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Dosing & Administration

Dosing and administration

TRUQAP’s 4 days on / 3 days off weekly dosing schedule

The recommended dose of TRUQAP is:

  • 400 mg (two 200 mg tablets) taken orally twice daily, approximately 12 hours apart (total daily dose of 800 mg),
  • for 4 days followed by 3 days off treatment.

Treatment with TRUQAP should continue until disease progression or unacceptable toxicity occurs.1

† Day 15 is Week 3 Day 1 of Cycle 1.

TRUQAP and fulvestrant are both started on the same day (Day 1 Cycle* 1).

Discuss the choice of a start date with your patients.

EXAMPLE FOR WEEK 1 CYCLE 1
MONDAY
TRUQAP +
fulvestrant
TUESDAY
TRUQAP
WEDNESDAY
TRUQAP
THURSDAY
TRUQAP
FRIDAY
 
SATURDAY
 
SUNDAY
 

* Each cycle has a duration of 28 days.

In pre-/peri-menopausal women, TRUQAP plus fulvestrant should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Concomitant use of strong and moderate CYP3A4 inhibitors increases capivasertib concentration, which may increase the risk of TRUQAP toxicities. TRUQAP dose should be reduced when used concomitantly with strong and moderate CYP3A4 inhibitors. Concomitant use of TRUQAP with strong CYP3A4 inducers is not recommended.

Advise your patient on how to take TRUQAP

Drink icon

Swallow whole

Food icon

Take with or
without food

Instruction icon

Patients should not drink or eat
grapefruit products during
treatment with TRUQAP*

Pill icon

Do not crush,
chew, dissolve or
divide tablets†

Correct glucose levels in patients with abnormal glucose levels before initiating TRUQAP. Due to the potential of TRUQAP to cause hyperglycemia, patients should be tested for fasting blood glucose (FG) levels and HbA1c prior to treatment and at regular intervals during treatment.

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.

If the patient vomits, a replacement dose should not be taken. The next dose of TRUQAP should be taken at the usual time.1

Overdose
There is currently no specific treatment in the event of an overdose with TRUQAP. In the event of an overdose, physicians should follow general supportive measures and patients should be treated symptomatically. In CAPItello-291, a patient with 2 weeks of continuous dosing experienced nausea and vomiting, hyperglycemia and acute kidney injury. For management of a suspected drug overdose, contact your regional poison control centre.1

* Grapefruit may interact with TRUQAP.
† Patients must not take any tablets that are broken, cracked, or that look damaged.

Dose modification overview

Dose modifications for adverse reactions:
A maximum of 2 dosing reductions are recommended, after which the patient should be discontinued from treatment with TRUQAP.

With all dose reductions, the schedule remains the same: 4 days of treatment followed by 3 days without treatment, every week.

Selected dosing in special populations1

Renal and hepatic impairment
  • Mild or moderate renal impairment
    (creatinine clearance 30 to 89 mL/min) or
  • Mild hepatic impairment
    (bilirubin ≤ upper limit of normal (ULN) and AST > ULN, or bilirubin >1 ULN to ≤1.5 ULN and any AST value)
No dose adjustment is recommended.
  • Moderate hepatic impairment
    (bilirubin >1.5x - 3.0x ULN and AST
    of any value)
Administer TRUQAP only if the benefit outweighs the risk and monitor closely for signs of toxicity.
Limited data are available.
  • Severe renal impairment
    (creatinine clearance 15 to 29 mL/min) or
  • Severe hepatic impairment
    (bilirubin >3.0x ULN and any AST)
TRUQAP is not recommended for patients, as safety and pharmacokinetics have not been studied in these patients.

AST=aspartate aminotransferase; BID=twice a day; ULN=upper limit of normal.

Selected adverse reactions

Diarrhea in patients receiving TRUQAP + fulvestrant

67.3%(n=239)

Experienced any grade

9.3%(n=33)

Experienced Grade 3 or 4

7.9%(n=28)

Required dose reduction

2.0%(n=7)

Discontinued

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Of the instances of diarrhea in the CAPItello-291 trial considered to be causally related to treatment based on assessment by the investigator:1

  • 58% (139/239) required antidiarrheal medications to manage symptoms.
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Median time to first diarrhea event (TRUQAP group): 8 days1,11

Recommended dose modifications for diarrhea*

Severity Recommendations TRUQAP dose
Grade 1 Recommendations Initiate appropriate anti-diarrheal therapy, maximize supportive care, and monitor as clinically indicated. TRUQAP dose
  • No TRUQAP dose adjustment required.
Grade 2 RecommendationsInitiate or intensify appropriate anti-diarrheal treatment and monitor as clinically indicated. TRUQAP dose
  • Interrupt TRUQAP dose for up to 28 days until recovery to
    ≤ Grade 1 and resume TRUQAP dosing at same dose or one lower dose level     as clinically indicated.
  • If Grade 2 diarrhea is persistent or recurring, maintain appropriate medical therapy and restart TRUQAP at one lower dose level, as clinically indicated.
Grade 3 Recommendations Initiate or intensify appropriate anti-diarrheal treatment and monitor as clinically indicated. TRUQAP dose
  • Interrupt TRUQAP.
  • If the symptoms improve to ≤ Grade 1 in 28 days, resume TRUQAP at one lower dose level.
  • If the symptoms do not improve to ≤ Grade 1 in 28 days, permanently discontinue TRUQAP.
Grade 4   TRUQAP dose
  • Permanently discontinue TRUQAP.

