TRUQAP 200 mg/1
capivasertib · TABLET, FILM COATED · AstraZeneca Pharmaceuticals LP
TRUQAP is a tablet, film coated containing capivasertib at 200 mg/1, taken oral. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- TRUQAP
- Generic Name
- capivasertib
- NDC Code (Product)
0310-9501- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA218197
- Marketing Start
- 11/16/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TRUQAP based on the presence of one or more of the following genetic alterations in tumor tissue: PIK3CA/AKT1/PTEN . ( 2.1 ) • Select patients for the treatment of mAPMN/S prostate cancer with TRUQAP based on PTEN deficiency in tumor tissue. ( 2.1 ) • Recommended Dosage: 400 mg orally twice daily, with or without food, for 4 days followed by 3 days off. ( 2.3 ) 2.1 Patient Selection Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TRUQAP, based on the presence of one or more of the following genetic alterations in tumor tissue: PIK3CA/AKT1/PTEN [see Clinical Studies (14) ] . Select patients for the treatment of metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with TRUQAP based on PTEN deficiency in tumor tissue [see Clinical Studies (14) ] . Information on FDA-authorized tests for patient selection for the detection of PIK3CA, AKT1, and PTEN alterations or PTEN deficiency are available at: http://www.fda.gov/CompanionDiagnostics 2.2 Recommended Evaluation B…
Contraindications
4 CONTRAINDICATIONS TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components. Severe hypersensitivity to TRUQAP or any of its components. (4)
Drug Interactions
7 DRUG INTERACTIONS • Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce TRUQAP dose. ( 2.6 , 7.1 ) • Moderate CYP3A Inhibitors: Reduce TRUQAP dose. ( 2.6 , 7.1 ) • Strong and Moderate CYP3A Inducers: Avoid concomitant use. ( 7.1 ) 7.1 Effects of Other Drugs on TRUQAP Table 8 describes drug interactions where concomitant use of another drug affects TRUQAP. Table 8: Drug Interactions with TRUQAP Strong CYP3A Inhibitors Clinical Impact • Capivasertib is a CYP3A substrate. Strong CYP3A inhibitors increase capivasertib exposure [see Clinical Pharmacology (12.3) ], which may increase the risk of TRUQAP adverse reactions. Prevention or Management • Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions [see Dosage and Administration (2.5) ] . Moderate CYP3A Inhibitors Clinical Impact • Capivasertib is a CYP3A substrate. Moderate CYP3A inhibitors increase capivasertib exposure [see Clinical Pharmacology (12.3) ], which may increase the risk of TRUQAP adverse reactions. Prevention or Management • When concomitantly used with moderate CYP3A inhib…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed in greater details in other sections of the labeling: • Hyperglycemia [see Warnings and Precautions (5.1) ] • Diarrhea [see Warnings and Precautions (5.2) ] • Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%), including laboratory abnormalities, in patients with: • HR-positive, HER2-negative breast cancer were diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis. ( 6.1 ) • PTEN-deficient mAPMN/S prostate cancer were increased fasting glucose, decreased hemoglobin, decreased lymphocytes, cutaneous adverse reactions, diarrhea, decreased potassium, increased creatinine, increased non-fasting glucose, increased alanine aminotransferase, increased triglycerides, increased aspartate aminotransferase, decreased sodium, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or w…
Frequently Asked Questions
What is TRUQAP used for?
TRUQAP contains capivasertib. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is TRUQAP a controlled substance?
TRUQAP is not classified as a controlled substance by the DEA.
What is the generic name for TRUQAP?
The generic name for TRUQAP is capivasertib. There are no other listed brand versions of capivasertib.
What is the NDC code for TRUQAP 200 mg/1?
The NDC (National Drug Code) for TRUQAP 200 mg/1 is 0310-9501, listed by AstraZeneca Pharmaceuticals LP.
Other TRUQAP Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)