Truqap Dosage/Direction for Use

Treatment with TRUQAP should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Patients with ER-positive, HER2-negative advanced breast cancer should be selected for treatment with TRUQAP based on the presence of one or more PIK3CA/AKT1/PTEN-alterations which should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used.
Posology: The recommended dose of TRUQAP is 400 mg (two 200 mg tablets) twice daily, approximately 12 hours apart (total daily dose of 800 mg), for 4 days followed by 3 days off treatment. (See Table 2.)

Click on icon to see table/diagram/image

TRUQAP should be co-administered with fulvestrant. The recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the Summary of Product Characteristics (SmPC) of fulvestrant for more information.
Missed dose: 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.
Vomiting: If the patient vomits, an additional dose should not be taken. The next dose of TRUQAP should be taken at the usual time.
Treatment duration: Treatment with capivasertib should continue until disease progression or unacceptable toxicity occurs.
Dose adjustments: Treatment with TRUQAP may be interrupted to manage adverse reactions and dose reduction can be considered. Dose reductions for TRUQAP should be carried out as described in Table 3. The dose of capivasertib can be reduced up to two times. Dose modification guidance for specific adverse reactions is presented in Tables 4-6. (See Table 3.)

Click on icon to see table/diagram/image

Hyperglycaemia: See Table 4.

Click on icon to see table/diagram/image

Diarrhoea: Secondary prophylaxis should be considered in patients with recurrent diarrhoea (see Precautions). (See Table 5.)

Click on icon to see table/diagram/image

Rash and other skin drug reactions: Consultation with a dermatologist for all grades of skin drug reactions regardless of the severity should be considered. In patients with persistent rash and/or previous occurrence of grade 3 rash, secondary prophylaxis should be considered by continuing oral antihistamines and/or topical steroids (see Precautions). (See Table 6.)

Click on icon to see table/diagram/image

Other toxicities: See Table 7.

Click on icon to see table/diagram/image

Co-administration with strong and moderate CYP3A4 inhibitors: Co-administration of TRUQAP with strong CYP3A4 inhibitors should be avoided. If co-administration cannot be avoided, the dose of TRUQAP should be reduced to 320 mg twice daily (equivalent to a total daily dose of 640 mg).
TRUQAP dose should be reduced to 320 mg twice daily (equivalent to a total daily dose of 640 mg) when co-administered with moderate CYP3A4 inhibitors.
After discontinuation of a strong or moderate CYP3A4 inhibitor, TRUQAP dosage (after 3 to 5 half-lives of the inhibitor) that was taken prior to initiating the strong or moderate CYP3A4 inhibitor should be resumed.
See Interactions for further information.
Special populations: Elderly: No dose adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics under Actions). 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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of TRUQAP in children aged 0-18 years of age has not been established. No data are available.
Method of administration: TRUQAP is for oral use. The tablets can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). They should be swallowed whole with water and not chewed, crushed, dissolved, or divided. No tablet should be ingested if it is broken, cracked, or otherwise not intact because these methods have not been studied in clinical trials.