Talzenna

Package leaflet: Information for the patient

Talzenna 0.1 mg hard capsules, 0.25 mg hard capsules, 0.35 mg hard capsules, 0.5 mg hard capsules, 1 mg hard capsules

talazoparib
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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Talzenna is and what it is used for
2. What you need to know before taking 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, also known
as a PARP (poly-ADP ribose polymerase) inhibitor.
Talzenna works by blocking PARP, an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and die.

What Talzenna is used for
Talzenna is a medicine used:

• on its own to treat adults with a type of breast cancer known as HER2-negative breast cancer who have an inherited abnormal BRCA gene. Your healthcare provider will perform a test to make sure Talzenna is the right choice for you;
• in combination with a medicine called enzalutamide, to treat adults with prostate cancer that no longer responds to hormone therapy or surgical treatment to lower testosterone.

Talzenna is used when the cancer has spread beyond the original tumour to other parts of the body.
If you have any questions about how Talzenna works or why this medicine has been prescribed for you,
please consult your doctor.

2. What you should know before taking 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 breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Talzenna and during treatment
if you experience any signs or symptoms described in this section.
Low blood cell counts
Talzenna reduces your blood cell counts: red blood cell count (anemia), white blood cell count (neutropenia), platelet count (thrombocytopenia). Signs and symptoms to watch for include:

• anemia: shortness of breath, extreme tiredness, paleness, or rapid heartbeat (these may be signs of low red blood cell count).
• neutropenia: infection, chills or shaking, or fever (these may be signs of low white blood cell count).
• thrombocytopenia: bruising or bleeding that lasts longer than normal after injury (these may be signs of low platelet count).

You will have regular blood tests during treatment with Talzenna to monitor your blood cells (white blood cells, red blood cells, and platelets).
Serious bone marrow-related conditions
In rare cases, low blood cell counts may be a sign of more serious bone marrow-related conditions such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Your doctor may decide to perform a bone marrow examination to confirm or rule out these conditions.
Blood clots
Talzenna may cause blood clots in the veins. Inform your doctor, pharmacist, or nurse if you experience signs or symptoms of blood clots in the veins, such as pain or stiffness, swelling, and redness in the affected leg (or arm), chest pain, shortness of breath, or dizziness.
Contraception in men and women
Women of childbearing potential and men with partners of childbearing potential must use an effective contraceptive method.
See the section “Contraception in men and women” below.
Children and adolescents
Talzenna must not be used in children and 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 over-the-counter medicines and herbal remedies. This is because Talzenna may affect how some other medicines work. In addition, some medicines may affect how Talzenna works.
In particular, the following medicines may increase the risk of side effects when taken with Talzenna:

• amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine, and verapamil – generally used to treat heart conditions.
• antibiotics containing clarithromycin and erythromycin – 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/AIDS infections.
• 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 certain supplements (see also section Talzenna with food and drink below).

The following medicines may reduce the effectiveness of Talzenna:

• carbamazepine and phenytoin – antiepileptic medicines 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 dietary supplements containing curcumin when taking Talzenna, as they may increase Talzenna’s side effects. Curcumin is found in turmeric root; therefore, you should not consume large amounts of turmeric root, although using spices in food is unlikely to cause problems.
Pregnancy
Talzenna may harm the unborn baby. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will perform a pregnancy test before you start taking Talzenna.

• You must not take Talzenna if you are pregnant, unless your doctor considers it necessary.
• You must avoid becoming pregnant while taking Talzenna.
• Consult your doctor if there is any possibility that you or your partner may become pregnant.

Contraception in men and women
Women of childbearing potential must use an effective contraceptive method during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since hormonal contraception is not recommended if you have breast cancer, you must use two non-hormonal contraceptive methods.
Speak to your healthcare provider for advice on the most suitable contraceptive method for you.
Men with female partners who are pregnant or of childbearing potential must use a contraceptive method, even after vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.
Breastfeeding
You must not breastfeed during treatment with Talzenna and for at least 1 month after the last dose. It is not known whether 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 experience dizziness, weakness, or tiredness (very common side effects of Talzenna), you must not drive or operate machinery.

3. How to take Talzenna

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Talzenna is taken orally once daily. The recommended dose is:

• for breast cancer: one 1 mg Talzenna capsule.
• for prostate cancer: Talzenna is taken with a medicine called enzalutamide. The usual dose of Talzenna is 0.5 mg.

If you experience certain side effects while taking Talzenna alone or in combination with enzalutamide (see section 4), your doctor may reduce the dose or temporarily or permanently discontinue treatment. Take Talzenna and enzalutamide exactly as directed by your doctor.
You may take Talzenna with food or between meals. Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. Do not open the capsules. Avoid contact with the capsule contents.
If you take more Talzenna than you should
If you have taken more Talzenna than your prescribed dose, contact your doctor or the nearest hospital immediately. Urgent treatment may be required.
Take the medicine package and this leaflet with you so that the doctor knows what you have taken.
If you forget to take Talzenna
If you miss a dose or vomit, take the next dose as scheduled. Do not take a double dose to make up for missed or vomited capsules.
If you stop taking Talzenna
Do not stop treatment with Talzenna unless instructed by your doctor.
If you have any questions about the use of 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.
Contact your doctor immediately if you experience any of the following symptoms, which may
indicate a serious blood disorder:
Very common (may affect more than 1 in 10 people)

• shortness of breath, severe tiredness, paleness, or rapid heartbeat – these may be signs of a low red blood cell count (anaemia).
• infection, feeling chills or shivers, having a fever or feeling hot – these may be signs of a low white blood cell count (neutropenia).
• bruising or bleeding longer than usual after injury – these may be signs of a low platelet count (thrombocytopenia).

