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JollyRX
205, Al Qaizi Building, Al Muteena Street, Deira , AE
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61b1b04aff75332941e0977b KYPROLIS 60 MG 1 VIAL https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61b1afc0e79b092ea1dd2247/webp/kyprolis-60-mg-1-vial.jpg

What is Kyprolis and how is it used?

Kyprolis is used to treat multiple myeloma.

What are side effects of Kyprolis?

Common side effects of Kyprolis are:

  • fatigue
  • low blood cell count and blood platelet levels
  • shortness of breath
  • diarrhea
  • constipation
  • nausea
  • fever
  • swelling of the extremities
  • weakness
  • upper respitarory tract infection
  • runny or stuffy nose
  • bronchitis
  • pneumonia
  • low blood potassium
  • low blood calcium
  • high blood sugar
  • muscle spasms
  • numbness and tingling in the extremities
  • insomnia
  • cough
  • rash
  • high blood pressure

Serious side effects of Kyprolis include:

Patients should be monitored closely and treatment withheld if these serious side effects of Kyprolis occur.

DESCRIPTION

Carfilzomib is a modified tetrapeptidyl epoxide, isolated as the crystalline free base. The chemical name for carfilzomib is (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2- yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4- phenylbutanamido)-4-methylpentanamide. Carfilzomib has the following structure:

KYPROLIS® (carfilzomib) Structural Formula - Illustration

Carfilzomib is a crystalline substance with a molecular weight of 719.9. The molecular formula is C40H57N5O7. Carfilzomib is practically insoluble in water and very slightly soluble in acidic conditions.

Kyprolis is a sterile, white to off-white lyophilized powder and is available as a single-dose 10 mg, 30 mg or 60 mg vial. Each 10 mg vial contains 10 mg of carfilzomib, 500 mg sulfobutylether beta-cyclodextrin, and 9.6 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 30 mg vial contains 30 mg of carfilzomib, 1500 mg sulfobutylether beta-cyclodextrin, and 28.8 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 60 mg vial contains 60 mg of carfilzomib, 3000 mg sulfobutylether beta-cyclodextrin, 57.7 mg citric acid, and sodium hydroxide for Ph adjustment (target pH 3.5).

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cardiac Toxicities [see WARNINGS AND PRECAUTIONS]
  • Acute Renal Failure [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Hypertension [see WARNINGS AND PRECAUTIONS]
  • Dyspnea [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Venous Thrombosis [see WARNINGS AND PRECAUTIONS]
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity and Hepatic Failure [see WARNINGS AND PRECAUTIONS]
  • Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]

PRECAUTIONS

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. Some events occurred in patients with normal baseline ventricular function. In clinical studies with Kyprolis, these events occurred throughout the course of Kyprolis therapy. Death due to cardiac arrest has occurred within one day of Kyprolis administration. In randomized, open-label, multicenter trials for combination therapies, the incidence of cardiac failure events was 8% and that of arrythmias was 8% (majority of which were atrial fibrillation and sinus tachycardia) [see ADVERSE REACTIONS].

Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold Kyprolis for Grade 3 or 4 cardiac adverse reactions until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment [see DOSAGE AND ADMINISTRATION].

While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure [see DOSAGE AND ADMINISTRATION].

In patients ≥ 75 years of age, the risk of cardiac failure is increased compared to younger patients. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications; for these patients, complete a comprehensive medical assessment (including blood pressure control and fluid management) prior to starting treatment with Kyprolis and remain under close follow-up [see Use In Specific Populations].

Acute Renal Failure

Cases of acute renal failure have occurred in patients receiving Kyprolis. Some of these events have been fatal. Renal insufficiency (including renal failure) has occurred in approximately 9% of patients who received Kyprolis. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. The risk of fatal renal failure was greater in patients with a baseline reduced estimated creatinine clearance (calculated using Cockcroft-Gault equation).

Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate [see DOSAGE AND ADMINISTRATION].

Tumor Lysis Syndrome

Cases of tumor lysis syndrome (TLS), including fatal outcomes, have been reported in patients who received Kyprolis. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.

Administer oral and intravenous fluids before administration of Kyprolis in Cycle 1 and in subsequent cycles as needed. Consider uric acid-lowering drugs in patients at risk for TLS. Monitor for TLS during treatment and manage promptly, including interruption of Kyprolis until TLS is resolved [see DOSAGE AND ADMINISTRATION].

Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS) and acute respiratory failure have occurred in approximately 2% of patients who received Kyprolis. In addition, acute diffuse infiltrative pulmonary disease, such as pneumonitis and interstitial lung disease, occurred in approximately 2% of patients who received Kyprolis. Some events were fatal.

In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.

Pulmonary Hypertension

Pulmonary arterial hypertension was reported in approximately 2% of patients who received Kyprolis, with Grade 3 or greater in less than 1%.

Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment.

Dyspnea

Dyspnea was reported in 25% of patients treated with Kyprolis, with Grade 3 or greater in 4%.

Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart Kyprolis based on a benefit/risk assessment [see Cardiac Toxicities, Pulmonary Toxicity and ADVERSE REACTIONS].

Hypertension

Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. In ASPIRE, the incidence of hypertension events was 17% in the KRd arm versus 9% in the Rd arm. In ENDEAVOR, the incidence of hypertension events was 34% in the Kd arm versus 11% in the Vd arm. In CANDOR, the incidence of hypertension events was 31% in the DKd arm versus 27% in the Kd arm. Some of these events have been fatal.

