Prospecto: Information for the Patient

Alecensa 150 mg Hard Capsules

alectinib

Read this entire prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Alecensa and for what it is used

2.What you need to know before starting to take Alecensa

3.How to take Alecensa

4.Possible adverse effects

5.Storage of Alecensa

6.Contents of the package and additional information

What is Alecensa

Alecensa is a cancer medication that contains the active ingredient alectinib.

How is Alecensa used

Alecensa is used to treat adults with a type of lung cancer called "non-small cell lung cancer" ("NSCLC") that is 'ALK positive' – this means that their cancer cells have a defect in a gene that produces a fusion of an enzyme called ALK (anaplastic lymphoma kinase); see below 'How Alecensa works'.

Your doctor may prescribe Alecensa:

• after cancer removal, as postoperative adjuvant treatment, or
• as first treatment for your lung cancer that has spread to other parts of the body (advanced), or if you have already been treated previously with a medication that contains 'crizotinib'.

How Alecensa works

Alecensa blocks the action of an enzyme called "anaplastic lymphoma kinase tyrosine kinase". Abnormal forms of this enzyme (due to the defect in the gene that produces it) help stimulate the growth of cancer cells. Alecensa may slow down or stop cancer growth and may prevent the tumor from recurring after surgical removal. It may also help reduce it.

If you have any questions about how Alecensa works or why this medication has been prescribed to you, ask your doctor, pharmacist, or nurse.

Do not take Alecensa

• if you are allergic to alectinib or any of the other ingredients in this medicine (listed in section6).

If you are unsure, consult your doctor, pharmacist or nurse before taking Alecensa.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Alecensa:

• if you have ever had stomach or intestinal problems such as perforation, or if you have conditions that cause inflammation inside the abdomen (diverticulitis), or if you have had abdominal cancer (metastasis). Alecensa may increase the risk of developing holes in the wall of your intestine.
• if you have a hereditary condition called "lactose intolerance", "congenital lactase deficiency" or "glucose-galactose malabsorption".

If you are unsure, consult your doctor, pharmacist or nurse before taking Alecensa.

Consult your doctor immediately after taking Alecensa:

• if you experience severe stomach or abdominal pain, fever, chills, illness, vomiting or abdominal rigidity or swelling, as these may be symptoms of holes in the wall of your intestine.

Alecensa may cause side effects that you should report to your doctor immediately. These include:

• liver damage (hepatotoxicity). Your doctor will perform blood tests before starting treatment, every 2weeks during the first 3months of treatment and less frequently thereafter. This is to check that you do not have any liver problems while taking Alecensa. Report to your doctor immediately if you experience any of the following side effects: yellowing of your skin or the white of your eyes, right upper stomach pain, dark urine, itching, loss of appetite, nausea or vomiting, fatigue, bleeding and bruising more easily
• slow heart rate (bradycardia)
• inflammation of the lungs (pneumonitis). Alecensa may cause a severe or potentially fatal inflammation of the lungs during treatment. Symptoms may be similar to lung cancer. Report to your doctor immediately if you experience new symptoms or worsening of existing symptoms, such as difficulty breathing, shortness of breath, cough with or without mucus, or fever
• intense muscle pain, sensitivity, and weakness (myalgia). Your doctor will perform blood tests at least every 2weeks during the first month and as needed during treatment with Alecensa. Report to your doctor immediately if you notice new muscle problems or if they worsen, including unexplained muscle pain or muscle pain that does not go away, sensitivity or weakness.
• abnormal destruction of red blood cells (hemolytic anemia). Report to your doctor immediately if you feel tired, weak or have difficulty breathing.

You should monitor these symptoms while taking Alecensa. See "Side effects" in section 4 for more information.

Sensitivity to sunlight

Do not take the sun for any prolonged period while taking Alecensa or for 7days after stopping treatment. You should use sunscreen and lip balm with a sun protection factor (SPF) of 50or higher to prevent burns.

Tests and analyses

During treatment with Alecensa, your doctor will perform blood tests before starting treatment, every 2weeks during the first 3months of treatment and less frequently thereafter. This is to check that you do not have any liver or muscle problems while taking Alecensa.

