS

NINTIB 150 is a tyrosine kinase inhibitor (TKI) which works by blocking the enzymes in cells of the lungs called tyrosine kinases. Blocking these enzymes helps to decrease fibrous tissue formation in the lungs, thereby stops the symptoms of lung disease getting worse.

DIRECTIONS FOR USE

Take NINTIB 150 as advised by your physician. Swallow the medicine with a glass of water. Do not crush, chew, or open the medicine. Your doctor will decide the correct dose and duration for you based upon your age, body weight and disease condition. Do not stop taking NINTIB 150 unless your doctor advises you to stop.

SIDE EFFECTS OF NINTIB 150

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try to take NINTIB 150 with or just after a meal or a snack. Stick to simple meals. Avoid eating oily, fried or spicy foods. Consult your doctor if the symptom gets worse.

Diarrhoea:

Drink lot of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Do not strain your eyes by watching screen for long time. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom gets worse.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the stomach pain does not improve, consult your doctor.

Decreased appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking NINTIB 150 inform your doctor if you are taking any of the following medicines:

• st. john’s wort (used to treat depression)
• laxatives such as bisacodyl, stool softeners such as lactulose (used to treat constipation)
• other medicines or dietary supplements (used to treat diarrhoea)
• blood thinners such as warfarin (used to prevent or treat blood clots)
• aspirin (used to treat fever and pain)

Overdosage:

If you or anyone else accidentally take too much of NINTIB 150, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep NINTIB 150 out of reach of children
• Store at room temperature

FAQs ABOUT NINTIB 150

Can I take NINTIB 150 during pregnancy?

NINTIB 150 is not recommended for use in pregnant women unless clearly advised by your doctor. Consult your doctor before taking NINTIB 150 if you are pregnant or planning to get pregnant.

What to do If I forget to take a dose of NINTIB 150?

You should take NINTIB 150 immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

Can I stop taking NINTIB 150 on my own?

Do not stop taking NINTIB 150 unless your doctor advises you to stop. Remember that it works to slow the decline in lung function only for as long as you keep taking it. If you stop taking NINTIB 150 suddenly it worsens the lung function and increases the risk of life-threatening complications.

What are the common side effects of NINTIB 150?

The common side effects of taking NINTIB 150 are diarrhoea, nausea, vomiting, stomach pain, loss of appetite, headache, weight loss, altered liver enzymes and high blood pressure. Consult your doctor if any of the side effect worsens.

Is NINTIB 150 safe to use in patients with liver disease?

NINTIB 150 should be taken with caution in patients with liver problems. Your doctor may monitor your liver function before and during treatment with NINTIB 150 to assess the risk of liver damage or any unusual effects. Consult your doctor before taking NINTIB 150.

REFERENCES

1. Linda Skidmore. Selected New drugs. Mosby’s 2021 Nursing Drug Reference. 34th edition. 2021. Page- 1354.

2. Pilar Rivera-Ortega, Conal Hayton, John Blaikley, Colm Leonard, and Nazia Chaudhuri. Nintedanib in the management of idiopathic pulmonary fibrosis: clinical trial evidence and real-world experience. NIH: National Library of Medicine, National Center for Biotechnology Information. PMC Pubmed Central. September 2018 [Accessed on 30th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6156214/

3. Ian Glaspole, Francesco Bonella, Elena Bargagli, Marilyn K. Glassberg, Fabian Caro, Wibke Stansen, Manuel Quaresma, Leticia Orsatti and Elisabeth Bendstrup. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. [Accessed on 30th July 2022] https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-021-01695-y

4. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in March 2020] [Accessed on 30th July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s013lbl.pdf

5. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in January 2022] [Accessed on 30th July 2022] https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Ofev/ofev.pdf

6. Central Drugs Standard Control Organization (CDSCO). Nintedanib. [Accessed on 30th July 2022] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Liver function tests
• Pulmonary function tests