TALZENNA 0.25 MG Hard capsule

Зміст інструкції

1. 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
   1. What is Talzenna and what is it 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

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

Read this leaflet carefully before you start taking this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 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 is Talzenna and what is it used for

What is Talzenna and how does it work
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 some cancer cells.
As a result, cancer cells can no longer repair themselves and die.

What is Talzenna used for
Talzenna is a medicine used

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

Talzenna is used when the carcinoma has spread beyond the original tumor 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
ask your doctor.

2. What you need to 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 signs or symptoms described in this section.
Low blood cell count
Talzenna lowers the count of your blood cells: red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia). Signs and symptoms to watch out for include:

• anemia:shortness of breath, severe fatigue, paleness, or a fast heartbeat (these may be signs of a low red blood cell count).
• neutropenia:infection, chills or shivering, or fever (these may be signs of a low white blood cell count).
• thrombocytopenia:bruising or bleeding more easily than normal when injured (these may be signs of a low 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 conditions related to the bone marrow
In rare cases, a low blood cell count may be a sign of more serious conditions related to the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Your doctor may decide to perform a bone marrow test to confirm or exclude these conditions.
Blood clots
Talzenna can cause blood clots in the veins. Tell 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 effective contraception.
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 medicines you get without a prescription and herbal medicines. This is because Talzenna can affect how some other medicines work. Also, some medicines can 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 - commonly used to treat heart conditions.
• 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/AIDS infections.
• cyclosporine - 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 the section Talzenna with food and drink, below).

The following medicines may reduce the effectiveness of Talzenna:

• carbamazepine and phenytoin - antiepileptics 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 while taking Talzenna, as they may increase the side effects of Talzenna. Curcumin is found in turmeric root, so you should not use large amounts of turmeric root, although using the spice in food is not a potential cause for concern.

Pregnancy
Talzenna can harm the unborn child. If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.
Your doctor will perform a pregnancy test before you start taking Talzenna.

• do not use Talzenna if you are pregnant, unless your doctor considers it necessary.
• avoid becoming pregnant while taking Talzenna.
• ask your doctor for advice if there is a possibility that you or your partner may become pregnant.

Contraception in men and women
Womenof childbearing potential must use effective contraception (birth control) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Because hormonal contraception is not recommended if you have breast cancer, you should use 2 non-hormonal contraceptive methods.
Talk to your healthcare provider for advice on the most suitable method of contraception for you.
Menwith female partners of childbearing potential must use contraception (birth control) during treatment with Talzenna and for at least 4 months after the last dose, even after a vasectomy.

Breastfeeding
Do 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 slightly impair your ability to drive and operate machines. If you experience dizziness, weakness or fatigue (very common side effects of Talzenna) you should not drive or use machines.

3. How to take Talzenna

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Dosage to be taken
Talzenna is taken orally once a day. 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 some undesirable effects occur during the intake of Talzenna alone or in combination
with enzalutamide (see section 4), your doctor may reduce the dose or interrupt the treatment,
temporarily or permanently. Take Talzenna and enzalutamide exactly as
indicated by your doctor.
You can 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
contents of the capsule.

If you take more Talzenna than you should
If you have taken more Talzenna than your normal dose, contact your doctor or the nearest
hospital immediately. Urgent treatment may be necessary.
what you have taken.

If you forget to take Talzenna
If you forget a dose or vomit, take the next dose as scheduled. Do not take a double
dose to compensate for forgotten or vomited capsules.

If you stop taking Talzenna
Do not stop treatment with Talzenna unless indicated by your doctor.
If you have any doubts 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.

Tell your doctor immediately if you experience any of the following symptoms, which may be signs of a serious blood disorder:
Very common(may affect more than 1 in 10 people)

• shortness of breath, severe fatigue, paleness or a fast heartbeat - these may be signs of a low red blood cell count (anaemia).
• infection, feeling chills or tremors, having a fever or feeling warm - these may be signs of a low white blood cell count (neutropenia).
• bruising or bleeding more easily than normal when injured - these may be signs of a low platelet count (thrombocytopenia).

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

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• abnormal number of blood cells due to serious problems with the bone marrow (myelodysplastic syndrome or acute myeloid leukaemia). See Warnings and precautions in section 2

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 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 on the
blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Talzenna contains
The active ingredient is talazoparib. Talzenna hard capsules are available in different dosages.

• 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 ingredients are:
• Capsule content: microcrystalline cellulose silicified (microcrystalline cellulose and silicon dioxide).
• 0.1 mg capsule coating: hypromellose and titanium dioxide (E171).
• 0.25 mg capsule coating: hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).
• 0.35 mg capsule coating: hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).
• 0.5 mg capsule coating: hypromellose, red iron oxide (E172) and titanium dioxide (E171).
• 1 mg capsule coating: 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 contents of the pack
Talzenna 0.1 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with
a white cap (with “Pfizer” imprinted in black) and a white body (with “TLZ 0.1” imprinted in black).
Talzenna 0.25 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with
an ivory-colored cap (with “Pfizer” imprinted in black) and a white body (with “TLZ 0.25” imprinted in
black).
Talzenna 0.35 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with
an ivory-colored cap (with “Pfizer” imprinted in black) and an ivory body (with “TLZ 0.35” imprinted in
black).
Talzenna 0.5 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with
a light pink cap (with “Pfizer” imprinted in black) and a white body (with “TLZ 0.5” imprinted in
black).
Talzenna 1 mg is supplied as an opaque hard capsule, approximately 14 mm × 5 mm, with
a light red cap (with “Pfizer” imprinted in black) and a white body (with “TLZ 1” imprinted in black).
Talzenna 0.1 mg is available in plastic bottles containing 30 hard capsules.
Talzenna 0.25 mg is available in perforated single-dose blisters containing 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 single-dose blisters containing 30 × 1 hard capsules and in
plastic bottles containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicine, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

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

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Malta
Vivian Corporation Ltd
Tel: +356 21344610

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Kύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Sverige
Pfizer AB
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.