Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - copiktra

Document Subject

Generated Narrative: MedicinalProductDefinition mp74778e8109bf478af8bf20ce15b25c4c

identifier: http://ema.europa.eu/identifier/EU/1/21/1542/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Copiktra 15 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-74778e8109bf478af8bf20ce15b25c4c

identifier: http://ema.europa.eu/identifier/EU/1/21/1542/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - copiktra

Attesters

What is in this leaflet

1. What Copiktra is and what it is used for
2. What you need to know before you take Copiktra
3. How to take Copiktra
4. Possible side effects
5. How to store Copiktra
6. Contents of the pack and other information

Copiktra is a cancer medicine that contains the active substance duvelisib. It works by blocking the effects of enzymes needed for the growth and survival of B-lymphocytes (a type of white blood cell). These enzymes are overactive in certain cancerous white blood cells and by blocking them Copiktra can kill and reduce the number of cancerous B-lymphocytes.

Copiktra is used for the treatment of cancers of B-lymphocytes called
chronic lymphocytic leukaemia (or small lymphocytic lymphoma) follicular leukaemia.

In these diseases the B-lymphocytes multiply too quickly and live too long, so there are too many of them in the blood or lymph nodes. Copiktra is used when patients have previously been given at least 2 other therapies that did not work or are no longer working.

Do not take Copiktra

• if you are allergic to duvelisib or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor before taking Copiktra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Copiktra,

• if you have an infection. This must be treated before you start taking Copiktra.
• if you have intestinal problems
• if you have lung or breathing problems

Infections Infections are common during Copiktra treatment, and can be serious and can lead to death. Tell your doctor, pharmacist, or nurse right away if you have fever, chills, or other signs of an infection during treatment with Copiktra. Your doctor may prescribe another medicine while you are taking Copiktra, to prevent certain types of infection.

Diarrhoea or inflammation of your intestine
Diarrhoea or inflammation of your intestine (colitis) is common during Copiktra treatment, and can be serious and can lead to death. Tell your doctor or pharmacist right away if you have any new or worsening diarrhoea, you pass mucus or blood when going to the toilet, or if you have severe abdominal (stomach area) pain. Your doctor or pharmacist should prescribe medicine to help your diarrhoea and check you at least weekly. If your diarrhoea is severe or anti-diarrhoea medicines do not work, you may need treatment with a steroid medicine.

Skin reactions
Copiktra can cause rashes and other skin reactions that can be serious and can lead to death. Tell your doctor or pharmacist right away if you get new or worsening skin rash, or other skin reactions during treatment with Copiktra, including:

• painful sores or ulcers on your skin, lips, or in your mouth
• severe rash with blisters or peeling skin
• rash with itching
• rash with fever Your doctor may need to prescribe medicines, including a steroid medicine, to treat your skin rash or other skin reactions.

Inflammation of the lungs
Copiktra can cause inflammation of your lungs which can be serious and can lead to death. Tell your doctor or pharmacist right away if you get new or worsening cough or difficulty breathing. Your doctor may do tests to check your lungs if you have breathing problems. Your doctor may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.

Elevated liver enzymes Copiktra may cause abnormalities in blood tests for your liver. Your doctor will check for liver problems during your treatment with Copiktra. Tell your doctor right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), abdominal pain, bruising or bleeding more easily than normal.

Blood counts Low white blood cell counts (neutropenia) and decrease in red blood cell (anaemia or bloodlessness) can occur in patients treated with Copiktra. Both can be serious. Your doctor will check your blood counts regularly. Tell your doctor right away if you get fever or any signs of infection, if you feel tired or dizzy, or if you have headache.

If you have any of the above serious side effects during treatment with Copiktra, your doctor may pause your treatment, change your dose of Copiktra, or completely stop your treatment with Copiktra.

Children and adolescents Do not give this medicine to children and adolescents under 18 years of age because it has not been studied in this age group.

Other medicines and Copiktra Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Copiktra can affect the way some other medicines work and some other medicines can affect the way Copiktra works.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
• alfuzosin, a medicine used to treat an enlarged prostate
• amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil, medicines used to treat high blood pressure and heart problems
• amprenavir, atazanavir, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, medicines used to treat HIV infections
• aprepitant, a medicine used to prevent vomiting
• boceprevir, telaprevir, medicines used to treat hepatitis C
• bosentan, a medicine used to treat pulmonary hypertension, a lung disease that makes breathing difficult
• budesonide, fluticasone, steroid medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• carbamazepine, mephenytoin, phenytoin, medicines used to prevent seizures
• ciclosporin, sirolimus, tacrolimus, medicines used to prevent organ rejection after a transplant
• ciprofloxacin, clarithromycin, erythromycin, nafcillin, telithromycin, medicines used to treat bacterial infections
• cisapride, a medicine used to relieve certain stomach problems
• colchicine, a medicine used to treat gout
• conivaptan, a medicine to treat heart problems
• dabigatran, warfarin, medicines used to prevent blood clots
• dasatinib, imatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
• dihydroergotamine, ergotamine, medicines used to treat migraine headache
• fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections
• midazolam, triazolam, when taken by mouth to help you sleep or relieve anxiety
• modafinil, a medicine used to treat excessive sleepiness
• oral or implanted hormonal contraceptives, used to prevent pregnancy
• pimozide, a medicine used to treat abnormal thoughts or feelings
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
• rifabutin, rifampicin medicines used to treat bacterial infections including tuberculosis
• sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
• statin medicines such as atorvastatin, lovastatin, simvastatin, used to lower cholesterol
• St. John s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
• trazodone, a medicine used to treat depression

