daratumumab

Trade Name:

Darzalex®

Appearance:

Clear, colourless to yellow solution, mixed into large bags of fluid

Monograph Name:

daratumumab

Monograph Body:

Drug Monograph

A - Drug Name

daratumumab

COMMON TRADE NAME(S): Darzalex®

B - Mechanism of Action and Pharmacokinetics

Daratumumab is an IgG1Ƙ human monoclonal antibody (mAb) that targets CD38 on the surface of cells in a variety of hematological malignancies. Based on in vitro studies, by binding to CD38, daratumumab induces immune mediated tumour cell death or apoptosis through Fc mediated cross-linking.

Distribution

Daratumumab is primarily localized to the vascular system with limited extravascular tissue distribution.

Time to steady state: Approximately by the 21st infusion (in monotherapy dosing schedule)

Metabolism

Likely via degradation into small peptides and amino acids via catabolic pathways.

Elimination

Cleared by parallel linear and nonlinear (saturable) target-mediated clearances.

Half-life

Terminal half-life increases with increasing dose and with repeated dosing

Mean estimated terminal half-life following the 1st 16mg/kg dose: 9 Days

Upon complete saturation of target mediated clearance and repeat dosing: 18 days

C - Indications and Status

Health Canada Approvals:

Multiple myeloma

Refer to the product monograph for a full list and details of approved indications.

D - Adverse Effects

Emetogenic Potential:

Minimal

Extravasation Potential: None

The following table lists adverse effects that occurred in > 5% of patients in a Phase 3 non-inferiority study comparing daratumumab (IV) 16 mg/kg with daratumumab (subcut) 1800 mg. It also includes severe or life-threatening adverse effects from other sources and post-marketing.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Atrial fibrillation (1%)	E
	Cardiotoxicity (<1%)	E
	Hypertension (9%) (may be severe)	I E
	Tachycardia (1%)	E
Gastrointestinal	Abdominal pain (6%)	E
	Constipation (8%)	E
	Diarrhea (11%)	E
	Nausea, vomiting (11%)	I E
General	Edema - limbs (6%)	E
	Fatigue (16%)	E
Hematological	Myelosuppression ± infection, bleeding (23%) (including anemia) (14% severe)	E D
Hepatobiliary	↑ LFTs (<5%) (may be severe)	E D
	Pancreatitis (1%)	E D
Hypersensitivity	Infusion related reaction (35%) (for first infusion) (including CRS and anaphylaxis - 5% severe)	I E
Immune	Antibody response (anti-daratumumab antibodies - <1%)	D
	↓ Immunoglobulins (2%)	E
Metabolic / Endocrine	Abnormal electrolyte(s) (6%)	E
Musculoskeletal	Musculoskeletal pain (12%)	E
Nervous System	Headache (9%)	E
	Insomnia (5%)	E
Ophthalmic	Blurred vision (6%)	E
Renal	Renal failure (<2%)	E D
Respiratory	Cough, dyspnea (14%)	E
	Rhinitis (5%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for daratumumab include infusion related reaction, myelosuppression ± infection, bleeding, fatigue, cough/dyspnea, musculoskeletal pain, diarrhea, and nausea/vomiting.

The majority (83%) of infusion reactions (IRs) occurred during the first infusion with incidence declining to 4% with subsequent infusions. Most reactions were grade 1 or 2, however, IRRs can be severe and include respiratory symptoms, cytokine release syndrome (CRS), anaphylaxis, nausea, rash and hypotension. Most reactions occurred during infusion or within 4 hours of completion (median onset was 1.5 h). Without post-infusion medications, infusion reactions can occur up to 48 hours post-infusion.

Infections may be severe, including when administered in combination. Opportunistic infections (e.g. cytomegalovirus) and herpes zoster virus reactivation, including fatal outcomes, were also reported. Hepatitis B reactivation has been observed post-marketing.

Daratumumab may worsen myelosuppression when used in combination with other chemotherapy agents for the treatment of multiple myeloma.

E - Dosing

Refer to protocol by which patient is being treated

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Consider antiviral prophylaxis for herpes zoster reactivation.

Daratumumab can interfere with cross-matching for blood transfusions; type and screen and RBC genotyping tests should be done before starting this drug.

