What is CUVITRU?
CUVITRU is a ready-to-use liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people
2 years and older.
IMPORTANT SAFETY INFORMATION
What is the most important information I need to know about CUVITRU?
CUVITRU can cause the following serious reactions:
- Severe allergic reactions causing difficulty in breathing or skin rashes
- Decreased kidney function or kidney failure
- Blood clots in the heart, brain, lungs, or elsewhere in the body
- Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
- Dark colored urine, swelling, fatigue, or difficulty breathing
Who should not use CUVITRU?
Do not use CUVITRU if you:
- Have had a severe allergic reaction to immune globulin or other blood products.
- Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.
What should I avoid while taking CUVITRU?
- CUVITRU can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take CUVITRU.
- Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.
What are the possible or reasonably likely side effects of CUVITRU?
CUVITRU can cause serious side effects. If any of the following problems occur after starting CUVITRU, stop the infusion immediately and contact your HCP or call emergency services:
- Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
- Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
- Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
- Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
- Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
- Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
- Fever over 100°F. This could be sign of an infection.
The following one or more possible side effects may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.
- Mild or moderate pain
- Redness
- Itching
The most common side effects that may occur are:
- Headache
- Nausea
- Fatigue
- Diarrhea
- Vomiting
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.
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.
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution
What is GAMMAGARD LIQUID?
- GAMMAGARD LIQUID is indicated for the treatment of primary humoral immunodeficiency diseases (PI) in patients two years of age and older. GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
- GAMMAGARD LIQUID is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI.
- GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.
Important Safety Information
What is the most important information that I should know about GAMMAGARD LIQUID?
GAMMAGARD LIQUID can cause the following serious reactions:
- Severe allergic reactions causing difficulty in breathing or skin rashes
- Decreased kidney function or kidney failure
- Blood clots in the heart, brain, lungs, or elsewhere in the body
- Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
- Dark colored urine, swelling, fatigue, or difficulty breathing
Who should not use GAMMAGARD LIQUID?
Do not use GAMMAGARD LIQUID if you:
- Have a known history of a severe allergic reaction to IgG or other blood products.
- Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.
GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:
- Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
- Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
- Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
- Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
- Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
- Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
- Fever over 100°F. This could be a sign of an infection.
Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine.
What are the possible or reasonably likely side effects of GAMMAGARD LIQUID for PI?
The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions: Mild or moderate pain, swelling, itching, redness, bruising, and warmth.
During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects: Headache, migraine, fever, fatigue, itching, rash/hives, cough, chest pain/tightness, chills/shaking chills, dizziness, nausea/vomiting, faster heart rate, upper abdominal pain, increased blood pressure, muscle cramps, and sore throat.
These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don't go away.
You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.
The risk information provided here is not comprehensive. To learn more, talk about GAMMAGARD LIQUID with your healthcare provider or pharmacist. The FDA-approved patient product labeling can be accessed by clicking here.
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution
What is HYQVIA?
- HYQVIA is a liquid medicine containing immune globulin and Recombinant Human Hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection.
- HYQVIA is indicated for the treatment of Primary Immunodeficiency (PI) involving the humoral immune system in adults.
- Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.
- HYQVIA is infused under the skin (subcutaneous).
- If you and your healthcare professional decide that home self-infusion of HYQVIA is right for you, then be sure you get instructions and training from your healthcare professional before using HYQVIA at home.
Important Safety Information
What is the most important information that I should know about HYQVIA?
- HYQVIA can cause blood clots.
- Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
- Your healthcare professional may perform blood tests regularly to check your IgG level.
- With your consent, your healthcare professional may provide blood samples to Shire plc, to test for antibodies that may form against the hyaluronidase part of Cuvitru.
- Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
- Talk to your healthcare professional if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling Medical Information at 1-866-424-6724.
Who should not take HYQVIA?
Do not take HYQVIA if you:
- Are allergic to IgG, hyaluronidase, other blood products, or human albumin (in the hyaluronidase solution).
- Have IgA deficiency with antibodies to IgA.
HYQVIA can cause serious side effects. Call your healthcare professional or go to your emergency department right away if you get:
- Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
- Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
- Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
- Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot.
- Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
- Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
What are the possible or reasonably likely side effects of HYQVIA?
- After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. Mild or moderate pain, redness, swelling, or itching may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions.
- The most common side effects of HYQVIA are headache, fatigue, nausea, fever, and vomiting.
- Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking Cuvitru. It is not known if there is any long term effect. In theory, these antibodies could react with your body's own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects.
These are not all the possible side effects with Cuvitru. Talk to your healthcare professional about any side effects that bother you or that don't go away.
Before starting HYQVIA, tell your healthcare professional if you:
- Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
- Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.
- Are pregnant, trying to become pregnant or are breast feeding.
You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire Drug Safety at 1-800-999-1785.
The risk information provided here is not comprehensive. To learn more, talk about HYQVIA with your healthcare provider or pharmacist. The FDA-approved patient labeling can be accessed by clicking here.
GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA < 1 µG/mL in a 5% Solution
Indication and Usage
GAMMAGARD S/D is an immune globulin indicated as replacement therapy for primary humoral immunodeficiency (PI) for adult and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic ITP to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.
GAMMAGARD S/D is for intravenous use only.
Important Safety Information
BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including GAMMAGARD S/D. 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, including GAMMAGARD S/D. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD S/D does not contain sucrose.
- For patients at risk of thrombosis, administer GAMMAGARD S/D 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
- GAMMAGARD S/D is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with < 1 µg/mL IgA in a 5% solution.
Warnings and Precautions
- Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
- Renal Dysfunction/Failure: Monitor renal function and urine output. For patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or with predisposition to acute renal failure, use the minimum infusion rate practicable for IV administration of GAMMAGARD S/D.
- Thrombosis: Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity.
- Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and symptoms of AMS.
- Hemolysis: Monitor for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
- Transfusion-Related Acute Lung Injury (TRALI): Monitor for pulmonary adverse reactions associated with TRALI.
- Transmittable Infectious Agents: Because the Immune Globulin Infusion (Human) is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses and other pathogens. No cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD S/D.
- Hyperproteinemia, increased serum viscosity, and alterations in serum sodium levels may occur.
- Interference with Laboratory Tests: False positive serological test results, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.
ADVERSE REACTIONS
The most common adverse reactions observed in = 5% of clinical trial patients during or within 48 hours of infusion were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis and flushing.
Serious adverse reactions reported postmarketing were anaphylaxis, acute renal failure, myocardial infarction, cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism, aseptic meningitis, acute hemolysis and TRALI.
Please see Full Prescribing Information, including Boxed Warning regarding Thrombosis, Renal Dysfunction and Acute Renal Failure, by clicking here.
References: 1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc. 2. U.S. Food and Drug Administration. User fee billable biologic products and potencies approved under section 351 of the PHS Act. 3. Suez D, Stein M, Gupta S, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700-712. 4. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015; 179(2):146-160. 5. Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Disease. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.6. Bousfiha A, Jeddane L, Al-Herz W, et al. The 2015 IUIS Phenotypic Classification for Primary Immunodeficiencies. J Clin Immunol. 2015;35(8):727-738. doi:10.1007/s10875-015-0198-5. published online October 7, 2015. 7. Immune Deficiency Foundation. Primary Immunodeficiency Diseases in America: 2007. The Third National Survey of Patients. Prepared by Abt. SRBI, Inc. May 1, 2009.8. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007;27(5):497-502.9. Modell F, Puente D, Modell V. From genotype to phenotype. Further studies measuring the impact of a Physician Education and Public Awareness Campaign on early diagnosis and management of primary immunodeficiencies. Immunol Res. 2009;44(1-3):132-149. 10. GAMMAGARD LIQUID [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 11. HYQVIA [Prescribing Information]. Lexington, MA: Baxalta US Inc.12. GAMMAGARD S/D [Prescribing Information] Westlake Village, CA: Baxalta US Inc. 13. 10 Warning Signs of Primary Immunodeficiency: Jeffrey Modell Foundation; 2016.14. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6(4):592-599.15. Data on File. Takeda US Inc. 2019
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