Children and adolescents

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

Other medicines and Alecensa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines obtained with or without a prescription and herbal medicines. This is because Alecensa may affect how other medicines work. Other medicines may also affect the way Alecensa works.

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

• digoxin, a medicine used to treat heart problems
• dabigatrán etexilate, a medicine used to treat blood clots
• metotrexato, a medicine used to treat severe joint inflammation, cancer and psoriasis.
• nilotinib, a medicine used to treat certain types of cancer
• lapatinib, a medicine used to treat certain types of breast cancer
• mitoxantrona, a medicine used to treat certain types of cancer or multiple sclerosis (a disease that affects the central nervous system and damages the protective covering of the nerves)
• everolimus, a medicine used to treat certain types of cancer or to prevent organ transplant rejection
• sirólimus, a medicine used to prevent organ transplant rejection
• topotecán, a medicine used to treat certain types of cancer
• medicines used to treat HIV/AIDS (e.g. ritonavir, saquinavir)
• medicines used to treat infections. This includes medicines to treat fungal infections (antifungals such as ketoconazol, itraconazol, voriconazol, posaconazol) and medicines that treat some types of bacterial infections (antibiotics such as telitromicina)
• St. John's Wort, a medicinal herb used to treat depression
• medicines used to stop seizures or attacks (antiepileptics such as phenytoin, carbamazepine or phenobarbital)
• medicines used to treat tuberculosis (e.g. rifampicina, rifabutina)
• nefazodona, a medicine used to treat depression.

Oral contraceptives

If you take Alecensa while using oral contraceptives, the oral contraceptives may be less effective.

Use of Alecensa with food and drinks

Inform your doctor or pharmacist if you drink grapefruit juice or eat grapefruits or bitter oranges while taking Alecensa, as they may modify the amount of Alecensa in your body.

Contraception, pregnancy and breastfeeding

Contraception - Information for women

• You should not become pregnant during treatment with this medicine. If you can become pregnant, you should use a highly effective contraceptive method during treatment and for at least 5 weeks after stopping treatment with Alecensa. If you take Alecensa while using oral contraceptives, the oral contraceptives may be less effective.

Contraception - Information for men

• You should not father a child during treatment with this medicine. If your partner can become pregnant, you should use a highly effective contraceptive method during treatment and for at least 3 months after stopping treatment.

Consult your doctor about the appropriate contraceptive methods for you and your partner.

Pregnancy

• Do not take Alecensa if you are pregnant as it may harm your baby.
• If you become pregnant while taking this medicine or within 5 weeks of your last dose, inform your doctor immediately.
• If your female partner becomes pregnant while you are taking the medicine or within 3 months of your last dose, inform your doctor and your female partner should seek medical advice.

Breastfeeding

• You should not breastfeed while taking this medicine. It is unknown whether Alecensa can pass into breast milk and harm your baby.

Driving and operating machinery

Be particularly careful when driving or operating machinery as you may develop vision problems or slow heart rate or low heart rate that may cause dizziness or fainting while taking Alecensa.

Alecensa contains lactose

Alecensa contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Alecensa contains sodium

This medicine contains 48mg of sodium (main component of table salt) per recommended daily dose (1200mg). This is equivalent to 2.4% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse again.

How much to take

• The recommended dose is 4 capsules (600 mg) twice a day.
• This is equivalent to a total of 8 capsules (1,200 mg) per day.

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

• The recommended dose is 3 capsules (450 mg) twice a day.
• This means you will take a total of 6 capsules (900 mg) each day.

Your doctor may reduce your dose, interrupt your treatment for a short period, or stop treatment completely if you are feeling unwell.

How to take it

• Alecensa is taken orally. You must swallow the capsules whole. Do not open or dissolve the capsules.
• Alecensa must be taken with food.

If you vomit after taking Alecensa

If you vomit after taking a dose of Alecensa, do not take an extra dose, wait for the next dose at the usual time.

If you take more Alecensa than you should

If you take more Alecensa than you should, inform your doctor immediately or go to the hospital. Bring the medication packaging and this leaflet with you.

