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 cannot cure lung scarring or fibrosis caused by interstitial lung disease, but it can help slow down how quickly the lungs get worse.

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-rays, CT scans and lung function tests to monitor your condition.
A stabilisation or slowing of decline on lung function testing indicates your medicine 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 medicines or if they prescribe you any new medicines.

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 medicine. Many side effects disappear when nintedanib is stopped.

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

This medicine can affect the liver, so you will need regular blood tests to check how your liver is working.

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, weight gain, swelling of the face, feet or lower legs, weight gain
• Chest pain that may spread to your arms, jaw, back or neck, difficulty 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

• It is safe to take nintedanib if you drink a small amount of alcohol. But having more than 4 standard drinks at once, even now and then, is not recommended.

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 while using 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 medicines out of reach of children.