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Prescribing Information    |   Important Safety Information    |   View Patient Site

Permanent J-Code J1554

Permanent J-Code J1554

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ASCENIV™
PATIENT STORIES

Learn from others how ASCENIV can make a positive difference when living with PI

Watch Sherry's story

Watch Lisa Marie's story

Watch Sherry's story

Watch Lisa Marie's story

Photo of ASCENIV patient Lisa Marie

“I'm so grateful that I have ASCENIV in my corner”

MEET LISA MARIE, 55-year-old nurse, married with a blended family of 5 children, living with a rare blood vessel disease in addition to PI

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MY STORY

For as long as I can remember, whenever I got sick, I would get very sick. One year, I had strep throat 13 times.

MY PI DIAGNOSIS

Despite my complicated health history, I was never quite sure what was wrong with me. At age 43, I was diagnosed with PI. I tried two other immunoglobulin treatments before switching to ASCENIV.

MY EXPERIENCE WITH ASCENIV

I now receive monthly infusions. I already can tell it’s made a major difference in my health.

As a nurse, I know the importance of protecting my immune system, especially being immunocompromised. I can go on trips with my friends and family – none of which would have been possible before beginning treatment.

I can do more and be more present for things that I had to give up because of PI.

Photo of ASCENIV patient Lynne

“Thanks to ASCENIV, I got my life back”

MEET LYNNE, 65-year-old caregiver, married with 2 children, who works with people who have developmental disabilities

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MY STORY

I had always felt like I had something going on with my health. My frequent absences due to sickness created challenges at work.

MY PI DIAGNOSIS

I received excellent care from my allergist and primary care physician, but I still was never consistently healthy.

After years of trying to determine what was wrong, I was diagnosed with PI at age 62.

MY EXPERIENCE WITH ASCENIV

My immunologist then prescribed me ASCENIV, and I’ve been receiving monthly infusions for two years. After being on treatment for a little while, I realized I was healthier for longer periods of time and spending less time resting or recovering from illnesses.

I’m able to do more of what I love and spend more time with the people I love.

Photo of ASCENIV patient Regina

“Before ASCENIV, I kind of just existed”

MEET REGINA, 50-year-old elementary math tutor, married with 3 children, one of whom also has PI

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MY STORY

My first encounter with PI was through my daughter. At 10 years old, she was finally diagnosed with the condition after having been sick with nonstop infections for two years.

I, too, had always struggled to recover from any type of sickness, even after taking antibiotics. But before my daughter became ill, I’d never heard of PI.

MY PI DIAGNOSIS

When I began to experience recurrent infections like my daughter did, I met with her immunologist. Soon after, I was diagnosed with PI at age 48 and was initially prescribed an immune globulin treatment.

My doctor then switched me to ASCENIV, and after a few months of treatment, I noticed a significant improvement in my health.

MY EXPERIENCE WITH ASCENIV

I feel better, and I’m back to living the life that I want.

I used to miss so much work due to being sick, and even when I was at work, I rarely felt completely well. But now, I don’t remember the last time I needed to take a sick day.

I’m so glad that my daughter and I received the diagnoses we needed. And I’m grateful that I found a way to get my life back through ASCENIV.

Photo of ASCENIV patient Sherry

“Thanks to ASCENIV, the old me is coming back"

MEET SHERRY, 51-year-old nurse, married with a daughter in college

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MY STORY

I didn’t think anything was wrong at first. I always thought I sufferer from constant infections because I worked in a nursing home where illnesses could easily be spread. But even after I moved to working in hospice care, I continued to get sick frequently.

MY PI DIAGNOSIS

After nine months of searching for the right diagnosis, my doctors told me I had PI. Over the next 16 years, I tried many different treatments that temporarily helped my symptoms but didn’t quite sustain me for as long as I needed. That all changed when I started ASCENIV.

MY EXPERIENCE WITH ASCENIV

Now, I can enjoy traveling, hiking, and spending time with my husband and loved ones without being worn out for days afterward. Living with primary immunodeficiency can be challenging, but for me, ASCENIV makes it easier. I’m glad my doctors helped me find the treatment that’s right for me.

Every patient’s experience with ASCENIV will vary, and there are potential risks and side effects with ASCENIV.

Indication

ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

Important Safety Information for ASCENIV™


WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

 

  • Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central 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 with the administration of IVIG products in predisposed patients.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV 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 for hyperviscosity.



Contraindications

ASCENIV is contraindicated in:

  • Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.

Warnings and Precautions

Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Thrombosis may occur following treatment with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at-risk patients, administer ASCENIV at the minimum infusion rate practicable.

Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.

Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.

IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.

Noncardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244).
After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.

Adverse Reactions

The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

For additional safety information about ASCENIV, please see full Prescribing Information.

Indication

ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

 

Important Safety Information for ASCENIV™

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central 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 with the administration of IVIG products in predisposed patients.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV 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 for hyperviscosity.

 

Contraindications

ASCENIV is contraindicated in:

  • Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.
Warnings and Precautions

Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Thrombosis may occur following treatment with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at-risk patients, administer ASCENIV at the minimum infusion rate practicable.

Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.

Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.

IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.

Noncardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244).

After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.

Adverse Reactions

The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

For additional safety information about ASCENIV, please see full Prescribing Information.