For Healthcare Professionals

How to administer PROLASTIN-C LIQUID

PROLASTIN‑C LIQUID is administered as a once-weekly intravenous (IV) infusion at a dose of 60 mg/kg body weight. The product is ready to use—no reconstitution required.1



PROLASTIN-C LIQUID should be given intravenously at a rate of 0.08 mL/kg/min as determined by the response and comfort of the patient.1

Dosing regimen

For intravenous use only

60 mg/kg Body Weight

The recommended dose of PROLASTIN-C LIQUID is 60 mg per kg of body weight.1

15 minutes to Infuse

It is typically infused in about 15 minutes at the rate of 0.08 mL per kg per minute.1

Administered Once Weekly

It is given once each week through an intravenous (IV) infusion as directed.1

Warning and precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur.
  • Monitor vital signs and observe the patient closely throughout the infusion.
  • Early signs and symptoms may include: pruritus (itching), generalized urticaria (hives), flushing, swollen lips, tongue, or uvula.

NOTE: If hypersensitivity symptoms occur, promptly stop PROLASTIN-C LIQUID infusion and begin appropriate therapy.

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Storage and handling

Follow proper storage and handling to maintain product integrity and ensure safe administration.

PROLASTIN-C LIQUID is shipped refrigerated but allows for short-term room temperature storage.
Do not freeze.1

Refrigerated Storage

Store at 36–46°F (2–8°C) until the expiration date on the label.1

Room Temperature

Store at up to 77°F (25°C) for a maximum period of 1 month only.1

Do Not Freeze

Do not use if frozen. Discard after 1 month at room temperature.1

Enrollment form

Fill out the enrollment form to get your patients started on PROLASTIN-C LIQUID.

Download Form Prescribing Information

Important Safety Information

PROLASTIN®-C LIQUID is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency). 


Limitations of Use

  • The effect of augmentation therapy with any alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in alpha1-PI 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 LIQUID are not available.
  • PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.

PROLASTIN-C LIQUID is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA or patients with a history of anaphylaxis or other severe systemic reaction to alpha1-PI products.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C LIQUID infusion and begin appropriate therapy.

Because PROLASTIN-C LIQUID is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

The most common adverse reactions during PROLASTIN-C LIQUID clinical trials in >5% of subjects were diarrhea and fatigue, each of which occurred in 2 subjects (6%).

Please see full Prescribing Information for PROLASTIN-C LIQUID.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References

  1. PROLASTIN®-C LIQUID (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.
  2. Data on file, Total Prolastin Patients Treated 2015–2024, Grifols.