PROLASTIN®-C

PROLASTIN®-C

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Important Safety Information

PROLASTIN®-C is a prescription infusion medication made of human plasma, designed to treat adults with emphysema due to severe hereditary deficiency of  alpha1-proteinase inhibitor. Alpha1-antitrypsin deficiency is a rare genetic disorder also known as a chronic obstructive pulmonary disease (COPD). The medication is contraindicated in patients with a history of anaphylaxis and in IgA-deficient patients with antibodies against IgA to avoid the risk of severe hypersensitivity.

Some patients may experience hypersensitivity reactions. Therefore, it is crucial for all infusions to be closely monitored by a healthcare professional. Tell your doctor immediately if you experience a skin rash, itching, scratchy throat, hives, breathing difficulties, or swelling of the face, throat, tongue, or lips.

Also, talk to your doctor about your medical history, as well as about all medications you’re currently talking — regardless of whether they’re prescription, over-the-counter, vitamins, or herbal supplements. PROLASTIN®-C should not be used to treat lung disease in patients in whom a severe alpha1-proteinase inhibitor has not been diagnosed.

What is the most important information I should know about PROLASTIN®-C?

Since PROLASTIN®-C is made with human plasma, it could be possible to transmit pathogens — including the variant Creutzfeldt-Jakob disease (vCJD) and Chreutzfelddt-Jacob disease (CJD). Patients undergoing treatment with PROLASTIN®-C can participate in the Prolastin Direct program, which provides personalized 24/7 support for patients. Once your healthcare provider has prescribed PROLASTIN®-C, you will get a phone call from a coordinator within 24 hours.

There is no clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN®-C. The effect of such augmentation therapy has not been conclusively demonstrated in clinical trials.

Side Effects of PROLASTIN®-C

As with any prescription medication, PROLASTIN®-C carries the risk of side effects. The most common ones include:

  • Fever
  • Headaches
  • Dizziness
  • Tingling skin
  • Muscle aches
  • Diarrhea
  • Fatigue
  • Pain at the injection site

In rare cases, patients may experience symptoms of serious health complications. Seek emergency medical care immediately if you experience any of the following:

  • Abdominal pain
  • Persistent fever
  • Persistent nausea and vomiting
  • Persistent sore throat
  • Unusual tiredness
  • Yellowing of the skin
  • Dark urine

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

PROLASTIN®-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) used to treat adult patients with alpha1-antitrypsin deficiency. Treatment is administered once a week, with doses varying depending on the patient’s body weight.

Please refer to the full prescribing information.