Pre-medications (prophylaxis for infusion reaction) for daratumumab monotherapy:

To be given at least 1 hour prior to infusion:

Corticosteroid IV (e.g. methylprednisolone 100 mg or equivalent)^*†
Oral antipyretic (e.g. acetaminophen 650-1000 mg)
H1-receptor antagonist IV/PO (e.g. diphenhydramine 25-50 mg or equivalent)
Famotidine 20 mg IV (or equivalent)
Montelukast 10 mg PO^**

_{^*This dose may be reduced following the second infusion (i.e. IV methylprednisolone 60 mg or equivalent).}

_{^†For daratumumab combination therapy, corticosteroid IV/PO (e.g. dexamethasone 20 mg) is recommended. When dexamethasone is a regimen specific corticosteroid, the treatment dose will serve as pre-medication on infusion days. Additional regimen specific corticosteroids (e.g. prednisone) should not be taken on infusion days when dexamethasone is given as pre-medication.}

_{^**The addition of montelukast given prior to the first infusion numerically reduced the incidence of respiratory IRs in the study by Nooka et al.}

Post-infusion medications for daratumumab monotherapy:

Oral corticosteroid (e.g. methylprednisolone 20 mg or equivalent) for 2 days post-infusion^‡
Consider bronchodilators (e.g. short and long acting) and inhaled corticosteroids if chronic obstructive pulmonary disorder^&***

_{^‡For daratumumab combination therapy, corticosteroid PO (e.g. dexamethasone 20 mg) on the day after infusion is recommended. When a regimen specific corticosteroid (e.g. dexamethasone or prednisone) is given the day after infusion, additional post-infusion medications may not be needed.}

_{^&For daratumumab combination therapy, consider adding an H1-receptor antagonist if the patient is at higher risk of respiratory complications.}

_{^***These may be discontinued after the 4th infusion if no major IRs occurred.}

For pre/post infusion medications used in daratumumab combination regimens, see the respective regimen monographs.

Adults:

Monotherapy:

Daratumumab 16mg/kg^* IV as per the following schedule:

Week	Schedule
1 - 8	Weekly (8 doses)
9 - 24	Every 2 weeks (8 doses)
25+	Every 4 weeks

*Splitting the first dose over 2 days has been described (8 mg/kg days 1 and 2) and may be considered. The same premedications listed above should be administered prior to both treatment days (Reece et al 2018).

Combination therapy:

Various schedules are used depending on the regimen. Refer to the product monograph or related regimen monographs for details.

Dosage with Toxicity:

No dose reductions of daratumumab are recommended. A dose delay may be required in case of myelosuppression. Consider supportive care with transfusions or growth factors, as needed.

Hepatitis B virus (HBV) reactivation: Hold daratumumab, concomitant steroids and chemotherapy. Consult with a HBV expert and manage appropriately. Restart of daratumumab treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV.

Table 1: Management of Infusion Reactions:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

Grade	Management	Re-challenge
1 or 2	Stop or slow the infusion rate. Manage the symptoms. Restart: Once symptoms have resolved, the infusion may be restarted at a rate of no more than 50% of the rate at which the reaction occurred. If no reaction occurs, escalate the rate at no more than 50 mL/hour every hour.	Re-challenge with pre-medications and with infusion rate modification (eg. Table 2 below).
3	Stop treatment. Aggressively manage symptoms. Restart: Once symptoms have resolved, the infusion may be restarted at a rate of no more than 50% of the rate at which the reaction occurred. If no reaction occurs, escalate the rate at no more than 50 mL/hour every hour.	Re-challenge with pre-medications and with infusion rate modification (eg. Table 2 below). If a grade 3 IR recurs for the 3^rd time, discontinue permanently (do not re-challenge).
4	Stop treatment. Aggressively manage symptoms.	Discontinue permanently (do not re-challenge).

Dosage with Hepatic Impairment:

Hepatic Impairment	Daratumumab Dose
Mild (total bilirubin 1 to 1.5 times ULN or AST > ULN)	No dose adjustment necessary
Moderate (total bilirubin >1.5 to 3 times ULN and any AST)	No data
Severe (total bilirubin >3 times ULN and any AST)	No data

Dosage with Renal Impairment:

No dose adjustment is necessary. Formal studies have not been conducted; daratumumab is not renally cleared.

Dosage in the elderly:

No dose adjustments necessary. No overall differences in effectiveness was observed but the incidence of serious adverse reactions (e.g., pneumonia) was more frequent in older compared to younger patients.

Dosage based on gender:

Based on population PK analysis, there are no significant differences between genders.

Dosage based on ethnicity:

No significant differences were seen between white and non-white patients in the population PK analysis.

Children:

Safety and efficacy have not been established.

F - Administration Guidelines

Daratumumab IV and subcutaneous formulations are not interchangeable. The dosing and administration of these products are different.

