Velmanase alfa Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 26, 2024.
Applies to velmanase alfa: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Hypersensitivity Reactions Including AnaphylaxisPatients treated with velmanase alfa-tycv have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during velmanase alfa-tycv administration. If a severe hypersensitivity reaction (eg anaphylaxis) occurs, discontinue velmanase alfa-tycv immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to velmanase alfa-tycv may be considered.
Serious side effects of Velmanase alfa
Along with its needed effects, velmanase 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 velmanase alfa:
More common
- Back pain
- bladder pain
- bloody or cloudy urine
- change in hearing
- chest tightness
- chills
- cough
- diarrhea
- difficult, burning, or painful urination
- ear drainage or pain
- fainting
- fast heartbeat
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- lower back or side pain
- muscle aches and pains
- nausea
- redness of the skin
- shivering
- sore throat
- stomach pain
- stuffy or runny nose
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Agitation
- coma
- confusion
- decreased urine output
- depression
- dizziness
- hostility
- lethargy
- muscle twitching
- rapid weight gain
- seizures
- stupor
- swelling of the face, ankles, or hands
Incidence not known
- Blurred vision
- chest pain or discomfort
- deafness
- delusions
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- hallucinations
- heart murmur
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- unsteadiness, trembling, or other problems with muscle control or coordination
Other side effects of Velmanase alfa
Some side effects of velmanase 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
- Difficulty in moving
- joint pain
- toothache
Incidence not known
- Decreased appetite
- joint swelling or warmth
- lack or loss of strength
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- watering of the eyes
For Healthcare Professionals
Applies to velmanase alfa: intravenous powder for injection.
General
-Nasopharyngitis (66%), hypersensitivity reactions (50%) and infusion-associated reactions (50%) were the most common side effects reported.
-Other very commonly reported reactions occurring in greater than 20% of patients included pyrexia, headache, arthralgia, weight increase, diarrhea, increased appetite and pain in extremity.[Ref]
Cardiovascular
IgAV or Henoch Schonlein Purpura occurred in one patient out of 38 (3%) with high antidrug antibody levels.[Ref]
Common (1% to 10%): Immunoglobulin A vasculitis (IgAV), bradycardia, cyanosis
Postmarketing reports: Aortic valve incompetence, endocarditis, hypotension, palpitations, tachycardia, vascular fragility[Ref]
Dermatologic
Very common (10% or more): Contusion, erythema, excoriation, rash, wound
Common (1% to 10%): Hyperhidrosis
Frequency not reported: Angioedema, cyanosis, urticaria
Postmarketing reports: Furuncle[Ref]
Gastrointestinal
Very common (10% or more): Gastroenteritis (13%), diarrhea, toothache (13%), upper abdominal pain
Common (1% to 10%): Nausea, abdominal pain, reflux gastritis
Frequency not reported: Emesis
Postmarketing reports: Odynophagia[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (13%)[Ref]
Hypersensitivity
Very common (10% or more): Hypersensitivity reactions (50%)
Common (1% to 10%): Anaphylaxis[Ref]
-Hypersensitivity reactions were reported in 36% of adult patients and 58% of pediatric patients.
-Anaphylaxis occurred in 2 patients (5%); severe hypersensitivity requiring medical treatment occurred in 3 pediatric patients (8%).
-Antidrug antibodies were positive in 80% of patients who experienced anaphylaxis or severe hypersensitivity.
-Signs and symptoms of anaphylaxis and severe hypersensitivity included cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.[Ref]
Immunologic
Frequency not reported: Drug antibodies, neutralizing antibodies[Ref]
-Patients who experienced severe hypersensitivity reactions and anaphylaxis were found to have a higher incidence of antidrug antibodies.
-Neutralizing and antidrug antibodies were found in patients in both the treatment and placebo groups.
-High levels of antidrug antibodies were associated with lower drug plasma concentrations and reduced therapeutic response in three pediatric patients.[Ref]
Local
Very common (10% or more): Infusion-associated reactions (50%)[Ref]
Symptoms of infusion-associated reactions occurring in both pediatric and adult patients included pyrexia, chills, erythema, vomiting, cough, urticaria, rash, and conjunctivitis.[Ref]
Metabolic
Common (1% to 10%): Increased appetite
Postmarketing reports: Decreased appetite[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (20%), back pain (13%)
Common (1% to 10%): Pain in extremity, joint stiffness, myalgia
Frequency not reported: Ligament sprain
Postmarketing reports: Joint swelling, joint warmth[Ref]
Nervous system
Very common (10% or more): Headache (33%), acute tonsillitis (13%), syncope (13%), post lumbar puncture syndrome
Common (1% to 10%): Seizures, loss of consciousness, confusional state, dizziness
Frequency not reported: Tremor
Postmarketing reports: Ataxia, nervous system disorder, somnolence[Ref]
Multiple seizures occurred in one patient out of 38 (3%) with no prior seizure history; a relationship between drug exposure and seizures was unable to be ruled out.[Ref]
Ocular
Very common (10% or more): Eye pruritus (13%)
Common (1% to 10%): Eyelid edema, eye irritation, ocular hyperemia
Frequency not reported: Conjunctivitis
Postmarketing reports: Increased lacrimation[Ref]
Other
Very common (10% or more): Pyrexia (40%), ear infections (13%), influenza (13%), increased weight, tooth extraction
Common (1% to 10%): Catheter site pain, feeling hot, malaise, procedural headache
Frequency not reported: Chills, facial swelling, fall, hyperthermia, otitis media
Postmarketing reports: Asthenia, bacterial disease carrier, deafness, fatigue, staphylococcal infection[Ref]
Psychiatric
Common (1% to 10%): Psychotic behavior, initial insomnia
Postmarketing reports: Agitation, encopresis, nervousness, psychotic disorder[Ref]
Renal
Common (1% to 10%): Acute renal failure[Ref]
-One episode of acute renal failure occurred in one patient out of 38 (3%); treatment was interrupted for 4 weeks with resolution of renal failure within 12 weeks of diagnosis.
-Concomitant use of ibuprofen was noted to have been received by patient.[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (66%)
Common (1% to 10%): Epistaxis
Frequency not reported: Cough, oropharyngeal pain, rhinitis, upper respiratory tract infection
Postmarketing reports: Pharyngeal edema, wheezing[Ref]
More about velmanase alfa
Patient resources
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Professional resources
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References
1. Product Information. Lamzede (velmanase alfa). Chiesi USA, Inc. 2023.
2. Product Information. Lamzede (velmanase alfa). Chiesi Ltd. 2022.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.