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Kyprolis is a brand name for Carfilzomib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. 3 Posology The dose is calculated using the patient’s baseline body surface area (BSA). 2 m2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
Kyprolis in combination with lenalidomide and dexamethasone When combined with lenalidomide and dexamethasone, Kyprolis is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28) as shown in table 1.
Each 28-day period is considered one treatment cycle. Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg).
From cycle 13, the day 8 and 9 doses of Kyprolis are omitted. Treatment may be continued until disease progression or until unacceptable toxicity occurs. 1). In combination with Kyprolis, lenalidomide is administered as 25 mg orally on days 1-21 and dexamethasone is administered as 40 mg orally or intravenously on days 1, 8, 15, and 22 of the 28-day cycles.
Appropriate dose reduction for the starting dose of lenalidomide should be considered according to the recommendations in the current lenalidomide summary of product characteristics, for example for patients with baseline renal impairment.
Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Table 1. Kyprolis in combination with lenalidomide and dexamethasone Cycle 1 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 20 20 - 27 27 - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - Cycles 2-12 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 27 27 - 27 27 - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - 4 Cycles 13 on Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Days 23-28 Kyprolis (mg/m2)a 27 27 - - - - 27 27 - - - Dexamethasone (mg) 40 - - 40 - - 40 - - 40 - Lenalidomide 25 mg daily - - a.
8. While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for evidence of volume overload, especially patients at risk for cardiac failure. 2). 2). The risk of cardiac failure is increased in elderly patients (≥ 75 years).
The risk of cardiac failure is also increased in Asian patients. A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended. Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical studies.
These patients may be at greater risk for cardiac complications. Patients with signs or symptoms of NYHA Class III or IV cardiac failure, recent history of myocardial infarction (in the last 4 months), and in patients with uncontrolled angina or arrhythmias, should have a comprehensive cardiological assessment, prior to starting treatment with Kyprolis.
This assessment should optimise the patient’s status, with particular attention to blood pressure control and fluid management. Subsequently patients should be treated with caution and remain under close follow-up. Electrocardiographic changes There have been cases of QT interval prolongation reported in clinical studies and post-marketing.
Cases of ventricular tachycardia have been reported in patients receiving Kyprolis. Pulmonary toxicity Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Some of these events have been fatal. 2). Pulmonary hypertension Pulmonary hypertension has been reported in patients treated with Kyprolis. Some of these events have been fatal. Evaluate as appropriate. 2). Dyspnoea Dyspnoea was commonly reported in patients treated with Kyprolis.
As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis. 6). g. congestive cardiac failure, pulmonary oedema, decreased ejection fraction), myocardial ischaemia and infarction have occurred following administration of Kyprolis.
Death due to cardiac arrest has occurred within a day of Kyprolis administration and fatal 10 outcomes have been reported with cardiac failure and myocardial infarction. 8. While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for evidence of volume overload, especially patients at risk for cardiac failure.
2). 2). The risk of cardiac failure is increased in elderly patients (≥ 75 years). The risk of cardiac failure is also increased in Asian patients. A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended.
Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical studies. These patients may be at greater risk for cardiac complications.
Patients with signs or symptoms of NYHA Class III or IV cardiac failure, recent history of myocardial infarction (in the last 4 months), and in patients with uncontrolled angina or arrhythmias, should have a comprehensive cardiological assessment, prior to starting treatment with Kyprolis.
This assessment should optimise the patient’s status, with particular attention to blood pressure control and fluid management. Subsequently patients should be treated with caution and remain under close follow-up. Electrocardiographic changes There have been cases of QT interval prolongation reported in clinical studies and post-marketing.
1. 6). As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contraindications.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Infusion time is 10 minutes and remains consistent throughout the regimen Kyprolis in combination with dexamethasone When combined with dexamethasone, Kyprolis is administered intravenously as a 30 minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 2.
Each 28-day period is considered one treatment cycle. Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Treatment may be continued until disease progression or until unacceptable toxicity occurs. When Kyprolis is combined with dexamethasone alone, dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycles.
Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Table 2. Kyprolis in combination with dexamethasone alone Cycle 1 Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Day 23 Days 24-28 Kyprolis (mg/m2)a 20 20 - 56 56 - 56 56 - - - - Dexamethasone (mg) 20 20 - 20 20 - 20 20 - 20 20 - Cycle 2 and all subsequent cycles Week 1 Week 2 Week 3 Week 4 Day 1 Day 2 Days 3-7 Day 8 Day 9 Days 10-14 Day 15 Day 16 Days 17-21 Day 22 Day 23 Days 24-28 Kyprolis (mg/m2)a 56 56 - 56 56 - 56 56 - - - - Dexamethasone (mg) 20 20 - 20 20 - 20 20 - 20 20 - a.
