Hizentra 10gm/50ml Inj, 50ml
WARNING: There is a chance of blood clots with this drug. The chance is raised in older people and in people with thick blood, heart problems, or a history of blood clots. The chance may also be higher if you must be in a bed or chair for some time, if you take estrogen, or if you use certain catheters. However, blood clots can happen even if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. @ COMMON USES: It is used to help prevent infections or make infections less severe in people with a weak immune system.It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunoglobulin
Pharmacologic Class
Immune Globulin (Human), Subcutaneous
Pregnancy Category
Category C
FDA Approved
Sep 2010
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hizentra is a medicine made from human blood plasma that contains antibodies. It is used to replace missing antibodies in people who have a weakened immune system (primary immunodeficiency) to help fight off infections. It is given as an injection under the skin (subcutaneous).
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion under the skin over a period of time. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before using this medication, wash your hands thoroughly. Do not shake the solution. If the medication has been stored in the refrigerator, allow it to reach room temperature before use. Do not heat the medication.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use it if the solution has changed color or has been frozen. Do not mix this medication with any other liquid medications. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Injection Site Rotation
Rotate the injection site as directed by your doctor to minimize the risk of skin irritation.
Disposal of Used Needles
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions carefully and read the package insert that comes with this medication. If you have questions about storage, consult your pharmacist.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion under the skin over a period of time. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before using this medication, wash your hands thoroughly. Do not shake the solution. If the medication has been stored in the refrigerator, allow it to reach room temperature before use. Do not heat the medication.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use it if the solution has changed color or has been frozen. Do not mix this medication with any other liquid medications. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Injection Site Rotation
Rotate the injection site as directed by your doctor to minimize the risk of skin irritation.
Disposal of Used Needles
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions carefully and read the package insert that comes with this medication. If you have questions about storage, consult your pharmacist.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Learn proper self-administration technique from a healthcare professional, including sterile technique, site rotation, and proper disposal of supplies.
- Maintain a regular administration schedule as prescribed by your doctor.
- Keep a record of your infusions, including date, time, dose, and injection sites.
- Stay hydrated, especially before and during infusions.
- Report any new or worsening symptoms to your healthcare provider promptly.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on prior IVIG/SCIG dose or patient weight. Weekly or bi-weekly administration. Initial dose for patients naive to IG therapy: 0.6 to 1.2 mL/kg (60 to 120 mg/kg) per week. Maintenance dose: Adjust to achieve desired clinical response and IgG trough levels.
Condition-Specific Dosing:
primary_immunodeficiency:
Initial dose: 0.6 to 1.2 mL/kg (60 to 120 mg/kg) per week. Maintenance dose: Adjust to achieve desired clinical response and IgG trough levels, typically 0.6 to 2.4 mL/kg (60 to 240 mg/kg) per week, administered weekly or bi-weekly. For patients switching from IVIG, the initial weekly Hizentra dose is calculated by dividing the monthly IVIG dose by 4.33.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adults. Safety and efficacy established in pediatric patients 2 years of age and older.
Child:
Dosing is weight-based, similar to adults. Safety and efficacy established in pediatric patients 2 years of age and older.
Adolescent:
Dosing is weight-based, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor renal function.
Moderate:
No specific dose adjustment recommended, but monitor renal function. Caution advised due to potential for renal dysfunction with immune globulins, though less common with SCIG.
Severe:
No specific dose adjustment recommended, but monitor renal function. Caution advised due to potential for renal dysfunction with immune globulins, though less common with SCIG.
Dialysis:
Not specifically studied; monitor IgG levels and clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Hizentra provides a broad spectrum of IgG antibodies that are present in normal human plasma. It replaces missing or deficient IgG antibodies in patients with primary immunodeficiency (PI), thereby reducing the frequency and severity of infections. The antibodies exert their therapeutic effect by binding to and neutralizing pathogens and toxins, and by modulating immune responses.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 69% (relative to IVIG) for total IgG, but the rate of absorption is slower, leading to more sustained serum IgG levels.
Tmax:
Approximately 5 days (range: 2-7 days) after subcutaneous administration.
FoodEffect:
Not applicable (administered subcutaneously).
Distribution:
Vd:
Similar to endogenous IgG, distributing between plasma and extravascular fluid compartments.
