Lamzede Side Effects

Generic name: velmanase alfa

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

Note: This document provides detailed information about Lamzede Side Effects associated with velmanase alfa. Some dosage forms listed on this page may not apply specifically to the brand name Lamzede.

Applies to velmanase alfa: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Hypersensitivity Reactions Including Anaphylaxis. Patients 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 side effects

• 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 side effects

• 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 side effects

• 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 adverse events

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

• Common (1% to 10%): Immunoglobulin A vasculitis (IgAV), bradycardia, cyanosis
• Postmarketing reports: Aortic valve incompetence, endocarditis, hypotension, palpitations, tachycardia, vascular fragility^[Ref]

IgAV or Henoch Schonlein Purpura occurred in one patient out of 38 (3%) with high antidrug antibody levels.^[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]

Further information

Lamzede side effects can vary depending on the individual. 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.

Medical Disclaimer