Darzalex Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Darzalex Injection (daratumumab) is a monoclonal antibody medicine used to treat multiple myeloma in adults, with the subcutaneous form also used for AL amyloidosis. It works by targeting a protein called CD38 on abnormal cells, helping the immune system destroy them. It is given by a doctor or nurse as an injection under the skin or a drip into a vein, along with other medicines to reduce the chance of reactions.

What is Darzalex Injection

Darzalex is a laboratory-made antibody medicine that targets a protein called CD38 found on myeloma cancer cells. It belongs to a group of medicines called monoclonal antibodies, which attach to specific abnormal cells so the immune system can destroy them.

Darzalex Injection uses

• A type of bone marrow cancer called multiple myeloma, in adults
• A blood disorder called AL amyloidosis (for Darzalex SC), where abnormal blood cells make excess abnormal proteins that build up in organs

Benefits of Darzalex Injection

• Treats multiple myeloma
• Targets CD38 on myeloma cells
• Helps destroy abnormal plasma cells
• Can be combined with several other multiple-myeloma medicines
• Used in both newly diagnosed and relapsed/refractory multiple myeloma

How Darzalex Injection works

Darzalex attaches to a protein called CD38 that is found in large amounts on myeloma cells. Once attached, it helps mark the cancer cells so your immune system can destroy them, and it can also damage the cancer cells directly.

Darzalex Injection dosage

This medicine is given to you by a doctor or nurse; you do not take it yourself at home. It may be given as an injection under the skin of the stomach area, or as a drip into a vein depending on the form prescribed. Before and after each dose, you will be given other medicines to help lower the chance of reactions, such as antihistamines, corticosteroids, and fever medicine. In the first week of treatment, your doctor may split the dose over two consecutive days.

It is important to keep all your scheduled appointments so your treatment continues to work properly. If you miss an appointment, contact your doctor to arrange another one as soon as possible.

Available forms and strengths

• Solution for subcutaneous injection (Darzalex SC)
• Concentrate for intravenous infusion (Darzalex IV)

Side effects of Darzalex Injection

Common

• Injection site reactions (redness, itching, swelling, pain, bruising, rash, bleeding)
• Constipation, diarrhoea, decreased appetite, abdominal pain
• Muscle spasm, muscle and joint pain, nerve damage causing tingling, numbness or pain
• Flu, lung infection (pneumonia), bronchitis, infections of the nose, sinuses or throat, COVID-19, urinary tract infection
• Low red blood cells (anaemia), low white blood cells, low platelets
• High blood sugar, low calcium, low potassium, low immunoglobulins
• Fever, tiredness or weakness, dizziness, fainting, headache, rash, dehydration, difficulty sleeping, chills, itching, unusual skin sensations, high or low blood pressure, weight loss, swelling of hands/ankles/feet, fluid build-up in the lungs

Serious

• Infusion-related reactions: chills, sore throat, cough, nausea, vomiting, itchy/runny/blocked nose, shortness of breath or breathing problems, chest discomfort, dizziness or light-headedness, itching, wheezing, eye pain, blurred vision
• Severe allergic reaction: swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
• Irregular heartbeat (atrial fibrillation), heart failure, heart attack
• Severe infection throughout the body (sepsis), inflamed liver (hepatitis), inflamed pancreas
• Reactivation of hepatitis B virus

Warnings and precautions

• Do not use this medicine if you are allergic to daratumumab or any of its ingredients.
• This medicine contains sorbitol. People with hereditary fructose intolerance (a rare genetic disorder) must not receive it, as they cannot break down fructose, which may cause serious side effects.
• This medicine can lower white blood cell and platelet counts, which may get worse during treatment if you already have such a blood disorder.
• This medicine should not be given to children or young people under 18 years of age because its effects in this age group are not known.
• Serious allergic reactions and other severe infusion reactions have in some cases resulted in death.
• This medicine can interfere with blood tests used to match your blood type before a transfusion, so tell anyone doing a blood test that you are using this medicine.
• If you are pregnant, think you might be pregnant, or are planning a pregnancy, talk to your doctor before starting treatment. 
• Tell your doctor right away if you become pregnant during treatment, as the medicine may harm the baby. Women should use effective contraception during treatment and for 3 months after finishing.
• Talk to your doctor if you are breastfeeding or planning to breastfeed. It is not known whether the medicine passes into breast milk or how it could affect the baby.
• No routine dose adjustment is generally specified solely for kidney impairment; overall treatment should be individualized.
• Tell your doctor if you have ever had a hepatitis B infection, since this medicine could cause the virus to become active again. Your doctor will check for signs of infection before, during, and for some time after treatment.
• Alcohol is not known to interact directly with this medicine, but it can cause similar side effects such as nausea, dizziness, and dehydration, which may become worse if combined.
• Be careful before driving or using machines or tools until you know how this medicine affects you, since it may make you feel tired.

Storage

• DARZALEX SC should be stored in a refrigerator (2 to 8 degrees Celsius) and equilibrated to ambient temperature (15 to 30 degrees Celsius) before use.
• The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours.
• Do not freeze.
• Store in the original package to protect from light. Do not shake.
• If the syringe containing DARZALEX SC is not used immediately, it can be stored for up to 24 hours refrigerated followed by up to 12 hours at 15 to 25 degrees Celsius and ambient light.
• Keep this medicine out of the sight and reach of children.
• Darzalex will be stored in a refrigerator at 2-8˚C.

When to see a doctor

• Call your doctor or nurse right away if you have signs of an infusion-related reaction, such as chills, sore throat, cough, nausea, vomiting, itchy/runny/blocked nose, or shortness of breath — these can occur up to 3-4 days after the injection.
• Get emergency help if you notice a severe allergic reaction, such as swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, or an itchy rash (hives).
• Tell your doctor right away if you notice increasing tiredness or yellowing of your skin or the whites of your eyes, which can be signs of hepatitis.
• Tell your doctor or nurse if you develop a fever, or notice signs of bruising or bleeding, as this medicine can lower blood cell counts.
• Tell your doctor immediately if you or your partner become pregnant during treatment.

Alternatives

• Darzalex Faspro
• Isatuximab
• Elotuzumab
• Bortezomib