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Alecensa 150 mg Hard Capsules

Last Updated on eMC 16-Oct-2017 View changes  | Roche Products Limited Contact details

Black Triangle icon This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

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.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/16/1169/001, EU/1/16/1169/002.



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.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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:

  • is ‘ALK-positive’ - this means your cancer cells have a fault in a gene that makes an enzyme called ALK (‘anaplastic lymphoma kinase’), see ‘How Alecensa works’, below
  • and is advanced
  • and has previously been treated with a medicine called ‘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 allergic to alectinib or any of the other ingredients of this medicine (listed in section 6).

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 have an inherited problem called ‘galactose intolerance’, ‘congenital lactase deficiency’ or ‘glucose-galactose malabsorption’.

If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.

Alecensa can cause side effects that you need to tell your doctor about straight away. These include:

  • liver injury (hepatotoxicity). Your doctor will take 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 problems while taking Alecensa. Tell your doctor straight away if you get any of the following signs: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
  • slow heart beat (bradycardia).
  • lung inflammation (pneumonitis). Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. The signs may be similar to those from your lung cancer. Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
  • severe muscle pain, tenderness, and weakness (myalgia). Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor straight away if you get new or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

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:

  • digoxin, a medicine used to treat heart problems
  • dabigatran etexilate, a medicine used to treat blood clots
  • methotrexate, a medicine used to treat certain types of cancer or to treat autoimmune diseases (e.g. rheumatoid arthritis)
  • nilotinib, a medicine used to treat certain types of cancer
  • lapatinib, a medicine used to treat certain types of breast cancer
  • mitoxantrone, a medicine used to treat certain types of cancer or autoimmune diseases (e.g. multiple sclerosis)
  • everolimus, a medicine used to treat certain types of cancer or used to prevent the body’s immune system from rejecting a transplanted kidney, heart or liver
  • sirolimus, a medicine used to prevent the body’s immune system from rejecting a transplanted kidney, heart or liver
  • topotecan, a medicine used to treat certain types of cancer
  • medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
  • medicines used to treat infections. These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin)
  • St. John’s Wort, a herbal medicine used to treat depression
  • medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
  • medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
  • nefazodone, a medicine used to treat depression

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

  • You should not become pregnant while taking this medicine. If you are able to become pregnant, you must use highly effective contraception while on treatment and for at least 3 months after stopping treatment. Talk to your doctor about the right methods of contraception for you and your partner. If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.

Pregnancy

  • Do not take Alecensa if you are pregnant. This is because it may harm your baby.
  • If you become pregnant when taking the medicine or during the 3 months after taking your last dose, tell your doctor straight away.

Breast-feeding

  • Do not breast-feed while taking this medicine. This is because it is not known if Alecensa can pass over into breast milk and could therefore harm your baby.

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

The recommended daily dose of Alecensa (1200 mg) contains 48 mg of sodium. Please take this amount into consideration if you are on a controlled sodium diet.

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

  • The recommended dose is 4 capsules (600 mg) twice a day.
  • This means you take a total of 8 capsules (1200 mg) each day.
  • 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

  • Alecensa is taken by mouth. Swallow each capsule whole. Do not open or dissolve the capsules.
  • You must take Alecensa with food.

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 it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
  • If it is less than 6 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
  • Do not take a double dose to make up for a missed dose.

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:

  • Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
  • New or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness (potential signs of muscle problems).
  • Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
  • New or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever - the signs may be similar to those from your lung cancer (potential signs of lung inflammation – pneumonitis). Alecensa can cause severe or life-threatening inflammation of the lungs during treatment.

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):

  • abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
  • you may feel tired, weak or short of breath due to a reduction in the number of red blood cells, known as anaemia
  • blurred vision, loss of sight, black dots or white spots in your vision, and seeing double (problems with your eyes)
  • vomiting – if you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time
  • constipation
  • diarrhoea
  • nausea
  • rash
  • 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.
  • swelling caused by fluid build-up in the body (oedema).

Common (may affect up to 1 in 10 people):

  • abnormal results of blood tests to check kidney function (high level of creatinine)
  • abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase).

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.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:medsafety@hpra.ie

Malta

ADR Reporting
Website:www.medicinesauthority.gov.mt/adrportal

United Kingdom

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Alecensa

  • Keep this medicine out of the sight and reach of children.
  • Do not take this medicine after the expiry date which is stated on the carton and either the blister or the bottle after EXP. The expiry date refers to the last day of that month.
  • If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
  • If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
  • 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.

6. Contents of the pack and other information

What Alecensa contains

  • The active substance is alectinib. Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
  • The other ingredients are:
    • Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose’), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium’), magnesium stearate and carmellose calcium
    • Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
    • Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.

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

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Roche Products Ltd.
Tel: +44 (0) 1707 366000

This leaflet was last revised in September 2017.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

uk-ie-mt-pil-Alecensa-tracked-170925-150mg-caps

Company contact details

Roche Products Limited

Company image
Address

Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW

Fax

+44 (0)1707 338 297

Medical Information e-mail
Medical Information Fax

+44 (0)1707 384555

Telephone

+44 (0)1707 366 000

Medical Information Direct Line

+44 (0)800 328 1629

Customer Care direct line

+44 (0)800 731 5711

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

alectinib hydrochloride

Legal categories

POM - Prescription Only Medicine

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