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TRUQAP is a brand name for Capivasertib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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 (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Truqap should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patients with 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-alterations using a validated test.
Posology The recommended dose of Truqap in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily approximately 12 hours apart (total daily dose of 800 mg) with or without food, for 4 days followed by 3 days off treatment.
See Table 1. Table 1 Truqap dosing schedule for each week Day 1 2 3 4 5* 6* 7* Morning 2 x 200 mg 2 x 200 mg 2 x 200 mg 2 x 200 mg Evening 2 x 200 mg 2 x 200 mg 2 x 200 mg 2 x 200 mg * No dosing on day 5, 6 and 7 Truqap should be co-administered with fulvestrant.
The recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, and 29, and once monthly thereafter. Refer to the approved Summary of Product Characteristics (SmPC) of fulvestrant for more information. In pre/perimenopausal women, Truqap plus fulvestrant should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
For men, consider administering a LHRH agonist according to current clinical practice standards. Refer to the approved Summary of Product Characteristics (SmPC) 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.
If a dose is missed and more than 4 hours have passed, 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. 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 capivasertib should be carried out as described in Table 2. The dose of capivasertib can be reduced up to two times. Dose modification guidance for specific adverse reactions is presented in Tables 3-5. Table 2 Truqap dose reduction guidelines for adverse reactions Truqap Dose and Schedule Number and Strength of Tablets First dose reduction 320 mg twice daily for 4 days followed by 3 days off treatment.
Summary of safety profile The safety profile of Truqap is based on data from 355 patients who received Truqap plus fulvestrant in CAPItello-291. 6%). 0%). 3%) patients receiving Truqap plus fulvestrant. 1%) patients. Dose reductions due to adverse reactions were reported in 64 (18%) patients.
9%). 1%) patients. 0%). Tabulated list of adverse reactions Adverse drug reactions are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness.
Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from available data).
4) 0 1 Urinary Tract Infection includes urinary tract infection, pyuria, and cystitis. 2 Hypersensitivity includes hypersensitivity, drug hypersensitivity and anaphylactic reaction. 3 Hyperglycaemia includes hyperglycaemia, blood glucose increased, diabetes mellitus, type 2 diabetes mellitus and diabetic metabolic decompensation.
4 Hypokalaemia includes blood potassium decreased and hypokalaemia. 5 Diabetic Ketoacidosis includes ketoacidosis. 6 Diarrhoea includes diarrhoea and frequent bowel movements. 7 Stomatitis includes stomatitis, aphthous ulcer and mouth ulceration.
8 Cutaneous adverse drug reactions include butterfly rash, dermatitis, dermatitis exfoliative generalised, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema, erythema multiforme, papule, rash, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, skin reaction, toxic skin eruption.
9 Fatigue includes asthenia, fatigue and malaise. 10 Pyrexia includes body temperature increased and pyrexia. 5%) patients receiving Truqap. 4%). 5%) patient discontinued treatment due to hyperglycaemia. 4%) patients receiving Truqap. 3%) patients.
9 mmol/mol) has not been studied as these patients were excluded from the phase III clinical study. 5%. 0%). 8). DKA can occur at any time during Truqap treatment. In some reported cases, DKA developed in less than 10 days. Patients with history of diabetes mellitus may require intensified anti-diabetic treatment and should be closely monitored.
Consultation with a diabetologist or a healthcare professional experienced in the treatment of hyperglycaemia is recommended for patients with diabetes. , excessive thirst, urinating more often than usual or greater amount of urine than usual, or increased appetite with weight loss) occur.
g. dehydration, malnourishment, concurrent chemotherapy/steroids, sepsis), the risk of hyperglycaemia progressing to diabetic ketoacidosis may be higher. DKA should be considered as one of the differential diagnoses in the event of additional nonspecific symptoms such as nausea, vomiting, abdominal pain, difficulty breathing, fruity odour on breath, confusion, unusual fatigue, or sleepiness.
In patients where DKA is suspected, Truqap treatment should be interrupted immediately. If DKA is confirmed, then Truqap should be permanently discontinued. Patients must be tested for fasting blood glucose (FG) levels and HbA1C prior to the start and during treatment with Truqap, in accordance with the intervals recommended in Table 7.
2 Table 3). g. infection, sepsis, raised HbA1c) (see Table 7). In addition to FG, monitoring of ketones (preferably in blood) and other metabolic parameters (as indicated) is recommended when a patient experiences hyperglycaemia. 2 Table 3, counselling on lifestyle changes is recommended for patients with baseline risk factors and those that develop hyperglycaemia during treatment with Truqap.