ProteinBinding:
Not applicable (it is a protein itself).
CnssPenetration:
Limited (IgG generally has limited penetration into the intact central nervous system).
Elimination:
HalfLife:
Approximately 26 days (range: 18-46 days), similar to endogenous IgG.
Clearance:
Variable, dependent on individual patient catabolism rates.
ExcretionRoute:
Primarily intracellular catabolism; no specific excretion route.
Unchanged:
Not applicable (it is catabolized).
Pharmacodynamics
OnsetOfAction:
Gradual, with steady-state IgG levels typically achieved after 4-6 weeks of regular weekly or bi-weekly administration.
PeakEffect:
Steady-state trough levels are maintained with regular dosing.
DurationOfAction:
Weekly or bi-weekly administration maintains therapeutic IgG levels.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Seizures
Bloating
Confusion
Swelling
Abnormal heartbeat
Mood changes
Muscle or joint pain
Changes in speech or eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes
Serious Lung Problems and Brain Inflammation
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
Trouble breathing
Shortness of breath
New or worsening cough
Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, seek medical help right away:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasms
Signs of a common cold
Flushing
* Cramps
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Seizures
Bloating
Confusion
Swelling
Abnormal heartbeat
Mood changes
Muscle or joint pain
Changes in speech or eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes
Serious Lung Problems and Brain Inflammation
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
Trouble breathing
Shortness of breath
New or worsening cough
Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, seek medical help right away:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasms
Signs of a common cold
Flushing
* Cramps
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction: difficulty breathing, wheezing, hives, rash, swelling of the face/lips/tongue, dizziness, fainting.
- Signs of infection: fever, chills, persistent pain, redness, or swelling at injection sites, unusual fatigue.
- Signs of blood clots: pain, swelling, warmth, or discoloration in an arm or leg; sudden shortness of breath; chest pain; severe headache.
- Signs of kidney problems: decreased urination, unusual swelling, sudden weight gain.
- Signs of aseptic meningitis syndrome (AMS): severe headache, stiff neck, sensitivity to light, nausea, vomiting, fever.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), an antibody that plays a key role in your immune system.
If you have hyperprolinemia, a condition characterized by elevated levels of proline in your blood.
If you have excess fluid in your body (overhydration) or have been advised to monitor your fluid intake.
* If you have low platelet levels (thrombocytopenia), a condition that may increase your risk of bleeding.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), an antibody that plays a key role in your immune system.
If you have hyperprolinemia, a condition characterized by elevated levels of proline in your blood.
If you have excess fluid in your body (overhydration) or have been advised to monitor your fluid intake.
* If you have low platelet levels (thrombocytopenia), a condition that may increase your risk of bleeding.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, consult your doctor, as some products may contain latex.
Before receiving any vaccinations, discuss the potential risks with your doctor, as certain vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Be aware that this medication may interfere with the accuracy of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you have a weakened immune system and have been exposed to measles, consult your doctor to discuss the potential risks. This medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, it may still pose a risk of transmitting diseases. Discuss this risk with your doctor.
Some products contain maltose, which can affect the accuracy of certain glucose tests, potentially leading to incorrect treatment of high or low blood sugar, resulting in severe and long-lasting consequences, including death. Consult your doctor to determine the most suitable blood sugar tests to use.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
Before receiving any vaccinations, discuss the potential risks with your doctor, as certain vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Be aware that this medication may interfere with the accuracy of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you have a weakened immune system and have been exposed to measles, consult your doctor to discuss the potential risks. This medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, it may still pose a risk of transmitting diseases. Discuss this risk with your doctor.
Some products contain maltose, which can affect the accuracy of certain glucose tests, potentially leading to incorrect treatment of high or low blood sugar, resulting in severe and long-lasting consequences, including death. Consult your doctor to determine the most suitable blood sugar tests to use.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While acute overdose is unlikely due to the nature of the product and administration route, very high doses could theoretically lead to fluid overload or hyperviscosity, especially in susceptible patients.
What to Do:
In case of suspected overdose, contact a healthcare professional or poison control center immediately (e.g., Call 1-800-222-1222). Management is supportive, focusing on fluid balance and monitoring for adverse effects.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella): Immune globulins may impair the efficacy of live attenuated virus vaccines. Vaccination with live virus vaccines should be deferred for at least 3 months after Hizentra administration. Revaccination may be necessary if administered within 14 days of vaccination.
