Glassia Side Effects Center

Last updated on RxList: 2/28/2022
Glassia Side Effects Center

What Is Glassia?

Glassia [Alpha1-Proteinase Inhibitor (Human)] Injection Solution is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha-antitrypsin deficiency). Glassia increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.

What Are Side Effects of Glassia?

Common side effects of Glassia include:

  • headache,
  • upper respiratory infection,
  • cough,
  • sinus infection,
  • chest discomfort,
  • dizziness,
  • shortness of breath,
  • nausea,
  • fatigue,
  • decreases in liver enzymes, and
  • worsening or flare-up of COPD in which breathing gets worse than usual.

Dosage for Glassia

The dose of Glassia is 60 mg/kg body weight intravenously once weekly.

What Drugs, Substances, or Supplements Interact with Glassia?

Glassia may interact with other drugs. Tell your doctor all medications and supplements you use.

Glassia During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Glassia; it is unknown if it would affect a fetus. It is unknown if Glassia passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Glassia [alpha-proteinase inhibitor (human)] Injection Solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Glassia Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash; confusion, feeling light-headed; fast heartbeats, chest tightness, difficult breathing; swelling of your face, lips, tongue, or throat.

Your doctor may also prescribe epinephrine (Epi-Pen) to keep with you in case you ever have an allergic reaction to alpha 1-proteinase inhibitor.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have:

  • wheezing, chest pain, trouble breathing;
  • dizziness, severe headache;
  • a seizure; or
  • sudden numbness or weakness, slurred speech, problems with vision or balance.

You may feel faint during the injection. You may need to rest for a short time afterward.

Common side effects may include:

  • cold symptoms such as runny or stuffy nose, sneezing, cough, sore throat;
  • headache;
  • muscle or joint pain;
  • weakness;
  • flushing (sudden warmth, redness, or tingly feeling);
  • nausea; or
  • bruising or bleeding where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Glassia Professional Information

SIDE EFFECTS

The serious adverse reaction observed during clinical trials with GLASSIA was exacerbation of chronic obstructive pulmonary disease (COPD).

The most common adverse reactions (>0.5% of infusions) in clinical trials were headache and upper respiratory infection.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety profile of GLASSIA was evaluated in a randomized, double-blind, active-control trial and an open-label, non-parallel, dose-escalation trial, in 65 subjects with pre-augmentation therapy serum Alpha1-PI levels less than 11 microM. In the randomized, double-blind, active-control trial, 50 subjects received weekly infusions of GLASSIA or the comparator Alpha1-PI product, Prolastin, at a dosage of 60 mg/kg for a total of 12 doses after which all subjects remaining in the trial were treated for another 12 weeks with GLASSIA only. Overall, 17 subjects received 12 doses and 32 subjects received 22 - 24 doses of GLASSIA during the trial. (One subject randomized to the comparator Alpha1-PI product did not receive any treatment with GLASSIA during the last 12 weeks of the trial.). In the open label, non-parallel, dose-escalation trial, 18 subjects received a single infusion of GLASSIA at dosages of 30, 60 or 120 mg/kg. The population treated in the two trials was 40-74 years old, 54% male, 100% Caucasian.

Tables 1 and 2 compare the adverse reactions reported during the initial 12 weeks (double-blind portion) of the randomized, active comparator trial in all subjects treated with GLASSIA with reactions in the concurrent Prolastin control group. Table 3 compares the frequency of adverse reactions as a percentage of all infusions for GLASSIA and Prolastin-treated subjects over the entire trial period.

Table 1: Number of Subjects/Infusions/Adverse Reactions* Occurring during the First 12 Weeks of Treatment

GLASSIA Prolastin
No. of subjects treated 33 17
No. of infusions 393 190
No. of subjects with serious adverse reactions (%)* 1 (3%) 1 (6%)
No. of subjects experiencing an adverse reaction* (%) 22 (67%) 15 (88%)
No. of adverse reactions* 47 39
*An adverse reaction is any adverse event which met any of the following criteria: (a) an adverse event that began within 72 hours following the end of product infusion, or (b) an adverse event considered by either the investigator or sponsor to be at least possibly related to product administration, or (c) an adverse event for which causality assessment was missing or indeterminate.

Table 2: Adverse Reactions* Occurring in > 5% of Subjects during the First 12 Weeks of Treatment

Adverse Event (AE) GLASSIA No. of subjects: 33 Prolastin No. of subjects: 17
No. of subjects with adverse reactions*(AR) (percentage of all subjects) No. of subjects with adverse reactions*(AR) (percentage of all subjects)
Cough 3 (9%) 4 (24%)
Upper respiratory tract infection 3 (9%) 0 (0%)
Headache 3 (9%) 3 (18%)
Sinusitis 2 (6%) 1 (6%)
Chest discomfort 2 (6%) 0 (0%)
Dizziness 2 (6%) 0 (0%)
Hepatic enzyme increased 2 (6%) 0 (0%)
*An adverse reaction is any adverse event which met any of the following criteria: (a) an adverse event that began within 72 hours following the end of product infusion, or (b) an adverse event considered by either the investigator or sponsor to be at least possibly related to product administration, or (c) an adverse event for which causality assessment was missing or indeterminate.

Table 3: Adverse Reactions* Frequency as a % of all Infusions (> 0.5%)

Adverse Event (AE) GLASSIA† No. of infusions: 960 Prolastin‡ No. of infusions: 190
No. of adverse reactions* (AR) (percentage of all infusions) No. of adverse reactions* (AR) (percentage of all infusions)
Upper respiratory tract infection 8 (0.8%) 0 (0.0%)
Headache 6 (0.6%) 3 (1.6%)
*An adverse reaction is any adverse event which met any of the following criteria: (a) an adverse event that began within 72 hours following the end of product infusion, or (b) an adverse event considered by either the investigator or sponsor to be at least possibly related to product administration, or (c) an adverse event for which causality assessment was missing or indeterminate.
†Throughout entire 24-week double-blind plus open-label trial period
‡Throughout initial 12-week double-blind period

Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

During the 12-week double blind portion of the randomized, active comparator trial, 4 subjects (12%) had a total of 7 exacerbations of chronic obstructive pulmonary disease (COPD) during GLASSIA treatment and 5 subjects (29%) had a total of 6 exacerbations of COPD during Prolastin treatment. Seventeen additional exacerbations in 14 subjects (28%) occurred during the 12-week open-label treatment period with GLASSIA. The overall rate of pulmonary exacerbations during treatment with either product was 1.3 exacerbations per subject per year. Testing for viral markers for HBV, HCV, HIV-1 and HIV-2 showed no seroconversions during either trial.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to GLASSIA with the incidence of antibodies to other products may be misleading.

In the double blind, randomized, active comparator trial of GLASSIA, low level anti-GLASSIA antibodies were detected in one subject at one time point (Week 12) and returned to negative at the end of the study (Week 24) despite continuous exposure to GLASSIA. No immune system adverse reactions were reported.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of GLASSIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea

Gastrointestinal Disorders: Nausea

General Disorders and Administration Site Conditions: Fatigue

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Glassia ( Alpha1 Proteinase Inhibitor (Human) for Intravenous Administration)

© Glassia Patient Information is supplied by Cerner Multum, Inc. and Glassia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors