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Pombiliti Side Effects

Generic name: cipaglucosidase alfa

Medically reviewed by Drugs.com. Last updated on Apr 26, 2023.

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

Applies to cipaglucosidase alfa: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Severe Hypersensitivity Reactions, Infusion-Associated Reactions, and Risk of Acute Cardiorespiratory Failure in Susceptible PatientsHypersensitivity Reactions Including AnaphylaxisPatients 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 PatientsPatients 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.

Serious side effects of Pombiliti

Along with its needed effects, cipaglucosidase alfa (the active ingredient contained in Pombiliti) 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

Other side effects of Pombiliti

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

Less common

For Healthcare Professionals

Applies to cipaglucosidase alfa: intravenous powder for injection.

General

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 (the active ingredient contained in Pombiliti) 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

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

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

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

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

References

1. Product Information. Pombiliti (cipaglucosidase alfa). Amicus Therapeutics U.S., Inc. 2023.

2. Product Information. Pombiliti (cipaglucosidase alfa). Amicus Therapeutics UK Operations Ltd. 2023.

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.

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