Talzenna - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib

• ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

• 1. What Talzenna is and what it is used for

• 2. What you need to know before you take Talzenna

• 3. How to take Talzenna

• 4. Possible side effects

• 5. How to store Talzenna

• 6. Contents of the pack and other information

1. What Talzenna is and what it is used for

What Talzenna is and how it works

Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor’.

Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and they die.

What Talzenna is used for

Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.

Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.

Your healthcare provider will perform a test to make sure that Talzenna is right for you.

If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Talzenna

Do not take Talzenna

• – If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in section 6).

• – If you are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you experience signs or symptoms described in this section.

Low blood cell counts

Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:

• - Anaemia: Being short of breath, feeling very tired, pale skin, or fast heartbeat – these may be signs of a low red blood cell count

• - Neutropenia: Infection, developing chills or shivering, or fever – these may be signs of a low white blood cell count

• - Thrombocytopenia: Bruising or bleeding for longer than usual if you hurt yourself – these may be signs of a low blood platelet count

You will have regular blood tests during treatment with Talzenna to check your blood cells (white blood cells, red blood cells, and platelets).

Serious problems with the bone marrow

Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may want to test your bone marrow to check for these problems.

Male and female contraception

Women who can become pregnant and men with partners who are or can become pregnant should use effective contraception.

Please see section “Male and female contraception” be­low.

Children and adolescents

Talzenna is not to be used in children or adolescents (under 18 years of age).

Other medicines and Talzenna

Tell your doctor, pharmacist or nurse 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 Talzenna can affect the way some other medicines work. Also some medicines can affect the way Talzenna works.

In particular, the following may increase the risk of side effects with Talzenna:

• – Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamil -generally used to treat heart problems.

• – Clarithromycin and erythromycin antibiotics – used to treat bacterial infections.

• – Itraconazole and ketoconazole – used to treat fungal infections.

• – Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir used to treat HIV infections/AIDS.

• – Ciclosporin – used in organ transplantation to prevent rejection.

• – Lapatinib – used to treat patients with certain types of breast cancer.

• – Curcumin (e.g. found in turmeric root) in some medicines (see also section Talzenna with food and drink below).

The following medicines may reduce the effect of Talzenna:

• – Carbamazepine and phenytoin – anti-epileptics used to treat seizures or fits.

• – St. John’s wort (Hypericum perforatum ) – a herbal remedy used to treat mild depression and anxiety.

Talzenna with food and drink

Do not use curcumin in food supplements while you are taking Talzenna as it may increase Talzenna’s side effects. Curcumin is found in turmeric root and you should not use large amounts of turmeric root, but using spices in food is not likely to cause a problem.

Pregnancy

Talzenna could harm an unborn baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will perform a pregnancy test prior to starting Talzenna.

• – You should not use Talzenna if you are pregnant.

• – You should not become pregnant while taking Talzenna.

• – Discuss contraception with your doctor if there is any possibility that you or your partner may

become pregnant.

Male and female contraception

Women who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods.

Talk to your healthcare provider about birth control methods that may be right for you.

Men with female partners who are pregnant or able to become pregnant should use effective birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.

Breast-feeding

You should not breast-feed while taking Talzenna and for at least 1 month after the last dose. It is not known if Talzenna passes into breast milk.

Fertility

Talazoparib may reduce fertility in men.

Driving and using machines

Talzenna may have a minor influence on the ability to drive and use machines. If you feel dizzy, weak, or tired (these are very common side effects of Talzenna), you should not drive or use machines.

3. How to take Talzenna

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

How much to take

The recommended dose is one 1-mg capsule taken by mouth once daily.

If you get certain side effects while you are taking Talzenna (see section 4), your doctor may lower your dose or stop treatment, either temporarily or permanently. The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.

Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. You can take Talzenna with food or between meals. Do not open the capsules. Contact with the capsule content should be avoided.

If you take more Talzenna than you should

If you have taken more Talzenna than your normal dose, contact your doctor or nearest hospital right away. Urgent treatment may be necessary.

Take the carton and this leaflet so that the doctor knows what you have been taking.

If you forget to take Talzenna

If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up for the forgotten or vomited capsules.

If you stop taking Talzenna

Do not stop taking Talzenna unless your doctor tells you to.

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

4. Possible side effects

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

Tell your doctor straight away if you notice any of the following symptoms which could be a sign of serious blood disorder:

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

• – Being short of breath, feeling very tired, having pale skin, or fast heartbeat – these may be signs of a low red blood cell count (anaemia).

• – Infection, developing chills or shivering, or fever or feeling hot – these may be signs of a low white blood cell count (neutropenia).

• – Bruising or bleeding for longer than usual if you hurt yourself – these may be signs of a low blood platelet count (thrombocytopenia).

Talk to your doctor if you get any other side effects. These can include:

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

• – Low counts of white blood cells, red blood cells, and blood platelets

• – Decreased appetite

• – Feeling dizzy

• – Headache

• – Feeling sick (nausea)

• – Being sick (vomiting)

• – Diarrhoea

• – Pain in the abdomen

• – Hair loss

Common (may affect up to 1 in 10 people)

• – Alteration in taste (dysgeusia)

• – Indigestion

• – Mouth inflammation

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. 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.

5. How to store Talzenna

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

This medicine does not require any special storage conditions.

Do not use this medicine if the pack is damaged or shows signs of tampering.

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.

6. Contents of the pack and other information

What Talzenna contains

• – The active substance is talazoparib. Talzenna hard capsules come in different strengths.

• – Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.

• – Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.

The other ingredients are:

• – Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).

• – 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)

• – 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)

What Talzenna looks like and contents of the pack

Talzenna 0.25 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).

Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).

Talzenna 0.25 mg is available in perforated unit dose blister packs of 30, or 60, or 90 hard capsules and in plastic bottles of 30 hard capsules.

Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Excella GmbH & Co. KG

Nürnberger Strasse 12

90537 Feucht

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Luxembourg/Lu­xemburg Pfizer NV/SA

Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: + 370 52 51 4000

Tél/Tel: +32 (0)2 554 62 11

Bt^rapuH n<|)aÜ3ep ^æKceMÔypr C’APÆ K.toh Etnrapua Tea.: +359 2 970 4333	Magyarország Pfizer Kft. Tel.: +36–1–488–37–00
Česká republika Pfizer, spol. s r.o. Tel: +420 283 004 111	Malta Vivian Corporation Ltd Tel: +356 21344610
Danmark Pfizer ApS Tlf: +45 44 20 11 00	Nederland Pfizer BV Tel: +31 (0)10 406 43 01
Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055–51000	Norge Pfizer AS Tlf: +47 67 52 61 00
Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500	Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15–0
EZÍ.áóa Pfizer EÂÂàc A.E. Tp/.: +30 210 6785 800	Polska Pfizer Polska Sp. z o.o. Tel.:+48 22 335 61 00
España Pfizer, S.L. Tel: +34 91 490 99 00	Portugal Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
France Pfizer Tél: +33 (0)1 58 07 34 40	România Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 00
Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 777	Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616161	Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 43 00 40

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Latvija

Pfizer Luxembourg SARL filiale Latvija

Tel: + 371 670 35 775

This leaflet was last revised in MM/YYYY.

Other sources of information

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

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