Darzalex (daratumumab) is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat multiple myeloma in adults.
Darzalex is prescribed in certain situations, typically in combination with other cancer drugs. It’s meant to be a long-term treatment.
Here are some fast facts about Darzalex:
- Active ingredient: daratumumab, which is a biologic
- Drug class: monoclonal antibody
- Drug form: solution given as an IV infusion by a healthcare professional
As with other drugs, Darzalex IV infusions can cause side effects. Read on to learn about potential common, mild, and serious side effects.
Darzalex and Darzalex Faspro compared
Darzalex and Darzalex Faspro are both approved to treat multiple myeloma in certain situations. Darzalex Faspro is also approved to treat light chain amyloidosis.
Both Darzalex and Darzalex Faspro contain daratumumab as their active ingredient. However, Darzalex Faspro contains an additional ingredient called hyaluronidase-fihj.
Darzalex is given as an IV infusion, while Darzalex Faspro is given as a subcutaneous injection. Both drugs are given by a doctor or another healthcare professional.
The focus of this article is Darzalex. If you’d like to learn about the side effects of Darzalex Faspro, you can refer to this article. For a general overview of Darzalex, including details about its uses, see this article.
Darzalex treatment can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who received Darzalex in clinical trials:
- upper respiratory infection, such as the common cold
- low levels of certain blood cells, including red blood cells and certain white blood cells
- constipation
- reaction to an infusion*
- mild diarrhea*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Darzalex injections. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Darzalex’s prescribing information.
Mild side effects that have been reported with Darzalex include:
- upper respiratory infection, such as the common cold
- fatigue
- cough
- fever
- chills
- shortness of breath
- weakness
- muscle spasm
- back pain
- loss of appetite
- headache
- insomnia
- constipation
- vomiting
- nausea
- diarrhea*
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect during Darzalex treatment and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
Darzalex may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Darzalex’s prescribing information.
If you develop serious side effects during Darzalex treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- Pneumonia. Symptoms can include:
- fever
- Peripheral sensory neuropathy (a condition typically caused by nerve damage). Symptoms can include:
- increased or decreased ability to feel sensations such as temperature or pain
- shooting, stabbing, or burning pain in the arms, hands, legs, or feet
- Peripheral edema (swelling). Symptoms can include:
- swelling in your arms, hands, legs, or feet
- stiffness or pain around the swollen area
- weight gain
- Low level of platelets (a type of blood cell that helps blood clot). Symptoms can include:
- bruising
- unusual bleeding, such as having a nosebleed without a known cause
- Shingles. Symptoms can include:
- skin rash that’s painful and generally occurs on the chest, abdomen, back, or along one side of the body
- Low level of certain white blood cells. This condition doesn’t typically cause symptoms. However, it can be identified with lab tests.
- Reaction to an infusion.*
- Severe diarrhea*
- Anemia (low level of red blood cells).*
- Allergic reaction.*
* For more information about this side effect, see “Side effect specifics” below.
Learn more about some of the side effects that Darzalex may cause. To find out how often side effects occurred in clinical trials, see the prescribing information.
Reaction to an infusion
Some people may have certain reactions to Darzalex IV infusions. These reactions may happen during the infusion or shortly after.
Mild infusion reactions were common in clinical trials of Darzalex. Mild reactions can cause symptoms such as hives, skin rash, or fever.
However, in rare cases, Darzalex may cause severe infusion reactions. Symptoms of a more serious reaction include:
- swelling under your skin, possibly in your eyelids, lips, hands, or feet
- swelling in your mouth or throat
- trouble breathing
- changes in blood pressure
- wheezing
- nausea and vomiting
You may have a higher risk of infusion reactions with your first Darzalex infusion than with later ones.
What you can do
To help lower your risk of a reaction during a Darzalex infusion, your doctor will give you certain medications. They’ll give them to you up to 3 hours before each Darzalex infusion. These drugs include:
- a steroid such as Medrol (methylprednisolone)
- an antihistamine such as Benadryl (diphenhydramine)
- a medication for fever such as Tylenol (acetaminophen)
To lower your risk of a reaction shortly after a Darzalex infusion, your doctor may have you take a steroid for the next few days.
Your doctor or the healthcare professional who gives you Darzalex will watch for symptoms of a reaction during your infusion. If you have mild symptoms, they may slow or stop the infusion. And to lower your risk of having symptoms again, they may give your next infusion over a longer period of time.
Keep watching for symptoms of infusion reactions after you leave the location where you receive your infusion. If you have mild symptoms, be sure to tell your doctor. However, if you have severe or life threatening symptoms after your Darzalex infusion, call 911 or your local emergency number right away.
If you’re concerned about reactions with Darzalex infusions, talk with your doctor. To learn more about how Darzalex is given by IV infusion, see this article.
Diarrhea
Darzalex treatment may cause diarrhea. Mild diarrhea was common in clinical trials of the drug. However, in rare cases, Darzalex may cause severe diarrhea.
