TRUQAP FILM-COATED TABLETS 160MG [SIN17112P]

Product Info

TRUQAP FILM-COATED TABLETS 160MG

[SIN17112P]

4.1 Therapeutic indications

TRUQAP is indicated 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-alteration following recurrence or progression on or after an endocrine-based regimen.

4.2 Posology and Method of administration

Patients with hormone receptor (HR) positive, HER2-negative advanced breast cancer should be selected for treatment with TRUQAP based on the presence of one or more PIK3CA/AKT1/PTEN genetic alterations using a validated test.

The recommended dose of TRUQAP in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off treatment. See Table 1.

The recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the approved Prescribing Information of fulvestrant for more information.

In pre/peri-menopausal women, TRUQAP plus fulvestrant should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. Refer to the approved Prescribing Information of fulvestrant for more information.

If a dose of TRUQAP is missed, it can be taken within 4 hours after the time it is usually taken. After more than 4 hours, the dose should be skipped. The next dose of TRUQAP should be taken at the usual time. There should be at least 8 hours between doses. If the patient vomits, an additional dose should not be taken. The next dose of TRUQAP should be taken at the usual time.

Duration of treatment

Treatment with TRUQAP should continue until disease progression or unacceptable toxicity occurs.

Dose adjustments

For Adverse Reactions

Treatment with TRUQAP may be interrupted to manage adverse reactions and dose reduction can be considered. If dose reduction is considered, the dose reduction guidelines are described in Table 2. The dose of TRUQAP can be reduced up to two times. Dose modification guidance for specific adverse reactions is presented in Table 3–5.

Hyperglycaemia

Consider a consult with diabetologist/endocrinologist when selecting the antidiabetic medicinal product, a potential for hypoglycaemia with antidiabetic medication administration on non-TRUQAP dosing days should be taken in account.

Diarrhoea

Consider secondary prophylaxis in patients with recurrent diarrhoea.

Rash and other Skin Drug Reactions

Consider consultation with a dermatologist for all grades of skin drug reactions regardless of the severity. In patients with persistent rash and/or previous occurrence of grade 3 rash, consider secondary prophylaxis by continuing oral antihistamines and/or topical steroids.

Other toxicities

Co-administration with strong CYP3A4 inhibitors

Avoid concomitant use with strong CYP3A inhibitors. If concomitant use with a strong CYP3A inhibitor cannot be avoided, the dose of TRUQAP should be reduced to 320 mg twice daily (equivalent to a total daily dose of 640 mg) for 4 days followed by 3 days off (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

When concomitantly used with a moderate CYP3A inhibitor, reduce the dosage of TRUQAP to 320 mg orally twice daily for 4 days followed by 3 days off.

After discontinuation of a strong or moderate CYP3A inhibitor, resume the TRUQAP dosage (after 3 to 5 half-lives of the inhibitor) that was taken prior to initiating the strong or moderate CYP3A inhibitor.

Special populations

Elderly

No dose adjustment is required for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There are limited data in patients aged ≥ 75 years.

Renal impairment

No dose adjustment is required for patients with mild or moderate renal impairment. TRUQAP is not recommended for patients with severe renal impairment, as safety and pharmacokinetics have not been studied in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required for patients with mild hepatic impairment. Limited data are available for patients with moderate hepatic impairment; TRUQAP should be administered to patients with moderate hepatic impairment only if the benefit outweighs the risk and these patients should be monitored closely for signs of toxicity. TRUQAP is not recommended for patients with severe hepatic impairment, as safety and pharmacokinetics have not been studied in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

TRUQAP is not indicated for use in paediatric patients, as safety and efficacy of TRUQAP in children and adolescents have not been established.

Method of administration

TRUQAP tablets should be swallowed whole with water and not chewed, crushed, dissolved, or divided. TRUQAP should not be ingested if it is broken, cracked, or otherwise not intact.

4.3 Contraindications

Prior severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.