Patient Medication Information: uses, side effects, how to take - Auro-Nintedanib
What is Auro-Nintedanib used for?
Auro-Nintedanib is used in adults to:
- treat a lung disease called Idiopathic Pulmonary Fibrosis (IPF).
- slow the rate of decline in lung function in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD). This may also be known as scleroderma lung disease.
- treat other chronic fibrosing Interstitial Lung Diseases (ILDs) where lung fibrosis continues to worsen (progress). This may also be known as progressive fibrosing ILD (PF-ILD).
How does Auro-Nintedanib work?
Auro-Nintedanib is a tyrosine kinase inhibitor. This type of medicine blocks some of the activity of tyrosine kinases (a type of cell proteins). This helps to reduce the decline in your lung function by slowing down the worsening of your pulmonary fibrosis (the scarring in your lungs).
What are the ingredients in Auro-Nintedanib?
Medicinal ingredient: Nintedanib Esylate
Non-medicinal ingredients: black ink (Opacode WB Black NS-78-17821), gelatin, glycerol, hard fat, liquid soya lecithin, medium chain triglycerides, red iron oxide, titanium dioxide and yellow iron oxide.
Auro-Nintedanib comes in the following dosage forms:
Capsules: 100 mg and 150 mg
Do not use Auro-Nintedanib if:
- you are allergic to nintedanib, peanut, soya, or any of the other ingredients in Auro-Nintedanib;
you are pregnant, think you may be pregnant or are planning to have a baby. If you
- become pregnant while taking Auro-Nintedanib, tell your healthcare professional right away. It may cause birth defects.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Nintedanib. Talk about any health conditions or problems you may have, including if you:
- have or had liver problems;
- have or had bleeding problems;
- have or had hypertension (high blood pressure) or artery dissection (tear in the artery wall);
- have a history of aneurysms (a problem with your blood vessels);
- have or had heart problems. Treatment with Auro-Nintedanib can cause heart problems such as myocardial infarctions (heart attack), hypertension (high blood pressure), aneurysms (a problem with your blood vessels), or artery dissection (tear in the artery wall). Your healthcare professional will monitor your health and will check your blood pressure before and during treatment. If heart problems appear, your healthcare professional may reduce or stop your dose;
- have or had a gastrointestinal perforation (a hole in your stomach or bowel). Treatment with Auro-Nintedanib can cause gastrointestinal perforation. Your healthcare professional will assess your health and may permanently stop treatment with Auro-Nintedanib if gastrointestinal perforation occur;
- have or had ischaemic colitis (inflammation of the bowel caused by reduced blood flow to the bowel). Your healthcare professional will assess your health and may permanently stop treatment with Auro-Nintedanib should ischaemic colitis occur and may restart Auro-Nintedanib once your ischaemic colitis is resolved;
- have or had a hollow organ perforation (a hole in your intestines, gallbladder, bile ducts, fallopian tubes or urinary bladder);
- have or had a peptic ulcer (a sore on the lining of your stomach);
- have or had diverticular disease (pouches that form along your digestive tract, typically in your colon);
- recently had surgery or will be having surgery, including stomach surgery;
- are breastfeeding or plan to breastfeed. It is not known whether Auro-Nintedanib is excreted into your breast milk;
- are taking blood-thinning medicines to prevent blood clotting;
- are taking nonsteroidal anti-inflammatory drugs (NSAIDS) to reduce pain, decrease fever, prevent blood clots and decrease inflammation at high doses;
- are taking corticosteroids (a class of drugs that lower inflammation in the body).
Other warnings you should know about:
Serious Liver Problems: Auro-Nintedanib has been associated with drug-induced liver injuries (DILIs), that can be serious and life-threatening. Your healthcare professional will do blood tests before and during treatment to check your liver function and determine if your dose of Auro-Nintedanib should be reduced or discontinued.
Stop taking Auro-Nintedanib and inform your doctor immediately if you have unexplained symptoms such as:
- yellowing of your skin or the white part of your eyes (jaundice);
- dark or brown (tea coloured) urine;
- pain on the upper right side of your stomach area (abdomen);
- bleeding or bruising more easily than normal;
- nausea;
- vomiting;
- loss of appetite, or;
- feeling tired.
Female Patients:
If you are able to get pregnant or think you are pregnant, there are specific risks you
must discuss with your healthcare professional.
- Your healthcare professional may ask you to take a pregnancy test before you start taking Auro-Nintedanib and during your treatment with Auro-Nintedanib.
- You must use highly effective birth control when you start Auro-Nintedanib, while taking Auro-Nintedanib and for at least 3 months after the last dose. If you use any form of hormonal contraceptives, you must also add a barrier method (such as a condom or sponge).
- The effectiveness of oral hormonal contraceptives may be reduced by vomiting and/or diarrhea or other conditions that decrease how well the oral contraceptive works. If you are taking oral hormonal contraceptives and have any of these conditions, you should use an alternative highly effective method of birth control (such as an IUD).
- If you become pregnant or think you are pregnant while taking Auro-Nintedanib, tell your healthcare professional or pharmacist right away.
Driving and Using Machines: Before you drive or do tasks that require special attention, wait until you know how you respond to Auro-Nintedanib.
