Immune Globulin Subcutaneous (Human) - hipp - Indications and Contraindications

Overview:

Immune Globulin Subcutaneous (Human) - hipp, a treatment for primary immunodeficiency disease (PIDD). PIDD includes various disorders that affect the immune system's cells, tissues, and proteins. Immune Globulin Subcutaneous (Human) - hipp is the first 20 percent subcutaneous immunoglobulin (SCIg) approved by the FDA (Food and Drug Administration) for PIDD. Patients can self-administer it under a doctor's supervision after proper training. Studies have shown Immune Globulin Subcutaneous (Human) - hipp to be safe and effective for treating PIDD. However, it has not been studied in newborns or infants. When given weekly, SCIg maintains consistent IgG (immunoglobulin G) levels in the blood, with lower peaks and higher troughs compared to monthly intravenous (IV) treatment.

Available Doses and Dosage Forms:

Immune Globulin Subcutaneous (Human) - hipp is a liquid with 16.5 percent IgG, which means it has 165 milligrams of IgG per milliliter, and it is given as a shot under the skin.

For Patients:

What Is Primary Immunodeficiency Disease?

Primary immunodeficiency, also known as PIDD, is a collection of conditions that cause the immune system to not work properly. When the immune system does not function well, a person is more prone to getting sick from infections.

How Does Immune Globulin Subcutaneous (Human) - hipp Work?

Immune globulin is made up of antibodies, specifically IgG, which are natural substances found in human blood plasma. These antibodies play a crucial role in defending the body against infections and aiding in fighting off illnesses when a person becomes sick.

What Is the Dosage of Immune Globulin Subcutaneous (Human) - hipp?

• The amount of Immune Globulin Subcutaneous (Human) - hipp needed by a person will vary depending on their condition and how strong the medicine is. The doctor will give them specific instructions on how much to take.

• The dose is based on the IgG level in the blood of adults and children two years of age and older, and the doctor may adjust the dose if needed.

• If a person is using this medicine for primary humoral immunodeficiency, they must have already been receiving IGIV treatment regularly for at least three months before starting this medicine.

• If the children are under two years old, their doctor will determine the appropriate dose for them.

What Are the Things to Inform the Doctor Before Taking the Immune Globulin Subcutaneous (Human) - hipp?

• Before deciding to use Immune Globulin Subcutaneous (Human) - hipp, the individual and their doctor need to consider its risks and benefits.

• Let the doctor know if the person has ever had any unusual or allergic reaction to Immune Globulin Subcutaneous (Human) -hipp or any other medication. Also, inform them about other allergies, such as to foods, dyes, preservatives, or animals. If the person is using over-the-counter products, read the labels carefully.

• For children under two years old, the safety and effectiveness of this medication have not been established.

• While there have not been specific problems noted in older adults, they may have age-related health issues that require caution and possibly a dose adjustment.

• There have not been enough studies to determine the risks of the medicine on breastfeeding infants. Consider the potential benefits and risks before using it while breastfeeding.

How Is Immune Globulin Subcutaneous (Human) - hipp Administered?

Immune Globulin Subcutaneous (Human) - hipp should only be injected under the skin. Before switching to Immune Globulin Subcutaneous (Human) - hipp, doctors should check the patient's blood IgG level to help decide the right dose. Here is how to figure out the dose:

• If switching from another IV immune globulin, use a conversion factor.

• If switching from another subcutaneous immune globulin, stick with the same dose.

• If using weekly then start Immune Globulin Subcutaneous (Human) - hipp a week after the last IV infusion. The initial weekly dose is calculated based on the previous IV dose.

• If using every other week then start Immune Globulin Subcutaneous (Human) - hipp one or two weeks after the last IV dose, or one week after the last subcutaneous dose. Use double the calculated weekly dose.

• If using more than once a week then start Immune Globulin Subcutaneous (Human) - hipp a week after the last IV or subcutaneous dose. Divide the weekly dose by how many times it is injected for each week.

• Adjust the dose based on how the patient's body processes the medicine and how they are responding to treatment.

What Are the Side Effects of Immune Globulin Subcutaneous (Human) - hipp?

The most common side effects of Immune Globulin Subcutaneous (Human) - hipp were:

• Reactions at the site where the medicine is injected (like redness, swelling, and itching).

• Headaches.

• Fever.

• Skin irritation.

