150 mg hard capsules 
alectinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
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 packaging and other information 

1. What Alecensa is and what it is used for

What is Alecensa 
Alecensa is a cancer medicine that contains the active substance alectinib.

What Alecensa is used for 
Alecensa is used to treat adults who have a type of lung cancer called “non-small cell lung cancer” (“NSCLC”). It is used if your lung cancer:

  • is “ALK-positive” – ​​this means that your cancer cells have a defect in a gene that forms an enzyme called ALK (anaplastic lymphoma kinase), see “How Alecensa works” below
  • and is advanced.

Alecensa can be prescribed to you as the first treatment for your lung cancer or if you have previously been treated with a medicine containing ‘crizotinib’.

How Alecensa works 
Alecensa blocks the effect of an enzyme called “ALK tyrosine kinase”. Abnormal forms of this enzyme (due to a defect in the gene that makes it) help to stimulate cancer cell growth. Alecensa can slow down or stop the growth of your cancer. It can also help shrink your cancer.

If you have any further questions on the use of Alecensa or why this medicine has been prescribed for you, ask your doctor, pharmacist, or nurse.

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 cautions

Talk to your doctor, pharmacist, or nurse before taking Alecensa:

  • if you have ever had problems with your stomach or intestines such as holes ( perforation ) or if you have a disease that causes inflammation on the inside of the intestine ( diverticulitis ) or if you have spread cancer inside the abdomen ( metastases ). It is possible that Alecensa may increase the risk of developing holes in the intestinal wall.
  • if you have a hereditary 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

Talk to your doctor immediately after taking Alecensa:

  • if you experience severe pain in the stomach or abdomen, fever, chills, nausea, vomiting, or a hard or bloated stomach, as this may be a symptom of a hole in the intestinal wall.

Aecensa can cause side effects that you must tell your doctor immediately. These include:

  • liver damage (hepatotoxicity). Your doctor will take blood samples before you start treatment, then every two weeks for the first 3 months of treatment, and then less often. This is done to make sure that you do not get any liver problems when you take Alecensa. Tell your doctor immediately if you get any of the following symptoms: yellow skin or whites of the eyes, pain on the right side of the stomach, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than usual.
  • slow heart rhythm ( bradycardia ).
  • pneumonia ( Pneumonitis ). Alecensa can cause severe or life-threatening swelling ( inflammation ) of the lungs during treatment. The symptoms may be similar to those from your lung cancer. Tell your doctor immediately if you experience any new or worsening symptoms including difficulty breathing, shortness of breath, coughing with or without mucus, or fever.
  • severe muscle pain, tenderness, and weakness ( myalgia ). Your doctor will take blood samples at least every two weeks during the first month of Alecena’s treatment and thereafter if necessary. Tell your doctor immediately if you get new or worsening symptoms of muscle problems including unexplained muscle pain or muscle pain that does not go away soreness or weakness.

Pay attention to these while taking Alecensa. See “Side Effects” in Section 4 for more information.

Sensitivity to sunlight

You should not be exposed to sunlight for any length of time while taking Alecensa and 7 days after stopping treatment. You need to use sunscreen and lip balm with a sun protection factor of 50 or higher to prevent sunburn.

Children and young people

Alecensa has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.

Tests and checks 

When you take Alecensa, your doctor will take blood samples before you start treatment, then every two weeks for the first 3 months of treatment, and then less often. This is to make sure that 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 over-the-counter and herbal remedies. This is because Alecensa may affect the way some other medicines work. Some other medicines may also affect the way Alecensa works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • digoxin, a drug 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 (eg rheumatoid arthritis )
  • nilotinib, a drug used to treat certain types of cancer
  • lapatinib, a drug used to treat certain types of breast cancer
  • mitoxantrone, a drug used to treat certain types of cancer or autoimmune diseases (eg multiple sclerosis )
  • everolimus, a drug 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 drug used to treat certain types of cancer
  • medicines used to treat AIDS / HIV (eg ritonavir, saquinavir)
  • drugs used to treat the infection. It includes medicines used to treat fungal infections ( antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines used to treat certain types of bacterial infections ( antibiotics such as telithromycin)
  • St. John’s wort, an herbal medicine used to treat depression
  • medicines used to stop seizures and seizures (medicines for epilepsy such as phenytoin, carbamazepine, and phenobarbital)
  • medicines used to treat tuberculosis (eg rifampicin, rifabutin)
  • nefazodone, a drug used to treat depression

Birth control pills

If you take Alecensa while taking birth control pills, the birth control pills may become less effective.

