Glassia Side Effects

Generic name: alpha 1-proteinase inhibitor

Note: This document contains side effect information about alpha 1-proteinase inhibitor. Some of the dosage forms listed on this page may not apply to the brand name Glassia.

Some side effects of Glassia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alpha 1-proteinase inhibitor: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking alpha 1-proteinase inhibitor (the active ingredient contained in Glassia) hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pain or burning when you urinate;

• wheezing, chest pain or tightness, trouble breathing; or

• vision changes.

Less serious side effects of alpha 1-proteinase inhibitor may include:

• nausea, bloating;

• headache, dizziness, drowsiness;

• feeling tired;

• back pain, joint or muscle pain;

• swelling in your hands or feet;

• flushing (warmth, redness, or tingly feeling);

• cold symptoms such as stuffy nose, sneezing, sore throat, cough; or

• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to alpha 1-proteinase inhibitor: intravenous powder for injection, intravenous solution

Respiratory

Respiratory side effects have included chest pain, pharyngitis, asthma, rhinitis, bronchitis, sinusitis, increased cough, upper and lower respiratory tract infections, dyspnea, chronic obstructive pulmonary disease (COPD) exacerbation, nasopharyngitis, pharyngolaryngeal pain, COPD, sore throat, bronchospasm, lung disorder, infective exacerbation of COPD, bilateral pulmonary infiltrates, and diffuse interstitial lung disease. Dyspnea has been reported during postmarketing experience.

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, dysgeusia, lethargy, lightheadedness, paresthesia, and migraine.

Other

Other side effects have included pain, back pain, viral infection, peripheral edema, chills, fever, chest pain, chest discomfort, influenza-like illness, pyrexia, delayed fever, influenza-like symptoms, allergic-like reactions, malaise, hot flush, asthenia, infection, and accidental injury. Chest pain, chills, and influenza-like illness have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included vasodilation, hypertension, tachycardia, hypotension, and transient increase in blood pressure. Tachycardia, hypotension, and hypertension (including transient increases of blood pressure) have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased platelet count, transient leukocytosis, dilutional anemia, ecchymosis, and hemorrhage.

Dermatologic

Dermatologic side effects have included pruritus, rash, erythema marginatum, and urticaria. Rash has been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included bloating, nausea, abdominal pain, diarrhea, and dyspepsia.

Hepatic

Hepatic side effects have included elevations (greater than 2 times the upper limit of normal) in aminotransferases (ALT or AST), increased hepatic enzyme (unspecified), and cholangitis.

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal discomfort, joint swelling, arthralgia, and myalgia.

Ocular

Ocular side effects have included abnormal vision.

Local

Local side effects have included injection site pain, injection site hemorrhage, and injection site reaction.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity during postmarketing experience.

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