GAVRETO HARD CAPSULES 100MG [SIN16755P]

Product Info

GAVRETO HARD CAPSULES 100MG

[SIN16755P]

2.1 THERAPEUTIC INDICATION(S)

Non-Small Cell Lung Cancer (NSCLC)

Gavreto is indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive, locally advanced or metastatic NSCLC.

RET-Mutant Medullary Thyroid Cancer (MTC)

Gavreto is indicated for the treatment of adult patients with locally advanced or metastatic RET-mutant MTC who require systemic therapy.

2.2 DOSAGE AND ADMINISTRATION

General

A validated assay is required for the selection of patients with a RET-gene fusion (NSCLC) or a RET-gene mutation (MTC).

Dosage

Gavreto hard capsules should be taken on an empty stomach. Do not to eat for at least 2 hours before and at least 1 hour after taking Gavreto.

Gavreto hard capsules should be swallowed whole with a glass of water and must not be opened or chewed.

Adults

The recommended dose of Gavreto for adults is 400 mg given orally, once daily.

Duration of Treatment

It is recommended that patients are treated with Gavreto until disease progression or unmanageable toxicity.

Delayed or Missed Doses

If a planned dose of Gavreto is missed, patients can make up that dose unless the next dose is due within 12 hours. Resume the regular daily dose schedule for Gavreto the next day.

If vomiting occurs after taking a dose of Gavreto, patients should take the next dose at the scheduled time.

Dose Modifications

Adverse Reactions

Management of adverse reactions may require temporary interruption, dose reduction, or discontinuation of treatment with Gavreto, based on the prescriber’s assessment of the patient’s safety or tolerability.

Table 1 provides recommended dose reduction advice. Recommendations for dose modifications for the management of specific adverse reactions are provided in Table 2. Gavreto treatment should be permanently discontinued if a patient is unable to tolerate the 100 mg once daily dose.

Interactions with other Medicinal Products

Dose Modification for Use with Cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) Inhibitors

Avoid coadministration of Gavreto with any of the following:

• Strong CYP3A4 inhibitors

• Moderate CYP3A4 inhibitors

• P-gp inhibitors

• Combined P-gp and strong CYP3A4 inhibitors.

• Combined P-gp and moderate CYP3A4 inhibitors.

If coadministration with any of the above inhibitors cannot be avoided, reduce the current dose of Gavreto as recommended in Table 3. After the coadministered inhibitor has been discontinued for 3 – 5 elimination half-lives of the inhibitor, the Gavreto dose that was taken prior to the inhibitor can be resumed.

Dose Modification for Use with CYP3A4 Inducers

Avoid coadministration of Gavreto with any of the following:

• Strong CYP3A4 inducers.

• Moderate CYP3A4 inducers.

If coadministration with any of the above inducers cannot be avoided, the dose of Gavreto should be increased as recommended in Table 4 starting on Day 7 of coadministration of Gavreto with the inducer. After the inducer has been discontinued for at least 14 days, the Gavreto dose that was taken prior to the use of the inducer can be resumed.

2.2.1 Special Dosage Instructions

Pediatric use

The safety and efficacy of Gavreto in pediatric patients (<18 years) have not been established.

Geriatric use

No dose adjustment of Gavreto is required in patients ≥ 65 years of age (see Section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment

No dose adjustment is required in patients with mild and moderate renal impairment. The safety and efficacy of Gavreto have not been studied in patients with severe renal impairment (see Section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Since pralsetinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment or end-stage renal disease.

Hepatic Impairment

No dose adjustment is required for patients with mild hepatic impairment. The safety and efficacy of Gavreto have not been studied in patients with moderate or severe hepatic impairment (see Section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.3 CONTRAINDICATIONS

Gavreto is contraindicated in patients with a known hypersensitivity to pralsetinib or any of the excipients.