Alecensa with food and drink

You should be careful about drinking grapefruit juice and eating grapefruit and oranges while you are being treated with Alecensa as it may change the amount of Alecensa in your body.

Contraceptives, pregnancy, and lactation – information for women 

Contraceptives – information for women 

  • You should not get pregnant while taking this medicine. If you can become pregnant, you must use a very effective method of contraception during treatment and for at least 3 months after stopping treatment. Talk to your doctor about the right contraceptive methods for you and your partner. If you take Alecensa while taking birth control pills, the birth control pills may become less effective.

Pregnancy 

  • Do not take Alecensa if you are pregnant. This is because it can harm your baby.
  • If you become pregnant while taking this medicine or for the first 3 months after taking your last dose, talk to your doctor immediately.

Breast-feeding

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

Driving and using machines

Take special care when driving and using machines as you may have vision problems, a slow heartbeat, or low blood pressure which may 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 have an intolerance to some sugars, talk to your doctor before taking this medicine.

Alecensa contains sodium

This medicine contains 48 mg of sodium (the main ingredient in table salt/table salt) per recommended daily dose (1200 mg). This corresponds to 2.4% of the highest recommended daily intake of sodium for adults.

How to take Alecensa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How much to take

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

If you have severe liver problems before starting treatment with Alecensa:

  • The recommended dose is 3 capsules (450 mg) twice daily.
  • This means that you should take a total of 6 capsules (900 mg) every day.

Sometimes your doctor may lower your dose, stop treatment for a short time, or stop your treatment altogether if you feel unwell.

How to take

  • Alecensa is taken by mouth. Swallow each capsule whole. The capsules must not be opened or dissolved.
  • 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 but 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 a 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 the next dose, take the missed dose as soon as you remember.
  • If it is less than 6 hours until the 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 product, 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 occur with this medicine.

Some side effects can be serious.

Tell your doctor immediately if you notice any of the following side effects. Your doctor may reduce the dose one, stop the treatment for a short time, or stop the treatment completely:

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

Other side effects are 

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common  (affects more than 1 in 10 people):

  • abnormal results on blood tests to detect liver problems (high levels of alanine aminotransferase, aspartate aminotransferase, and bilirubin )
  • abnormal results on blood tests to detect muscle damage (high levels of creatine phosphokinase)
  • you may feel tired, weak, and short of breath due to a reduced number of red blood cells, so-called anemia
  • vomiting – if you vomit after taking a dose of Alecensa, do not take an extra dose, take your next dose at the usual time
  • constipation
  • diarrhea
  • nausea
  • rash
  • swelling caused by fluid accumulation in the body ( edema )
  • weight gain.

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

  • abnormal results on blood tests to check kidney function (high level of creatinine )
  • blurred vision, loss of vision, blackheads or white spots in the visual field, and double vision (problems with your eyes)
  • abnormal blood test results to control liver or skeletal disease (high level of alkaline phosphatase)
  • inflammation of the oral mucosa
  • sensitivity to sunlight – you should not be exposed to sunlight for any length of time while taking Alecensa and 7 days after stopping treatment. You need to use sunscreen and lip balm with a sun protection factor of 50 or higher to prevent sunburn.
  • altered sense of taste
  • rapid loss of kidney function (kidney problems).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alecensa

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and either the blister or the can after “Ed. that ”. The expiration date is the last day of the specified month.
  • If Alecensa is packaged in blisters, store it in the original package. Moisture sensitive.If Alecensa is packaged in cans, store it in the original package. Close the jar tightly. Moisture sensitive.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is alectinib. Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
  • Other ingredients are:
    • Capsule contents: lactose monohydrate (see section 2 “Alecensa contains lactose”), hydroxypropyl cellulose, sodium lauryl sulfate (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
    • Ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), carnauba wax, white shellac, and glycerol monooleate.

What the medicine looks like and the contents of the pack

Alecensa hard capsules are white, with “ALE” printed in black ink on the top and “150 mg” printed in black ink on the bottom.

The capsules are supplied in blisters and are available in cartons containing 224 hard capsules (4 packs of 56). The capsules are also supplied in plastic jars containing 240 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer 

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Wahlen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Finland / FinlandRoche Oy Puh / Tel: +358 (0) 10 554 500

Muhammad Nadeem

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