Applies to olipudase alfa: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Hypersensitivity Reactions Including AnaphylaxisPatients treated with olipudase alfa-rpcp have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during olipudase alfa-rpcp administration. If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, olipudase alfa-rpcp should be discontinued immediately and appropriate medical treatment should be initiated. In patients with severe hypersensitivity reaction, a desensitization procedure to olipudase alfa-rpcp may be considered.
Serious side effects of Olipudase alfa
Along with its needed effects, olipudase alfa 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 olipudase alfa:
More common
- Blurred vision
- body aches or pain
- chest tightness
- confusion
- cough
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dryness or soreness of the throat
- fast, pounding, or irregular heartbeat or pulse
- fever
- hives, itching, or skin rash
- hoarseness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- trouble breathing
- trouble in swallowing
- unusual tiredness or weakness
- voice changes
Incidence not known
- Back pain
- chills
- headache
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nausea and vomiting
Other side effects of Olipudase alfa
Some side effects of olipudase alfa 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
- Diarrhea
- difficulty in moving
- flushing, redness of the skin
- lack or loss of strength
- muscle or joint pain
- redness of the eye
- sneezing
- throat irritation
- unusually warm skin
For Healthcare Professionals
Applies to olipudase alfa: intravenous powder for injection.
General
Most frequently reported adverse drug reactions were hypotension, ocular hyperemia, pyrexia, cough, diarrhea, rhinitis, abdominal pain, vomiting, headache, urticaria, nausea, rash, arthralgia, pruritus, fatigue, myalgia, increased C-reactive protein, and pharyngitis.[Ref]
Cardiovascular
Very common (10% or more): Hypotension (15%), tachycardia (13%)
Common (1% to 10%): Palpitation, hot flush, flushing[Ref]
Dermatologic
Very common (10% or more): Urticaria (50%), rash (38%), pruritus (25%)
Common (1% to 10%): Erythema, papule, angioedema, fixed eruption, papular rash, macular rash, maculopapular rash, erythematous rash, pruritic rash, morbilliform rash, macule, erythema[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (75%), abdominal pain (63%), vomiting (50%), nausea (38%)
Common (1% to 10%): Upper abdominal pain, abdominal discomfort, gastrointestinal pain[Ref]
Hepatic
Common (1% to 10%): Hepatic pain, increased alanine aminotransferase, increased aspartate aminotransferase
Immunologic
Patients treated with this drug who developed IgG antidrug antibodies had a higher percentage of hypersensitivity reactions than those who did not develop IgG antidrug antibodies.[Ref]
Very common (10% or more): Anaphylactic reaction (13%), hypersensitivity (13%)[Ref]
Local
Very common (10% or more): Infusion site swelling (13%)
Common (1% to 10%): Asthenia, pain, catheter site pain, catheter site related reaction, catheter site pruritus, catheter site swelling[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (38%), myalgia (11.7%)
Common (1% to 10%): Bone pain, back pain[Ref]
Nervous system
Very common (10% or more): Headache (54%)[Ref]
Ocular
Very common (10% or more): Ocular hyperemia (15%), ocular discomfort, eye pruritus[Ref]
Other
Very common (10% or more): Pyrexia (100%), fatigue (25%), increased C-reactive protein (13%), elevated transaminase levels (13%)
Common (1% to 10%): C-reactive protein abnormal, chills, increased serum ferritin, increased body temperature[Ref]
Respiratory
Very common (10% or more): Cough (75%), rhinitis (75%), pharyngitis (25%), pharyngeal swelling (13%)
Common (1% to 10%): Dyspnea, throat irritation, pharyngeal edema, throat tightness, wheezing, larynx irritation[Ref]
