Genetic Information Nondiscrimination Act (GINA)
GINA (Title II) Takes Effect November 21, 2009
On November 21, 2009, Title II of the Genetic Information Nondiscrimination Act (GINA) of 2008 will take effect. Title II prohibits most employers from using genetic information for hiring, firing, and promotion decisions, and for any decisions regarding terms of employment.
Title I of GINA, which took effect on May 21, 2009, protects against discrimination in health coverage by prohibiting health insurers or health plan administrators from requesting or requiring genetic information of an individual or the individual's family members.
As you and your patients make decisions about genetic testing, it is important to understand the protections afforded by the full implementation of GINA. For more detailed information, review the Fact Sheet from the National Human Genome Research Institute of the National Institutes of Health or the FAQs from the Genetics and Public Policy Center.
GINA (Title I) Takes Effect May 21, 2009
The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits discrimination in health coverage and employment based on genetic information. The sections of GINA which relate to health coverage (Title I) take effect beginning May 21, 2009. The sections of GINA relating to employment (Title II) will take effect on November 21, 2009.
GINA (Title I) generally prohibits health insurers or health plan administrators from requesting or requiring genetic information from an individual or an individual's family members. Using genetic information for decisions regarding coverage, rates, or preexisting conditions is also prohibited.
GINA (Title II) prohibits most employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment.
For more detailed information about GINA, visit these websites:
National Human Genome Research Institute
Genetics and Public Policy Center
GLASSIA [Alpha1-Proteinase Inhibitor (Human)]
GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency.
- The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been demonstrated in randomized, controlled clinical trials.
- Clinical data demonstrating the long term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
- GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.
Detailed Important Risk Information for GLASSIA
- GLASSIA is contraindicated in IgA deficient patients with antibodies against IgA. GLASSIA is contraindicated in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products.
- GLASSIA is made from human plasma. It may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- Administer GLASSIA at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately.
- Administer GLASSIA within 3 hours of entering the vials.
- Safety and effectiveness in patients over 65 years of age have not been established.
- Two serious adverse reactions observed on two separate occasions during clinical studies with GLASSIA were cholangitis and exacerbation of chronic obstructive pulmonary disease (COPD).
- The most common product-related adverse reactions in clinical studies were headache and dizziness.
Please see GLASSIA Full Prescribing Information for full prescribing details.
ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]
ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema.
- The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
- Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with ARALAST NP or ARALAST are not available.
- ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.
Detailed Important Risk Information for ARALAST NP
- ARALAST NP is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.
- ARALAST NP is derived from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- The recommended rate of administration (≤0.08 mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactoid reactions occur, the infusion should be discontinued immediately.
- Safety and effectiveness in patients over age 65 years of age have not been established.
- ARALAST NP should be administered at room temperature within three (3) hours after reconstitution and should be administered alone, without mixing with other agents or diluting solutions.
- The safety of ARALAST NP was evaluated with ARALAST in a crossover clinical PK comparability study. The most common adverse events deemed related to ARALAST NP included headache and musculoskeletal discomfort. No serious adverse reactions or deaths were reported in the study. In the ARALAST pivotal study, the most common adverse events were headache and somnolence.
Please see ARALAST NP Full Prescribing Information for full prescribing details.
