Product Information for the Patient

Talzenna 0.1 mg Hard Capsules

Talzenna 0.25 mg Hard Capsules

Talzenna 1 mg Hard Capsules

talazoparib

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Talzenna and how it works

Talzenna contains the active ingredient talazoparib. It is a type of cancer medication known as a “PARP (poly-ADP ribose polymerase) inhibitor”.

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

What is Talzenna used for

Talzenna is a medication that is used

• in monotherapy to treat adults with breast cancer of a type known as HER2 (by its English acronym) negative cancer that presents an abnormal hereditary germinal BRCA (by its English acronym) gene. Your doctor will perform a test to ensure that Talzenna is suitable for you.
• in combination with a medication called enzalutamide to treat adults with prostate cancer that no longer responds to hormone therapy or surgical treatment to reduce testosterone.

Talzenna is used when 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 medication, consult your doctor.

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

Consult your doctor, pharmacist or nurse before starting to take Talzenna and during treatment if you experience the signs or symptoms described in this section.

Low blood cell counts

Talzenna reduces blood cell counts, such as red blood cell count (anemia), white blood cell count (neutropenia) or platelet count (thrombocytopenia). The signs and symptoms you should watch for include:

• Anemia:feeling short of breath, feeling very tired, pale skin or rapid heartbeat; these may be signs of low red blood cell count.
• Neutropenia:infection, chills or shivering, or fever; these may be signs of low white blood cell count.
• Trombocytopenia:having bruises or bleeding for longer than usual if you get hurt; these may be signs of low platelet count.

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

Severe bone marrow problems

In rare cases, low blood cell counts may 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. Inform your doctor, pharmacist or nurse if you experience signs or symptoms of blood clots in the veins, such as:

dull pain or stiffness, swelling and redness in the affected leg (or arm), chest pain, difficulty breathing or dizziness.

Male and female contraception

Women who may become pregnant and men with partners who may become pregnant should use effective contraceptive methods.

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

Children and adolescents

Talzenna is not indicated for the treatment of children or adolescents (under 18 years of age).

Other medicines and Talzenna

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medicine. This includes medicines obtained without a prescription and herbal medicines. This is because Talzenna may affect how other medicines work. Also, certain 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.
• Cyclosporine - which is used in organ transplantation to prevent rejection.
• Lapatinib - which is used to treat patients with certain types of breast cancer.
• Curcumin (which is 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 - antiepileptic medicines used to treat seizures or fits.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used to treat mild depression and anxiety.

Taking Talzenna with food and drink

Do not use curcumin in dietary 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 be harmful to the fetus. If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine. Your doctor will perform a pregnancy test before starting treatment with Talzenna.

• Do not use Talzenna if you are pregnant unless your doctor considers it necessary.
• Do 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

Womenwho may become pregnant should 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 it is not recommended to use hormonal contraceptives if you have breast cancer, you should use two non-hormonal contraceptive methods.

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

Menwith female partners who are pregnant or may become pregnant should 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 unknown whether Talzenna passes into breast milk.

Fertility

Talazoparib may reduce male fertility.

Driving and using machines

The influence of Talzenna on your ability to drive and use machines is small. If you feel dizzy, weak or tired (these are very common side effects of Talzenna), do not drive or use machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Amount to Take

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 medication called enzalutamida.
• The usual dose of Talzenna is 0.5 mg (two 0.25 mg capsules).

If you experience certain adverse effects while taking Talzenna alone or in combination with enzalutamida (see section 4), your doctor may reduce your dose or temporarily or permanently discontinue treatment. Take Talzenna and enzalutamida exactly as your doctor has instructed.

You can take Talzenna with food or without food. Swallow the entire capsule 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 usual dose, contact your doctor or the nearest hospital immediately. Emergency treatment may be necessary.

Bring the packaging and this leaflet so that your doctor knows what you have been taking.

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 make up for the missed or vomited capsules.

If You Discontinue Treatment with Talzenna

Do not discontinue treatment with Talzenna unless your doctor instructs you to do so.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform 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 low red blood cell count (anemia).
• Infection, developing chills or shivering, or fever or feeling feverish - these may be signs of low white blood cell count (neutropenia).
• Having petechiae or bleeding for longer than usual if injured - these may be signs of low platelet count (thrombocytopenia).

Consult your doctor if you have any other side effect. These may include:

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

• Low white blood cell, red blood cell, and platelet counts
• Loss of appetite
• Dizziness
• Headache
• Unpleasantness (nausea)
• Vomiting
• Diarrhea
• Abdominal pain
• Hair loss

Common(may affect up to 1 in 10 people)

• Disgeusia (disturbance of taste)
• Swollen and painful legs, chest pain, difficulty breathing, rapid breathing, or rapid heart rate, as they 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 severe bone marrow problems (myelodysplastic syndrome or acute myeloid leukemia). See “Warnings and precautions” in section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bottle, or blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

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 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg of talazoparib.

The other components are:

• Capule content: microcrystalline cellulose silicified (microcrystalline cellulose and silicon dioxide).
• Capsule coating of 0.1 mg: hypromellose and titanium dioxide (E171).
• Capsule coating of 0.25 mg: hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).
• Capsule coating of 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).

Appearance of the product and contents of the package

Talzenna 0.1 mg is presented in a hard, opaque capsule of 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 presented in a hard, opaque capsule of approximately 14 mm × 5 mm, with a cream-colored cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black).

Talzenna 1 mg is presented in a hard, opaque capsule of 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 of 30 hard capsules.

Talzenna 0.25 mg is available in pre-cut single-dose blisters of 30 x 1, 60 x 1 or 90 x 1 hard capsules and in plastic bottles of 30 hard capsules.

Talzenna 1 mg is available in pre-cut single-dose blisters of 30 x 1 hard capsules and in plastic bottles of 30 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Excella GmbH & Co. KG

Nürnberger Strasse 12

90537 Feucht

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:MM/YYYY.

Other sources of information

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