Monitoring
Baseline Monitoring
Serum IgG trough levels
Rationale: To establish baseline and guide initial dosing, especially when switching from IVIG or another SCIG product.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal status, especially in patients with pre-existing renal impairment or risk factors for renal dysfunction.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum IgG trough levels
Frequency: Initially after 2-3 months of therapy, then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Individualized, typically aiming for levels that prevent serious infections (e.g., >500-700 mg/dL, or higher based on patient response).
Action Threshold: If trough levels are consistently below target or if patient experiences recurrent infections, consider dose adjustment.
Signs and symptoms of infection
Frequency: Continuously by patient/caregiver and at each clinical visit.
Target: Absence of recurrent or severe infections.
Action Threshold: Recurrent infections may indicate inadequate dosing or need for further evaluation.
Injection site reactions
Frequency: With each administration and at clinical visits.
Target: Minimal or no local reactions.
Action Threshold: Severe or persistent reactions may require site rotation, slower infusion, or re-evaluation of therapy.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with risk factors for renal dysfunction.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant increase may warrant further investigation and dose adjustment if related to therapy (rare with SCIG).
Symptom Monitoring
- Signs of allergic or anaphylactic reactions (e.g., hives, generalized urticaria, tightness of the chest, wheezing, hypotension, dyspnea, syncope)
- Signs of infection (e.g., fever, chills, malaise, localized pain, swelling, redness)
- Injection site reactions (e.g., pain, redness, swelling, itching, bruising, warmth, nodule formation)
- Signs of thrombosis (e.g., pain, swelling, discoloration of an extremity, shortness of breath, chest pain, abdominal pain)
- Signs of aseptic meningitis syndrome (AMS) (e.g., severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, vomiting)
Special Patient Groups
Pregnancy
Hizentra is classified as Pregnancy Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly in the third trimester. Clinical experience with immune globulins suggests no harmful effects on the course of pregnancy, fetus, or neonate. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk as IgG transfer is minimal.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Significant transfer of maternal IgG to the fetus occurs, which may provide passive immunity to the neonate. No known adverse effects on the fetus or neonate from maternal use.
Lactation
Immune globulins are naturally present in human milk. No adverse effects on the breastfed infant are expected. Considered compatible with breastfeeding.
Infant Risk:
L2 - Safer. Drug shown to have no increase in adverse effects in infants.
Pediatric Use
Safety and efficacy have been established in pediatric patients 2 years of age and older for primary immunodeficiency. Dosing is weight-based. No specific dose adjustments are typically needed compared to adults, but careful monitoring of IgG levels and clinical response is important.
Geriatric Use
No specific dose adjustments are required for elderly patients. However, caution should be exercised in patients with pre-existing cardiovascular or renal risk factors, as these conditions may be more prevalent in the elderly. Monitor for signs of thrombosis or renal dysfunction.
Clinical Information
Clinical Pearls
- Hizentra is for subcutaneous administration only; do NOT administer intravenously.
- Rotate injection sites to minimize local reactions. Common sites include abdomen, thigh, upper arm, and lateral hip.
- Infusion rates should be slow initially and gradually increased as tolerated. Multiple injection sites can be used simultaneously to accommodate larger volumes.
- Patients should be trained by a healthcare professional on proper self-administration techniques, including aseptic preparation and injection.
- Ensure adequate hydration before and during administration to reduce the risk of adverse reactions.
- Patients should carry an emergency identification card stating they are receiving immune globulin therapy.
Alternative Therapies
- Other subcutaneous immune globulin (SCIG) products (e.g., Cuvitru, Xembify, HyQvia, Gamunex-C/Gammaked for SC use)
- Intravenous immune globulin (IVIG) products (e.g., Gammagard Liquid, Gamunex-C, Octagam, Privigen, Flebogamma, Panzyga)
- For primary immunodeficiency, other treatments are generally not considered direct alternatives to immunoglobulin replacement therapy.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month depending on dose and patient weight. per 10gm/50ml vial
Insurance Coverage:
Specialty drug, typically covered under the medical benefit (Part B for Medicare) or pharmacy benefit for commercial plans. Requires prior authorization and often patient-specific dosing justification.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.