Talzenna 0.25 mg Capsules

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). …

• Take TALZENNA with or without food
• Breast Cancer • The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. • For adverse reactions, consider dosing interruption or dose reduction
• HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • The recommended dosage of TALZENNA is 0.5 mg taken orally once daily with enzalutamide until disease progression or unacceptable toxicity. • Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
• Patient Selection Information on the FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics . g BRCA m HER2-negative Locally Advanced or Metastatic Breast Cancer Select patients
• For the treatment of advanced breast cancer with TALZENNA based on the presence of germline BRCA mutations [see Indications and Usage , Clinical Studies ]
• HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer Select patients
• For the treatment of HRR gene-mutated mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR ( ATM , ATR , BRCA1 , BRCA2 , CDK12 , CHEK2 , FANCA , MLH1 , MRE11A , NBN , PALB2 , or RAD51C ) [see Indications and Usage , Clinical Studies ]
• An FDA-approved test for the detection of HRR gene mutations for use with TALZENNA is not currently available. …

Table 4. Dosage Forms and Strengths Capsule Strength Description 0.1 mg White cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black) 0.25 mg Ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black) 0.35 mg Ivory cap (printed with “Pfizer” in black) and an ivory body (printed with “TLZ 0.35” in black) 0.5 mg Light pink cap (prin …

• The safety and effectiveness of TALZENNA have not been established
• In pediatric patients

In clinical trials of TALZENNA enrolling 494 patients with advanced solid tumors who received TALZENNA 1 mg daily as a single agent, 85 (17%) patients were ≥65 years of age, and this included 19 (4%) patients who were ≥75 years old. There were 5 patients ≥85 years old. In the TALAPRO-2 trial, of 197 patients who received TALZENNA, 77% were ≥65 years of age, while 30% were ≥75 years of age. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information). • MDS/AML : Advise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions
• This may be a sign of hematological toxicity or a more serious uncommon bone marrow problem called MDS or AML, which have been reported in patients who received PARP inhibitors [see Warnings and Precautions ] . …

• None
• None

• P-gp Inhibitors : Reduce the dose when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions. ( 2.7 , 7.1 ) • BCRP Inhibitors : Monitor for potential increased adverse reactions. ( 7.1 ) 7.1 Effect of Other Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the dose of TALZENNA [see Dosage and Administration (2.7) ] . …

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) : MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed. ( 5.1 ) • Myelosuppression : TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. ( 5.2 ) • Embryo-Fetal Toxicity : TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception. …

The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelodysplastic Syndrome/Acute Myeloid Leukemia [see Warnings and Precautions (5.1) ] • Myelosuppression [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥20%) as a single agent, including laboratory abnormalities, are: • Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite. …

8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , TALZENNA can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on TALZENNA use in pregnant women to inform a drug-associated risk. …

Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.