• Asthma symptoms.

• Diarrhea.

• Coughing.

Missed Dose:It is important to stick to the treatment schedule with Immune Globulin Subcutaneous (Human) - hipp. If the person misses a dose or forgets to take it, they should get in touch with their doctor or pharmacist to find out what they should do next.

Storage:

• Immune Globulin Subcutaneous (Human) - hipp comes in single-use vials of different sizes, ranging from one to eight grams. The packaging materials do not contain natural rubber latex.

• Store Immune Globulin Subcutaneous (Human) - hipp between two degrees Celsius to eight degrees Celsius (36 degrees Fahrenheit to 46 degrees Fahrenheit) for up to 36 months from the manufacturing date. If needed, it can be kept at room temperature (up to 25 degrees Celsius or 77 degrees Fahrenheit) for up to six months, but do not refrigerate it again after that.

• Always keep the vial in its outer carton to protect it from light and check the expiration date before using. Never freeze it or mix it with other products. Also, avoid shaking the vial.

• Use sterile techniques when preparing and administering Immune Globulin Subcutaneous (Human) - hipp. Before use, check each vial for any particles in the solution. If it looks cloudy or contains particles, do not use it.

• Each vial is for single-use only, so discard any leftover product after each infusion as per local guidelines.

For Doctors:

Indication:Immune Globulin Subcutaneous (Human) - hippis a medicine that contains 16.5 percent of immune globulin and is given as a shot under the skin. It is used to treat a condition called primary humoral immunodeficiency (PI) in adults and children who are two years old or older. This includes various conditions like common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies, among others.

Dose and Dosing Considerations:Give Immune Globulin Subcutaneous (Human) - hipp regularly, from once a day up to once every two weeks. Patients can slowly increase the speed and amount of the infusion every few weeks as long as they can handle it. Here are some guidelines:

• For the first two infusions, use a certain amount of solution.

• After that, the patient can increase the amount gradually over time.

• For adults 17 years and older, start with up to 25 mL (milliliter) at each infusion site and gradually increase by about 10 mL every few weeks, up to a maximum of 40 mL.

• For kids seven to 17 years old, start with up to 15 mL at each site and increase by about five to 10 mL.

• An individual can use up to six different sites for the infusion, with at least two inches between each site. Change the site each time when the medicine is given.

What Are the Pharmacological Aspects of Immune Globulin Subcutaneous (Human) - hipp?

• Pharmacodynamics: Immune Globulin Subcutaneous (Human) - hipp mainly consists of IgG antibodies that can fight against many different types of infections, similar to what is found in the general population. It is made from pooled material from at least 1000 donors, and the distribution of IgG subclasses is similar to what is naturally found in human blood. Giving enough Immune Globulin Subcutaneous (Human) - hipp can bring low IgG levels back to normal. However, there have not been specific studies done to understand exactly how it works in the body.

• Mechanism of Action: Immune Globulin Subcutaneous (Human) - hipp contains a diverse range of antibodies that can help fight off many different types of bacteria and viruses. It closely resembles the distribution of antibodies found naturally in human blood. Although there is no evidence on how it works in primary humoral immunodeficiency (PI), giving enough of it can bring low levels of immune globulin G back to normal, which helps the body fight infections better.

• Pharmacokinetics: In a study with 37 participants (18 adults and 19 children), blood samples were taken before and after receiving Immune Globulin Subcutaneous (Human) - hipp through either IV or SC (subcutaneous) methods. The goal was to compare the amount of medicine absorbed into the body with each method. The results showed that SC delivery provided similar exposure to IV delivery. Serum IgG levels stayed steady during SC treatment, with slightly higher levels than IV treatment. Using Immune Globulin Subcutaneous (Human) - hipp every other week at double the weekly dose is expected to have similar IgG exposure compared to weekly dosing. Similarly, giving Immune Globulin Subcutaneous (Human) - hipp more frequently (two, three, five, or seven times a week) with the same total dose is expected to have similar IgG exposure as weekly dosing.

Toxicity:

• Carcinogenesis, Mutagenesis, Impairment of Fertility: No animal studies were done to see if Immune Globulin Subcutaneous (Human) - hipp causes cancer, genetic mutations, or affects fertility.

