Kamada is excited to launch the New Cytogam Website

Click here to visit www.cytogam.com

A new ISHLT Voices podcast:

Unlocking Hyperimmunes - Emerging Clinical Data about Cytogam

Antiviral Effect of Cytomegalovirus Immune Globulin after Liver Transplantation in Patients who were not CMV Donor Positive/Recipient Negative

Jennifer K.L. Chow, MD, MS, FAST; Laura A. McDermott, BS; David R. Snydman, MD, FAST

Tufts Medical Center, Boston, MA

View the recording of Dr. Jennifer Chow presenting the poster, presented at ATC 2024

Watch now

Available on Demand: CMV Stream

Click here to watch on www.cmvstream.com

Featuring leading experts discussing CMV Management after SOT.

June 1 – 5, 2024

American Transplant Congress (ATC)

Philadelphia, PA

Kamada to exhibit at this year's meeting in Philadelphia!
Meet us at Booth #720 to discover more about how you can help your transplant patients

Learn more

June 5, 2024 - 6 pm EST

Advanced Strategies for CMV Management after SOT

Live Online Event

Send your questions and interact with the specialists as they delve into the latest challenges and developments in this field.
For the full scientific program, panel member list and registration click here

Our Products

CMV infection remains one of the most common complications for solid organ transplant recipients¹ and is still considered “the troll of transplantation."²

As an immune globulin, CYTOGAM^® offers a complementary mechanism of action to antiviral agents, working outside the cell, thus adding enhanced protection against CMV post-transplant.^3,4,5

References

Haidar G, Boeckh M, Singh N. Cytomegalovirus infection in solid organ and hematopoietic cell transplantation: state of the evidence. J Infect Dis. 2020;221(S1):S23-S31. doi: 10.1093/infdis/jiz454
Stern A, Papnicolaou GA. CMV prevention and treatment in transplantation: what’s new in 2019. Curr Infect Dis Rep. 2019; 21(11): 45. doi:10.1007/s11908-019-0699-0
Grossi PA, Mohacsi P, Szabolcs Z, Potena L. Cytomegalovirus immunoglobulin after thoracic transplantation: an overview. Transplantation. 2016; 100: S1-S4
Carbone J. The immunology of posttransplant CMV infection: potential effect of CMV immunoglobulins on distinct components of the immune response to CMV. Transplantation. 2016;100: S11-S18
Valantine HA, Luikart H, Doyle R, et al. Impact of cytomegalovirus hyperimmune globulin on outcome after cardiothoracic transplantation: a comparative study of combined prophylaxis with CMV hyperimmune globulin versus ganciclovir alone. Transplantation. 2001;72(10):1647-1652

Resources

ISHLT Voices Podcast

Mechanism of Action Video

ATC 2024 Tufts PosterNew

ATC 2024 Tufts Poster - Introduction VideoNew

Antiviral Effect of Cytomegalovirus Immune Globulin after Liver Transplantation in Patients who were not CMV Donor Positive/Recipient Negative

Jennifer K.L. Chow, MD, MS, FAST; Laura A. McDermott, BS; David R. Snydman, MD, FAST

Tufts Medical Center, Boston, MA

View the recording of Dr. Jennifer Chow presenting the poster, presented at ATC 2024

2024 CEoT Product Theater – Breakthroughs in Hyperimmune Therapy

2024 CEoT Product Theater – Anti-CMV Prophylaxis Strategies and Immune Response (in Lung Transplantation)

IDWeek 2023 UTSW Poster

Germer et al. 2016 Reprint Summary

Barten et al. 2022 Reprint Summary

View Important Safety Information

HEPAGAM B is the only Hepatitis B Immune Globulin (HBIG):

Approved for post-transplant prophylaxis of hepatitis B in liver transplants.¹
Proven to be safe and effective in preventing HBV recurrence following liver transplants²
With actual potency indicated on each vial to ensure high dosing accuracy¹

References

Kamada corporate presentation, September 2022
Terrault NA, Kilic M, Karademir S, et al. HepaGam B after liver transplant in patients with hepatitis B virus. Available at: https://www.researchgate.net/publication/267792129_Orthotopic_HepaGam_B_After_Liver_Transplant_in_Patients_with_Hepatitis_B_Virus. Accessed July 27, 2022

Resources

Hepagam B

View Important Safety Information

Varicella-zoster virus (VZV) infection remains a significant concern for transplant patients without sufficient VZV immunity¹.

