Nintedanib

• While taking nintedanib you must see your rheumatologist regularly to ensure the treatment is working and to minimise any possible side effects.
• If you stop nintedanib for any reason you must contact your rheumatologist. Failure to do so may mean that your continued treatment may no longer be funded. 
• If you are worried about any side effects, you should contact your rheumatologist as soon as possible.
• If you are taking nintedanib and plan to become pregnant you must discuss the timing with your doctor.

Nintedanib while it cannot cure lung fibrosis or scarring associated with interstitial lung disease, it can slow down the progression or decline in lung function.

Discuss with your doctor if you would like to stop taking nintedanib.

If you stop or delay your treatment, your disease may get worse. Keep taking your treatment, unless advised by your rheumatologist to stop or unless serious side effects occur (see Side effects).
 

You may have a combination of blood tests, chest X-ray’s and CT scans to monitor your condition.
A stabilisation or slowing of decline on lung function testing indicates your medication is working.

Nintedanib is taken by mouth in capsule form. It comes in 100mg or 150mg capsules.
The capsules should be swallowed whole and not be crushed.

When should nintedanib be taken?
Nintedanib is taken twice daily with a full glass of water at the same time each day. It should be taken with or immediately after food.

If a dose is missed, the next dose should be taken at the next scheduled time; do not make up for a missed dose or exceed the maximum dosage of 300 mg/day.
 

The usual starting dose for adults is 150 mg twice daily (approximately 12 hours apart).
In patients who do not tolerate this dose, the dose may be reduced to 100 mg twice a day.

Some medicines can stop nintedanib working properly (for example, ketoconazole, clarithromycin, erythromycin, cyclosporine, rifampicin, carbamazepine, phenytoin and St John’s wort) and others can increase the side effects of nintedanib (for example, blood thinning medicines like warfarin, apixaban, rivaroxaban and dabigatran can increase your risk of bleeding). 

Your doctor will check what other medicines you are taking before prescribing you nintedanib.

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products. It is important that you let your GP know that you are taking nintedanib when they are reviewing your current medications or if they prescribe you any new medications.

Do not smoke before and during treatment with this medicine.
 

You might experience side effects with your treatment. Tell your doctor if you notice side effects that you think are caused by this medication. Many side effects disappear when nintedanib treatment is stopped.

Most common possible side effects
The most common side effects reported are are nausea, vomiting, diarrhoea, abdominal pain, decreased appetite, weight loss, rash, increased blood pressure, bleeding.

Liver function may be affected and regular monitoring blood tests will be ordered.

Less common or rare possible side effects
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, difficult or painful urination, swelling of the face, feet, or lower legs, weight gain
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Severe diarrhoea, nausea, vomiting, stomach pain
• Unusual bleeding, bruising, or weakness
   

Infections

• Before you take nintedanib, tell your doctor about all of your medical conditions, including if you have:
  • Liver problems
  • Heart problems
  • A history of blood clots
  • A bleeding problem or a family history of a bleeding problem
  • Stomach or digestion problems or have had recent surgery in your abdomen or stomach

Surgery

• Nintedanib can cause problems with bleeding, if surgery is planned, it is important to let your rheumatologist know.

Use with alcohol

• Nintedanib can be used safely with a moderate intake of alcohol. However, drinking more than 4 standard drinks on one occasion, even if infrequently, is strongly discouraged.

Use in pregnancy and when breastfeeding

• Nintedanib must not be used in pregnant or breastfeeding women.

• If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 3 months after the last dose.

• Do not breastfeed during treatment with this medicine.

Store below 25°C. Store in the original package in order to protect from moisture.

Protect from exposure to high humidity and avoid excessive heat.

Keep all medications out of reach of children.