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The leading alpha1 augmentation therapy for 20 years is now improved

  • Shorter Infusion Time: delivers twice the active protein per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min
  • Higher Purity: delivers ≥ 90% pure Alpha-1 protein allowing it to be more concentrated than Prolastin

Find out more about new PROLASTIN-C

Interpreting Grifols AlphaKit Test Results

The results of Grifols AlphaKit tests are fast and confidential. The Grifols AlphaKit measures AAT levels in your patient’s blood. If the level is below 11 µM, and your patient is symptomatic, consider treatment.

The Grifols AlphaKit also determines AAT genotype and phenotype. Here are the more common phenotypes and their corresponding AAT levels.1
µM
mg/dL
MM (2 normal copies)20-53150-350
MZ (1 normal copy, 1 deficient copy)12-2890-210
SS (2 marginally deficient copies)13-27100-210
SZ (1 deficient copy, 1 marginally deficient copy)10-1675-120
ZZ (2 deficient copies)2.5-720-45
NULLNULL (2 nonfunctional copies)00

*Adapted from Alpha1 Association.1

Family risk associated with presence of deficiency allele

Allele Algorithm

Examples of inheritance of AAT-deficient alleles:

A) One parent is homozygous normal (2 M alleles) and one parent is homozygous abnormal alpha-1 (two Z alleles): children have a 100% chance of being a carrier for alpha-1.

B) Both parents are heterozygous carriers of abnormal alleles (one normal M allele and one abnormal Z allele): children have a 25% chance of being an Alpha-1 patient, a 50% chance of being a carrier for Alpha-1 and a 25% chance of having two normal alleles.

Serum AAT levels are lower in patients with abnormal alleles4,5

Range of serum AAT levels by Phenotype

Carriers are at increased risk of lung disease including lung cancer3,4,5

Learn about treatment of patients with Alpha-1 and information for carriers of Alpha-1.

next: Treatment & Management of Alphas >

Important Safety Information

PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency). The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI) on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials. PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

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 reactions during clinical trials in ≥ 1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus.

PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., 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 1-800-FDA-1088.

References
  1. How Is Alpha-1 Diagnosed? Alpha1 Association. http://www.alpha1.org/whatisalpha1/howdiagnosed.php. Accessed on September 30, 2009.
  2. Family Risk Is Associated With Presence of Deficiency Allele. Slide 67 of Myths and Realities of Chronic Obstructive Pulmonary Disease (COPD): Rethinking What We Know. Talecris Code # PR106-0709.
  3. Yang P, Sun Z, Krowka MJ, et al. Alpha1-antitrypsin deficiency carriers, tobacco smoke, chronic obstructive pulmonary disease, and lung cancer risk. Arch Intern Med. 2008;168(10):1097-1103.
  4. University of Florida College of Medicine AAT Deficiency Detection Laboratory.
  5. Wise RA. α1-Antitrypsin deficiency. The Merck Manuals Online Medical Library. http://www.merck.com/mmpe/sec05/ch049/ch049b.html#CIHFAGBJ. Accessed July 6, 2008.
  6. PROLASTIN-C [package insert]. Grifols.