ALECENSA 150 mg Hard Capsule

Зміст інструкції

1. Alecensa 150 mg hard capsules
   1. What is Alecensa and what is it used for
   2. What you need to know before taking Alecensa
   3. How to take Alecensa
   4. Possible side effects
   5. How to store Alecensa
   6. Package contents and other information

Alecensa 150 mg hard capsules

alectinib

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Alecensa and what is it used for

What is Alecensa
Alecensa is an anti-cancer medicine that contains the active substance alectinib.

What is Alecensa used for
Alecensa is used for the treatment of adult patients with a type of lung cancer called
“non-small cell lung cancer” or “NSCLC” which is “ALK-positive”, meaning that the
cancer cells have a defect in a gene that produces an enzyme called ALK fusion
(“anaplastic lymphoma kinase”); see the paragraph “How Alecensa works” below.
Alecensa may be prescribed to you:

• after removal of the cancer as post-surgical (adjuvant) treatment; or
• as first-line treatment for lung cancer that has spread to other parts of the body (advanced stage) or if you have previously been 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 defects in the gene that produces it) help to promote the growth of cancer
cells. Alecensa may slow down or stop the growth of the cancer you have and may
prevent the cancer from returning after surgical removal, as well as help to reduce the
cancer mass.
If you have any questions about how Alecensa works or why this medicine has been prescribed to
you, ask your doctor, pharmacist or nurse.

2. What you need to know before taking 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 unsure, ask your doctor, pharmacist or nurse before taking Alecensa.

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

• if you have previously had problems with your stomach or intestines, e.g., perforations, if you have conditions that cause inflammation inside your abdomen (diverticulitis) or if the cancer has spread to your abdomen (metastases). Alecensa may increase the risk of developing perforations of the intestinal wall;
• if you suffer from a hereditary condition called “galactose intolerance”, “Lapp lactase deficiency” or “glucose-galactose malabsorption”. If you are unsure, ask your doctor, pharmacist or nurse before taking Alecensa.

See your doctor immediately after taking Alecensa:

• if you experience severe stomach or abdominal pain, fever, chills, feeling unwell, vomiting or abdominal rigidity or swelling, these could be symptoms of perforation of the intestinal wall.

Alecensa can cause side effects that you must report to your doctor immediately. These effects
include:

• liver damage (hepatotoxicity). Your doctor will perform blood tests before starting treatment, then every 2 weeks for the first 3 months of treatment and, subsequently, with a lower frequency. This is to check for any liver problems during therapy with Alecensa. Tell your doctor immediately if you notice any of the following symptoms: yellowing of the skin or the whites of your eyes, pain in the right side of your abdomen, dark urine, itchy skin, decreased appetite compared to normal, nausea or vomiting, fatigue, increased ease of bleeding or bruising compared to normal;
• slowed heartbeat (bradycardia);
• lung inflammation (pneumonitis). During treatment, Alecensa may cause severe swelling (inflammation) of the lungs, which can be life-threatening. The signs of this condition may be similar to those of lung cancer that you have. Tell your doctor immediately if you notice the appearance of new signs or worsening of existing ones, including difficulty breathing, shortness of breath, cough with or without mucus, or fever;
• severe pain, tenderness and weakness in the muscles (myalgia). Your doctor will perform blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor immediately if you notice the appearance of new signs of muscle problems or worsening of existing ones, including unexplained or persistent muscle pain, tenderness or weakness;
• abnormal breakdown of red blood cells (hemolytic anemia). Tell your doctor immediately if you feel tired, weak or short of breath.

Pay attention to these side effects during treatment with Alecensa. For further
information see section 4 “Possible side effects”.

Sun sensitivity
During treatment with Alecensa and for 7 days after stopping it, do not expose yourself to sunlight for long
periods of time. You should apply a sunscreen and lip balm with a sun protection factor (SPF) of 50 or
higher to protect yourself from sunburn.

