Lamzede Side Effects

Generic name: velmanase alfa

Medically reviewed by Drugs.com. Last updated on Mar 26, 2024.

Note: This document contains side effect information about velmanase alfa. Some dosage forms listed on this page may not apply to the brand name Lamzede.

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 Lamzede

Along with its needed effects, velmanase alfa (the active ingredient contained in Lamzede) 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 Lamzede

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]