Daratumumab infusion should be administered at the appropriate initial infusion rate with incremental escalation. Subsequent infusion rate escalation or dilution reduction should only be considered if the previous infusion was well-tolerated (Table 2).

Table 2: Standard infusion rates

	Dilution volume	Initial Infusion Rate (1st hr)	Increments of infusion rate	Max infusion rate	Approximate infusion time
Week 1 (single dose infusion)	1000 mL	50 mL/hr	50 mL/hr every hour	200 mL/hr	6.5 hr
Week 1 (split dose infusion; applicable to days 1 and 2)	500 mL	50 mL/hr	50 mL/hr every hour	200 mL/hr	4 hr
Week 2^a	500 mL	50 mL/hr	50 mL/hr every hour	200 mL/hr	4 hr
Subsequent Infusions^{b, c}	500 mL	100 mL/hr	50 mL/hr every hour	200 mL/hr	3.25 hr

^a If single dose infusion is used for week 1, the 500 mL dilution volume for the 16 mg/kg dose should be used only if there were no IRRs in the previous week.
^b Initial infusion rate should only be modified if treatment in Weeks 1 and 2 were well-tolerated (no ≥ grade 1 IRRs during ≥100 mL/hr).
^cIf the patient did not experience an IR in the first 2 infusions of daratumumab, consideration can be given to administer daratumumab as a rapid infusion starting with the 3rd dose (20% of the dose over 30 minutes at 200 mL/hour, then the remaining 80% of the dose over 60 minutes at 450 mL/hour).

Missed doses should be administered as soon as possible and the dosing schedule adjusted accordingly. The treatment interval should be maintained.
Daratumumab should be diluted in 0.9% Sodium Chloride; remove a volume from the IV bag that is equal to the required volume of daratumumab solution.
Daratumumab solution is colourless to yellow.
The diluted solution may develop very small, translucent to white proteinaceous particles. Do not use if opaque particles, discolouration, or other foreign particles.
Administer by IV infusion using an infusion set with a flow regulator and an in-line, low protein-binding filter (0.22 or 0.2 µm).
The infusion bag must be made of PVC, polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).
Polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE administration sets must be used.
Do not infuse concomitantly in the same IV line with other agents.
Store vials at 2^oC - 8^oC
Do not shake or freeze, protect from light.

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

G - Special Precautions

Contraindications:

Patients with a history of severe hypersensitivity to daratumumab or who have hypersensitivity to any ingredient in the formulation or component of the container.

Other Warnings/Precautions:

Daratumumab can cause severe infusion-related reactions (IRRs), including anaphylaxis. It should only be administered by healthcare professionals with appropriate medical support to manage these reactions. Pre and post infusion medications should be administered (see Dosing section).

Other Drug Properties:

Carcinogenicity: No information available

Pregnancy and Lactation:

Crosses placental barrier: Likely

Has not been studied in pregnant women. IgG1 monoclonal antibodies are known to transfer across the placenta.
Fetotoxicity: Likely

Based on its mechanism of action, daratumumab may cause fetal myeloid or lymphoid-cell depletion and decreased bone density.
Pregnancy:
- Daratumumab is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for at least 3 months after the last dose.
- If exposure to daratumumab occurred in utero, live vaccines should not be administered to the infant until a hematology evaluation has been completed.
Breastfeeding:
- Breastfeeding is not recommended during treatment.
- It is not known whether daratumumab is excreted into breastmilk. Human IgG is excreted in breast milk.
Fertility effects: No information available

H - Interactions

Daratumumab interferes with the indirect antiglobulin (Coombs) test by binding to CD38 on RBCs. Daratumumab-mediated positive Coombs test may persist for up to 6 months after treatment completion. Patient's blood should be typed and screened prior to initiating treatment. Notify blood transfusion centres of this in the event of a planned transfusion and educate patients.
Daratumumab may interfere with the serum protein electrophoreses (SPE) and immunofixation (IFE) assays used to monitor M-protein. This can impact the monitoring of response and disease progression in some patients with IgG kappa myeloma protein.