Contact your doctor if you experience any other side effects, which may include:
Very common (may affect more than 1 in 10 people)

• low count of white blood cells, red blood cells, and platelets
• reduced appetite
• dizziness
• headache
• feeling unwell (nausea)
• illness (vomiting)
• diarrhoea
• abdominal pain
• hair loss

Common (may affect up to 1 in 10 people)

• altered taste (dysgeusia)
• swollen and painful leg, chest pain, shortness of breath, rapid breathing or rapid heartbeat, as these may be signs of blood clots in a vein
• indigestion
• inflammation of the mouth

Uncommon (may affect up to 1 in 100 people)

• abnormal blood cell count due to serious bone marrow problems (myelodysplastic syndrome or acute myeloid leukaemia). See Warnings and precautions in section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system detailed in Annex 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 stated on the carton, 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 packaging is damaged or shows signs of tampering.
Do not dispose of medicines 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 Talzenna contains
The active substance is talazoparib. Talzenna hard capsules are available in different strengths.

• Talzenna 0.1 mg hard capsules: each hard capsule contains talazoparib tosylate equivalent to 0.1 mg of talazoparib.
• Talzenna 0.25 mg hard capsules: each hard capsule contains talazoparib tosylate equivalent to 0.25 mg of talazoparib.
• Talzenna 0.35 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.35 mg of talazoparib.
• Talzenna 0.5 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.5 mg of talazoparib.
• Talzenna 1 mg hard capsules: each hard capsule contains talazoparib tosylate equivalent to 1 mg of talazoparib.
  The other components are:
• Capsule content: silicified microcrystalline cellulose (microcrystalline cellulose and silicon dioxide).
• Capsule coating for 0.1 mg: hypromellose and titanium dioxide (E171).
• Capsule coating for 0.25 mg: hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).
• Capsule coating for 0.35 mg: hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).
• Capsule coating for 0.5 mg: hypromellose, red iron oxide (E172) and titanium dioxide (E171).
• Capsule coating for 1 mg: hypromellose, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Talzenna and package contents
Talzenna 0.1 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with a white cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black).
Talzenna 0.25 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Talzenna 0.35 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with an ivory cap (printed with “Pfizer” in black) and an ivory body (printed with “TLZ 0.35” in black).
Talzenna 0.5 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with a light pink cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.5” in black).
Talzenna 1 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Talzenna 0.1 mg is available in plastic bottles containing 30 hard capsules.
Talzenna 0.25 mg is available in perforated unit dose blister packs of 30 × 1, 60 × 1 or 90 × 1 hard capsules and in plastic bottles containing 30 hard capsules.
Talzenna 0.35 mg is available in plastic bottles containing 30 hard capsules.
Talzenna 0.5 mg is available in plastic bottles containing 30 hard capsules.
Talzenna 1 mg is available in perforated unit dose blister packs of 30 × 1 hard capsules and in plastic bottles containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Excella GmbH & Co. KG
Nürnberger Strasse 12
90537 Feucht
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Pfizer Luxembourg SARL filiāle Latvijā
Pfizer NV/SA Tel: + 371 670 35 775
Tél/Tel: +32 (0)2 554 62 11

България Lietuva
Пфайзер Люксембург САРЛ, Клон България Pfizer Luxembourg SARL filialas Lietuvoje
Тел.: +359 2 970 4333 Tel: + 370 52 51 4000

Česká republika Magyarország
Pfizer, spol. s r.o. Pfizer Kft.
Tel: +420 283 004 111 Tel.: +36-1-488-37-00

Danmark Malta
Pfizer ApS Vivian Corporation Ltd
Tlf: +45 44 20 11 00 Tel: +356 21344610

Deutschland Nederland
PFIZER PHARMA GmbH Pfizer bv
Tel: +49 (0)30 550055-51000 Tel: +31 (0)800 63 34 636

Eesti Norge
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00

Ελλάδα Österreich
Pfizer Ελλάς A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ: +30 210 6785 800 Tel: +43 (0)1 521 15-0

España Polska
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: +34 91 490 99 00 Tel.: +48 22 335 61 00

France Portugal
Pfizer Laboratoires Pfizer, Lda.
Tél: +33 (0)1 58 07 34 40 Tel: +351 21 423 5500

Hrvatska România
Pfizer Croatia d.o.o. Pfizer Romania S.R.L.
Tel: +385 1 3908 777 Tel: +40 (0) 21 207 28 00

Ireland Slovenija
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0)1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ísland Slovenská republika
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: +354 540 8000 Tel: + 421 2 3355 5500

Italia Suomi/Finland
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 430 040

Kύπρος Sverige
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer AB
Τηλ: +357 22 817690 Tel: +46 (0)8 550 520 00

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