Laboratory Tests: Auro-Nintedanib can cause abnormal blood test results. Your healthcare professional will do regular blood tests during your treatment. Your healthcare professional will decide when to perform these tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Auro-Nintedanib:
- ketoconazole used to treat fungal infections;
- erythromycin used to treat bacterial infections;
- rifampicin, an antibiotic used to treat tuberculosis;
- carbamazepine or phenytoin used to treat seizures;
- pirfenidone used to treat idiopathic pulmonary fibrosis;
- St. John’s Wort, a herbal medicine.
Do not eat foods containing grapefruit, grapefruit juice or Seville oranges during your treatment with Auro-Nintedanib. This is because it could affect the way the medicine works and may lead to side effects.
How to take Auro-Nintedanib:
- Auro-Nintedanib should only be prescribed by physicians with the appropriate training and experience in the diagnosis and treatment of the conditions for which Auro-Nintedanib is indicated.
- Take Auro-Nintedanib exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- It is important to take Auro-Nintedanib every 12 hours about the same time each day for as long as your healthcare professional has prescribed.
Take Auro-Nintedanib with food and swallowed whole with water. Do NOT open, chew or crush the capsule.
- Wash your hands if you accidentally come into contact with the contents of the capsule.
- Do not reduce the dose or stop taking Auro-Nintedanib without consulting your healthcare professional.
Usual dose:
Take 150 mg twice a day. The maximum daily dose is 300 mg.
Your dose will depend on your current health, if you take certain other medications, or if you have certain side effects. Your healthcare professional will monitor your health throughout your treatment and may interrupt, reduce or stop your dose.
Overdose:
If you think you, or a person you are caring for, have taken too much Auro-Nintedanib, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you have forgotten to take your dose, carry on and take your next dose at the usual time. Do not double dose.
What are possible side effects from using Auro-Nintedanib?
These are not all the possible side effects you may have when taking Auro-Nintedanib. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea, which may lead to a loss of fluid and important electrolytes in your body. At the first signs of diarrhea, drink plenty of fluids and start anti-diarrheal treatment. In most patients, diarrhea was of mild to moderate intensity and occurred within the first 3 months of treatment;
- nausea and vomiting; in most patients, nausea and vomiting was of mild to moderate intensity;
- abdominal pain;
- areas of hair loss;
- bleeding;
- constipation;
- dizziness;
- decreased appetite;
- gas;
- headache;
- heartburn;
- musculoskeletal pain;
- weight decrease.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Diarrhea | ✓ | ||
| Nausea | ✓ | ||
| Abdominal pain | ✓ | ||
| COMMON | |||
| Vomiting | ✓ | ||
| Decreased weight | ✓ | ||
| Decreased appetite | ✓ | ||
| Bleeding | ✓ | ||
| UNCOMMON | |||
| Serious liver problems or Jaundice (build up of bilirubin in the blood): increased liver enzymes levels (liver test), yellowing of the skin or the white part of the eyes, dark or brown (tea coloured) urine, abdominal pain, nausea, vomiting, loss of appetite, bleeding or bruising more easily than normal, or feeling tired, light-coloured stool, and itching all over your body | ✓ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse, heart palpitations, and vision disorders | ✓ | ||
| Gastrointestinal perforation (a hole in the wall of your stomach or bowels): severe constant abdominal pain with tenderness, distension, nausea and vomiting | ✓ | ||
| Myocardial infarction (heart attack): upper abdominal pain, fever, a fast heartbeat, shortness of breath, tenderness when touching the abdomen, nausea or vomiting | ✓ | ||
| Pancreatitis (inflammation of the pancreas): severe upper abdominal pain radiating to the back, fever, nausea and vomiting | ✓ | ||
| Thrombocytopenia (low blood platelets): easily bruised, rash with reddish-purplish spots usually on the lower legs, longer than usual bleeding from a cut, bleeding from your gums or nose, bleeding in urine or in your stool (black like tar stool), fatigue and weakness | ✓ | ||
| Rash/itchy skin | ✓ | ||
| Proteinuria (excess proteins in urine): swelling of the hands, feet, or face | ✓ | ||
| Ischaemic colitis (inflammation of the bowel): sudden or gradual pain, tenderness or cramping in the abdomen, bleeding in your stool, diarrhea, which can be urgent or vomiting | ✓ | ||
| VERY RARE | |||
| Artery dissection (tear in the artery wall): sudden severe pain in the back, chest or abdomen | ✓ | ||
| Artery aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart, and brain): symptoms differ by the site and include coughing, coughing up blood, strong pain high in your neck or in your back when you didn't hurt yourself, problems swallowing, hoarse voice, and unusual pulsing in your chest or abdomen | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Posterior reversible encephalopathy syndrome/ reversible posterior leukoencephalopathy syndrome (a neurological disorder): headache, vision problems including blindness, seizure, feeling tired or low energy, altered mental function, including confusion and mild to severe high blood pressure | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health- products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Do not use this medicine after the expiry date which is stated on the carton. Store at 15-30°C. Store in the original blister in order to protect from moisture.
Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Keep out of reach and sight of children.
If you want more information about Auro-Nintedanib:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website http://www.auropharma.ca/, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.