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Hizentra for IVIg Therapy

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Hizentra for IVIg Therapy

Hizentra belongs to the class of medications called (immunoglobulins) immune globulin subcutaneous (Human).  Hizentra is used to treat primary immunodeficiency conditions. People who use this medication are said to be undergoing immune globulin therapy.

 

Hizentra is used for the treatment of weakened immune activity.  It treats nerve conditions such as demyelinating polyneuropathy. 

 

The U.S. Food and Drug Administration (FDA) first endorsed the medication in 2010.  Since then, It has gained in popularity.  It’s the world’s most prescribed immunoglobulin medication with up to 9.3 million exposures since 2010. 

 

The color of Hizentra runs from clear and pale yellow to light brown. The medication offers choices in pre-filled syringes and vials.

 

 

While some people prefer syringes, others may feel more secure with vials. However, your physician can help you make informed decisions. The syringes always come in five to twenty millimeters. It is also available in vials of five to fifty millimeters.

 

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How Does it Work?

Hizentra’s active ingredient, human immunoglobulin, is a highly purified protein derived from the plasma of healthy individuals. It acts as the body’s soldier to ward off bacterial and viral infections. It creates a balanced immune system

One way the immune system can be unbalanced is when it becomes hyperactive. When the immune response is hyperactive, it is known as “autoimmunity.” The drug modifies the immune hyperactivity through a mechanism called “immunomodulation.” Hence, the goal of immunomodulation is to regulate immune hyperactivity and prepare the body against potential threats.

 

Who Can Use It?

Adults and children over two years old can use Hizentra. Patients who use this medication are often those who suffer from nerve disorders such as Chronic Inflammatory Demyelinating Polyneuropathy and immune system diseases such as (but not limited to): 

 

 Immune System Diseases

  • The Humoral Immune Defect In Congenital Agammaglobulinemia
  • Common Variable Immunodeficiency
  • X-linked Agammaglobulinemia
  • Wiskott-aldrich Syndrome
  • Severe Combined Immunodeficiencies

 

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Proper Dosage

Hizentra must be used according to doctors’ instructions.  Hizentra is administered subcutaneously through a needle that is positioned under the skin, it can be administered by a healthcare professional or self-administered after proper training.  

Hizentra must be administered in steady amounts. Individuals may utilize up to eight different infusion sites to infuse this medication in multiple body areas.

 

Avoiding Adverse Effects

  • The doctor or pharmacist will quantify the correct dosage based on the patient’s weight and response to treatment.
  • It is not advisable to change the dosage intervals without consulting their physician.
  • If a patient misses a dose, they can contact the doctor to modify the dosage plan.
  • If a patient overuses the dose, they should seek medical help.
  • Patients are advised against consuming large doses in a bid to achieve quicker effects. The consequences may be fatal.

 

Other Dosage and Usage Requirements

  • Do Not Use The Medication If It Is Cloudy Or Has Other Colors.
  • Do Not Use The Medication If There Are Particles In It.
  • Do Not Shake The Hizentra Vial Or Pre-filled Syringe.
  • Make Sure That You Do Not Infuse The Drug Into Your Vein.
  • Make Sure You Assemble The Hizentra Supplies Like Needles In A Clean Place.
  • Wash Your Hands Before And After Every Use.
  • Discard Any Unused Product And All Used Disposable Supplies After Each Infusion. 

 

 

 

Side Effects

hizentra Medical Staff Talks with IVIG Patient

Although not everyone will have to battle with these side effects, it’s important to look at them.

 

Reactions Around the Injection Site

  •   Rash
  •   Pain 
  •   Redness
  •   Swelling
  •   Itching
  •   Bruising

 

Other Side Effects

  • Headache
  • Flu-like symptoms
  • Hypertension
  • Pain  (including pain in the chest, back, joints, arms, legs)
  • Blood clot
  • Cough
  • Shortness of breath
  • Runny or stuffy nose 

 

Severe Side Effects

If the following side effects are observed, tell your doctor right away or go to the emergency room:

Signs Of A Bad Allergic Reaction

Hives, trouble breathing, wheezing, dizziness, or fainting

Signs Of A Kidney Problem

Reduced urination, sudden weight gain, or swelling in your legs

 

Signs Of A Blood Clot

  • Pain and/or swelling of an arm or leg with warmth over the affected area
  • Discoloration of an arm or leg
  • Unexplained shortness of breath, chest pain, or discomfort that worsens on deep breathing
  • Unexplained rapid pulse, or numbness or weakness on one side of the body

 

Signs Of Brain Swelling Called Meningitis

Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light

 

Signs Of A Blood Problem

Brown or red urine, fast heart rate, yellow skin or eyes.

 

Sign of an Infection

Fever over 100ºF

 

Seek a Doctors help if you have Chest pains or trouble breathing

 

The effects, as mentioned earlier, may occur after prolonged observation of immune globulin therapy. In rare cases, an ulcer may develop in the injection site. Your doctor can regulate the potential side effects if the dosage is taken properly. On the other hand, patients can also manage the effects by drinking a lot of water after the therapy.

Side effects that are not necessarily on the list may also surface. In such cases, the patients should seek medical help.

 

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Can Pregnant Women And Breastfeeding Mothers Take The Medication?

There are limited details to indicate any possible negative effects the medication may have on pregnant women and nursing mothers. It’s unknown whether Hizentra can pose a danger to the fetus or the woman’s reproductive organs.