Tests and checks
Before starting treatment and during taking Alecensa your doctor will perform blood tests, then every 2
weeks for the first 3 months of treatment and, subsequently, with a lower frequency. This is to check for
any liver or muscle problems during therapy with Alecensa.

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

Other medicines and Alecensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal remedies.
Alecensa can affect the action of some medicines, just as other medicines can
interfere with the action of Alecensa.
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 prevent blood clots;
• methotrexate, a medicine used to treat severe joint inflammation, cancer and psoriasis (skin disease);
• nilotinib, a medicine used to treat some types of cancer;
• lapatinib, a medicine used to treat some types of breast cancer;
• mitoxantrone, a medicine used to treat some types of cancer or multiple sclerosis (a disease affecting the central nervous system that damages the protective covering of the nerves);
• everolimus, a medicine used to treat some types of cancer or, in the case of organ transplantation, to prevent rejection by the immune system;
• sirolimus, a medicine used, in the case of organ transplantation, to prevent rejection by the immune system;
• topotecan, a medicine used to treat some types of cancer;
• medicines used to treat acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV) (e.g., ritonavir, saquinavir);
• medicines used to treat infections. These include medicines for the treatment of fungal infections (antifungals, such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines for the treatment of some types of bacterial infections (antibiotics such as telithromycin);
• St John's Wort (hypericum), a herbal medicine used to treat depression;
• medicines used to stop seizures (antiepileptics 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 are taking oral contraceptives while taking Alecensa, they may be less
effective.

Alecensa with food and drink
Tell your doctor or pharmacist if you drink grapefruit juice or eat grapefruit or Seville oranges during treatment with Alecensa, as these may change the amount of
Alecensa in your body.

Contraception, pregnancy and breastfeeding - information for women
Contraception– information for women

• You should not become pregnant while taking this medicine. If there is a possibility of becoming pregnant, you should use highly effective contraceptive methods during treatment and for at least 3 months after stopping treatment. Talk to your doctor about the most suitable methods of contraception for you and your partner. If you are taking oral contraceptives while taking Alecensa, they may be less effective.

Pregnancy

• If you are pregnant, do not take Alecensa, as it may be harmful to the baby.
• If you become pregnant while taking the medicine or within 3 months of administering the last dose, tell your doctor immediately.

Breastfeeding

• Do not breastfeed during treatment with this medicine, as it is not known whether Alecensa is excreted in breast milk and could therefore be harmful to the baby.

Driving and operating machinery
Be particularly careful when driving vehicles and operating machinery, as
treatment with Alecensa may cause vision problems, a slowed
heartbeat or a drop in blood pressure, which can cause fainting or
dizziness.

Alecensa contains lactose
Alecensa contains lactose (a type of sugar). If your doctor has told you that you have an intolerance or
that you do not digest some sugars, contact your doctor before taking this medicine.

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

3. How to take Alecensa

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
are unsure, ask your doctor, pharmacist or nurse.

How much medicine to take

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

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

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

If you do not feel well, in some cases your doctor may reduce the dose to be taken, suspend the
treatment for a short period of time or discontinue it permanently.

How to take the medicine

• Alecensa is taken orally. Swallow the capsules whole. Do not open or dissolve the capsules.
• Alecensa must be taken with meals.

If you vomit after taking Alecensa
If you vomit after taking a dose of Alecensa, do not take another dose, but simply take the next one at the scheduled time.

If you take more Alecensa than you should
If you take more Alecensa than you should, contact a doctor or go to the hospital immediately.

If you forget to take Alecensa

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

If you stop taking Alecensa
Do not stop treatment with this medicine without first talking to your doctor. It is
important to take Alecensa twice a day until your doctor prescribes it.
If you have any doubts about 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 everyone gets them.
With this medicine you may experience the following side effects. Some side effects may be serious.

