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Talzenna® 0.25 mg hard capsules

Talzenna® 1 mg hard capsules

talazoparib

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

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  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
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What Talzenna is and how it works

Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor’.

Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and they die.

What Talzenna is used for

Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.

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

Your healthcare provider will perform a test to make sure that Talzenna is right for you.

If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.

" } }, { "title" : "2. What you need to know before you take Talzenna", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "2. What you need to know before you take X" }, "text" : { "status" : "additional", "div" : "
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" } }, { "title" : "Warnings and precautions", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "Warnings and precautions" }, "text" : { "status" : "additional", "div" : "

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

Low blood cell counts

Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:

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

Serious problems with the bone marrow

Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may want to test your bone marrow to check for these problems.

Male and female contraception

Women who can become pregnant and men with partners who are or can become pregnant should use effective contraception.

Please see section “Male and female contraception” below.

" } }, { "title" : "Children and adolescents", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "Children and adolescents" }, "text" : { "status" : "additional", "div" : "

Talzenna is not to be used in children or adolescents (under 18 years of age).

" } }, { "title" : "Other medicines and Talzenna", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "Other medicines and Talzenna" }, "text" : { "status" : "additional", "div" : "

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 can affect the way some other medicines work. Also some medicines can affect the way Talzenna works.

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

The following medicines may reduce the effect of Talzenna:

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Do not use curcumin in food supplements while you are taking Talzenna as it may increase Talzenna’s side effects. Curcumin is found in turmeric root and you should not use large amounts of turmeric root, but using spices in food is not likely to cause a problem.

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Talzenna could harm an unborn baby. If you are pregnant or breast-feeding, 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 perform a pregnancy test prior to starting Talzenna.

Male and female contraception

Women who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods.

Talk to your healthcare provider about birth control methods that may be right for you.

Men with female partners who are pregnant or able to become pregnant should use effective birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.

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You should not breast-feed while taking Talzenna and for at least 1 month after the last dose. It is not known if Talzenna passes into breast milk.

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Talazoparib may reduce fertility in men.

" } }, { "title" : "Driving and using machines", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "Driving and using machines" }, "text" : { "status" : "additional", "div" : "

Talzenna may have 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), you should not drive or use machines.

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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The recommended dose is one 1-mg capsule taken by mouth once daily.

If you get certain side effects while you are taking Talzenna (see section 4), your doctor may lower your dose or stop treatment, either temporarily or permanently. The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.

Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. You can take Talzenna with food or between meals. Do not open the capsules. Contact with the capsule content should be avoided.

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If you have taken more Talzenna than your normal dose, contact your doctor or nearest hospital right away. Urgent treatment may be necessary.

Take the carton and this leaflet so that the doctor knows what you have been taking.

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If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up for the forgotten or vomited capsules.

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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 or pharmacist or nurse.

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following symptoms which could be a sign of serious blood disorder:

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

Talk to your doctor if you get any other side effects. These can include:

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

Common (may affect up to 1 in 10 people)

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If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

" } }] }, { "title" : "5. How to store Talzenna", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "5. How to store X" }, "text" : { "status" : "additional", "div" : "

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 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 pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

" } }, { "title" : "6. Contents of the pack and other information", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "6. Contents of the pack and other information" }, "text" : { "status" : "additional", "div" : "
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The other ingredients are:

Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).

" } }, { "title" : "What Talzenna looks like and contents of the pack", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "What X looks like and contents of the pack" }, "text" : { "status" : "additional", "div" : "

Talzenna 0.25 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).

Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).

Talzenna 0.25 mg is available in perforated unit dose blister packs of 30, or 60, or 90 hard capsules and in plastic bottles of 30 hard capsules.

Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.

Not all pack sizes may be marketed.

" } }, { "title" : "Marketing Authorization Holder and Manufacturer", "code" : { "coding" : [{ "system" : "https://www.mhra.gov.uk/", "code" : "100000155538" }], "text" : "Marketing Authorization Holder and Manufacturer" }, "text" : { "status" : "additional", "div" : "

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Manufacturer

Excella GmbH & Co. KG

Nürnberger Strasse 12

90537 Feucht

Germany

For any information about this medicine, please contact:

Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161

This leaflet was last revised in 12/2021

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" }, "identifier" : [{ "system" : "http://www.mhra.gov.uk/", "value" : "4471bb15-7f52-4fcd-b615-8674ce6eb91e" }], "type" : { "coding" : [{ "system" : "http://hl7.org/fhir/medicinal-product-type", "code" : "MedicinalProduct", "display" : "Medicinal Product" }] }, "domain" : { "coding" : [{ "system" : "http://hl7.org/fhir/medicinal-product-domain", "code" : "Human", "display" : "Human use" }] }, "status" : { "coding" : [{ "system" : "http://hl7.org/fhir/publication-status", "code" : "active", "display" : "active" }] }, "legalStatusOfSupply" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi", "code" : "100000072084", "display" : "Medicinal product subject to medical prescription" }] }, "name" : [{ "productName" : "Talzenna® (talazoparib) 1 mg hard capsules", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/lists/220000000000", "code" : "220000000001" }], "text" : "Full name" }, "part" : [{ "part" : "Talzenna", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/lists/220000000000", "code" : "220000000002" }], "text" : "Invented name part" } }, { "part" : "talazoparib", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/lists/220000000000", "code" : "220000000003" }], "text" : "Scientific name part" } }, { "part" : "1 mg", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/lists/220000000000", "code" : "220000000004" }], "text" : "Strength part" } }, { "part" : "Capsule, hard", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/lists/220000000000", "code" : "220000000005" }], "text" : "Pharmaceutical dose form part" } }], "usage" : [{ "country" : { "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "GBR", "display" : "United Kingdom" }] }, "jurisdiction" : { "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "GBR", "display" : "United Kingdom" }] }, "language" : { "coding" : [{ "system" : "urn:ietf:bcp:47", "code" : "en", "display" : "English" }] } }] }] } }] }