Severe diarrhea associated with dehydration and acute kidney injury was reported in patients treated with TRUQAP.

* Diarrhea includes diarrhea and frequent bowel movements.

Hyperglycemia* in patients receiving TRUQAP + fulvestrant

14.1%(n=50)

Experienced any grade

2.3%(n=8)

Experienced Grade 3 or 4

0.6%(n=2)

Required dose reduction

0.6%(n=2)

Discontinued due to hyperglycemia or diabetic ketoacidosis

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Of the instances of hyperglycemia in the CAPItello-291 trial considered to be causally related to treatment based on assessment by the investigator:

  • 44% (22/50) were treated with antihyperglycemic medication including insulin in 12% and metformin in 32%.1
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Median time to first hyperglycemia event (TRUQAP group): 15 days1,11

Some cases of diabetic ketoacidosis have been reported with a fatal outcome.

In the setting of additional co-morbidities and treatments (e.g., dehydration, malnourishment, concurrent chemotherapy/steroids, sepsis) the risk of hyperglycemia progressing to diabetic ketoacidosis may be higher. Diabetic ketoacidosis can occur at any time during treatment with TRUQAP. In some reported cases, diabetic ketoacidosis developed in less than 10 days.

Recommended schedule for monitoring FG and HbA1c levels

Schedule of FG monitoring and HbA1c levels‡

At screening, before initiating TRUQAP

Test for FG levels and HbA1c.

Optimize the patient’s level of blood glucose.

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After initiating TRUQAP

Monitor FG at Weeks 1, 2, 4, 6 and 8 after starting TRUQAP and at least once a month thereafter.

HbA1c should be monitored every 3 months.

Additional monitoring/self-monitoring may be required in accordance with the instructions of a healthcare professional, especially within the first 2 weeks of treatment.

After initiating TRUQAP

In patients with diabetes:

Monitor/self-monitor FG daily for the first 2 weeks of treatment.

Continue to monitor FG as frequently as needed to manage hyperglycemia according to the instructions of a healthcare professional.

Additional HbA1c testing is recommended on Week 4, and then at least every 3 months, in patients with diabetes, pre-diabetes, or hyperglycemia at baseline.

After initiating Truqap

If hyperglycemia develops after initiating treatment with TRUQAP (please see table below for recommended dose modifications):

Monitor fasting glucose at least twice weekly (on days on and off TRUQAP treatment until FG decreases to baseline levels).

During treatment with an anti-diabetic medication, FG should be monitored at least once a week for 2 months, followed by once every 2 weeks or as clinically indicated.

  • More frequent FG and HbA1c monitoring is required in patients with a medical history of diabetes mellitus, pre-diabetes, in patients with risk factors for hyperglycemia or other conditions which may require intensified glycemia management.
    - Monitoring of HbA1c, ketones (preferably in blood) and other metabolic parameters (as indicated), in addition to FG, is recommended in these patients.
  • Counselling on lifestyle changes is recommended for patients with baseline risk factors for hyperglycemia and for those who develop hyperglycemia during treatment with TRUQAP.

Recommended dose modifications for hyperglycemia

Dose modifications and management are based on pre-dose FG and/or HbA1c levels.

