Cipaglucosidase Alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 2, 2024.

Applies to cipaglucosidase alfa: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Severe Hypersensitivity Reactions, Infusion-Associated Reactions, and Risk of Acute Cardiorespiratory Failure in Susceptible Patients. Hypersensitivity Reactions Including Anaphylaxis. Patients treated with cipaglucosidase alfa-atga have experienced life-threatening hypersensitivity reactions, including anaphylaxis.

Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during cipaglucosidase alfa-atga administration.

If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, cipaglucosidase alfa-atga should be discontinued immediately, and appropriate medical treatment should be initiated.

In patients with severe hypersensitivity reaction, desensitization measures to cipaglucosidase alfa-atga may be considered.Infusion-Associated Reactions (IARs)Patients treated with cipaglucosidase alfa-atga have experienced severe IARs.

If severe IARs occur, immediately discontinue the cipaglucosidase alfa-atga infusion, initiate appropriate medical treatment, and assess the benefits and risks of readministering cipaglucosidase alfa-atga following severe IARs.

Patients with an acute underlying illness at the time of cipaglucosidase alfa-atga infusion may be at greater risk for IARs.

Patients with advanced Pompe disease may have compromised cardiac and respiratory function, which may predispose them to a higher risk of severe complications from IARs.Risk of Acute Cardiorespiratory Failure in Susceptible Patients. Patients susceptible to fluid volume overload, or those with acute underlying respiratory illness or compromised cardiac or respiratory function for whom fluid restriction is indicated may be at risk of serious exacerbation of their cardiac or respiratory status during cipaglucosidase alfa-atga infusion.

More frequent monitoring of vitals should be performed during cipaglucosidase alfa-atga infusion in such patients.

Other side effects

Some side effects of cipaglucosidase 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

• diarrhea

Less common side effects

• acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• constipation
• difficulty in moving
• full or bloated feeling
• general feeling of discomfort or illness
• heartburn
• indigestion
• joint or muscle pain
• lack or loss of strength
• loss of taste
• muscle spasms
• pressure in the stomach
• stomach discomfort, upset, or pain
• swelling of the stomach area

Serious side effects

Along with its needed effects, cipaglucosidase 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 cipaglucosidase alfa:

Less common side effects

• blurred vision
• chest tightness
• chills
• confusion
• cough
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• hives, itching, skin rash
• increased blood pressure
• lower back or side pain
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms and occasionally, upper chest
• shakiness in the legs, arms, hands, or feet
• sweating
• trembling or shaking of the hands or feet
• trouble breathing
• unusual tiredness or weakness

For healthcare professionals

Applies to cipaglucosidase alfa: intravenous powder for injection.

General adverse events

The most common adverse reactions occurring in 5% of patients or greater who were treated with this drug in combination with miglustat were headache, diarrhea, fatigue, nausea, abdominal pain, and pyrexia.

The most common adverse reactions attributable only to cipaglucosidase alfa were chills, dizziness, flushing, somnolence, chest discomfort, cough, infusion site swelling, and pain.^[Ref]

Cardiovascular

• Common (1% to 10%): Flushing, increased blood pressure/hypertension, tachycardia including sinus tachycardia
• Uncommon (0.1% to 1%): Hypotension, pallor

Dermatologic

• Common (1% to 10%): Rash, pruritus, urticaria, hyperhidrosis
• Uncommon (0.1% to 1%): Skin abrasion, skin discoloration, skin edema

Rash included erythematous rash and macular rash.

Urticaria included mechanical urticaria and urticarial rash.

Gastrointestinal

• Common (1% to 10%): Abdominal distension, diarrhea, upper and lower abdominal pain, nausea, dysgeusia, dyspepsia, constipation, flatulence, vomiting
• Uncommon (0.1% to 1%): Esophageal pain, esophageal spasm, oral discomfort, oral pain, swollen tongue

Hematologic

• Common (1% to 10%): Decreased platelet count
• Uncommon (0.1% to 1%): Decreased lymphocyte count

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (up to 27%)

Anaphylaxis signs and symptoms included dyspnea, rash, hypotension, bronchospasm, edema, pharyngeal edema, and tongue swelling.

Severe hypersensitivity reaction symptoms included urticaria, pruritus, and flushing.

Immunologic

• Very common (10% or more): Anti-drug antibodies (up to 89%), enzyme inhibiting antibodies (up to 82%), infusion-associated reactions (up to 32%)

Local

• Common (1% to 10%): Infusion site swelling, infusion site pain

Musculoskeletal

• Common (1% to 10%): Muscle spasm, flank pain, myalgia, arthralgia, muscular weakness
• Uncommon (0.1% to 1%): Muscle fatigue, musculoskeletal stiffness

Nervous system

• Common (1% to 10%): Headache, dizziness, paresthesia, tremor, somnolence
• Uncommon (0.1% to 1%): Balance disorder, burning sensation, presyncope

Headache included migraine and migraine with aura.

Other

• Common (1% to 10%): Pyrexia, chills, malaise, pain, asthenia, fatigue, chest discomfort
• Uncommon (0.1% to 1%): Body temperature fluctuations, non-cardiac chest pain, peripheral swelling, facial pain

Respiratory

• Common (1% to 10%): Dyspnea, cough
• Uncommon (0.1% to 1%): Asthma, oropharyngeal discomfort, pharyngeal edema, wheezing

Further information

Cipaglucosidase alfa 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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