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
CBC	Baseline and before each dose
Blood	Type and screen prior to starting daratumumab. In the event of a planned transfusion, notify blood transfusion centres.
Electrolytes, renal function tests	Baseline and as clinically indicated
Liver function tests	Baseline and as clinically indicated
Immunoglobulin levels	Baseline and as clinically indicated
Clinical toxicity assessment for infusion-related reactions, hypersensitivity, infection, anemia, bleeding, GI and cardiac effects	Baseline and at each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

New Drug Funding Program (NDFP Website )

Daratumumab in Combination with a Bortezomib-Based Regimen for Newly Diagnosed Transplant Ineligible Multiple Myeloma
Daratumumab in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Transplant Ineligible Multiple Myeloma
Daratumumab and Bortezomib in combo w Cyclo and Dex - Previously Untreated Light Chain (AL) Amyloidosis
Daratumumab - In Combination with Lenalidomide and Dexamethasone for Relapsed Multiple Myeloma
Daratumumab - In Combination with Bortezomib and Dexamethasone for Relapsed Multiple Myeloma

K - References

Lonial A, Weiss BW, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Jan; 387: 1551-60.

Mateos MV, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380.

Nooka AK, Gleason C, Sargeant MO, et al. Managing Infusion Reactions to New Monoclonal Antibodies in Multiple Myeloma: Daratumumab and Elotuzumab. J Oncol Pract. 2018 Jul;14(7):414-22.

pan-Canadian Oncology Drug Review Final Clinical Guidance Report: Daratumumab (Darzalex) + Rd for Newly Diagnosed Multiple Myeloma, March 2020.

Product Monograph. Darzalex (daratumumab). Janssen Inc. Dec 8, 2021 and April 30, 2024.

Product Monograph. Darzalex SC (daratumumab). Janssen Inc. June 22, 2022.

Reece DE, Phillips MJ. Infusion Reactions with Monoclonal Antibody Therapy in Myeloma: Learning from Experience. J Oncol Pract. 2018 Jul;14(7):425-6.

January 2026 Updated Pregnancy/Lactation section

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.

Info Sheet Name:

daratumumab (patient)

Info Sheet Introduction:

For treating a type of blood cancer called multiple myeloma

Info Sheet Date: Tuesday, January 24, 2023 Info Sheet body:

Medication Information Sheet

daratumumab (DAR a TOOM ue mab)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Darzalex®

Appearance:

Clear, colourless to yellow solution, mixed into large bags of fluid

What is this medication for?

For treating a type of blood cancer called multiple myeloma

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:

liver problems (including hepatitis),
shingles (herpes zoster), or
or any allergies.

Daratumumab may affect certain lab tests. Be sure your health care team and the person doing your blood test know that you will be starting daratumumab. Additional blood bank lab tests are required before starting this medication.

Remember to:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this treatment may affect your sexual health.
How this treatment may affect your ability to have a baby, if this applies to you.

This treatment may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until 3 months after your last treatment dose. Talk to your health care team about which birth control options are best for you.
Do not breastfeed while on this treatment.

How is this medication given?

This medication is given through an IV (injected into a vein). Talk to your health care team about your treatment schedule.
This medication may be given over a longer period of time for the first dose(s). If you don’t have problems with the first infusion(s), it will be given over a shorter time for the following doses.
If you missed your treatment appointment, talk to your health care team to find out what to do.
You will be given daratumumab along with other medications to help prevent side effects or prevent a reaction.

To Prevent Allergic Reaction

You will be given medications before your treatment to help prevent allergic reactions before they start.

There are different types of medications to stop allergic reactions. They are called:
- antihistamines (such as diphenhydramine or Benadryl®)
- analgesics/antipyretics (such as acetaminophen or Tylenol®)
- H₂ blockers (such as ranitidine or famotidine)
- corticosteroids (such as prednisone)
- inhalers or a medication you take by mouth to keep airways open or lower irritation (if you have or had breathing problems)

To Prevent Hepatitis B Flare Ups

If you have ever been infected with hepatitis B, there is a risk that this treatment can cause it to flare up (come back). Tell your health care team if you have had hepatitis B. You may need to take medication to prevent a hepatitis B flare-up.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?

Although this medication is unlikely to interact with other medications, vitamins, foods and natural health products, tell your health care team about all of your:
- prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
- natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
Check with your health care team before starting or stopping any of them.
This drug may affect certain lab tests, such as the test for matching your blood type. This may happen for up to 6 months after your last daratumumab dose. Be sure your health care team and person doing the blood test know you are using this medication.

What should I do if I feel unwell, have pain, a headache or a fever?

Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).
- Fever can be a sign of infection that may need treatment right away.
- If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.

How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
  
  OR
- 38.0°C (100.4°F) or higher for at least one hour.

If you do have a fever:

Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
Ask your health care team for the Fever pamphlet for more information.

If you do not have a fever but have mild symptoms such as headache or mild pain:

Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

What to DO while on this medication:

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
DO tell your health care team about any serious infections that you have now or have had in the past.

