0.25 mg or 1 mg hard capsules
talazoparib
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 cancer medicine called a “PARP inhibitor” (poly-adenosine diphosphate ribose polymerase inhibitor).
Patients with certain changes ( mutations ) in genes called BRCA are at risk of developing certain types of cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in some cancer cells. As a result, the cancer cells cannot repair themselves and they die.
What Talzenna is used for
Talzenna is used to treat adults with a type of breast cancer called HER2 -negative breast cancer that has an abnormal inherited BRCA gene.
Talzenna is used if cancer has spread beyond the first tumor or further to other parts of the body.
Your doctor will do a test to see if Talzenna is a suitable treatment for you.
If you have any questions about how Talzenna works or why you have been prescribed this medicine, you can ask your doctor.
What you need to know before you use 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 your treatment if you get any of the signs and symptoms described in this section.
Low blood cell counts
Talzenna reduces the number of blood cells, e.g. red blood cells ( anemia ), white blood cells ( neutropenia ), or platelets ( thrombocytopenia ). Signs and symptoms you need to look out for are:
- Anemia: You become short of breath, feeling very tired, have pale skin, or have a fast heart rate – these may be signs of a low red blood cell count.
- Neutropenia: Infection, you get chills or shakes, or get a fever – these can be signs of low white blood cell counts.
- Thrombocytopenia: You bruise or bleed longer than normal when you injure yourself – this may be a sign of low platelet counts.
Blood samples are taken regularly during treatment with Talzenna to check your blood cells (white and red blood cells and platelets ).
Serious impact on bone marrow a
In rare cases, a low blood cell count can be a sign of a more serious effect on the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The doctor may take samples of the bone marrow to check this.
Contraceptives for men and women
Women who may become pregnant and men with partners who are or may become pregnant should use effective contraception.
See the section “Contraceptives for men and women” below.
Children and young people
Talzenna should not 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 also applies to over-the-counter medicines, (traditional) herbal medicines, and herbal medicines. Talzenna can affect how other medicines work. In addition, some medicines can affect how Talzenna works.
The following medicines may in particular increase the risk of side effects from Talzenna:
- Amiodarone , carvedilol, dronedarone, propafenone , quinidine , ranolazine and verapamil – often used for heart problems.
- Clarithromycin and erythromycin – are antibiotics used to treat bacterial infections.
- Itraconazole and ketoconazole – are used against fungal infections.
- Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir – used for HIV infection/AIDS.
- Cyclosporine – is used to prevent transplant rejection.
- Lapatinib – is used to treat certain types of breast cancer.
- Curcumin – (e.g. found in turmeric) 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-epileptic drugs to reduce seizures and convulsions.
- St. John’s wort ( Hypericum perforatum ) – is a herbal remedy used for mild depression and mild anxiety.
Talzenna with food, drink, and alcohol
Do not use dietary supplements that contain curcumin while taking Talzenna as it may increase the side effects of Talzenna. Curcumin is found in turmeric and you should not use large amounts of turmeric. However, its use as a seasoning in food is not likely to cause problems.
Pregnancy, breastfeeding, and fertility
Talzenna can cause birth defects. If you are pregnant or breastfeeding, 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 do a pregnancy test before you start Talzenna.
- You should not use Talzenna if you are pregnant.
- You should not become pregnant while taking Talzenna.
- Discuss contraception with your doctor if you or your partner are at risk of becoming pregnant.
Contraceptives for men and women
Women of childbearing potential should use effective contraception during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since the use of a hormonal contraceptive is not recommended if you have breast cancer, you should use two non-hormonal contraceptives. Discuss with the doctor/midwife which contraceptives are suitable for you.
Men who have a female partner who is pregnant or may become pregnant should use effective contraception (even after vasectomy) during treatment with Talzenna and for at least 4 months after the last dose.
Breast-feeding
You should 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 fertility in men.
Driving ability and use of machinery
Talzenna may have a minor effect 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 avoid driving or using machines.