Severe diarrhea could cause a loss of electrolytes leading to dehydration.
What you can do
It’s important to stay hydrated during Darzalex treatment. Be sure to drink plenty of fluids. Drinks such as Gatorade or Pedialyte can keep you hydrated. They can also help prevent the loss of electrolytes or get your electrolytes back to their typical level.
If you have bothersome or severe diarrhea during Darzalex treatment, talk with your doctor. They may recommend medications to ease your symptoms.
Anemia
Anemia may occur with Darzalex treatment. This condition is caused by a low level of red blood cells. Anemia was a common side effect in clinical trials of Darzalex.
Fatigue is the most common symptom of anemia. Other possible symptoms include lightheadedness, shortness of breath, and skin that looks paler than usual.
What you can do
Be sure to tell your doctor if you have symptoms of anemia during Darzalex treatment. They may check your red blood cell level to see if anemia is the cause.
If you have a low level of red blood cells, your doctor may wait until your level returns to normal before giving your next Darzalex infusion.
Allergic reaction
As with most drugs, Darzalex can cause an allergic reaction in some people.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should continue Darzalex treatment. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Be sure to talk with your doctor about your health history before you receive Darzalex. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Chronic obstructive pulmonary disease (COPD). If you have COPD, be sure to talk with your doctor before starting Darzalex treatment. COPD could worsen breathing problems that may happen as a reaction to Darzalex infusions. Your doctor may give you certain medications to help with your breathing during Darzalex treatment.
Hepatitis B virus (HBV). Before starting Darzalex treatment, tell your doctor if you have HBV or if you’ve had it in the past. HBV is a virus that causes the hepatitis B infection. In rare cases, Darzalex could cause HBV to become active again. This means this drug could cause you to have symptoms of a hepatitis B infection.
If you have HBV, your doctor may check for symptoms of hepatitis B infection before, during, and after treatment. If you have symptoms, such as increased tiredness or jaundice, your doctor will advise if it’s safe to receive Darzalex.
Allergic reaction. If you’ve had an allergic reaction to Darzalex or any of its ingredients, your doctor will likely not prescribe Darzalex. Ask your doctor what other medications may be better options for you.
History of shingles or chickenpox. Before starting Darzalex treatment, tell your doctor if you’ve had shingles or chickenpox in the past. Both conditions are caused by the herpes zoster virus. Darzalex could cause this virus to become active again, which could cause you to have symptoms of shingles. If you’ve had shingles or chickenpox, your doctor may give you treatments to help prevent shingles during Darzalex treatment.
Alcohol with Darzalex
There is no known interaction between Darzalex and alcohol.
However, keep in mind that drinking alcohol during Darzalex treatment could worsen some of the drug’s side effects. Examples include vomiting, nausea, and diarrhea.
If you drink alcohol, your doctor can recommend the amount that’s safe for you to drink during Darzalex treatment.
Pregnancy and breastfeeding during Darzalex treatment
Below is information about receiving Darzalex while pregnant or breastfeeding.
Darzalex and pregnancy
Darzalex treatment isn’t safe during pregnancy. Your doctor will likely not recommend you receive Darzalex treatment while you’re pregnant. This is because the way Darzalex works in your body could cause congenital anomalies (commonly known as “birth defects”) in a developing fetus.
To ensure you aren’t pregnant before starting Darzalex treatment, your doctor may give you a pregnancy test.
If you or your partner can become pregnant, talk with your doctor. They’ll recommend effective birth control options for you. Females* should use birth control during Darzalex treatment and for at least 3 months after their last dose. If you become pregnant during Darzalex treatment, tell your doctor right away.
The manufacturer of Darzalex hasn’t provided birth control recommendations for males* receiving the drug. If you’re male and concerned about your birth control options during Darzalex treatment, talk with your doctor.
Darzalex and breastfeeding
It isn’t known if Darzalex treatment is safe while breastfeeding. It’s unknown if Darzalex can pass into breast milk or cause side effects in a child who is breastfed.
It’s important to note Darzalex may be prescribed in combination with other cancer drugs. And these drugs may not be safe to take while breastfeeding.
Before starting Darzalex treatment, tell your doctor if you’re breastfeeding or planning to breastfeed. They can advise on the risks and benefits of receiving the drug while breastfeeding. And they can advise if other medications you’re taking with Darzalex are safe to take while breastfeeding.
* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
As with most drugs, both mild and serious side effects are possible with Darzalex. If you have bothersome or serious side effects with Darzalex, talk with your doctor.
If you’d like to learn more about Darzalex, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of receiving the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Darzalex. For details about other aspects of Darzalex, refer to this article.
- Dosage. To learn more about Darzalex dosage, see this article.
- Drug comparison. Learn how Darzalex compares with Empliciti and Kyprolis.
- A look at multiple myeloma. For details about multiple myeloma, see our cancer hub and list of cancer and oncology articles. You can also refer to this article for more about Darzalex and multiple myeloma.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.