Table 7 Schedule of monitoring of fasting glucose and HbA1c levels in patients treated with Truqap Recommended schedule for the monitoring of fasting glucose and HbA1c levels in all patients treated with Truqap Recommended schedule of monitoring of fasting glucose and HbA1c levels in patients with diabetes and treated with Truqap1 At screening, before initiating treatment with Truqap Test for fasting blood glucose (FG) levels, HbA1c, and optimise the patient’s level of blood glucose (see Table 3).
1.
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Two 160 mg tablets Second dose reduction 200 mg twice daily for 4 days followed by 3 days off treatment. 9 mmol/L or HbA1C > 7% No Truqap dose adjustment required. Consider initiation or intensification of oral anti- diabetic treatmente.
9 mmol/L Initiate or intensify oral anti-diabetic treatment. 9 mmol/L). If recovery occurs in ≤28 days, resume Truqap at the same dose and maintain initiated or intensified anti-diabetic treatment. 9 mmol/L) is reached in more than 28 days restart at one lower dose level and maintain initiated or intensified anti-diabetic treatment.
9 mmol/L) and consult a diabetologist. Initiate or intensify oral anti-diabetic treatment. Consider additional anti-diabetic medicinal products such as insulinf, as clinically indicated. Consider intravenous hydration and provide appropriate clinical management as per local guidelines.
9 mmol/L) within 28 days, restart Truqap at one lower dose level and maintain initiated or intensified anti- diabetic treatment. 9 mmol/L) within 28 days following appropriate treatment permanently discontinue Truqap. 8 mmol/L) Withhold Truqap and consult with a diabetologist.
Initiate or intensify appropriate anti-diabetic treatment. Consider insulinf, (dosing and duration as clinically indicated), intravenous hydration and provide appropriate clinical management as per local guidelines. 8 mmol/l) within 24 hours, then follow the guidance in the table for the relevant grade.
8 mmol/l) after 24 hours, permanently discontinue Truqap treatment. 4. 03. c Considerations should be also given to increases in HbA1C. 4 for further recommendations on monitoring of glycaemia and other metabolic parameters. e Consultation with a diabetologist should be considered when selecting the anti-diabetic medicinal product.
A potential for hypoglycaemia with anti-diabetic medicinal product administration on non-Truqap dosing days should be taken into account. 4). f There is limited experience in patients receiving insulin when being treated with Truqap.
4). Table 4 Recommended dose modification for Truqap for diarrhoea CTCAE Gradea Recommendations Grade 1 No Truqap dose adjustment required. Initiate appropriate anti-diarrhoeal therapy, maximise supportive care and monitor as clinically indicated.
Grade 2 Initiate or intensify appropriate anti-diarrhoeal treatment and monitor as clinically indicated. […]
The median time to first occurrence was 8 days (1 to 519). In the 257 patients with diarrhoea, anti-diarrheal medication was required in 59% (151/257) of patients to manage diarrhoea symptoms. 7%) patients discontinued Truqap due to diarrhoea.
1%). 5%) patients. The median time to first occurrence was 12 days (1-377). 9%) of patients who received capivasertib. 8% (74/165) were treated with […]
Monitor fasting glucose at weeks 1, 2, 4, 6 and 8 after treatment start and monthly thereafter. It is recommended to test FG pre-dose at Day 3 or 4 of the dosing week. HbA1c should be monitored every 3 months. After initiating treatment with Truqap Monitor/self-monitor fasting glucose regularly, more frequently in the first 4 weeks and especially within the first 2 weeks of treatment, according to the instructions of a healthcare professional*.
Monitor/self-monitor fasting glucose daily for the first 2 weeks of treatment. Then continue to monitor fasting glucose as frequently as needed to manage hyperglycaemia according to the instructions of a healthcare professional*. Additional HbA1c testing is recommended at week 4 with diabetes, pre-diabetes, or hyperglycaemia at baseline.
e. on days on and off capivasertib treatment) until FG decreases to baseline levels2. Consultation with a healthcare practitioner with expertise in the treatment of hyperglycaemia should be considered. 2, Table 3). If hyperglycaemia develops after initiating treatment with Truqap During treatment with anti-diabetic medication, FG should be monitored for at least once a week for 2 months, followed by once every 2 weeks or as clinically indicated2.
* All glucose monitoring should be performed at the physician’s discretion as clinically indicated. 9 mmol/L) during treatment, in patients with concomitant use of corticosteroids, or in those with intercurrent infections, or other conditions which may require intensified glycaemia management to prevent worsening of impaired glucose metabolism and potential complications, namely diabetic ketoacidosis.
Recommended schedule for the monitoring of fasting glucose and HbA1c levels in all patients treated with Truqap Recommended schedule of monitoring of fasting glucose and HbA1c levels in patients with diabetes and treated with Truqap1 2 It is recommended to test FG pre-dose at Day 3 or 4 of the dosing […]