Medical Editor: John P. Cunha, DO, FACOEP
What Is Talzenna?
Talzenna (talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
What Are Side Effects of Talzenna?
Common side effects of Talzenna include:
- fatigue,
- anemia,
- nausea,
- low white blood cell count (neutropenia),
- headache,
- low blood platelets (thrombocytopenia),
- vomiting,
- hair loss,
- diarrhea, and
- decreased appetite
Dosage for Talzenna
The recommended dose of Talzenna is 1 mg taken as a single oral daily dose, with or without food.
What Drugs, Substances, or Supplements Interact with Talzenna?
Talzenna may interact with P-gp inhibitors and BCRP inhibitors. Tell your doctor all medications and supplements you use.
Talzenna During Pregnancy and Breastfeeding
Talzenna is not recommended for use during pregnancy; it may harm a fetus. A pregnancy test is recommended for females of reproductive potential prior to initiating Talzenna treatment. Females of reproductive potential are advised to use contraception during treatment and for at least 7 months following the last dose of Talzenna. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while using Talzenna and for at least 1 month after the final dose.
Additional Information
Our Talzenna (talazoparib) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
A lump in the breast is almost always cancer. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- blood in your urine or stools;
- easy bruising, unusual bleeding, purple or red spots under your skin;
- weight loss;
- low red blood cells (anemia)--pale skin, weakness, feeling tired or short of breath, cold hands and feet; or
- low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- low blood cell counts;
- nausea, vomiting, diarrhea, loss if appetite;
- hair loss;
- headache; or
- feeling weak or tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Talzenna (Talazoparib Capsules)
SLIDESHOW
Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelodysplastic Syndrome/Acute Myeloid Leukemia [see WARNINGS AND PRECAUTIONS]
- Myelosuppression [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Treatment Of gBRCAm HER2-negative Locally Advanced Or Metastatic Breast Cancer
EMBRACA
The safety of TALZENNA as monotherapy was evaluated in gBRCAm patients with HER2-negative locally advanced or metastatic breast cancer who had previously received no more than 3 lines of chemotherapy for the treatment of locally advanced/metastatic disease. EMBRACA was a randomized, open-label, multi-center study in which 412 patients received either TALZENNA 1 mg once daily (n=286) or a chemotherapy agent (capecitabine, eribulin, gemcitabine, or vinorelbine) of the healthcare provider's choice (n=126) until disease progression or unacceptable toxicity. The median duration of study treatment was 6.1 months in patients who received TALZENNA and 3.9 months in patients who received chemotherapy. Dosing interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA and 50% of those receiving chemotherapy; dose reductions due to any cause occurred in 53% of TALZENNA patients and 40% of chemotherapy patients. Permanent discontinuation due to adverse reactions occurred in 5% of TALZENNA patients and 6% chemotherapy patients.
Table 3 and Table 4 summarize the most common adverse reactions and laboratory abnormalities, respectively, in patients treated with TALZENNA or chemotherapy in the EMBRACA study.
Table 3: Adverse Reactionsa (in >20% of Patients Receiving TALZENNA) in EMBRACA
| Adverse Reactions | TALZENNA N=286 (%) | Chemotherapy N=126 (%) | ||||
| Grades 1-4 | Grade 3 | Grade 4 | Grades 1-4 | Grade 3 | Grade 4 | |
| Blood and lymphatic system disorders | ||||||
| Anemiab | 53 | 38 | 1 | 18 | 4 | 1 |
| Neutropeniac | 35 | 18 | 3 | 43 | 20 | 16 |
| Thrombocytopeni ad | 27 | 11 | 4 | 7 | 2 | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 21 | <1 | 0 | 22 | 1 | 0 |
| Nervous system disorders | ||||||
| Headache | 33 | 2 | 0 | 22 | 1 | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 49 | <1 | 0 | 47 | 2 | 0 |
| Vomiting | 25 | 2 | 0 | 23 | 2 | 0 |
| Diarrhea | 22 | 1 | 0 | 26 | 6 | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopeciae | 25 | 0 | 0 | 28 | 0 | 0 |
| General disorders and administration site conditions | ||||||
| Fatiguef | 62 | 3 | 0 | 50 | 5 | 0 |
| Abbreviations: AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute; N=number of patients. a raded according to NCI CTCAE 4.03. b Includes anemia, hematocrit decreased, hemoglobin decreased, and red blood cell count decreased. c Includes febrile neutropenia, neutropenia and neutrophil count decreased. d Includes thrombocytopenia and platelet count decreased. e For TALZENNA, Grade 1 in 23%, and Grade 2 in 2%. For the chemotherapy arm, Grade 1 in 20%, and Grade 2 in 8%. f Includes fatigue and asthenia. | ||||||
The following adverse reactions have been identified in <20% of the 286 patients receiving TALZENNA, and thus were not included in Table 3: abdominal pain (19%), dizziness (17%), leukopenia (17%), dysgeusia (10%), dyspepsia (10%), stomatitis (8%), and lymphopenia (7%).
Table 4 : Laboratory Abnormalities Reported in ≥25% of Patients in EMBRACA
| Parameter | EMBRACA Study | |||||
| TALZENNA Na=286 (%) | Chemotherapy Na=126 (%) | |||||
| Grades 1-4 | Grade 3 | Grade 4 | Grades 1-4 | Grade 3 | Grade 4 | |
| Decrease in hemoglobin | 90 | 39 | 0 | 77 | 6 | 0 |
| Decrease in leukocytes | 84 | 14 | 0.3 | 73 | 22 | 2 |
| Decrease in neutrophils | 68 | 17 | 3 | 70 | 21 | 17 |
| Decrease in lymphocytes | 76 | 17 | 0.7 | 53 | 8 | 0.8 |
| Decrease in platelets | 55 | 11 | 4 | 29 | 2 | 0 |
| Increase in glucoseb | 54 | 2 | 0 | 51 | 2 | 0 |
| Increase in aspartate aminotransferase | 37 | 2 | 0 | 48 | 3 | 0 |
| Increase in alkaline phosphatase | 36 | 2 | 0 | 34 | 2 | 0 |
| Increase in alanine aminotransferase | 33 | 1 | 0 | 37 | 2 | 0 |
| Decrease in calcium | 28 | 1 | 0 | 16 | 0 | 0 |
| Abbreviation: N=number of patients. a This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter. b This number represents non-fasting glucose. | ||||||
Read the entire FDA prescribing information for Talzenna (Talazoparib Capsules)
© Talzenna Patient Information is supplied by Cerner Multum, Inc. and Talzenna Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.