How to take Talzenna
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended dose is one capsule of 1 mg taken orally once a day.
If you experience certain side effects while taking Talzenna (see section 4), your doctor may lower your dose or stop treatment, temporarily or completely. The dose can be reduced to 0.75 mg (three capsules of 0.25 mg) once daily or 0.5 mg (two capsules of 0.25 mg) once daily or 0.25 mg (one capsule of 0.25 mg) once daily.
Swallow the capsule whole with a glass of water. The capsules must not be chewed or crushed. You can take Talzenna with food or between meals. The capsules must not be opened. Avoid contact with the contents of the capsule.
If you have taken too much Talzenna
If you have taken more Talzenna than your usual dose, contact your doctor or nearest hospital immediately. You may need emergency treatment.
Take the carton and this leaflet with you so the doctor knows what you have taken.
If you forget to take Talzenna
If you miss a dose or vomit it up, take the next dose as planned. Do not take a double dose to make up for capsules you have forgotten or vomited up.
If you stop taking Talzenna
Do not stop taking Talzenna unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
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 users)
- You become short of breath, feeling very tired, have pale skin or have a fast pulse – these may be signs of a low number of red blood cells ( anemia ).
- Infection, getting chills or shaking, or fever, or feeling warm – may be signs of a low white blood cell count ( neutropenia ).
- You bruise or bleed longer than normal when you injure yourself – this may be a sign of a low platelet count ( thrombocytopenia ).
Talk to your doctor if you get any other side effects, such as:
Very common (may affect more than 1 in 10 users)
- low levels of white blood cells, red blood cells, and platelets
- reduced appetite
- dizziness
- headache
- nausea
- vomiting
- diarrhea
- stomach pains
- hair loss
Common (may affect up to 1 in 10 users)
- taste change ( dysgeusia )
- digestive problems
- inflammation of the mouth.
How to store Talzenna
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and can or blister card after EXP. The expiration date is the last day of the specified month.
The medicine has no special storage instructions.
Do not use this medicine if the packaging is damaged or appears to have been tampered with.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is talazoparib. Talzenna hard capsules are available in different strengths.
- Talzenna 0.25 mg hard capsules: each hard capsule contains talazoparibtosylate equivalent to 0.25 mg talazoparib.
- Talzenna 1 mg hard capsules: each hard capsule contains talazoparibtosylate equivalent to 1 mg talazoparib.Other ingredients are:
- Capsule content: silicon-modified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicon dioxide).
- Capsule shell 0.25 mg capsule: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
- Capsule shell 1 mg capsule: hypromellose (HPMC), iron oxide yellow (E172), titanium dioxide (E171), and iron oxide red (E172)
Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Appearance and package sizes of the medicine
Talzenna 0.25 mg is an opaque, hard capsule, approximately 14.30 mm x 5.32 mm, with an off-white body (with “Pfizer” printed in black) and white body (with “TLZ 0.25” printed in black).
Talzenna 1 mg is an opaque, hard capsule, approximately 14.30 mm x 5.32 mm, with a bright red cap (with “Pfizer” printed in black) and white body (with “TLZ 1” printed in black).
Talzenna 0.25 mg is available in perforated single-dose blisters with 30, 60, or 90 hard capsules, as well as in plastic cans containing 30 hard capsules.
Talzenna 1 mg is available in perforated single-dose blisters with 30 hard capsules, as well as in plastic cans 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
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer NV/SATel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
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| DeutschlandPFIZER PHARMA GmbHPhone: +49 (0)30 550055-51000 | NorwayPfizer iPhone: +47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branch phone: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePfizer Hellas AETel: +30 210 6785 800 | PolishPfizer Polska Sp. z o. oTel.: +48 22 335 61 00 |
| SpainPfizer, SLPhone: +34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: +351 21 423 5500 |
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| CyprusPfizer Ελλάς Α.Ε. (Cyprus Branch)Phone: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaPhone: + 371 670 35 775 |