Alecensa

Patient information leaflet

Alecensa 150 mg hard capsules

alectinib
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 an anticancer medicine that contains the active substance alectinib.
What Alecensa is used for
Alecensa is used to treat adult patients with a type of lung cancer called
"non-small cell lung cancer" or "NSCLC" that is "ALK-positive", meaning that
the cancer cells have a defect in a gene that produces an enzyme known as ALK fusion
("anaplastic lymphoma kinase"); see the section “How Alecensa works” below.
Alecensa may be prescribed to you:

• after removal of the cancer as post-surgical treatment (adjuvant); 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) contribute to the growth of cancer cells. Alecensa may slow down or stop the growth of your cancer, prevent the cancer from returning after surgical removal, and help reduce the size of tumours.
If you have any questions about how Alecensa works or why this medicine has been prescribed for you, speak to your doctor, pharmacist, or nurse.

2. What you should know before taking Alecensa

Do not take Alecensa

• if you are allergic to alectinib or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor, pharmacist, or nurse before taking Alecensa.

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

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

Contact your doctor immediately after taking Alecensa:

• if you experience severe stomach or abdominal pain, fever, chills, malaise, vomiting, or abdominal stiffness or swelling, as these could be symptoms of intestinal wall perforation.

Alecensa may cause side effects that you must report immediately to your doctor. 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 less frequently thereafter. This allows monitoring for liver problems during Alecensa therapy. Inform your doctor immediately if you notice any of the following symptoms: yellowing of the skin or whites of the eyes, pain in the right side of the abdomen, dark urine, skin itching, reduced appetite, nausea or vomiting, fatigue, or increased tendency to bleed or bruise;
• slow heart rate (bradycardia);
• lung inflammation (pneumonitis). During treatment, Alecensa may cause severe swelling (inflammation) of the lungs, which could be life-threatening. The signs of this condition may resemble those of the lung cancer you have. Inform your doctor immediately if you develop new symptoms or if existing symptoms worsen, including difficulty breathing, shortness of breath, cough (with or without mucus), or fever;
• severe muscle pain, tenderness, and weakness (myalgia). Your doctor will perform blood tests at least every 2 weeks during the first month and as needed thereafter during Alecensa treatment. Inform your doctor immediately if you develop new signs of muscle problems or if existing symptoms worsen, including unexplained or persistent muscle pain, tenderness, or weakness;
• abnormal breakdown of red blood cells (hemolytic anemia). Inform your doctor immediately if you feel tired, weak, or short of breath.

Be aware of these adverse effects during treatment with Alecensa. For further information, see section 4 “Possible side effects”.
Sensitivity to sunlight
During treatment with Alecensa and for 7 days after stopping it, avoid prolonged exposure to sunlight. You should apply sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher to protect against sunburn.
Tests and monitoring
Before starting treatment and during Alecensa therapy, your doctor will perform blood tests every 2 weeks for the first 3 months, and less frequently thereafter. This allows monitoring for liver or muscle problems during Alecensa treatment.
Children and adolescents
Alecensa has not been studied in children and adolescents. Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Alecensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription and herbal remedies.
Alecensa may affect the action of certain drugs, and other medicines may interfere with the action of Alecensa.
In particular, inform 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 (a skin disease);
• 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 multiple sclerosis (a disease of the central nervous system that damages the protective covering of nerves);
• everolimus, a medicine used to treat certain types of cancer or, in organ transplant patients, to prevent immune system rejection;
• sirolimus, a medicine used in organ transplant patients to prevent immune system rejection;
• topotecan, a medicine used to treat certain 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 antifungal medicines (antimycotics such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines for treating certain bacterial infections (antibiotics such as telithromycin);
• St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression;
• medicines used to prevent 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 using oral contraceptives while taking Alecensa, they may be less effective.
Alecensa with food and drink
Inform your doctor or pharmacist if during treatment with Alecensa you drink grapefruit juice or eat grapefruit or Seville oranges, as these may alter the amount of Alecensa in your body.
Contraception, pregnancy and breastfeeding – information for women
Contraception, pregnancy and breastfeeding
Contraception – information for women

• You must not become pregnant while taking this medicine. If you are of childbearing potential, you must use highly effective contraceptive methods during treatment and for at least 5 weeks after stopping treatment. If you are using oral contraceptives during Alecensa treatment, they may be less effective.

Contraception – Information for men

• You must not father a child while taking this medicine. If your partner is of childbearing age, you must use a highly effective contraceptive method during treatment and for at least 3 months after stopping treatment.

Discuss with your doctor which contraceptive methods are suitable for you and your partner.
Pregnancy

• Do not take Alecensa if you are pregnant, as it could be harmful to the unborn child.
• If you become pregnant while taking the medicine or within 5 weeks after the last dose, inform your doctor immediately.
• If your partner becomes pregnant while you are taking the medicine or within 3 months after the last dose, inform your doctor immediately. Your partner should seek medical advice.

