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Patient education can play an important role in chronic disease management

Patient education is a vital component in caring for patients with a chronic disease because it informs and involves patients in understanding both the disease state and the care instructions necessary for their condition. It also helps patients understand any lifestyle changes that they will need to make to help manage their condition. You can support your patients with the following resources.

GAMMAGARD LIQUID Patient Brochure

Helps patients understand CIDP and the symptoms it can create, as well as showing dosing and safety information for GAMMAGARD LIQUID.

Download Patient Brochure

How GAMMAGARD LIQUID is made

Informs patients on the creation of GAMMAGARD LIQUID, from the donor selection process to purification and the dedicated virus inactivation steps.

Before we get started, let’s go through some important safety information. GAMMAGARD LIQUID is indicated as a replacement therapy for primary humoral immunodeficiency (Pl) in adult and pediatric patients two years of age or older, as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN), and as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). LIMITATIONS OF USE (CIDP): GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy. GAMMAGARD LIQUID for PI is for intravenous or subcutaneous use. GAMMAGARD LIQUID for MMN and CIDP is for intravenous use only.

IMPORTANT SAFETY INFORMATION WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose. For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. Please see additional Important Safety Information in this video, and the accompanying Full Prescribing Information.

Want to see one of the world’s most precious assets?

It’s not a diamond, it's not gold.

This is human plasma, and it’s used to create immunoglobulin therapies, like GAMMAGARD LIQUID.

Pretty cool, huh?

But do you know how these therapies are made? Let me show you.

Precious things need to be handled with care. And this is no exception.

It’s not a process that can be rushed. No, no.

It’s a journey of dedication and care.

The process takes up to a year and follows rigorous quality and safety measures.

It begins with donor selection.

Potential donors are strictly screened before their plasma is collected and their donation is tested for viruses and infections.

Then, experts carefully remove the IgG antibodies that are needed to create the final product. After this, they purify the antibodies IgG antibodies in several stages.

And, while donor screening and donation testing minimize the chances of viruses, three specialized steps clear any viruses that may still be there.

Immunoglobulin therapies are all produced in a similar way, but their features are different.

GAMMAGARD LIQUID is designed with patient needs in mind.

Its specific characteristics make it suitable for a broad range of patients.

For example, it doesn’t contain any added sugar or sodium, which may be important things to consider for patients who are watching their salt and sugar intake.

Looking good!

After a final inspection, GAMMAGARD LIQUID is shipped to the people it’s prescribed to.

People like me!

INDICATIONS

GAMMAGARD LIQUID is indicated as a replacement therapy for primary humoral immunodeficiency (Pl) in adult and pediatric patients two years of age or older, as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN), and as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

LIMITATIONS OF USE (CIDP): GAMMAGARD LIQUID has not been studied in immunoglobulin-naïve patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms.

Individualize the duration of any treatment beyond 6 months based upon the patient's response and demonstrated need for continued therapy.

GAMMAGARD LIQUID for PI is for intravenous or subcutaneous use.

GAMMAGARD LIQUID for MMN and CIDP is for intravenous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE.

Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

CONTRAINDICATIONS

History of anaphylactic or severe systemic hypersensitivity reactions to human IG.
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Acute renal dysfunction/failure has been reported in association with infusions of GAMMAGARD LIQUID. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and use the minimum infusion rate practicable for IV administration. If renal function deteriorates, consider discontinuation.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from a pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: GAMMAGARD LIQUID contains blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema has been reported with IV-administered IG, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because GAMMAGARD LIQUID is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

ADVERSE REACTIONS

The serious adverse reactions observed in clinical studies in PI was aseptic meningitis, and in MMN were pulmonary embolism and blurred vision.

The most common adverse reactions observed in ≥5% of patients were:

IV administration for PI: Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.

Subcutaneous administration for PI: Infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.

IV administration for MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

IV administration for CIDP: Headache, pyrexia, anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, and pain in extremity.

DRUG INTERACTIONS

Passive transfer of antibodies may transiently interfere with immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

Please see the accompanying Full Prescribing Information provided with this material, or on the GAMMAGARD LIQUID website www.gammagard.com/hcp.

Organizations for your patients

Your patients may benefit from connecting with these foundations and professional societies that focus on a multitude of different things regarding CIDP.

The GBS/CIDP Foundation International*

This organization provides support for patients with several related conditions and provides help finding treatment specialists and ways to connect with other patients.

Neuropathy Action Foundation (NAF)*

This helpful organization posts brochures, news, and quarterly newsletters and provides information on navigating insurance.

The Foundation for Peripheral Neuropathy*

You’ll find lists of foundation-recommended neurologists and get to explore patient support groups.

American Association of Neuromuscular and Electrodiagnostic Medicine*

The American Association of Neuromuscular and Electrodiagnostic Medicine is a nonprofit association dedicated to improving the quality of medical care provided to people with muscle and nerve disorders.

Caregiver Action Network (CAN)*

Caregiver Action Network is an organization that works to improve the quality of life for the millions of Americans who care for loved ones with chronic conditions, disabilities, disease, or the frailties of old age.

American Neuromuscular Foundation (ANF)*

A nonprofit organization dedicated to strengthening the global effort to cure neuromuscular disease. See the work and programs for people with neuromuscular diseases.

*This organization is a third-party resource and not associated with Takeda.

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