Applies to elapegademase: intramuscular solution.

Serious side effects of Elapegademase

Along with its needed effects, elapegademase 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 elapegademase:

Rare

• Black, tarry, stools
• body aches or pain
• burning, dry or itching eyes
• change in hearing
• chest pain
• chills
• cough
• coughing or spitting up blood
• diarrhea
• difficulty in breathing
• discharge, excessive tearing
• ear congestion
• ear drainage
• earache
• fever
• general feeling of discomfort or illness
• headache
• itching in the genitals or other skin areas
• itching of the ears
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• painful or difficult urination
• pale skin
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• scaling
• seizures
• severe pain in the side and back
• shivering
• sneezing
• sore mouth or tongue
• sore throat
• stiff neck
• stomach cramps and pain
• sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thickening of bronchial secretions
• trouble sleeping
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• watery diarrhea

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• blood in the urine or stools
• dark urine
• dizziness
• general body swelling
• nosebleeds
• pain, warmth, or burning in the fingers, toes, and legs
• pinpoint red spots on the skin
• problems with vision or hearing
• weight loss
• yellowing of the eyes or skin

Other side effects of Elapegademase

Some side effects of elapegademase 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:

Rare

• Change in walking and balance
• clumsiness or unsteadiness
• difficulty in moving
• ear canal irritation
• headache, severe and throbbing
• injection site discomfort
• lack or loss of strength
• mouth or throat pain
• muscle pain or stiffness
• rash
• swelling of the face or nose
• tearing of the skin
• tooth pain
• upper stomach pain

Incidence not known

• Redness and itching at the injection site

For Healthcare Professionals

Applies to elapegademase: intramuscular solution.

Hematologic

Very common (10% or more): Lymphadenopathy (16%)

Postmarketing reports: Hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, autoimmune thrombocytopenia^[Ref]

Immunologic

Very common (10% or more): Influenza (16%), stoma site infection (16%)

Frequency not reported: Immunogenicity^[Ref]

Local

Postmarketing reports: Injection site erythema^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (16%)^[Ref]

Ocular

Very common (10% or more): Conjunctivitis (16%)^[Ref]

Metabolic

Very common (10% or more): Injection site discomfort (16%), laceration (16%)^[Ref]

Genitourinary

Very common (10% or more): Groin abscess (16%)^[Ref]

Oncologic

Postmarketing reports: Lymphomas^[Ref]

Respiratory

Very common (10% or more): Cough (50%), productive cough (16%), epistaxis (16%), pulmonary haemophilus infection (16%), hemoptysis (16%), nasal edema (16%), upper respiratory tract infection (16%)^[Ref]

Other

Very common (10% or more): Fatigue (16%), cerumen impaction (16%), ear canal irritation (16%), ear lobe infection (16%), otitis externa (16%)^[Ref]

General

The most common adverse effects were cough (50%) and vomiting (33%)^[Ref]

Nervous system

Very common (10% or more): Asthenia (16%), convulsion (16%), gait disturbance (16%), migraine (16%)^[Ref]

Renal

Very common (10% or more): Nephrolithiasis (16%)^[Ref]

Dermatologic

Very common (10% or more): Fungal skin infection (16%), rash (16%), face swelling (16%)

Postmarketing reports: Urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (33%), abdominal pain upper (16%), dental caries (16%), tooth abscess (16%), tooth extraction (16%), diarrhea (16%), GI infection (16%), hematochezia (16%), nausea (16%), oral candidiasis (16%), oropharyngeal pain (16%)^[Ref]