Active ingredient
- alectinib hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0843.
Alecensa 150 mg Hard Capsules
Package leaflet: Information for the patient
Alecensa 150 mg hard capsules
alectinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
What is in this leaflet
1. What Alecensa is and what it is used for
2. What you need to know before you take Alecensa
3. How to take Alecensa
4. Possible side effects
5. How to store Alecensa
6. Contents of the pack and other information
1. What Alecensa is and what it is used for
What Alecensa is
Alecensa is a cancer medicine that contains the active substance alectinib.
What Alecensa is used for
Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’). It is used if your lung cancer:
Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib’.
How Alecensa works
Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth. Alecensa may slow down or stop the growth of your cancer. It may also help to shrink your cancer.
If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
2. What you need to know before you take Alecensa
Do not take Alecensa:
If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Alecensa:
If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
Talk to your doctor right away after having taken Alecensa:
Look out for these while you are taking Alecensa. See ‘Side effects’ in section 4 for more information.
Sensitivity to sunlight
Do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop. You need to apply sunscreen and lip balm with a Sun Protection Factor of 50 or higher to help prevent sunburn.
Children and adolescents
Alecensa has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years.
Tests and checks
When you take Alecensa your doctor will do blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often. This is to check you do not have any liver or muscle problems while taking Alecensa.
Other medicines and Alecensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines. This is because Alecensa can affect the way some other medicines work. Also some other medicines can affect the way Alecensa works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Oral contraceptives
If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Alecensa with food and drink
You should use caution when drinking grapefruit juice or eating grapefruit or Seville oranges while on treatment with Alecensa as they may change the amount of Alecensa in your body.
Contraception, pregnancy, and breast-feeding - information for women
Contraception – information for women
Pregnancy
Breast-feeding
Driving and using machines
Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
Alecensa contains lactose
Alecensa contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Alecensa contains sodium
This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg). This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Alecensa
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
If you have severe liver problems before starting your treatment with Alecensa:
Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell.
How to take
If you vomit after taking Alecensa
If you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time.
If you take more Alecensa than you should
If you take more Alecensa than you should, talk to a doctor or go to hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take Alecensa
If you stop taking Alecensa
Do not stop taking this medicine without talking to your doctor first. It is important to take Alecensa twice a day for as long as your doctor prescribes it for you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Some side effects could be serious.
Tell your doctor straight away if you notice any of the following side effects. Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:
Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Alecensa
6. Contents of the pack and other information
What Alecensa contains
What Alecensa looks like and contents of the pack
Alecensa hard capsule are white, with ‘ALE’ printed in black ink on the cap and ‘150 mg’ printed in black ink on the body.
The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56). The capsules are also available in plastic bottles containing 240 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2022.
gb-pil-Alecensa-clean-220103-150mg-caps
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
+44 (0)1707 366 000
+44 (0)800 328 1629
+44 (0)800 731 5711
+44 (0)1707 338 297
+44 (0)1707 384555