Carfilzomib

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Generic Name: Carfilzomib Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Carfilzomib used for?

Carfilzomib is used to treat a certain type of cancer (multiple myeloma). Carfilzomib can be used alone or along with other medications (such as lenalidomide, dexamethasone). It works by helping to slow the growth and spread of cancer cells.

How should I take Carfilzomib?

is used to treat a certain type of cancer (multiple myeloma). Carfilzomib can be used alone or along with other medications (such as lenalidomide, dexamethasone). It works by helping to slow the growth and spread of cancer cells.

How do I store Carfilzomib?

Store intact vials at 2°C to 8°C. Store in original carton until use to protect from light. Reconstituted drug (in the vial or in a syringe) and preparations diluted for infusion in D5W are stable for 4 hours at room temperature or for 24 hours refrigerated at 2°C to 8°C.

There may be different brands of Carfilzomib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Carfilzomib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Carfilzomib?

Before taking carfilzomib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, heart attack, heart rhythm problems), high blood pressure, kidney disease, liver disease, certain viral infections (herpes, shingles).

Carfilzomib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially heart problems.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, diaphragm with spermicide) while taking this medication. Females should use reliable forms of birth control during and for 1 month after treatment with carfilzomib. Males and their female partner should use reliable forms of birth control during and for 3 months after treatment with carfilzomib. If you or your partner become pregnant or may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Carfilzomib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Carfilzomib. Carfilzomib is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Carfilzomib?

Dizziness, lightheadedness, nausea, vomiting, loss of appetite, diarrhea, constipation, and tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, numbness/tingling of arms/legs, fainting, fast/irregular heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), yellowing eyes/skin, persistent nausea/vomiting, stomach/abdominal pain, dark urine, mental/mood changes (such as confusion), severe/persistent headache.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Carfilzomib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

Get medical help right away if you have any very serious side effects, including: sudden pain/swelling/redness in the legs, chest/jaw/left arm pain, trouble breathing, seizure, vision changes, weakness on one side of the body, trouble speaking, confusion, black/bloody stools, vomit that looks like coffee grounds.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Carfilzomib?

Carfilzomib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Carfilzomib?

Carfilzomib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Carfilzomib?

Carfilzomib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Carfilzomib.

What is the dose of Carfilzomib for an adult?

Usual Adult Dose for Multiple Myeloma

BEFORE INITIATING DOSING:

-Hydrate patients with both oral fluids (30 mL/kg at least 48 hours before Cycle 1, Day 1) and IV fluids (250 to 500 mL prior to each dose in Cycle 1). If needed, give an additional 250 to 500 mL of IV fluids following drug administration. Continue oral and/or IV hydration, as needed, in subsequent cycles. Monitor for volume overload and adjust hydration to individual need (especially in patients with or at risk for cardiac failure).

-Monitor serum potassium levels regularly.

-Premedicate with dexamethasone at the recommended dose for either monotherapy or combination therapy. Administer dexamethasone orally or IV at least 30 minutes but no more than 4 hours prior to all doses during Cycle 1 to reduce infusion reactions. Reinstate dexamethasone if symptoms occur during subsequent cycles.

-Infuse over 10 or 30 minutes depending on dosing regimen. Do not administer as a bolus. Flush the IV line with normal saline or 5% dextrose immediately before and after drug administration. Do not mix this drug with or administer as an infusion with other products.

-Calculate the dose based on the actual BSA of the patient at baseline. Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%.

-Thromboprophylaxis is recommended for patients being treated with the combination of this drug with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.

-Antiviral prophylaxis should be considered to decrease the risk of herpes zoster reactivation.

IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE:

-Cycle 1: 20 mg/m2 IV over 10 minutes on Days 1 and 2; if tolerated, increase to 27 mg/m2 IV over 10 minutes on Days 8, 9, 15, and 16 of a 28-day cycle

-Cycles 2 through 12: 27 mg/m2 IV over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle

-Cycle 13 and later: Omit the Day 8 and 9 doses

-Discontinue this drug after Cycle 18

-Lenalidomide 25 mg is taken orally on Days 1 through 21 and dexamethasone 40 mg orally or IV on Days 1, 8, 15, and 22 of the 28-day cycles

-Each 28-day period is considered one cycle.

-Continue therapy until disease progression or unacceptable toxicity occurs.

-Refer to the lenalidomide and dexamethasone prescribing information for other concomitant medications.

