Applies to daratumumab / hyaluronidase: subcutaneous solution.
Serious side effects
Along with its needed effects, daratumumab/hyaluronidase may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking daratumumab / hyaluronidase:
More common
- Bladder pain
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision
- body aches or pain
- burning, numbness, tingling, or painful sensations
- chest pain, discomfort, or tightness
- confusion
- cough
- coughing that sometimes produces a pink frothy sputum
- difficult or labored breathing
- difficult, burning, or painful urination
- dizziness or lightheadedness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- facial swelling
- fainting
- fast or irregular heartbeat
- fever or chills
- frequent urge to urinate
- headache
- increased sweating
- itching
- loss of voice
- nausea or vomiting
- nervousness
- painful blisters on the trunk of the body
- pale skin
- pounding in the ears
- rapid weight gain
- runny or stuffy nose
- sore throat
- swelling in the legs, ankles, or feet
- tingling of the hands or feet
- trouble breathing
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Bloating
- darkened urine
- difficulty swallowing
- hives
- indigestion
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- yellow eyes or skin
Other side effects
Some side effects of daratumumab / hyaluronidase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
- diarrhea
- difficulty in moving
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- rash
- sleeplessness
- stomach pain
- trouble sleeping
- unable to sleep
For Healthcare Professionals
Applies to daratumumab / hyaluronidase: subcutaneous solution.
Hematologic
Very common (10% or more): Neutropenia, thrombocytopenia[Ref]
Hypersensitivity
Very common (10% or more): Hypersensitivity and systemic administration reactions (11%)
Postmarketing reports: Anaphylactic reaction[Ref]
Local
Common (1% to 10%): Injection-site reaction, peripheral edema[Ref]
Musculoskeletal
Very common (10% or more): Back pain (10%)
Common (1% to 10%): Arthralgia, musculoskeletal chest pain, muscle spasms[Ref]
Metabolic
Common (1% to 10%): Decreased appetite, hyperglycemia, hypocalcemia, dehydration[Ref]
Psychiatric
Common (1% to 10%): Insomnia[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Hepatic
Common (1% to 10%): Hepatitis B reactivation[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (24%)
Common (1% to 10%): Cough, pneumonia, dyspnea, pulmonary edema, bronchitis[Ref]
Other
Infectious:
Common (1% to 10%): Influenza, herpes zoster, sepsis[Ref]
General
Very common (10% or more): Fatigue (15%), pyrexia (13%)
Common (1% to 10%): Chills[Ref]
Nervous system
Common (1% to 10%): Dizziness, peripheral sensory neuropathy, paresthesia[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, hypotension, atrial fibrillation[Ref]
Dermatologic
Common (1% to 10%): Pruritus, rash[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (15%)
Common (1% to 10%): Nausea, constipation, vomiting, abdominal pain,
Postmarketing reports: Pancreatitis[Ref]
