TANSTRIVE HARD CAPSULES 40MG [SIN16990P]

Product Info

TANSTRIVE HARD CAPSULES 40MG

[SIN16990P]

1 INDICATIONS AND USAGE

1.1 RET Fusion-Positive Non-Small Cell Lung Cancer

TANSTRIVE is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.

1.2 RET-Mutant Medullary Thyroid Cancer

TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy.

1.3 RET Fusion-Positive Thyroid Cancer

TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for treatment with TANSTRIVE based on the presence of a RET gene fusion (NSCLC or thyroid cancer) or specific RET gene mutation (MTC) in tumor specimens [see Clinical Studies (14) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.2 Important Administration Instructions

TANSTRIVE may be taken with or without food unless coadministered with a proton pump inhibitor (PPI) [see Dosage and Administration (2.4), Clinical Pharmacology (12.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.3 Recommended Dosage

The recommended dosage of TANSTRIVE based on body weight is:

• Less than 50 kg: 120 mg

• 50 kg or greater: 160 mg

Take TANSTRIVE orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity. Swallow the capsules whole. Do not crush or chew the capsules.

Do not take a missed dose if it is less than 6 hours until next scheduled dose.

If vomiting occurs after TANSTRIVE administration, do not take an additional dose and continue to the next scheduled time for the next dose.

2.4 Dosage Modifications for Concomitant Use of Acid-Reducing Agents

Avoid concomitant use of a PPI, a histamine-2 (H2) receptor antagonist, or a locally-acting antacid with TANSTRIVE [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. If concomitant use cannot be avoided:

• Take TANSTRIVE with food when coadministered with a PPI.

• Take TANSTRIVE 2 hours before or 10 hours after administration of an H2 receptor antagonist.

• Take TANSTRIVE 2 hours before or 2 hours after administration of a locally-acting antacid.

2.5 Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 1.

Permanently discontinue TANSTRIVE in patients unable to tolerate three dose reductions. The recommended dosage modifications for adverse reactions are provided in Table 2.

2.6 Dosage Modifications for Concomitant Use of Strong and Moderate CYP3A Inhibitors

Avoid concomitant use of strong and moderate CYP3A inhibitors with TANSTRIVE. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the TANSTRIVE dose as recommended in Table 3. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume TANSTRIVE at the dose taken prior to initiating the CYP3A inhibitor [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.7 Dosage Modification for Severe Hepatic Impairment

Reduce the recommended dosage of TANSTRIVE for patients with severe hepatic impairment as recommended in Table 4 [see Use in Specific Populations (8.7) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

4 CONTRAINDICATIONS

None.