Severity† Recommendations TRUQAP dose
Grade 1 > ULN-160 mg/dL
or
> ULN-8.9 mmol/L
or
HbA1c >7%
 RecommendationsConsider initiation or intensification
of oral anti-diabetic treatment.		 TRUQAP dose
  • No TRUQAP dose adjustment required.
Grade 2 >160-250 mg/dL
or
>8.9-13.9 mmol/L
 RecommendationsInitiate or intensify oral anti-diabetic
treatment without dose adjustment
of TRUQAP.		 TRUQAP dose
  • If FG does not decrease to ≤160 mg/dL (or ≤8.9 mmol/L) with
    treatment, interrupt TRUQAP for up to 28 days until FG level
    decreases to ≤160 mg/dL (or ≤8.9 mmol/L).
  • If improvement to ≤160 mg/dL (or ≤8.9 mmol/L) is reached within
    28 days, restart TRUQAP at the same dose level and maintain
    initiated or intensified anti-diabetic treatment.
  • If improvement to ≤160 mg/dL (or ≤8.9 mmol/L) is reached after
    28 days, restart TRUQAP at one lower dose level and maintain
    initiated or intensified anti-diabetic treatment.
Grade 3 >250-500 mg/dL
or
>13.9-27.8 mmol/L
 RecommendationsWithhold TRUQAP and consult a
healthcare professional experienced
in the treatment of hyperglycemia.
Initiate or intensify oral anti-diabetic
treatment. Consider additional anti-
diabetic medicinal products such as
insulin, as clinically indicated.		 TRUQAP dose
  • If FG decreases to ≤160 mg/dL (or ≤8.9 mmol/L) within 28 days,
    restart TRUQAP at one lower dose level and maintain initiated or
    intensified anti-diabetic treatment.
  • If FG does not decrease to ≤160 mg/dL (or ≤8.9 mmol/L) within
    28 days following appropriate treatment, permanently
    discontinue TRUQAP.
  • If symptoms of diabetic ketoacidosis are observed, withhold
    TRUQAP immediately. If diabetic ketoacidosis is confirmed,
    permanently discontinue TRUQAP.
Grade 4 >500 mg/dL
or
>27.8 mmol/L
or
life-threatening
sequelae of
hyperglycemia
RecommendationsWithhold TRUQAP and consult a
healthcare professional experienced
in the treatment of hyperglycemia.
Initiate or intensify oral anti-diabetic
treatment. Consider insulin,
intravenous hydration and provide
appropriate clinical management as
per local guidelines.		 TRUQAP dose
  • If FG decreases to ≤500 mg/dL (or ≤27.8 mmol/L) within 24 hours,
    then follow the guidance in the table for the relevant grade.
  • If FG is confirmed at >500 mg/dL (or >27.8 mmol/L) after 24 hours,
    permanently discontinue TRUQAP treatment.
  • For life-threatening sequelae of hyperglycemia, permanently
    discontinue TRUQAP.
  • If symptoms of diabetic ketoacidosis are observed, withhold
    TRUQAP immediately. If diabetic ketoacidosis is confirmed,
    permanently discontinue TRUQAP.

Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia.

The safety of TRUQAP in patients with Type 1 diabetes, diabetes requiring insulin or those with an HbA1c of ≥8% has not been studied.

CTCAE=Common Terminology Criteria for Adverse Events; FG=fasting glucose.
* Hyperglycemia includes PTs of hyperglycemia and blood glucose increased.
† Severity grading per CTCAE Version 5.0; severity grading for hyperglycemia per CTCAE Version 4.03.
‡ It is recommended to test FG pre-dose on Day 3 or 4 of the dosing week.

Cutaneous adverse reactions in patients receiving TRUQAP + fulvestrant

46.5%(n=165)

Experienced any grade

16.9%(n=60)

Experienced Grade 3 or 4

6.5%(n=23)

Required dose reduction

6.5%(n=23)

Discontinued due to cutaneous reactions

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Of the instances of cutaneous reactions in the CAPItello-291 trial considered to be causally related to treatment based on assessment by the investigator:

  • 61% (101/165) required treatment with steroids.
    - Of these, 39.3% were treated with topical corticosteroids and 21.8% with systemic steroids.
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Median time to first rash event (TRUQAP group): 12 days1,11

Recommended dose modifications for cutaneous adverse reactions

Severity Recommendations TRUQAP dose
Grade 1 RecommendationsInitiate emollients and consider
adding an oral non-sedating
antihistamine treatment as clinically
indicated to manage symptoms.		 TRUQAP dose
  • No TRUQAP dose adjustment required.
Grade 2 RecommendationsInitiate or intensify topical steroid
treatment and consider non-
sedating oral antihistamines.		 TRUQAP dose
  • If no improvement with treatment, interrupt TRUQAP.
  • Resume at the same dose level once the rash becomes clinically tolerable.
Grade 3 RecommendationsInitiate appropriate dermatological
treatment with topical steroid of
moderate/higher strength, non-
sedating oral antihistamines and/or
systemic steroids.		 TRUQAP dose
  • Interrupt TRUQAP.
  • If symptoms improve within 28 days to ≤ Grade 1, restart TRUQAP
    at one lower dose level.
  • If the symptoms do not improve to ≤ Grade 1 in 28 days,
    discontinue TRUQAP.
  • In patients with reoccurrence of ≥ Grade 3 rash, permanently
    discontinue TRUQAP.
Grade 4   TRUQAP dose
  • Permanently discontinue TRUQAP.

Cutaneous adverse reactions including erythema multiforme (EM), palmar-plantar erythrodysesthesia and drug reaction with eosinophilia and systemic symptoms (DRESS) were reported in patients treated with TRUQAP.

Recommended dose modifications for other adverse reactions

Severity Recommendations TRUQAP dose
Grade 1 RecommendationsInitiate appropriate medical therapy
and monitor as clinically indicated.		 TRUQAP dose
  • No TRUQAP dose adjustment required.
Grade 2   TRUQAP dose
  • Interrupt TRUQAP until symptoms improve to ≤ Grade 1.
Grade 3 RecommendationsIf symptoms improve, restart
TRUQAP at same dose or one lower
dose level as clinically appropriate.		 TRUQAP dose
  • Interrupt TRUQAP until symptoms improve to ≤ Grade 1.
Grade 4   TRUQAP dose
  • Permanently discontinue TRUQAP.
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