Cipaglucosidase Alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 16, 2024.

Applies to cipaglucosidase alfa: intravenous powder for solution.

Precautions

It is very important that your doctor check your progress closely to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant with can harm your unborn baby. If you are woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment and for at least 60 days after the last dose. If you think you have become pregnant whiles using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have chest discomfort, fever, chills or shaking, confusion, difficulty swallowing, dizziness, fast heartbeat, flushing, redness of the skin, increase or decrease blood pressure, trouble breathing, itching or rash, unusually warm skin, or lightheadedness, or fainting after receiving this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

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:

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:

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

See also:

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.

Medical Disclaimer