Subcutaneous IG Info Needed
July 18, 2017 at 3:12 pm
The long-and-short: I have been receiving IVIG infusions for two days every three weeks since 2013. I must take time off from work to have infusions.
My neurologist recently prescribed weekly subcutaneous IG (“sub-q IG”) infusions in place of IVIG. My insurance company denied the request because Hyzentra is not FDA approved for use in treating CIDP.
Both are the same drug; human immunoglobulin.
1) Subcutaneous IG is infused and stored in the fatty tissue of the abdomen. I am told this has the effect of a “time release” of the drug, versus IV infusion directly into the circulatory system. This modulates the benefits of IG over time.
2) Sub-q IG is given on a weekly basis, versus every three weeks, enhancing the consistency of the benefits, and reducing or eliminating the extremes in the patient’s ability/disability. (I am nearly crippled every third week when I am due for my next infusion.)
3) For the first three sub-q IG treatments, an in-home infusion nurse trains the patient; the patient self-administers the drug thereafter. Infusions can be done over the weekend, obviating the need for the patient to take time off from work. (I would enjoy using my PTO for an actual vacation!)
4) No longer tethered to IVIG clinics or in-home nursing services and schedules, sub-q IG could allow the patient to travel more readily.
5) The expense to the insurance company could be reduced by not paying for several hours of in-home nursing care every three weeks.
IG has been demonstrably effective in keeping the advance of paralysis from my CIDP at bay.
There is no reason to believe a subcutaneous delivery of IG to a CIDP patient would be any less effective than IV infusions of the same drug.
I think sub-q IG treatments for CIDP have the potential to drastically improve the lives of patients, as well as the potential to reduce costs for the insurance companies.
ARE THERE ANY STUDIES BEING CONDUCTED OF SUBCUTANEOUS IG AS A TREATMENT FOR CIDP?
ARE THERE ANY BRANDS OF SUBCUTANEOUS IG THAT HAVE BEEN APPROVED BY THE FDA FOR USE IN TREATING CIDP?
I believe the risk is minimal, and the potential benefits are significant.
I appreciate any feedback/guidance I can get. Thank you.
July 18, 2017 at 3:51 pm
If the Forum search function was working (it’s been broken for a few months now) you would have been able to read many posts on the subject and not have to create a new thread.
Please see the following thread for info, it links mosts of the related posts too:
If your specific questions aren’t answered in through that thread, please post any outstanding questions there and we will do our best to answer them.
July 19, 2017 at 11:56 am
Thank you, Jim! I’ve posted my remaining questions there.
July 21, 2017 at 1:52 am
Posted on Twitter 7/1917:
FDA Accepts CSL Behring’s Supplemental Biologics License Application for Hizentra® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication
KING OF PRUSSIA, Pa. — 19 July 2017
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental Biologics License Application (BLA) for Hizentra® [Immune globulin subcutaneous (Human) 20% liquid] for the treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. CIDP is a rare immune-mediated disorder of the peripheral nerves and the effects can worsen over time.
“We remain committed to CIDP patients and their families and the review of this application is another step towards delivering on our promise to them.” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “We’re also excited about the possibility of adding a CIDP indication for our industry-leading portfolio of immunoglobulin therapies.”
The application was based on data from the largest-ever randomized CIDP trial, PATH (Polyneuropathy And Treatment with Hizentra®). The clinical trial was completed in March and was designed to demonstrate the efficacy, safety and tolerability of two different doses of CSL Behring’s subcutaneous immunoglobulin (SCIG), Hizentra®, compared with placebo, in the maintenance treatment of CIDP patients previously treated with intravenous immunoglobulin (IVIG).
Hizentra®, the no. 1 prescribed immunoglobulin therapy in treating primary immunodeficiencies (PI), the most prescribed SCIG worldwide, and the only 20 percent SCIG designed with the natural stabilizer L-proline, was self-administered by patients and care givers throughout the study. Subjects were allowed to use dose volumes up to 50 mL/site and infusion rates of up to 35 mL/hour, to provide them with greater flexibility and autonomy to infuse when and where they choose. A long-term open label extension study is ongoing and is expected to be completed later this year.