Copiktra with food and drink Avoid drinking grapefruit juice. Grapefruit juice can affect the way Copiktra works.

Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. A pregnancy test should be conducted before taking Copiktra.

Use of Copiktra should be avoided during pregnancy.

If you become pregnant during treatment with Copiktra, tell your doctor as soon as possible.

Breast-feeding

It is not known if Copiktra passes into breast milk. Do not breast-feed during treatment with Copiktra and for at least 1 month after the last dose.

Contraception Use effective contraception, which includes two forms of reliable contraception, during treatment and for at least 1 month after receiving the last dose of Copiktra.

Contraceptive pills It is not known if Copiktra reduces the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Copiktra you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Driving and using machines Copiktra is unlikely to affect your ability to drive and use machines.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose of Copiktra is 25 mg taken by mouth twice a day. However, your doctor may change your dose of Copiktra or ask you to stop taking Copiktra if you get particular side effects. Do not change your dose or stop taking Copiktra without talking to your doctor first.

Swallow Copiktra capsules whole.
Do not open, break, or chew the capsules . You may take Copiktra with food or between meals. Tell your doctor or caregiver if you have problems swallowing these capsules.

If you take more Copiktra than you should If you take too much Copiktra, call your doctor or pharmacist right away or go to the nearest hospital emergency room. Take the medicine and this leaflet with you so that you can easily describe what you have taken.

If you forget to take Copiktra Take care not to miss a dose of Copiktra. If you miss a dose of Copiktra by less than 6 hours, take the missed dose right away, and then take the next dose at your usual time. If you miss a dose by more than 6 hours, wait and take the next dose at your usual time. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Copiktra Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be serious.

Get medical help immediately if you experience any of the following:

• Fever, chills, or other signs of an infection
• New or worsening diarrhoea, stool with mucus or blood, or severe abdominal (stomach area) pain
• New or worsening skin rash, or other skin reactions including
• painful sores or ulcers on your skin, lips, or in your mouth * severe rash with blisters or peeling skin * rash with itching and/or fever
• New or worsening cough or difficulty breathing

Other side effects

Very common: may affect more than 1 in 10 people

• Infections of the upper and lower respiratory tract, lung infection (pneumonia)
• Decrease in some white blood cells (neutropenia)
• Decrease in red blood cell (anaemia)
• Decrease in cells in the blood that help the blood to clot (thrombocytopenia)
• Decreased appetite
• Headache
• Shortness of breath (dyspnoea)
• Cough
• Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting, nausea, stomach pain
• Difficulty passing stools (constipation)
• Skin rash sometimes with blisters
• Pain in the muscles, bones (musculoskeletal pain) and joints (arthralgia)
• Fever
• Feeling tired or weak
• Increased level of a specific protein in blood that measures function of pancreas
• Increased levels of liver enzymes seen in blood tests

Common: may affect up to 1 in 10 people

• Infection can spread to vital organs causing the organs to not function properly (sepsis)
• Inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing)

Uncommon: may affect up to 1 in 100 people

• Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with increase in white blood cell counts (eosinophilia) and symptoms affecting the whole body)

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects 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.

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 the blister after EXP. The expiry date refers to the last day of that month.

Store below 30 C.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Copiktra contains

• The active substance is duvelisib. Each hard capsule contains 15 mg or 25 mg duvelisib (as monohydrate).
• The other ingredients are: Capsule content: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. Capsule shell: gelatin, titanium dioxide (E 171), red iron oxide (E 172). Printing black ink: shellac glaze, iron oxide black (E 172), propylene glycol, ammonium hydroxide.

What Copiktra looks like and contents of the pack

Copiktra 15 mg hard capsules

• Opaque pink capsule with duv 15 mg printed on the body in black ink.
• Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).

Copiktra 25 mg hard capsules

• Opaque capsule with a white to off-white body and Orange cap with duv 25 mg printed on the body in black ink.
• Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).

Marketing Authorisation Holder Secura Bio Limited 32 Molesworth Street Dublin 2
Ireland

Manufacturer
Millmount Healthcare Limited (trading as PCI Pharma Services) Block 7, City North Business Campus Stamullen, Co. Meath, K32 YDIreland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: