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Prolastin 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 Prolastin.

For the Consumer

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

Along with its needed effects, alpha 1-proteinase inhibitor (the active ingredient contained in Prolastin) 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 alpha 1-proteinase inhibitor:

More Common

  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Rare

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • feeling faint, dizzy, or lightheadedness
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pounding in the ears
  • rapid weight gain
  • shivering
  • slow or fast heartbeat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting

Incidence Not Known

  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Some side effects of alpha 1-proteinase inhibitor 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

  • Feeling of warmth
  • itching skin
  • muscle or bone pain
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating

Rare

  • Back pain
  • bloating
  • change in taste
  • changes in vision
  • fever
  • hives or welts
  • loss of taste
  • pain
  • redness of the skin
  • sleepiness or unusual drowsiness
  • swelling of the joints
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

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

Respiratory

Common (1% to 10%): Cough, dyspnea, rhinorrhea, pharyngitis

Uncommon (0.1% to 1%): Cough increased

Frequency not reported: COPD exacerbations[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Other

Common (1% to 10%): Fatigue, peripheral edema, pyrexia, chest pain, chest discomfort, lethargy

Frequency not reported: Abdominal and extremity rash

Postmarketing reports: Malaise, influenza-like illness, pain, asthenia, feeling abnormal[Ref]

Cardiovascular

Common (1% to 10%): Hot flush

Postmarketing reports: Increased blood pressure, flushing[Ref]

Dermatologic

Common (1% to 10%): Pruritus, urticaria[Ref]

Gastrointestinal

Very common (10% or more): Nausea (10.5%)

Common (1% to 10%): Diarrhea

Postmarketing reports: Vomiting[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity including anaphylactoid/anaphylactic reactions[Ref]

Hepatic

Common (1% to 10%): Hepatic enzyme increased[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal discomfort (16%)

Common (1% to 10%): Back pain, chills

Postmarketing reports: Arthralgia, myalgia[Ref]

Local

Common (1% to 10%): Vessel puncture site bruise

Postmarketing reports: Injection site reaction[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (13.2%)[Ref]

Immunologic

Very common (10% or more): Upper respiratory tract infection (12.5%)

Common (1% to 10%): Oral candidiasis, sinusitis

Frequency not reported: Anti-alpha 1-proteinase inhibitor (the active ingredient contained in Prolastin) antibodies[Ref]

References

1. "Product Information. Aralast NP (alpha 1-proteinase inhibitor)." Baxter I.V. Systems Division, Round Lake, IL.

2. "Product Information. Prolastin-C (alpha 1-proteinase inhibitor)." Grifols USA LLC, Los Angeles, CA.

3. "Product Information. Glassia (alpha 1-proteinase inhibitor)." Baxter Healthcare Corporation, Deerfield, IL.

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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