TALZENNA 1 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Talzenna 0.1mg hard capsules

Talzenna 0.25mg hard capsules

Talzenna 0.35mg hard capsules

Talzenna 0.5mg hard capsules

Talzenna 1mg hard capsules

Talazoparib

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 Talzenna and what is it used for
2. What you need to know before you take Talzenna
3. How to take Talzenna
4. Possible side effects
5. Storage of 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 cancer medicine known as a "PARP (poly-ADP ribose polymerase) inhibitor".

Talzenna works by blocking the PARP protein, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells cannot be repaired and eventually die.

What is Talzenna used for

Talzenna is a medicine used

• as monotherapy to treat adults with breast cancer of a type known as HER2-negative breast cancer that has a germline BRCA gene mutation. Your doctor will perform a test to ensure that Talzenna is suitable for you.

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

If you have any questions about how Talzenna works or why you have been prescribed this medicine, 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 breastfeeding.

Warnings and precautions

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

Low blood cell count

Talzenna decreases blood cell counts, such as red blood cell count (anemia), white blood cell count (neutropenia), or platelet count (thrombocytopenia). The signs and symptoms to look out for include:

• Anemia:feeling short of breath, feeling very tired, pale skin, or rapid heartbeats; these may be signs of a low red blood cell count.
• Neutropenia:infection, chills, or shaking, or fever; these may be signs of a low white blood cell count.
• Thrombocytopenia:bruising or bleeding for longer than usual if you are injured; these may be signs of a low platelet count.

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

Serious bone marrow problems

Rarely, low blood cell counts can be a sign of more serious bone marrow problems, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Your doctor may want to examine your bone marrow to detect these problems.

Blood clots

Talzenna may 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, difficulty breathing, or dizziness.

Male and female contraception

Women who can become pregnant and men with partners who are or may become pregnant must use effective contraceptive methods.

See the section "Male and female contraception" below.

Children and adolescents

Talzenna is not indicated for the treatment of 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 may affect how other medicines work, and some medicines may affect how Talzenna works.

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

• Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine, and verapamil - which are generally used to treat heart problems.
• Clarithromycin and erythromycin, antibiotics - which are used to treat bacterial infections.
• Itraconazole and ketoconazole - which are used to treat fungal infections.
• Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, and tipranavir - which are used to treat HIV/AIDS infections.
• Cyclosporine - which is used in organ transplantation to prevent rejection.
• Lapatinib - which is used to treat patients with certain types of breast cancer.
• Curcumin (found, for example, in turmeric root) in some medicines (see also the section "Taking Talzenna with food and drink").

The following medicines may reduce the effect of Talzenna:

• Carbamazepine and phenytoin - antiepileptics used to treat seizures or fits.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat mild depression and anxiety.

Taking Talzenna with food and drink

Do not use curcumin in food supplements while taking Talzenna, as it may increase the side effects of Talzenna. Curcumin is found in turmeric root and you should not use large amounts of turmeric root, although it is likely that using spices in food will not cause any problems.

Pregnancy

Talzenna may harm the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will perform a pregnancy test before you start treatment with Talzenna.

• Do not take Talzenna if you are pregnant unless your doctor considers it necessary.
• Do not become pregnant while taking Talzenna.
• Talk to your doctor about contraception if there is any chance that you or your partner may become pregnant.

Male and female contraception

Womenwho can become pregnant must use an effective method of birth control (contraception) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since hormonal contraceptives are not recommended if you have breast cancer, you must use two non-hormonal contraceptive methods.

Ask your healthcare professional about the contraceptive methods that may be suitable for you.

Menwith female partners who are pregnant or who can become pregnant must use an effective method of birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.

Breastfeeding

Do not breastfeed while taking 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 male fertility.

Driving and using machines

Talzenna has 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), do not drive or use machines.

3. How to take Talzenna

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

Dose

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 you experience certain side effects while taking Talzenna alone or in combination with enzalutamide (see section 4), your doctor may reduce your dose or interrupt treatment temporarily or permanently. Take Talzenna and enzalutamide exactly as your doctor has told you.

You can take Talzenna with or without food. Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. Do not open the capsules. Contact with the contents of the capsule 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 the nearest hospital immediately. Emergency treatment may be necessary.

Take the pack and this leaflet with you to show the doctor what you have taken.

If you forget to take Talzenna

If you forget a dose or vomit, take the next dose as planned. Do not take a double dose to make up for 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, 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 notice any of the following symptoms that could be a sign of a serious blood disorder:

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

• Feeling short of breath, feeling very tired, pale skin, or rapid heartbeats; these may be signs of a low red blood cell count (anemia).
• Infection, developing chills or shaking, or fever or feeling feverish - these may be signs of a low white blood cell count (neutropenia).
• Bruising or bleeding for longer than usual if you are injured - these may be signs of a low platelet count (thrombocytopenia).

Tell your doctor if you have any other side effects. These may include:

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

• Low white blood cell count, low red blood cell count, and low platelet count
• Decreased appetite
• Feeling dizzy
• Headache
• Feeling sick (nausea)
• Vomiting
• Diarrhea
• Abdominal pain
• Hair loss

Common(may affect up to 1 in 10 people)

• Taste disorder (dysgeusia)
• Swollen and painful legs, chest pain, difficulty breathing, rapid breathing, or rapid heart rate, as these may be signs of blood clots in the veins
• Indigestion
• Mouth inflammation

Uncommon(may affect up to 1 in 100 people)

• Abnormal blood cell counts due to serious bone marrow problems (myelodysplastic syndrome or acute myeloid leukemia). See "Warnings and precautions" in section 2.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, including 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. Storage of 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, bottle, or blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Talzenna

The active ingredient is talazoparib. Talzenna hard capsules are available in different doses.

• Talzenna 0.1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.1 mg of talazoparib.
• Talzenna 0.25 mg hard capsules: each 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 capsule contains talazoparib tosylate equivalent to 1 mg of talazoparib.

The other components are:

• Capsule content: silicified microcrystalline cellulose (microcrystalline cellulose and silicon dioxide).

• 0.1 mg capsule shell: hypromellose and titanium dioxide (E171).
• 0.25 mg capsule shell: hypromellose, yellow iron oxide (E172), and titanium dioxide (E171).
• 0.35 mg capsule shell: hypromellose, yellow iron oxide (E172), and titanium dioxide (E171).
  • 0.5 mg capsule shell: hypromellose, red iron oxide (E172), and titanium dioxide (E171).

• 1 mg capsule shell: 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).

Appearance of the Product and Container Content

Talzenna 0.1 mg is presented in a 14 mm × 5 mm, approximately, opaque hard capsule 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 presented in a 14 mm × 5 mm, approximately, opaque hard capsule 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 presented in a 14 mm × 5 mm, approximately, opaque hard capsule 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 presented in a 14 mm × 5 mm, approximately, opaque hard capsule 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 presented in a 14 mm × 5 mm, approximately, opaque hard capsule 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 of 30 hard capsules.

Talzenna 0.25 mg is available in precut unit dose blisters of 30 × 1, 60 × 1, or 90 × 1 hard capsules and in plastic bottles of 30 hard capsules.

Talzenna 0.35 mg is available in plastic bottles of 30 hard capsules.

Talzenna 0.5 mg is available in plastic bottles of 30 hard capsules.

Talzenna 1 mg is available in precut unit dose blisters of 30 × 1 hard capsules and in plastic bottles of 30 hard capsules.

Only some 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 on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:06/2025.

Other Sources of Information

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