Talaparib Talazoparib 1mg Capsules 30's

Talazoparib is a prescription medicine used as a single agent for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer, and, in combination with enzalutamide, for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Talazoparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. It blocks the PARP1 and PARP2 enzymes involved in DNA repair, leading to increased DNA damage, decreased cell proliferation, and cell death, particularly in cancer cells with BRCA or other DNA repair gene mutations.

Talazoparib is particularly relevant in tumors with impaired homologous recombination DNA repair, such as those carrying certain BRCA1 or BRCA2 mutations.

This medicine is taken orally, once daily, with or without food, and treatment continues until disease progression or unacceptable toxicity, as directed by the treating oncologist. Patients are selected for therapy based on an approved companion diagnostic test.

HER2-negative locally advanced or metastatic breast cancer

Talazoparib is indicated for adults with:

Deleterious or suspected deleterious germline BRCA-mutated

HER2-negative

Locally advanced or metastatic breast cancer.

Patients should be selected using an appropriate approved companion diagnostic where applicable.

Metastatic castration-resistant prostate cancer

Talazoparib, in combination with enzalutamide, is indicated for adults with:

HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The relevant homologous recombination repair gene alteration should be identified using an approved diagnostic test where required.

Talazoparib inhibits PARP1 and PARP2 and also traps PARP proteins on DNA.

Normally, PARP participates in repairing single-strand DNA damage.

When PARP is inhibited:

DNA damage → impaired repair → accumulation of DNA damage → cancer-cell death

This effect can be particularly pronounced in cancer cells that already have defects in the homologous recombination repair pathway, including certain BRCA1/BRCA2-mutated tumors.

This concept is sometimes described as synthetic lethality.

In simple terms:

BRCA/HRR-deficient cancer cell + PARP inhibition → inability to adequately repair DNA → cancer-cell death

The usual recommended adult dose is 1 mg orally once daily.

Talazoparib is taken once daily, with or without food.

• Take the capsule at approximately the same time every day.
• Swallow the capsule whole.
• Do not crush, chew, or dissolve the capsule.
• Follow the exact dose prescribed by the oncologist.

Reduced dose

Dose reductions may be required depending on:

• Kidney function
• Blood cell counts
• Adverse reactions
• Concomitant medicines.

Lower capsule strengths, including 0.25 mg, allow dose adjustment when required.

Missed dose

• If a dose is missed or vomiting occurs after taking the medicine, do not take an additional dose to compensate.
• Take the next dose at the regularly scheduled time unless the treating physician provides different instructions.

Common:

• Fatigue
• Nausea
• Headache
• Decreased appetite
• Vomiting
• Diarrhea
• Constipation
• Hair loss
• Anemia
• Low platelet count
• Low white blood cell count
• Dizziness
• Abdominal discomfort

The frequency and severity can vary depending on the cancer being treated and whether talazoparib is used alone or with another medicine.

Serious:

Bone marrow suppression

This is one of the most important safety concerns.

Talazoparib can cause significant decreases in:

• Hemoglobin/red blood cells
• White blood cells
• Neutrophils
• Platelets

This can result in:

Anemia → fatigue, weakness, shortness of breath

Neutropenia → increased infection risk

Thrombocytopenia → bruising or bleeding

Complete blood counts should therefore be monitored regularly.

Contact the healthcare team promptly for:

• Fever
• Chills
• Signs of infection
• Unusual bleeding
• Easy bruising
• Severe weakness
• Shortness of breath

Myelodysplastic syndrome / Acute myeloid leukemia

Rare but serious cases of:

• Myelodysplastic syndrome (MDS)
• Acute myeloid leukemia (AML)

have been reported with PARP inhibitors, including talazoparib.

Patients receiving prolonged treatment should be monitored for persistent or unexplained blood-count abnormalities.

Secondary malignancies

Because talazoparib interferes with DNA repair, long-term treatment requires appropriate monitoring for rare secondary hematologic malignancies.

Severe anemia

Anemia can become clinically significant and may require:

• Dose interruption
• Dose reduction
• Blood transfusion
• Additional medical evaluation.

Talazoparib has clinically important drug-interaction considerations.

Talazoparib is a substrate of P-glycoprotein (P-gp).

Certain P-gp inhibitors can increase talazoparib exposure and potentially increase toxicity.

Depending on the specific interacting medicine and indication, the physician may need to consider dose adjustment or alternative therapy.

Examples of medicines that may require particular attention include certain:

• P-gp inhibitors
• Cardiovascular medicines
• Anti-infective medicines

Always provide your oncologist/pharmacist with a complete list of medicines and supplements.

Other anticancer medicines

When talazoparib is prescribed together with enzalutamide, the interaction profile of both medicines needs to be considered.

Do not start, stop, or change any medicine without consulting the treating physician.

Store talazoparib capsules at 20°C–25°C (68°F–77°F).

Permitted temperature excursions are generally 15°C–30°C (59°F–86°F).

Keep capsules:

• In their original container
• Protected from excessive moisture
• At room temperature
• Out of reach of children.

Do not use capsules that are damaged or expired.

• Take talazoparib exactly as prescribed.
• Take it once daily at approximately the same time.
• Swallow the capsule whole.
• Do not crush or chew the capsule.
• Attend all scheduled complete blood count (CBC) monitoring.
• Report fever or signs of infection promptly.
• Report unusual bruising or bleeding.
• Tell your doctor if you develop severe fatigue or breathlessness.
• Inform your doctor about all prescription medicines, OTC medicines, and supplements.
• Tell your healthcare team about any previous bone-marrow disorders or blood cancers.
• Do not become pregnant during treatment.
• Discuss contraception with your oncologist before starting treatment.
• Do not breastfeed while receiving talazoparib.
• Do not stop treatment without consulting your oncologist.