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Prolastin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Prolastin (Alpha1-Proteinase Inhibitor [Human]) is used to treat alpha 1-antitrypsin deficiency, which can lead to emphysema (damage to the air sacs in the lungs). It is a protein. Common side effects include pain at the injection site, fever, dizziness, headache, drowsiness, numb/tingling skin, and muscle aches.
The recommended dosage of Prolastin is 60 mg/kg body weight administered intravenously once weekly. Other drugs may interact with Prolastin. Tell your doctor all medications and supplements you use. During pregnancy, Prolastin should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Prolastin (Alpha1-Proteinase Inhibitor [Human]) 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Prolastin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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.
Read the entire detailed patient monograph for Prolastin (Alpha) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Prolastin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.
This medication is made from human blood. There is a very small chance that you may get infections from this medication (including viral infections such as hepatitis, parvovirus B19), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including persistent fever, persistent sore throat, stuffy nose, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, stop receiving the drug and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: hives, rash, itching/swelling (especially of the face/tongue/throat), chest tightness, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Prolastin (Alpha)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Prolastin FDA Prescribing Information: Side Effects
Therapeutic administration of Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) , 60 mg/kg weekly, has been demonstrated to be well tolerated. In clinical studies, six reactions were observed with 517 infusions of Prolastin (alpha) , or 1.16%. None of the reactions was severe.18 The adverse reactions reported included delayed fever (maximum temperature rise was 38.9°C, resolving spontaneously over 24 hours) occurring up to 12 hours following treatment (0.77%), light-headedness (0.19%), and dizziness (0.19%).18 Mild transient leukocytosis and dilutional anemia several hours after infusion have also been noted.18 Since market entry, occasional reports of other flu-like symptoms, allergic-like reactions, chills, dyspnea, rash, tachycardia, and, rarely, hypotension have also been received. Rare cases of transient increase in blood pressure or hypertension and chest pain have also been reported.
Read the entire FDA prescribing information for Prolastin (Alpha) »
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Prolastin User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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