Hizentra passes through the placenta increasingly after thirty weeks of gestation. It follows that the medication should be administered to pregnant women only if it is clearly needed. However, it must be taken with caution and with permission from a doctor.

You should also tell your doctor if you plan to get pregnant. The same approach also applies to breastfeeding mothers.

 

How Should This Medication Be Administered?

Self-administer Hizentra only after you have received adequate training from either a healthcare professional or a doctor. The infusion is typically carried out in subcutaneous zones like the thigh, lateral hip, belly, and upper arm.

 

Can Hizentra Be Given Intravenously (IV)?

HIZENTRA is manufactured to be infused under your skin only (subcutaneously). DO NOT inject HIZENTRA into a blood vessel (vein or artery).

 

Infusion Rate

The physician will determine the dose and infusion rate based on the patient’s needs and tolerability. The infusion is given using an infusion pump.

It follows that the dose and infusion rate should be administered as minimally as possible. Increasing dosage amounts should be done only if necessary. 

 

 

How Fast Does Hizentra Work?

The onset of action may vary for patients. A patient’s body weight, the quantity of the medication infused and many other factors may influence the duration time to take effect.  The median infusion time based on the clinical trials was about 1.5–2 hours for PI, and about 1 hour for CIDP.

 

Patients often begin to see results from their treatments by noticing better control of their symptoms or the disease progression has slowed.   During this time, your doctor will closely monitor and track to see if there are improvements in relieving the symptoms associated with your primary diagnosis.

 

Interactions

Drug Interactions

Some medications can impact how Hizentra works in the body. In any case, the medication may impair the effect of the co-used drugs. As such, it’s important to apply caution when using any of these drugs in order to avoid any negative interactions. 

The passive transfer of antibodies with immunoglobulin administration may interfere with the response to live virus vaccines such as:

  • Measles
  • Mumps
  • Rubella
  • Varicella

It’s important to give your doctor notice when using other prescriptions.

 

Disease Interactions

It’s Not Safe To Use Hizentra When You Have The Following Conditions:

  • Allergy To Hizentra Or Any Of Its Properties
  • Allergy To Polysorbate 80    
  • Blood Disease
  • Thrombosis
  • Dehydration
  • Renal Disease
  • Hyperprolinemia (Excessive Proline In The Body)

 

Other Contraindications

Hizentra may interact with specific blood tests and impair them for a certain time. 

Patients should inform their doctor about the therapy before any blood work.

 

Storage

When storing Hizentra, you need to take note of the following:

  • Make sure you keep the medication outside the vicinity of children and pets.
  • Make sure you do not use it after its expiration date indicated on the pack.
  • Do not store the medication above 77 degrees Fahrenheit. 
  • Protect from light and heat. Make sure to store the medicine in the original carton. 

.

Hizentra can be stored for as long as 30 months.

 

How Much Does Hizentra Cost?

Hizentra is expensive. However, the cost of this medication depends on various factors. They include the patient’s insurance status and coinsurance regulation. Other factors run from individual prescriptions to sickness insurance. For patients who do not have any insurance plans, the following table will provide an overview of the cost of Hizentra. Note that the prices are recognizable only in the U.S.

Size Per Unit Cost
5 ml 41.80 dollars 209.01 dollars
10 ml 40.85 dollars 408.52 dollars
20 ml 40.38 dollars 807.53 dollars
50 ml 40.09 dollars 2,004.58 dollars

 

 

Where Can Patients Obtain Hizentra?

Hizentra can be obtained from any reputable specialty pharmacy. It may also be purchased over the internet via online specialty pharmacies. However, buying from an online store may be quite risky because you could end up purchasing a low-quality or fake medication. 

To avoid this, it is best to buy from a licensed online pharmacy. AmeriPharma Specialty Care is a reliable and certified online pharmacy that sells Hizentra and other immune therapy medications. Not only that,  they help with e-diagnoses in cases where patients do not have prescriptions.

 

 

Co-pay Assistance

For patients who cannot afford the cost of Hizentra, there are co-pay assistance relief programs in place. Typically, these programs are committed to appropriating timely resources to ensure that patients can commence immune globulin therapy as soon as possible. 

They reduce financial burdens for patients and the members of their families.

Notable among the organizations that offer co-pay assistance for this medication is AmeriPharma Specialty Care. 

 

 

Sources

http://www.hizentra.com/pi

http://www.pmnewswire.com/news-releases/hizentra-immune-globulin-subcutaneous-human-20-liquid-label-update-provides-new-dosing-guidelines-for-physicians-allowing-for-greater-flexibility-in-treating-cidp-patients-301280065.html

http://www.medicines.org.uk/emc/product/4643/xpil/print#gref

European Medicines Agency. 2018. “An Overview of Hizentra and why it is authorized in the EU.” p.1

http://www.singlecare.com/prescription/hizentra/what-is

http://www.drugs.com/drug-interactions/immune-globulin-subcutaneous,hizentra.html

http://www.drugs.com/price-guide/hizentra

http://ameripharmaspecialty.com/ig-home-infusion

http://www.webmd.com/drugs/2/drug-153823/hizentra-subcutaneous/details

http://www.nps.org.au/medicine-finder-hizentra-vial

http://www.nps.org.au/medicine-finder/hizentra-vial#full-pi

 

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