Hizentra® (Immune Globulin Subcutaneous [Human]), the first 20 percent SCIG developed for subcutaneous use, is registered in over 46 countries and approved in North America, Europe and Japan. Hizentra®, the world’s most prescribed SCIG, has a proven track record of safety, efficacy and tolerability and has over 3.6 million exposures worldwide since 2010. In the United States, Hizentra® is indicated for the treatment of patients with primary immunodeficiency. In all 29 European/European Economic Area member states and Japan, Hizentra® is authorized for treating patients diagnosed with PI as well as secondary immunodeficiencies.
For country specific indication information, visit:
Switzerland: https://compendium.ch/mpro/mnr/22484/html/de (German) or https://compendium.ch/mpro/mnr/22484/html/fr (French)
United States: http://www.hizentra.com/Professional/Prescribing-Information.aspx
Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
WARNING: THROMBOSIS – Thrombosis may occur with immune globulin products, including Hizentra®. 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.
For patients at risk of thrombosis, administer Hizentra® 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. See full prescribing information for complete boxed warning.
Hizentra® is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra®, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra® is contraindicated in patients with hyperprolinemia. Hizentra® is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.
Hizentra® should be administered subcutaneously only. Do not administer intravenously.
IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra®. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.
Monitor patients for aseptic meningitis syndrome (AMS), which has been reported with SCIg. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. Also monitor patients for clinical signs of hemolysis or transfusion-related acute lung injury (TRALI).
Hizentra® is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most common adverse reactions (observed in 5% or more of study subjects receiving Hizentra®) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine and pain.
Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.
Please see full prescribing information for Hizentra® including boxed warning.
CIDP is a rare disorder of the peripheral nerves (those outside the brain and spinal cord). The condition is immune-mediated and the effects can worsen over time. The protective covering of the nerves is damaged, which may cause numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP can occur at any age and is more common in men than in women. If left untreated, approximately 30 percent of CIDP patients will progress to wheelchair dependence.
For more information about the PATH study, visit http://www.clinicaltrials.gov and search with identifier: NCT01545076.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than 60 countries. For more information visit http://www.cslbehring.com and follow us on http://www.Twitter.com/CSLBehring.
Office: +1 610 878 4802
Mobile: +1 610 306 9355
July 21, 2017 at 1:28 pm
Thank you so much for the update. I hope and pray to have FDA approval for using Hizentra for CIDP patients soon! This gives me hope for a much better future.
July 21, 2017 at 2:26 pm
Since I am in a nursing facility that refuses to,let me have IVig on site and the incursion center won’t take me if I can’t walk, I am really hoping this can be approved soon. I see my neuro on August 8 and the UC Irvine Neuromuscular Center August 14, I would like this started. I am tapering off Prednisone right now as it hasn’t worked as hoped.
July 21, 2017 at 4:42 pm
The first protocol they tried on me was a high dose of Prednisone for six weeks in 2013, and it seems that’s what they do with most CIDP patients. On the one hand, it makes sense because Prednisone is utterly inexpensive. However, I think it’s counterproductive. I haven’t met one yet that Prednisone works for. It nearly destroyed me, and I still don’t feel I’ve ever quite bounced back from it. The IVIG did help me to improve, but I’ve never gotten to the level of health I enjoyed BEFORE they put me on Prednisone. I hope the sub-q will be approved by the FDA for use with CIDP patients soon, though I don’t know whether to expect that to happen in weeks, months, or years.
I had an acute attack this time last year and my legs were mostly paralyzed. I spent the better part of May and June in two hospitalizations (five treatments of plasmapheresis did nothing to help me) and a week in a skilled nursing facility, and I was only 55 at the time.
I’ll have you — and all CIDP patients — in my prayers for effective treatment and recovery of abilities. I hope you can leave the nursing home soon and get back to your life.
November 8, 2017 at 12:35 am
My neuro said the dose (sub-cue)wasn’t high enough for my needs. Maybe that is the challenge others are having.
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