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 infant.

Driving and using machines
Exercise particular caution when driving vehicles or operating machinery, as treatment with Alecensa may cause vision problems, a slow heart rate, or low blood pressure, which could lead to fainting or dizziness.
Alecensa contains lactose
Alecensa contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance or difficulty digesting certain sugars, consult your doctor before taking this medicine.
Alecensa contains sodium
This medicine contains 48 mg of sodium (the main component of table salt) per recommended daily dose (1200 mg). This is equivalent to 2.4% of the maximum daily dietary sodium intake recommended for an adult.

3. How to take Alecensa

Take this medicine exactly as instructed by your doctor or pharmacist. If
you are unsure, consult your doctor, pharmacist, or nurse.
How much medicine to take

• The recommended dose is 4 capsules (600 mg), taken 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), taken 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 your dose, temporarily suspend
treatment, or stop it permanently.
How to take the medicine

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

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
dose 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 hospital immediately.
Take the medicine pack and leaflet with you.
If you forget to take Alecensa

• If there are more than 6 hours until your next dose, take the missed dose as soon as you remember.
• If there are less than 6 hours until your next dose, skip the missed dose. Then take the next dose at the scheduled time.
• Do not take a double dose to make up for a forgotten 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 daily for as long as your doctor prescribes it.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience the following side effects with this medicine. Some side effects could be serious.
If you notice any of the following side effects, inform your doctor immediately. Your doctor may reduce your dose, temporarily stop treatment or permanently discontinue it:

• new symptoms or worsening of existing ones including difficulty breathing, shortness of breath, cough with or without mucus, or fever; symptoms may resemble those of the lung cancer you have (possible signs of lung inflammation - pneumonia). During treatment, Alecensa may in fact cause a severe and potentially life-threatening inflammation of the lungs;
• yellowing of the skin or the whites of the eyes, pain in the right side of the abdomen, dark urine, skin itching, reduced appetite, nausea or vomiting, fatigue, increased tendency to bleed or bruise (possible signs of liver problems);
• new or worsening muscle problems, including unexplained or persistent muscle pain, tenderness or weakness (possible signs of muscle problems);
• fainting, dizziness and low blood pressure (possible signs of slowed heart rate);
• feeling tired, weak or short of breath (possible signs of abnormal breakdown of red blood cells, known as haemolytic anaemia).

Other side effects
Tell 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 blood test results indicating possible liver problems (increased alanine aminotransferase, aspartate aminotransferase and bilirubin);
• abnormal blood test results indicating possible muscle damage (increased creatine phosphokinase);
• abnormal blood test results indicating possible liver disease or bone disorders (increased alkaline phosphatase);
• feeling tired, weak or short of breath due to a reduced number of red blood cells (anaemia);
• vomiting – if you vomit after taking a dose of Alecensa, do not take another dose; simply take the next dose at the scheduled time;
• constipation;
• diarrhoea;
• nausea;
• rash;
• swelling due to fluid retention (oedema);
• weight gain.

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

• abnormal blood test results indicating kidney function problems (increased creatinine);
• inflammation of the mouth lining;
• sensitivity to sunlight – during treatment with Alecensa and for 7 days after stopping it, avoid prolonged exposure to sunlight. You should apply sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher to protect against sunburn;
• altered sense of taste;
• eye problems, including blurred vision, vision loss, black spots or white spots in the visual field, and double vision;
• increased levels of uric acid in the blood (hyperuricaemia).

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, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 use this medicine after the expiry date which is stated on the pack and on the blister or bottle after Exp. The expiry date refers to the last day of that month.
• If Alecensa is packaged in blisters, store the medicine in the original packaging to protect it from moisture.
• If Alecensa is packaged in bottles, store the medicine in the original packaging and keep the bottle tightly closed to protect it from moisture.
• Do not dispose of any medicine via 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 components are:
  • Capsule contents: monohydrate lactose (see section 2 “Alecensa contains lactose”), hydroxypropylcellulose, sodium lauryl sulfate (see section 2 “Alecensa contains sodium”), magnesium stearate and calcium carmellose;
  • Capsule cap: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax;
  • Printing ink: red iron oxide (E172), yellow iron oxide (E172), aluminium lake, indigo carmine (E132), carnauba wax, white shellac gum and glyceryl mono-oleate.

Description of the appearance of Alecensa and contents of the pack
Alecensa hard capsules are white, printed with “ALE” and “150 mg” in black ink on the cap and body of the capsule, respectively.
The capsules are supplied in blisters and available in packs containing 224 hard capsules (4 packs of 56 capsules). 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
Grenzach-Wyhlen
Germany

Manufacturer
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 Authorisation Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 474 5444

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Roche (Hellas) A.E. Roche AB
Τηλ: +30 210 61 66 100 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

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