What is Talzenna™(talazoparib)?
Talzenna™ (talazoparib) is a medication that is approved to treat adults with metastatic or locally advanced HER2- breast cancer, who also have one of the BRCA gene mutations that often lead to breast cancer. BRCA1 and BRCA2 mutations account for about 5-10% of breast cancer cases in US women.
People with BRCA1 or 2 gene mutations inherit them from their families. The normal function of these genes is to help repair DNA, the molecular instruction manual inside every cell in the body. When DNA accumulates mistakes or mutations, the cells that contain these mistakes can become cancerous and multiply without stopping. People without adequate protection against mistakes in their DNA are at increased risk of developing cancer. About 55-65 percent of people who are BRCA1 carriers and 45-55 percent for BRCA2 carriers will develop breast cancer by age 70.4
Breast cancer tumors can be characterized as HER2+ or HER2- cancers. HER2 refers to a particular protein that appears on the surface of cancer cells and makes the cells multiply faster. When cancer cells produce too many HER2 molecules, they are referred to as HER2+ tumors. HER2- cancers produce few or no HER2 molecules. Locally advanced breast cancer typically means the breast tumor is large or the breast cancer has spread beyond the breast to the chest wall, skin, or lymph nodes, but it has not spread to other parts of the body. Metastatic breast cancer has spread to other parts of the body.
What are the ingredients in Talzenna?
The active ingredient in Talzenna is talazoparib.
How does talazoparib work?
Talazoparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is a molecule that is particularly important in repairing the DNA of cells with BRCA1 and BRCA2 mutations. Talazoparib binds to PARP molecules, which prevents them from working properly. This allows breast cancer cells to accumulate DNA damage, which eventually kills them.
What are the possible side effects of talazoparib?
Common side effects with talazoparib include:
- Tiredness or weakness
- Low numbers of red or white blood cells
- Low number of platelets, which help stop bleeding
- Loss of appetite
- Hair loss
In some patients, talazoparib may cause more harmful side effects. These include bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people with cancer who have previously been treated with chemotherapy or certain other cancer medicines developed MDS or AML during or after treatment with talazoparib. MDS and AML may be life-threatening. If you develop MDS or AML, your healthcare provider will stop treatment with talazoparib.6
Low blood cell counts are a common side effect of talazoparib, but they can be signs of a more serious problem. Tell your doctor if you experience extreme tiredness, weight loss, fever, frequent infections, blood in the urine or stool, bruising or bleeding, or shortness of breath.6 Talazoparib may cause harm to an unborn baby and should not be used by women who are pregnant. Women who could become pregnant should utilize effective birth control while taking talazoparib and for at least seven months following the final dose. Men with female partners who can become pregnant, or who are pregnant, should utilize effective birth control while taking talazoparib and for at least four months following the final dose (patients should discuss appropriate birth control methods with their doctor). Talazoparib has not been tested or approved in children.6
This is not a complete list of all potential side effects of talazoparib. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.
It is not known if talazoparib passes through breast milk. Women who are breastfeeding or plan to breastfeed should talk to their doctor before starting treatment with talazoparib. Women should not breastfeed while taking talazoparib and for at least one month after treatment is finished.
Things to note about talazoparib
Before taking talazoparib, tell your doctor if you6:
- Have kidney problems
- Are pregnant or plan to become pregnant or are breastfeeding
Before beginning treatment with talazoparib, patients should talk to their doctor about all their health conditions, as well any medications (prescription and over-the-counter), vitamins, and herbal supplements they are taking. Some medications or supplements may interfere with each other and may cause serious side effects. It is important for doctors to test your blood cell counts before and regularly during therapy with talazoparib since it can cause serious, harmful reductions in blood cell numbers.5
Talazoparib comes in a capsule-type pill that is taken orally. Your doctor will determine the appropriate talazoparib dosing regimen and administration schedule for you. It is important to follow this schedule exactly as instructed, and not to stop taking talazoparib or any accompanying medications on your own, unless you are instructed to do so by your doctor.5
Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their talazoparib regimen. For more information about talazoparib, read the complete prescribing information.