If you notice any of the following side effects, tell your doctor immediately.The
doctor may reduce the dose to be taken, suspend treatment for a short period of time
or discontinue it permanently:

• new or worsening signs including difficulty breathing, shortness of breath, cough with or without mucus, or fever; the signs may be similar to those of lung cancer you have (possible signs of lung inflammation - pneumonia). During treatment, Alecensa can cause, in fact, a life-threatening severe inflammation of the lungs;
• yellowing of the skin or the whites of the eyes, pain in the upper right side of the abdomen, dark urine, skin itching, reduced appetite compared to normal, nausea or vomiting, fatigue, increased ease of bleeding or bruising compared to normal (possible signs of liver problems);
• new signs of muscle problems or worsening of existing ones, including unexplained or persistent muscle pain, tenderness or weakness (possible signs of muscle problems);
• fainting, dizziness and low blood pressure (possible signs of slowed heartbeat);
• feeling tired, weak or short of breath (possible signs of abnormal breakdown of red blood cells, known as hemolytic anemia).

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 blood test results to check for liver problems (increased alanine aminotransferase, aspartate aminotransferase and bilirubin);
• abnormal blood test results to check for muscle damage (increased creatine phosphokinase);
• abnormal results of the blood test to check for liver disease or bone disorders (increased alkaline phosphatase);
• you may feel tired, weak or short of breath due to a decrease in the number of red blood cells (anemia);
• vomiting - if you vomit after taking a dose of Alecensa, do not take another dose, but simply take the next one at the scheduled time;
• constipation;
• diarrhea;
• nausea;
• skin rash;
• swelling caused by fluid accumulation in the body (edema);
• weight gain.

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

• abnormal results of the blood test to check kidney function (increased creatinine);
• inflammation of the oral mucosa;
• sensitivity to sunlight - during treatment with Alecensa and for 7 days after its discontinuation, do not expose yourself to sunlight for long periods of time. You will need to apply a sunscreen and lip balm with a protection factor (SPF) of 50 or higher to protect yourself from sunburn;
• altered sense of taste;
• eye problems, including blurred vision, vision loss, black spots or white spots in the field of vision and double vision;
• increased uric acid levels in the blood (hyperuricemia).

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

• kidney problems, including rapid loss of kidney function (acute kidney injury) Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

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 packaging and on the blister or bottle after Scad. The expiry date refers to the last day of that month.
• If Alecensa is packaged in blisters, keep the medicine in the original packaging to protect it from moisture.
• If Alecensa is packaged in bottles, keep the medicine in the original packaging and keep the bottle tightly closed to protect it from moisture.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alecensa contains

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

Description of Alecensa and package contents
Alecensa hard capsules are white in colour, with “ALE” and “150 mg” imprinted with black ink, respectively, on the cap and body of the capsule.
The capsules are supplied in blisters and are available in packs containing 224 hard capsules (4 packs of 56 capsules). The capsules are also available in plastic bottles 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
79639 Grenzach-Wyhlen
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

България
Рош България ЕООД
Тел: +359 2 474 5444

Luxembourg/Luxemburg
(See/siehe Belgique/Belgien)

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Malta
(See Ireland)

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Ελλάδα
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

France
Roche
Tél: +33 (0) 1 47 61 40 00

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

Hrvatska
Roche d.o.o.
Tel: +385 1 4722 333

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0700

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ísland
Roche Pharmaceuticals A/S
c/o Icepharma hf
Sími: +354 540 8000

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Italia
Roche S.p.A.
Tel: +39 - 039 2471

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

Kύπρος
Γ.Α.Σταμάτης & Σια Λτδ.
Τηλ: +357 - 22 76 62 76

Sverige
Roche AB
Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000
The European Medicines Agency will review at least annually new information on this

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

ANNEX IV
CONCLUSIONS RELATING TO THE REQUEST FOR ANNUAL DATA EXCLUSIVITY PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:

• data exclusivity for a period of one yearTaking into account the provisions of Article 14(11) of Regulation 726/2004/EC, the Committee for Medicinal Products for Human Use (Committee for Human Medicinal Products, CHMP) has examined the data presented by the marketing authorisation holder and considers that the new therapeutic indication provides a significant clinical benefit compared to existing therapies, as further described in the European Public Assessment Report (European Public Assessment Report, EPAR).