VARIZIG^® is recommended as first-line treatment by leading guidelines for VZV post-exposure prophylaxis, to effectively reduce disease severity and complications after exposure of a high-risk individual to VZV^1-3.

References

Varicella Zoster virus in solid organ transplantation: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice, 2019.
The CDC updated Recommendations for Use of VARIZIG - United States, 2013.
Red-Book: 2021–2024 Report of the Committee on Infectious Diseases.

Resources

Treatment Algorithm

Clinical Compendium

View Important Safety Information

Research Collaborations

Kamada's Clinical Program aims to innovate in areas like solid organ transplantation. We specialize in hyperimmune plasma-derived therapies and seek to collaborate with the transplant community for clinical research.

If you are interested in sharing your clinical expertise, please contact our Director of Medical Affairs, Winston Ally at winstona@kamada.com

Important Safety Information

Cytogam [Cytomegalovirus Immune Globulin Intravenous (Human)]

Indication and Usage:

Cytogam® is an intravenous immunoglobulin containing standardized amount of antibody to cytomegalovirus. It is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

Important Safety Information:

Cytogam® is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deﬁciency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including Cytogam.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insuﬃciency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable. Those containing sucrose as a stabilizer, like Cytogam, account for a disproportionate share of the total number of reports of renal dysfunction and acute renal failure when given at daily doses of 350 mg/kg or greater.

During administration, the patient’s vital signs should be monitored continuously, and careful observation made for any symptoms throughout the infusion. Epinephrine and diphenhydramine should be available for the treatment of an acute and anaphylactic reactions.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Immune Globulin Intravenous (Human) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The potential risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

Cytogam® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as ﬂushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam.

Please see full Prescribing Information for full prescribing details.

To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HepaGam B® [Hepatitis B immune globulin intravenous (Human)]

Indication and Usage:

HepaGam B® is a Hepatitis B Immune Globulin Intravenous (Human) indicated for the following: Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients, Post-exposure prophylaxis including: acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to persons with acute HBV infection.

Important Safety Information

Individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive HepaGam B®. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have severe, potentially life-threatening allergic reactions.

For post-exposure prophylaxis indications, HepaGam B® must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B® should be given only if the expected benefits outweigh the potential risks.

HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is a sterile solution of gamma globulin (IgG) made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jacob disease (CJD) agent.

Severe hypersensitivity reactions may occur with HepaGam B®. Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Dosage and Administration in the prescribing information must be closely followed.

Thrombotic events may occur during or following treatment with IVIG products. Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity.

The maltose contained in HepaGam B® can interfere with some types of blood glucose monitoring systems. This can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.

The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).

Please see full Prescribing Information for full prescribing details.

To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

VARIZIG [Varicella Zoster Immune Globulin (Human)]

Indication and Usage

VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high-risk individuals. High-risk groups include: immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants less than one year of age, adults without evidence of immunity, pregnant women.

VARIZIG administration is intended to reduce the severity of varicella.

Important Safety Information

VARIZIG contains trace amounts of IgA. Individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG. IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction. Thrombotic events may occur during or following treatment with immune globulin products. Administer VARIZIG intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG if the expected benefits outweigh the potential risks. Severe hypersensitivity reactions may occur following VARIZIG administration. In case of hypersensitivity, discontinue administration of VARIZIG immediately and provide appropriate treatment. Because VARIZIG is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease agent, and, theoretically, the Creutzfeldt-Jakob disease agent.

The most serious adverse drug reactions observed in clinical trials for all subjects and patients include pyrexia, nausea, and vomiting. The most common adverse drug reactions observed in clinical trials for all subjects and patients were injection site pain, headache, chills, fatigue, rash, and nausea.

Please see full Prescribing Information for complete prescribing details.

To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Close Important Safety Information