What NOT to DO on this medication:

DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

What are the side effects of this medication?

The following table lists side effects that you may have when getting daratumumab. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on daratumumab.

Common Side Effects (25 to 49 out of 100 people)
Allergic reaction (May be severe) What to look for? The most common symptoms include fever, flushing, itchiness, rash, swollen lips, face or tongue, wheezing, difficulty swallowing or breathing, chest and throat tightness. It may happen during or shortly after your treatment is given to you and may be severe. What to do? Tell your nurse right away if you feel any signs of allergic reaction during or just after your treatment. You may be given medicines to prevent or treat this reaction. Talk to your health care team for advice if you have a mild skin reaction.	Get emergency medical help right away for severe symptoms.

Common Side Effects (25 to 49 out of 100 people)

Side effects and what to do

When to contact health care team

Allergic reaction

(May be severe)

What to look for?

The most common symptoms include fever, flushing, itchiness, rash, swollen lips, face or tongue, wheezing, difficulty swallowing or breathing, chest and throat tightness.
It may happen during or shortly after your treatment is given to you and may be severe.

What to do?

Tell your nurse right away if you feel any signs of allergic reaction during or just after your treatment.
You may be given medicines to prevent or treat this reaction.
Talk to your health care team for advice if you have a mild skin reaction.

Get emergency medical help right away for severe symptoms.

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Low neutrophils (white blood cells) in the blood (neutropenia) (May be severe) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol® (acetaminophen), or Advil® (ibuprofen)). Do not eat or drink anything hot or cold right before taking your temperature. You have a fever if your temperature taken in your mouth (oral temperature) is: 38.3°C (100.9°F) or higher at any time OR 38.0°C (100.4°F) or higher for at least one hour. What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.	If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.
Low platelets in the blood (May be severe) When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding red or pink coloured urine (pee) What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.	Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away.
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. Ask your health care team for the Fatigue pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.
Cough and feeling short of breath What to look for? You may have a cough and feel short of breath. Symptoms that commonly occur with a cough are: wheezing or a whistling breathing runny nose sore throat heartburn weight loss fever and chills Rarely this may be severe with chest pain, trouble breathing or coughing up blood. What to do? Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?". If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away. If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.	Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away.
Mild joint, muscle pain or cramps What to look for? New pain in your muscles or joints, muscle cramps, or feeling achy. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.
Diarrhea What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day).
Nausea and vomiting (Generally mild) What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. If you were given anti-nausea medication(s), take them as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe.

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

irregular heartbeat, fainting (passing out), shortness of breath or chest pain
yellowish skin or eyes
pain on the right side of your belly, in the centre of your belly (may spread to your back) or pain in your lower back
swelling in your hands, ankles, feet or other areas of your body, weight gain that is not normal for you
unusually dark pee or peeing less than usual

Who do I contact if I have questions or need help?

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

Other Notes:

____________________________________________________________________________

September 2022 Updated/Revised info sheet

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

daratumumab patient.pdf Info Sheet (French):

daratumumab pour le patient.pdf Monograph:

daratumumab.pdf Funding Program: New Drug Funding Program Funding Instance:

Daratumumab in Combination with a Bortezomib-Based Regimen for Newly Diagnosed Transplant Ineligible Multiple Myeloma
Daratumumab in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Transplant Ineligible Multiple Myeloma
Daratumumab and Bortezomib in combo w Cyclo and Dex - Previously Untreated Light Chain (AL) Amyloidosis
Daratumumab - In Combination with Lenalidomide and Dexamethasone for Relapsed Multiple Myeloma
Daratumumab - In Combination with Bortezomib and Dexamethasone for Relapsed Multiple Myeloma

Phonetic Spelling:

DAR a TOOM ue mab

Eligibility Form:

Daratumumab in Combination with a Bortezomib-Based Regimen for Newly Diagnosed Transplant Ineligible Multiple Myeloma

Daratumumab - In Combination with Bortezomib and Dexamethasone for Relapsed Multiple Myeloma

Daratumumab - In Combination with Lenalidomide and Dexamethasone for Relapsed Multiple Myeloma

Daratumumab in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Transplant Ineligible Multiple Myeloma

Daratumumab and Bortezomib in combo w Cyclo and Dex - Previously Untreated Light Chain (AL) Amyloidosis Cancer Type: Hematologic Multiple Myeloma Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Thursday, January 29, 2026 Universal Date: 2026-01-29 00:00:00 AddThis: Title URL: daratumumab Drug Display Status: Active Revision Summary:
Drug Monograph: Updated Pregnancy/Lactation section