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PROLASTIN-C is a medicine that is given through a needle into a vein. While it is a prescription medicine, PROLASTIN-C is not a prescription you pick up at your pharmacy. PROLASTIN-C is shipped directly to you, to your doctor, or to an infusion center authorized by you and your doctor.1
The dosing of PROLASTIN-C is based on how much you weigh. The recommended dose is 60 milligrams for each kilogram (2.2 pounds) of your body weight given once a week.1
You can receive PROLASTIN-C at a rate of up to 0.08 milliliters for each kilogram per minute. The average infusion takes about 15 minutes to infuse.1
PROLASTIN-C does not need to be refrigerated and can be stored at room temperature, but the temperature should not exceed 25°C (77°F). You should also avoid freezing PROLASTIN-C because the bottle holding the diluent (sterile water) might break.1
PROLASTIN®-C (alpha1-proteinase inhibitor [human]) is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency).
The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI), including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.
PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.
PROLASTIN-C is contraindicated in IgA-deficient patients with antibodies against IgA due to risk of hypersensitivity.
Hypersensitivity reactions may occur. Should evidence of hypersensitivity reaction be observed, promptly stop infusion and begin appropriate therapy.
PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with antibodies against IgA.
The most common drug-related adverse reaction observed at a rate of > 5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.
Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Please see accompanying PROLASTIN-C full Prescribing Information for complete prescribing details.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 11-800-FDA-1088