DOSE IN COMBINATION WITH DEXAMETHASONE:

-Cycle 1: 20 mg/m2 IV over 30 minutes on Days 1 and 2; if tolerated, increase to 56 mg/m2 IV over 30 minutes on Days 8, 9, 15, and 16 of a 28-day cycle

-Cycles 2 and later: 56 mg/m2 IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle

-Dexamethasone 20 mg is taken orally or IV Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle; administer dexamethasone 30 minutes to 4 hours before this drug.

-Administer dexamethasone 30 minutes to 4 hours before this drug.

-Continue therapy until disease progression or unacceptable toxicity.

-Refer to the dexamethasone prescribing information for other concomitant medications.

MONOTHERAPY BY THE 10-MINUTE INFUSION:

-Cycle 1: 20 mg/m2 IV over 10 minutes on Days 1 and 2; if tolerated, increase to 27 mg/m2 IV over 10 minutes on Days 8, 9, 15, and 16 of a 28-day cycle

-Cycles 2 through 12: 27 mg/m2 IV over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle

-Cycle 13 and later: Omit the Day 8 and 9 doses.

-Premedicate with dexamethasone 4 mg orally or IV 30 minutes to 4 hours before each dose of this drug in Cycle 1, then as needed to prevent infusion reactions.

-Continue therapy until disease progression or unacceptable toxicity.

MONOTHERAPY BY THE 30-MINUTE INFUSION:

-Cycle 1: 20 mg/m2 IV over 30 minutes on Days 1 and 2; if tolerated, increase to 56 mg/m2 IV over 30 minutes on Days 8, 9, 15, and 16 of a 28-day cycle

-Cycles 2 through 12: 56 mg/m2 IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle

-Cycle 13 and later: Omit the Day 8 and 9 doses.

-Premedicate with dexamethasone 8 mg orally or IV 30 minutes to 4 hours before each dose of this drug in Cycle 1, then as needed to prevent infusion reactions.

-Continue therapy until disease progression or unacceptable toxicity.

Comments:

-For patients on hemodialysis, administer this drug after the hemodialysis procedure.

Uses:

-In combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy

-As a single agent for the treatment of relapsed or refractory multiple myeloma who have received 1 or more lines of therapy

Renal Dose Adjustments

-Serum creatinine 2 x baseline or greater, OR CrCl less than 15 mL/min, OR CrCl decreased to 50% or less of baseline, OR need for hemodialysis: Withhold dose and monitor renal function (serum creatinine or CrCl).

-If attributable to this drug, resume when renal function has recovered to within 25% of baseline; start at 1 dose level reduction.

-If not attributable to this drug, dosing may be resumed at the discretion of the physician.

-The dose is to be administered after the hemodialysis procedure for patients on hemodialysis.

Liver Dose Adjustments

Mild or moderate hepatic impairment: Reduce dose by 25%.

Severe hepatic impairment: Dosing recommendations cannot be made.

Dose Adjustments

HEMATOLOGIC TOXICITY:

-Absolute neutrophil count (ANC) less than 0.5 X 10(9)/L: Withhold dose; if recovered to 0.5 x 10(9)/L or greater, continue at the same dose level. For subsequent drops to less than 0.5 x 10(9) /L, follow the same recommendations as above and consider 1 dose level reduction when restarting therapy.

-Febrile neutropenia (ANC less than 0.5 x 10(9)/L and an oral temperature of more than 38.5C or 2 consecutive readings of more than 38C for 2 hours): Withhold dose; if ANC returns to baseline grade and fever resolves, resume at the same dose level.

-Platelets less than 10 X 10(9)/L or evidence of bleeding with thrombocytopenia: Withhold dose; if recovered to greater than or equal to 10 x 10(9)/L and/or bleeding is controlled, continue at the same dose level. For subsequent drops to less than 10 x 10(9)/L, follow the same recommendations as above and consider 1 dose level reduction when restarting therapy.

DOSE LEVEL REDUCTION GUIDELINES:

If initial dose is 27 mg/m2:

-First dose reduction: 20 mg/m2

-Second dose reduction: 15 mg/m2

-Third dose reduction: Discontinue therapy

If initial dose is 56 mg/m2:

-First dose reduction: 45 mg/m2

-Second dose reduction: 36 mg/m2

-Third dose reduction: 27 mg/m2; if toxicity persists discontinue therapy

Dialysis

Patients with end stage renal disease on dialysis: Administer the dose after the dialysis procedure.

What is the dose of Carfilzomib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Carfilzomib available?

Carfilzomib is available in the following dosage forms and strengths:

  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Carfilzomib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: September 1, 2018 | Last Modified: September 1, 2018

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