ALECENSA 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Alecensa 150 mg Hard Capsules

alectinib

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.

Contents of the Pack

1. What is Alecensa and what is it used for
2. What you need to know before you take Alecensa
3. How to take Alecensa
4. Possible side effects
5. Storage of Alecensa
6. Package contents and further information

1. What is Alecensa and what is it 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 with a type of lung cancer called "non-small cell lung cancer" ("NSCLC") that is 'ALK positive' – this means that your 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'.

You may be given Alecensa:

• after surgery to remove the cancer, as a post-operative treatment (adjuvant), or
• as a first treatment for your lung cancer that has spread to other parts of the body (advanced), or if you have already been treated with a medicine that contains 'crizotinib'.

How Alecensa works

Alecensa blocks the action of an enzyme called "tyrosine kinase ALK". The 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 the growth of the cancer and may prevent the tumor from coming back after surgical removal. It may also help reduce it.

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 starting Alecensa:

• if you have ever had stomach or intestinal problems such as holes (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 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 stomach or abdominal pain, fever, chills, illness, vomiting, or abdominal rigidity or swelling, as these could be symptoms of holes in the wall of your intestine.

Alecensa may cause side effects that you should tell your doctor about immediately. These include:

• liver damage (hepatotoxicity). Your doctor will perform blood tests before starting treatment, every 2 weeks during the first 3 months of treatment, and less frequently thereafter. This is to check that you do not have any liver problems while taking Alecensa. Tell your doctor immediately if you experience any of the following side effects: yellowing of your skin or the whites of your eyes, pain in the right side of your stomach, dark urine, itching of the skin, decreased appetite, nausea or vomiting, tiredness, bleeding, or bruising more easily.
• slow heart rate (bradycardia)
• inflammation of the lungs (pneumonitis). Alecensa may cause severe or potentially life-threatening inflammation of the lungs during treatment. The symptoms may be similar to those of your lung cancer. Tell 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.
• severe muscle pain, sensitivity, and weakness (myalgia). Your doctor will perform blood tests at least every 2 weeks during the first month and as needed during treatment with Alecensa. Tell your doctor immediately if you notice new or worsening muscle problems, including unexplained muscle pain or muscle pain that does not go away, sensitivity, or weakness.
• abnormal destruction of red blood cells (hemolytic anemia). Tell your doctor immediately if you feel tired, weak, or have difficulty breathing.

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

Sensitivity to sunlight

Do not sunbathe for any length of time while taking Alecensa or for 7 days after stopping treatment. You should use sunscreen and lip balm with a Sun Protection Factor (SPF) of 50 or higher to avoid sunburn.

Tests and analyses

During treatment with Alecensa, your doctor will perform blood tests before starting treatment, every 2 weeks during the first 3 months 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 give this medicine to children or adolescents under 18 years of age.

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 may affect the way other medicines work. Other medicines may also affect the way Alecensa works.

Tell your doctor or pharmacist, in particular, 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 severe inflammation of the joints, cancer, and psoriasis
• 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 that affects the central nervous system and damages the protective covering of nerves)
• everolimus, a medicine used to treat certain types of cancer or to prevent organ transplant rejection
• sirolimus, a medicine used to prevent organ transplant rejection
• topotecan, a medicine used to treat certain types of cancer
• medicines used to treat HIV/AIDS (e.g., ritonavir, saquinavir)
• medicines used to treat infections, including antifungal medicines (e.g., ketoconazole, itraconazole, voriconazole, posaconazole) and antibiotics (e.g., telithromycin)
• St. John's Wort, a herbal medicine used to treat depression
• medicines used to prevent seizures or fits (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 take Alecensa while using oral contraceptives, the oral contraceptives may be less effective.

Using Alecensa with food and drinks

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

Contraception, pregnancy, and breastfeeding

Contraception - Information for women

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

Talk to your doctor about the contraceptive methods that are suitable 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 in the 5 weeks after your last dose, tell your doctor immediately.
• If your female partner becomes pregnant while you are taking this medicine or in the 3 months after your last dose, tell your doctor immediately and your female partner should seek medical advice.

Breastfeeding

• Do not breastfeed while taking this medicine. It is not known whether Alecensa passes into breast milk, and therefore may harm your baby.

Driving and using machines

Be careful while driving or using machines, as you may develop vision problems or slow heart rate or low blood pressure that may lead to fainting or dizziness 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 some sugars, talk to your doctor before taking this medicine.

Alecensa contains sodium

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

3. 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 a day.
• This is equivalent to a total of 8 capsules (1200 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) per day.

Occasionally, your doctor may reduce your dose, interrupt your treatment for a short period, or stop treatment altogether if you feel unwell.

How to take it

• Alecensa is taken by mouth. You should 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 an extra dose, wait until 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 immediately. Take the medicine pack and this leaflet with you.

If you forget to take Alecensa

• If it is more than 6 hours before your next dose, take the missed dose as soon as you remember.
• If it is less than 6 hours 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 a forgotten dose.

If you stop taking Alecensa

Do not stop taking this medicine without talking to your doctor first. It is important that you take Alecensa twice a day for the time your doctor has prescribed.

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 may be serious.

Tell 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, or stop treatment altogether:

• New symptoms or worsening of symptoms, including difficulty breathing, shortness of breath, cough with or without mucus, or fever. The symptoms may be similar to those of your lung cancer (potential symptoms of pneumonitis). Alecensa may cause severe or potentially life-threatening inflammation of the lungs during treatment.
• Yellowing of your skin or the whites of your eyes, pain in the right side of your stomach, dark urine, itching of the skin, decreased appetite, nausea or vomiting, tiredness, bleeding, or bruising more easily (potential symptoms of liver problems).
• New symptoms or worsening of symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, 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 (signs of potential hemolytic anemia).

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 to check liver function (elevated levels of alanine aminotransferase, aspartate aminotransferase, and bilirubin)
• abnormal blood test results to check muscle damage (elevated levels of creatine phosphokinase)
• abnormal blood test results to check liver disease or bone disorders (high levels of alkaline phosphatase)
• you may notice tiredness, 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 until your 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 blood test results to check kidney function (high levels of creatinine)
• inflammation of the mouth mucosa
• sensitivity to sunlight: do not sunbathe for any length of time while taking Alecensa and for 7 days after stopping treatment. You should use sunscreen and lip balm with a Sun Protection Factor (SPF) of 50 or higher to avoid sunburn
• altered sense of taste
• vision problems such as blurred vision, loss of vision, seeing black or white spots, and double vision
• increased levels of uric acid 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 blister or bottle after EXP. The expiry date refers to the last day of the month shown.
• For the blister pack presentation of Alecensa, store in the original package to protect from moisture.
• For the bottle presentation of Alecensa, store in the original package and keep the bottle tightly closed to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Alecensa Composition

• The active ingredient is alectinib. Each hard capsule contains alectinib hydrochloride equivalent to 150 mg of alectinib.
• The other components are:
• Capsule Content: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), aluminum carmine indigo lacquer (E132), carnauba wax, white lacquer, and glycerol monooleate.

Product Appearance and Container Content

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

The capsules are presented in blisters and are available in packs containing 224 hard capsules (4 packs of 56). They are also available in plastic bottles containing 240 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.