KYPROLIS (carfilzomib): How to use, Side Effects, Dosage

KYPROLIS (carfilzomib): How to use, Side Effects, Dosage

What is Kyprolis?

KYPROLIS (carfilzomib) for Injection is an antineoplastic agent available for intravenous use only. KYPROLIS is available as a single-use vial. Each vial of KYPROLIS 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).

Carfilzomib is a modified tetrapeptidyl epoxide, isolated as the crystalline free base.

Chemical name: (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

Color: sterile, white to off-white lyophilized powder

Molecular weight: 719.9

Molecular formula: C40H57N5O7

Soluble in: Acidic conditions

Insoluble in: Water

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How to use Kyprolis?

Kyprolis will be given to you by a doctor or nurse. The dose will be calculated based on your height and weight (body surface area). Your doctor or nurse will determine the dose of Kyprolis that you receive.

Kyprolis will be given as an infusion into a vein. The infusion may last up to 30 minutes. Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment. Each 28-day period is one treatment cycle. This means that Kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The doses on day 8 and 9 of each cycle will not be given from cycle 13 onwards if you are treated with Kyprolis in combination with lenalidomide and dexamethasone.

Most patients will receive treatment for as long as their disease improves or remains stable. However, Kyprolis treatment may also be stopped if you experience side effects that cannot be managed. Together with Kyprolis you will also be given either lenalidomide and dexamethasone, or only dexamethasone. You may also be given other medicines.

Dosage of Kyprolis

Administer intravenously over 2 to 10 minutes, 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).

Recommended Cycle 1 dose is 20 mg/m2/day and if tolerated increase Cycle 2 dose and subsequent cycles doses to 27 mg/m2/day.

Hydrate patients prior to and following administration.

Pre-medicate with dexamethasone prior to all Cycle 1 doses, during the first cycle of dose escalation, and if infusion reaction symptoms develop or reappear.

Modify dosing based on toxicity.

Overdosage

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.

Side effects of Kyprolis

As with any prescription medicine, it is important to consider the common side effects. Talk with your care team about how you can manage some of the side effects for you may have with Kyprolis. In clinical trials, these are the most common side effects.

In patients taking KYPROLIS + lenalidomide + dexamethasone (K+Rd) and in patients taking KYPROLIS + dexamethasone (K+d):

Low red blood cell count

Low white blood cell count

Diarrhea

Trouble breathing

Tiredness (fatigue)

Low platelets

Fever

Sleeplessness (insomnia)

Muscle spasm

Cough

Upper airway (respiratory tract) infection

Decreased potassium levels

In patients taking KYPROLIS as a single agent (monotherapy):

Low red blood cell count

Tiredness (fatigue)

Low platelets

Nausea

Fever

Trouble breathing

Diarrhea

Headache

Cough

Swelling of the lower legs or hands

Please if you have any questions about KYPROLIS (carfilzomib), you can ask us by commenting below this text, we'll answer you as soon as possible.

KYPROLIS Carfilzomib

Drugs that may interact with Kyprolis

A total of 304 drugs are known to interact with Kyprolis (carfilzomib).

114 major drug interactions

190 moderate drug interactions

Common medications checked in combination with Kyprolis (carfilzomib):

acyclovir (Zovirax, Sitavig)

allopurinol (Zyloprim, Lopurin, Aloprim)

amlodipine (Norvasc)

Aspirin Low Strength (aspirin)

Cytoxan (cyclophosphamide)

Darzalex (daratumumab)

Decadron (dexamethasone)

dexamethasone (Decadron, Dexamethasone Intensol, Dexasone, Hexadrol, Decadron Phosphate, Injectable, Zonacort, Decadron-LA, Dexacen-4, LoCort, Adrenocot LA, TaperDex, Dalalone, Dalalone DP, Dalalone LA, Decaject, Decaject LA, Zema Pak, Baycadron, Dexacort Phosphate in Respihaler, Solurex LA, Solurex, Adrenocot, De-Sone LA, Dexacort-LA, Dexasone LA, Dexone, Dexone LA, Primethasone, ZoDex, Dexacorten, Medidex, Medidex LA, Dexpak Taperpak)

Dexamethasone Intensol (dexamethasone)

gabapentin (Neurontin, Gralise, Gabarone, Fanatrex)

levofloxacin (Levaquin, Levaquin Leva-Pak)

lisinopril (Zestril, Prinivil, Qbrelis)

lovastatin (Mevacor, Altoprev, Altocor)

Norvasc (amlodipine)

ondansetron (Zofran, Zofran ODT, Zuplenz)

Pepcid (famotidine)

Plavix (clopidogrel)

Pomalyst (pomalidomide)

Revlimid (lenalidomide)

Velcade (bortezomib)

Zofran (ondansetron)

Zometa (zoledronic acid)

Kyprolis (carfilzomib) alcohol/food Interactions:

There is 1 alcohol/food interaction with Kyprolis (carfilzomib)

Kyprolis (carfilzomib) disease Interactions:

There are 12 disease interactions with Kyprolis (carfilzomib) which include:

Tls

Cardiac Disease

Dyspnea

Hemorrhage

Hepatic Toxicity

Hypertension

Pres

Pulmonary Hypertension

Pulmonary Toxicity

Renal Failure

Ttp/Hus

Venous Thrombosis

Warnings of Kyprolis

Cardiac Toxicities: Monitor for signs and symptoms of cardiac failure or ischemia. Withhold Kyprolis and evaluate promptly.

Acute Renal Failure: Monitor serum creatinine regularly.

Tumor Lysis Syndrome (TLS): Administer pre-treatment hydration.  Monitor for TLS, including uric acid levels and treat promptly.

Pulmonary Toxicity, including Acute Respiratory Distress Syndrome, Acute Respiratory Failure, and Acute Diffuse Infiltrative Pulmonary Disease: Withhold Kyprolis and evaluate promptly.

Pulmonary Hypertension: Withhold Kyprolis and evaluate.

Dyspnea: For severe or life-threatening dyspnea, withhold Kyprolis and evaluate.

Hypertension Including Hypertensive Crisis: Monitor blood pressure regularly. If hypertension cannot be controlled, interrupt treatment with Kyprolis.

Venous Thrombosis: Thromboprophylaxis is recommended.

Infusion Reactions: Premedicate with dexamethasone.

Hemorrhage: Fatal or serious cases of hemorrhage may occur, including gastrointestinal, pulmonary, and intracranial hemorrhage. Promptly evaluate signs and symptoms of blood loss.

Thrombocytopenia: Monitor platelet counts; interrupt or reduce Kyprolis dosing as clinically indicated.

Hepatic Toxicity and Hepatic Failure: Monitor liver enzymes regularly. Withhold Kyprolis if suspected.

Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Kyprolis if suspected.

Posterior Reversible Encephalopathy Syndrome (PRES): Consider neuro-radiological imaging (MRI) for onset of visual or neurological symptoms; discontinue Kyprolis if suspected.

Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Patients.

Embryo-Fetal Toxicity: Kyprolis can cause fetal harm. Females of reproductive potential should avoid becoming pregnant while being treated.

KYPROLIS Carfilzomib

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