Optimize blood pressure prior to starting Kyprolis. Monitor blood pressure regularly in all patients while on Kyprolis. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.

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KYPROLIS 60 MG 1 VIAL

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Description of product

What is Kyprolis and how is it used?

Kyprolis is used to treat multiple myeloma.

What are side effects of Kyprolis?

Common side effects of Kyprolis are:

  • fatigue
  • low blood cell count and blood platelet levels
  • shortness of breath
  • diarrhea
  • constipation
  • nausea
  • fever
  • swelling of the extremities
  • weakness
  • upper respitarory tract infection
  • runny or stuffy nose
  • bronchitis
  • pneumonia
  • low blood potassium
  • low blood calcium
  • high blood sugar
  • muscle spasms
  • numbness and tingling in the extremities
  • insomnia
  • cough
  • rash
  • high blood pressure

Serious side effects of Kyprolis include:

Patients should be monitored closely and treatment withheld if these serious side effects of Kyprolis occur.

DESCRIPTION

Carfilzomib is a modified tetrapeptidyl epoxide, isolated as the crystalline free base. The chemical name for carfilzomib is (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2- yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4- phenylbutanamido)-4-methylpentanamide. Carfilzomib has the following structure:

KYPROLIS® (carfilzomib) Structural Formula - Illustration

Carfilzomib is a crystalline substance with a molecular weight of 719.9. The molecular formula is C40H57N5O7. Carfilzomib is practically insoluble in water and very slightly soluble in acidic conditions.

Kyprolis is a sterile, white to off-white lyophilized powder and is available as a single-dose 10 mg, 30 mg or 60 mg vial. Each 10 mg vial contains 10 mg of carfilzomib, 500 mg sulfobutylether beta-cyclodextrin, and 9.6 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 30 mg vial contains 30 mg of carfilzomib, 1500 mg sulfobutylether beta-cyclodextrin, and 28.8 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 60 mg vial contains 60 mg of carfilzomib, 3000 mg sulfobutylether beta-cyclodextrin, 57.7 mg citric acid, and sodium hydroxide for Ph adjustment (target pH 3.5).

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cardiac Toxicities [see WARNINGS AND PRECAUTIONS]
  • Acute Renal Failure [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Hypertension [see WARNINGS AND PRECAUTIONS]
  • Dyspnea [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Venous Thrombosis [see WARNINGS AND PRECAUTIONS]
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity and Hepatic Failure [see WARNINGS AND PRECAUTIONS]
  • Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]

PRECAUTIONS

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. Some events occurred in patients with normal baseline ventricular function. In clinical studies with Kyprolis, these events occurred throughout the course of Kyprolis therapy. Death due to cardiac arrest has occurred within one day of Kyprolis administration. In randomized, open-label, multicenter trials for combination therapies, the incidence of cardiac failure events was 8% and that of arrythmias was 8% (majority of which were atrial fibrillation and sinus tachycardia) [see ADVERSE REACTIONS].

Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold Kyprolis for Grade 3 or 4 cardiac adverse reactions until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment [see DOSAGE AND ADMINISTRATION].

While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure [see DOSAGE AND ADMINISTRATION].

In patients ≥ 75 years of age, the risk of cardiac failure is increased compared to younger patients. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications; for these patients, complete a comprehensive medical assessment (including blood pressure control and fluid management) prior to starting treatment with Kyprolis and remain under close follow-up [see Use In Specific Populations].

Acute Renal Failure

Cases of acute renal failure have occurred in patients receiving Kyprolis. Some of these events have been fatal. Renal insufficiency (including renal failure) has occurred in approximately 9% of patients who received Kyprolis. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. The risk of fatal renal failure was greater in patients with a baseline reduced estimated creatinine clearance (calculated using Cockcroft-Gault equation).

Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate [see DOSAGE AND ADMINISTRATION].

Tumor Lysis Syndrome

Cases of tumor lysis syndrome (TLS), including fatal outcomes, have been reported in patients who received Kyprolis. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.

Administer oral and intravenous fluids before administration of Kyprolis in Cycle 1 and in subsequent cycles as needed. Consider uric acid-lowering drugs in patients at risk for TLS. Monitor for TLS during treatment and manage promptly, including interruption of Kyprolis until TLS is resolved [see DOSAGE AND ADMINISTRATION].

Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS) and acute respiratory failure have occurred in approximately 2% of patients who received Kyprolis. In addition, acute diffuse infiltrative pulmonary disease, such as pneumonitis and interstitial lung disease, occurred in approximately 2% of patients who received Kyprolis. Some events were fatal.

In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.

Pulmonary Hypertension

Pulmonary arterial hypertension was reported in approximately 2% of patients who received Kyprolis, with Grade 3 or greater in less than 1%.

Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment.

Dyspnea

Dyspnea was reported in 25% of patients treated with Kyprolis, with Grade 3 or greater in 4%.

Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart Kyprolis based on a benefit/risk assessment [see Cardiac Toxicities, Pulmonary Toxicity and ADVERSE REACTIONS].

Hypertension

Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. In ASPIRE, the incidence of hypertension events was 17% in the KRd arm versus 9% in the Rd arm. In ENDEAVOR, the incidence of hypertension events was 34% in the Kd arm versus 11% in the Vd arm. In CANDOR, the incidence of hypertension events was 31% in the DKd arm versus 27% in the Kd arm. Some of these events have been fatal.

Optimize blood pressure prior to starting Kyprolis. Monitor blood pressure regularly in all patients while on Kyprolis. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.

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