If you forget to take Alecensa

• If more than 6 hours have passed before your next dose, take the missed dose as soon as you remember.
• If less than 6 hours have passed before your next dose, do not take the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Alecensa

Do not stop treatment with this medication without consulting your doctor first. It is essential to take Alecensa twice a day for the time your doctor has prescribed.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may cause the following side effects.

Some side effects may be serious.

Inform your doctor immediately if you experience any of the following side effects.Your doctor may reduce your dose, interrupt your treatment for a short period of time, or discontinue treatment altogether:

• New symptoms or worsening of symptoms, including difficulty breathing, shortness of breath, or cough with or without mucus, or fever. Symptoms may be similar to those of lung cancer (potential symptoms of lung inflammation: pneumonitis). Alecensa may cause severe or potentially fatal lung inflammation during treatment.
• Yellowing of the skin or white of the eyes, pain on the right side of the stomach, dark urine, itching, loss of appetite, nausea, or vomiting, fatigue, bleeding, or bruising more easily (potential symptoms of liver problems).
• New symptoms or worsening of symptoms of muscle problems, including unexplained muscle pain or persistent muscle pain, sensitivity, or weakness (potential symptoms of muscle problems).
• Fainting, dizziness, and low blood pressure (potential symptoms of slow heart rate).
• Feeling tired, weak, or having difficulty breathing (potential symptoms of abnormal red blood cell destruction, known as hemolytic anemia).

Other side effects

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

Very common (may affect more than 1 in 10 people):

• Abnormal results in blood tests to check liver function (elevated levels of alanine aminotransferase, aspartate aminotransferase, and bilirubin)
• Abnormal results in blood tests to check for muscle damage (elevated levels of creatine phosphokinase)
• Abnormal results in blood tests to detect liver disease or bone disorders (high level of alkaline phosphatase)
• You may notice fatigue, weakness, or shortness of breath due to a reduction in the number of red blood cells, known as anemia
• Vomiting: if you vomit after taking a dose of Alecensa, do not take an extra dose, wait for the next dose at the usual time
• Constipation
• Diarrhea
• Nausea
• Rash
• Swelling caused by fluid retention in the body (edema)
• Weight gain.

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

• Abnormal results in blood tests to check kidney function (high level of creatinine)
• Mouth mucosa inflammation
• Sensitivity to sunlight: do not expose yourself to sunlight for any period of time while taking Alecensa and for 7 days after stopping treatment. You should use sunscreen and lip balm with a Sun Protection Factor of 50 or higher to prevent burns
• Alteration of taste
• Visual problems such as blurred vision, loss of vision, black or white spots, and double vision
• Increased levels of uric acid in the blood (hyperuricemia)

Rare (may affect up to 1 in 100 people):

• Renal problems, including rapid loss of kidney function (acute renal insufficiency)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and in the blister pack or bottle after EXP. The expiration date is the last day of the month indicated.
• For the presentation in blister packs of Alecensa, store in the original packaging to protect it from moisture.
• For the presentation in bottles of Alecensa, store in the original packaging and keep the bottle perfectly closed to protect it from moisture.
• Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Alecensa

• The active ingredient is alectinib. Each hard capsule contains alectinib chlorhydrate equivalent to 150mg of alectinib.
• The other components are:
• Capsule content:monohydrate lactose (see section2 "Alecensa contains lactose"), hydroxypropylcellulose, sodium lauryl sulfate (see section2 “Alecensa contains sodium”), magnesium stearate and calcium carmelose.
• Capsule coating:hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), cornstarch and carnauba wax.
• Printing ink:iron oxide red (E172), iron oxide yellow (E172), aluminium lake carmine indigo (E132), carnauba wax, white lacquer and monooleate of glycerol.

Appearance of the product and contents of the package

Alecensa hard capsules are white with “ALE” printed in black ink on the cap and “150mg” printed in black ink on the body.

The capsules are presented in blisters and are available in packages containing 224hard capsules (4packages of56). They are also available in plastic bottles containing 240hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Responsible for manufacturing

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.