Infusion time is 30 minutes and remains consistent throughout the regimen Kyprolis in combination with daratumumab and dexamethasone When combined with daratumumab and dexamethasone, Kyprolis is administered intravenously as a 30-minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 3.
Each 28-day period is considered one treatment cycle. 5 Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Treatment may be continued until disease progression or until unacceptable toxicity occurs. Dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15 and 16 and 40 mg orally or intravenously on day 22 of each 28 day cycle.
For patients > 75 years of age, administer 20 mg of dexamethasone orally or intravenously weekly after the first week. Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis. Daratumumab can be administered intravenously or subcutaneously.
If given intravenously, daratumumab is given at a dose of 16 mg/kg actual body weight; with a split dose of 8 mg/kg in cycle 1 on days 1 and 2. Afterwards, daratumumab is administered as 16 mg/kg once weekly on days 8, 15 and 22 of cycle 1 and days 1, 8, 15 and 22 of cycle 2, then every 2 weeks for 4 cycles (cycles 3 to 6) and then every 4 weeks for the remaining cycles or until disease progression.
Alternatively, daratumumab can be given subcutaneously at a dose of 1800 mg on days 1, 8, 15 and 22 of cycle 1 and days 1, 8, 15 and 22 of cycle 2, then every 2 weeks for 4 cycles (cycles 3 to 6) and then every 4 weeks for […]
Evaluate dyspnoea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. 8). Hypertension Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal.
Hypertension was reported more frequently in patients who received Kyprolis in combination with daratumumab in study 20160275. It is recommended to control hypertension prior to starting and during treatment. All patients should be routinely evaluated 11 for hypertension while on Kyprolis and treated as needed.
If the hypertension cannot be controlled, the Kyprolis dose should be reduced. 2). Acute renal failure Cases of acute renal failure have been reported in patients who received Kyprolis. Some of these events have been fatal. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy.
In phase 3 clinical studies the incidence of adverse events of acute renal failure was higher in subjects with lower baseline creatinine clearance than that among subjects with higher baseline creatinine clearance. Creatinine clearance was stable over time for the majority of patients.
Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance. 2). Tumour lysis syndrome Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Patients with a high tumour burden should be considered to be at greater risk for TLS. 2). Uric acid lowering medicinal products should be considered in patients at high risk for TLS. Evidence of TLS during treatment should be monitored for, including regular measurement of serum electrolytes, and managed promptly.
2). Infusion reactions Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis. Symptoms may include fever, chills, arthralgia, myalgia, facial flushing, facial oedema, vomiting, weakness, shortness of breath, hypotension, syncope, bradycardia, chest tightness, or angina.
These reactions can occur immediately following or up to 24 hours after administration of Kyprolis. 2). g. gastrointestinal, pulmonary and intracranial haemorrhage) have been reported in patients treated with Kyprolis, often associated with thrombocytopenia.
8). Kyprolis causes thrombocytopenia with platelet nadirs observed on day 8 or day 15 of each 28-day cycle […]
Cases of ventricular tachycardia have been reported in patients receiving Kyprolis. Pulmonary toxicity Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Some of these events have been fatal. 2). Pulmonary hypertension Pulmonary hypertension has been reported in patients treated with Kyprolis. Some of these events have been fatal. Evaluate as appropriate. 2). Dyspnoea Dyspnoea was commonly reported in patients treated with Kyprolis.
Evaluate dyspnoea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. 8). Hypertension Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal.
Hypertension was reported more frequently in patients who received Kyprolis in combination with daratumumab in study 20160275. It is recommended to control hypertension prior to starting and during treatment. All patients should be routinely evaluated 11 for hypertension while on Kyprolis and treated as needed.
If the hypertension cannot be controlled, the Kyprolis dose should be reduced. 2). Acute renal failure Cases of acute renal failure have been reported in patients who received Kyprolis. Some of these events have been fatal. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy.
In phase 3 clinical studies the incidence of adverse events of acute renal failure was higher in subjects with lower baseline creatinine clearance than that among subjects with higher baseline creatinine clearance. Creatinine clearance was stable over time for the majority of patients.
Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance. 2). Tumour lysis syndrome Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Patients with a high tumour burden should be considered to be at greater risk for TLS. 2). Uric acid lowering medicinal products should be considered in patients at high risk for TLS. Evidence of TLS during treatment should be monitored for, including regular measurement of serum electrolytes, and managed promptly.
2). Infusion reactions Infusion reactions, including life-threatening reactions, have been reported […]