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KYPROLIS

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Overview

What is KYPROLIS?

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:

Carfilzomib is a crystalline substance with a molecular weight of 719.9. The molecular formula is CHNO. 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 30 mg or 60 mg vial. Each 30 mg vial contains 30 mg of carfilzomib, 1500 mg sulfobutylether beta-cyclodextrin, and 28.9 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).



What does KYPROLIS look like?



What are the available doses of KYPROLIS?

For injection:  30 mg or 60 mg, lyophilized powder in single-dose vial for reconstitution ()

What should I talk to my health care provider before I take KYPROLIS?

How should I use KYPROLIS?

Kyprolis is a proteasome inhibitor that is indicated:

See Full Prescribing Information for dosing. ()

Hydrate prior to and following Kyprolis administration as needed. ()

Premedicate Kyprolis infusions with dexamethasone prior to all Cycle 1 doses and if infusion reaction symptoms develop or reappear. ()

Administer the 20/56 mg/m regimen by 30-minute infusion and the 20/27 mg/m regimen by 10-minute infusion. ()


What interacts with KYPROLIS?

Sorry No Records found


What are the warnings of KYPROLIS?

Sorry No Records found


What are the precautions of KYPROLIS?

Sorry No Records found


What are the side effects of KYPROLIS?

Sorry No records found


What should I look out for while using KYPROLIS?

None.

Use with Other CNS Depressants

Use with Imipramine and Desipramine

Drugs that inhibit alprazolam metabolism via cytochrome P450 3A

Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)

Drugs and other substances demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam)

in vitro

in vivo

in vitro

Drugs demonstrated to be inducers of CYP3A


What might happen if I take too much KYPROLIS?

Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia, and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.

There is no known specific antidote for Kyprolis overdosage. In the event of overdose, the patient should be monitored, specifically for the side effects and/or adverse reactions listed in .


How should I store and handle KYPROLIS?

Unopened vials should be stored refrigerated (2°C to 8°C; 36°F to 46°F). Retain in original package to protect from light.Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320Alprazolam tablets are available as follows: (Blue colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘1.0’)Bottles of 30 NDC 63187-966-30Bottles of 60 NDC 63187-966-60Bottles of 90 NDC 63187-966-90 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Manufactured by:Natco Pharma Ltd.Kothur 509-228Telangana, INDIARepackaged by:Proficient Rx LPThousand Oaks, CA 91320


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor that irreversibly binds to the N-terminal threonine-containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome. Carfilzomib had antiproliferative and proapoptotic activities in solid and hematologic tumor cells. In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumor growth in models of multiple myeloma, hematologic, and solid tumors.

Non-Clinical Toxicology
None.

Array

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive 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 a randomized, open-label, multicenter trial evaluating Kyprolis in combination with lenalidomide and dexamethasone (KRd) versus lenalidomide/dexamethasone (Rd), the incidence of cardiac failure events was 6% in the KRd arm versus 4% in the Rd arm.  In a randomized, open-label, multicenter trial of Kyprolis plus dexamethasone (Kd) versus bortezomib plus dexamethasone (Vd), the incidence of cardiac failure events was 11% in the Kd arm versus 3% in the Vd arm.

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 events until recovery, and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment   .

While adequate hydration is required prior to each dose in Cycle 1, all patients should also be monitored 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 .

In patients ≥ 75 years of age, the risk of cardiac failure is increased compared to patients ˂ 75 years of age. 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 and should have a comprehensive medical assessment (including blood pressure control and fluid management) prior to starting treatment with Kyprolis and remain under close follow-up  .

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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