• Animal Toxicology and/or Pharmacology: Immune Globulin Subcutaneous (Human) - hipp was tested in various standard animal studies to check for safety. When given to mice with Streptococcus pneumoniae, it helped improve survival rates. Trace amounts of TNBP and Octoxynol may be in Immune Globulin Subcutaneous (Human) - hipp, but studies in animals and labs showed they were not harmful to genes, did not cause mutations, and did not affect fetal development when given to pregnant animals.

Clinical Studies:Two clinical studies were conducted to evaluate Immune Globulin Subcutaneous (Human) - hipp in patients with primary humoral immunodeficiency (PI). The first study involved 75 subjects (37 adults and 38 children) who received weekly injections of Immune Globulin Subcutaneous (Human) - hipp for a 12 week period followed by a year-long evaluation. The study aimed to assess the effectiveness, safety, and tolerability of Immune Globulin Subcutaneous (Human) - hipp. No serious bacterial infections were reported during this study. The second study involved 27 patients (17 adults and 10 children) with PI. They received Immune Globulin Subcutaneous (Human) - hipp injections either weekly or every other week. The main goal of this study was to evaluate the long-term safety and tolerability of Immune Globulin Subcutaneous (Human) - hipp. Only one adult experienced a serious bacterial infection during this study. Overall, both studies showed promising results in terms of preventing serious bacterial infections and reducing the need for antibiotics and hospitalizations among patients with PI.

What Are the Contraindications of Immune Globulin Subcutaneous (Human) - hipp?

People who have had a very serious allergic reaction to human immune globulin or any parts of Immune Globulin Subcutaneous (Human) - hipp, like Polysorbate 80, should not use it. This also applies to patients who lack IgA antibodies and have a history of being sensitive to them.

Warnings and Precautions:Immune Globulin Subcutaneous (Human) - hipp can cause severe allergic reactions and anaphylaxis. People who lack IgA antibodies and have antibodies against IgA are at a higher risk of these reactions.

• Blood clots may happen with Immune Globulin Subcutaneous (Human) - hipp.

• Blood sugar readings might be falsely high during and after using Immune Globulin Subcutaneous (Human) - hipp with certain glucose testing systems.

• Aseptic meningitis syndrome may occur within two days of treatment.

• Keep an eye on patients for signs of kidney problems, such as changes in urine output, and watch for signs of hemolysis (when red blood cells break down).

• Watch out for lung problems like transfusion-related acute lung injury.

• Since Immune Globulin Subcutaneous (Human) - hipp is made from human blood plasma, there's a slight risk of passing on infections like viruses or variant Creutzfeldt-Jakob disease (vCJD), though this risk is very low.

What Are the Drug Interactions of Immune Globulin Subcutaneous (Human) - hipp?

The antibodies are passed on through immunoglobulin treatments like Immune Globulin Subcutaneous (Human) - hipp might affect the results of certain blood tests. Additionally, they could interfere with the body's response to live virus vaccines such as those for measles, mumps, rubella, and chickenpox. In case a person recently had Immune Globulin Subcutaneous (Human) - hipp shot, they should inform the doctors giving the vaccine, so the doctors can take the necessary precautions.

Specific Considerations:

• Pregnancy: There is no data on whether Immune Globulin Subcutaneous (Human) - hipp can harm a fetus when given to a pregnant woman. However, it is known that immune globulins, like Immune Globulin Subcutaneous (Human) - hipp, can pass from the mother to the baby more as the pregnancy progresses. In the general population, the risk of birth defects and miscarriage is about two to four percent and 15 to 20 percent, respectively.

• Lactation: There is no data on whether Immune Globulin Subcutaneous (Human) - hipp can harm a breastfeeding baby. Doctors should consider the benefits of breastfeeding along with the mother's need for Immune Globulin Subcutaneous (Human) - hipp and any potential risks.

• Pediatric Use: Immune Globulin Subcutaneous (Human) - hipp is safe and effective for children aged two to 17 with primary humoral immunodeficiency. Studies showed similar results in children and adults, but adults had more infusion site reactions. Pediatric patients did not need different doses from adults to reach the desired IgG levels. However, it is not approved for children under two.

• Geriatric Use: There is not enough data to know if older adults respond differently to Immune Globulin Subcutaneous (Human) - hipp. Doctors should be cautious when dosing elderly patients and may start with lower doses to reduce the risk of certain adverse reactions, especially if they have other health issues or are taking other medications.