Daratumumab

By Medically reviewed by hellodoktor

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

Uses

What is Daratumumab used for?

Daratumumab is used to treat a certain type of cancer (multiple myeloma). Daratumumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

How should I take Daratumumab?

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor on a treatment schedule, usually once a week for the first 2 months. Afterward, your doctor may direct you to receive this medication less often. Follow your doctor’s treatment schedule carefully.

Daratumumab may cause serious infusion reactions during or soon after treatment. Your doctor may prescribe other medications before and after each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as itchy/runny nose, nausea, vomiting, throat irritation, trouble breathing, fever, cough, headache, or chills.

The dosage is based on your medical condition, weight, and response to treatment.

To get the most benefit, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive this medication.

How do I store Daratumumab?

Store intact vials at 2°C to 8°C (36°F to 46°F). Do not freeze or shake; protect from light. Solutions diluted for infusion should be administered immediately at room temperature and in room light; diluted solution may be kept at room temperature for a maximum of 15 hours (including infusion time). If not used immediately, solutions diluted for infusion may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F) and protected from light; do not freeze. Discard any unused portion of the solution.

There may be different brands of Daratumumab 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 Daratumumab 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 Daratumumab?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease (COPD).

Daratumumab can make you more likely to get infections or may worsen any current infections. 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.

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

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using daratumumab. Daratumumab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. 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 Daratumumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Daratumumab. Daratumumab 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 Daratumumab?

Tiredness, back pain, joint pain, diarrhea, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding.

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 sore throat that doesn’t go away, fever, chills, 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 Daratumumab?

This medication may interfere with certain lab tests (such as Coombs’ test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Daratumumab 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 Daratumumab?

Daratumumab 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 Daratumumab?

Daratumumab 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 Daratumumab.

What is the dose of Daratumumab for an adult?

Usual Adult Dose for Multiple Myeloma

Monotherapy and combination therapy with lenalidomide and low-dose dexamethasone (4-week cycle regimen):

-Weeks 1 to 8: 16 mg/kg once a week

-Weeks 9 to 24: 16 mg/kg once every 2 weeks

-Weeks 25 and beyond: 16 mg/kg once every 4 weeks until disease progression

Combination therapy with bortezomib and dexamethasone (3-week cycle regimen):

-Weeks 1 to 9: 16 mg/kg once a week (total of 9 doses)

-Weeks 10 to 24: 16 mg/kg every 3 weeks (total of 5 doses)

-Weeks 25 and beyond: 16 mg/kg every 4 weeks

Comments:

-Pre-and post-infusion medications should be given prior to initiating therapy with this drug.

-For dosing instructions of combination agents administered with this drug see the manufacturer product information.

-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.

Manufacturer recommended infusion rates and management of infusion related reactions (IRRs):

FIRST INFUSION:

-Dilution volume: 1000 mL

-Initial rate (first hour): 50 mL/hr

-Rate increment: 50 mL/hr every hour

-Maximum rate: 200 mL/hr

SECOND INFUSION:

-Dilution volume: 500 mL

-Initial rate (first hour): 50 mL/hr

-Rate increment: 50 mL/hr every hour

-Maximum rate: 200 mL/hr

SUBSEQUENT INFUSIONS:

-Dilution volume: 500 mL

-Initial rate (first hour): 100 mL/hr

-Rate increment: 50 mL/hr every hour

-Maximum rate: 200 mL/hr

COMMENTS:

-Consider incremental escalation of the infusion rate only in the absence of IRRs.

-Use a dilution volume of 500 mL only if there were no Grade 1 (mild) or greater IRRs during the first 3 hours of the first infusion; otherwise, continue to use a dilution volume of 1000 mL and instructions for the first infusion.

-Use a modified initial rate for subsequent infusions (i.e., third infusion and onward) only if there were no Grade 1 (mild) or greater IRRs during a final infusion rate of 100 mL/hr or greater in the first 2 infusions; otherwise, continue to use instructions for the second infusion.

Premedications:

Premedicate approximately 1 to 3 hours prior to every infusion:

1) Corticosteroid (long- or intermediate-acting);

-Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, the dose of corticosteroid may be reduced (oral or IV methylprednisolone 60 mg).

-Combination therapy: Administer 20 mg dexamethasone prior to every infusion (give IV prior to the first infusion and oral administration may be considered prior to subsequent infusions).

2) Antipyretic: Acetaminophen 650 to 1000 mg orally

3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg orally or IV

Post-infusion medication (administer post-infusion medication to reduce the risk of delayed IRRs to all patients):

-Monotherapy: Administer an oral corticosteroid (20 mg methylprednisolone) or equivalent, on each of the 2 days following all infusions (beginning the day after the infusion).

-Combination therapy: Administer low-dose oral methylprednisolone (20 mg or less) or equivalent, the day after the infusion; however, if a background regimen-specific corticosteroid (e.g., dexamethasone) is administered the day after the infusion, additional post-infusion medications may not be needed.

Comments:

-For dosing instructions of combination agents administered with this drug see the manufacturer product information.

-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.

-For any patients with a history of chronic obstructive pulmonary disease, post-infusion medications such as short and long-acting bronchodilators and inhaled corticosteroids should be prescribed; following the first 4 infusions, if the patient experiences no major IRRs, these additional inhaled post-infusion medications may be discontinued.

-Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting this drug and continue for 3 months following discontinuation of therapy.

Uses:

-In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy

-As monotherapy, for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.

Dose Adjustments

For infusion related reactions (IRRs) of any grade/severity, interrupt the infusion and manage symptoms (this may require further reduction in the rate of infusion or discontinuation of therapy):

-Grade 1 to 2 (mild to moderate): After symptoms resolve, resume the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, infusion rate escalation may resume at increments up to the maximum rate of 200 mL/hour.

-Grade 3 (severe): After symptoms resolve, restart the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, resume infusion rate escalation as outlined above in the “Manufacturer recommended infusion rates and management of IRRs”. Repeat this procedure in the event of recurrence of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of a Grade 3 or greater IRR.

-Grade 4 (life threatening): Permanently discontinue therapy.

Other Comments

Administration information:

-This drug should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage IRRs.

-Administer only as an IV infusion after dilution.

Reconstitution/preparation/storage advice:

-The manufacturer product information should be consulted.

Patient advice:

-The patient should be instructed to read the patient labeling.

-Patients should be advised to seek immediate medical attention for any signs of infusion reactions (i.e., itchy, runny or blocked nose, chills, nausea, throat irritation, cough, headache, shortness of breath, or difficulty breathing).

-Patients should be advised to inform healthcare providers including blood transfusion centers/personnel that they are taking this drug, in the event of a planned transfusion.

What is the dose of Daratumumab 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 Daratumumab available?

Daratumumab is available in the following dosage forms and strengths:

  • Intravenous solution.

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 Daratumumab, 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.

Review Date: August 16, 2018 | Last Modified: September 12, 2019

Sources
You might also like