Hizentra 4gm/20ml Inj, 20ml
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 plasma that contains antibodies (proteins that fight infections). It is used to help people whose bodies don't make enough of their own antibodies (like in primary immunodeficiency) or to help reduce nerve damage and improve muscle strength in certain nerve conditions (like chronic inflammatory demyelinating polyneuropathy). It is given as an injection under the skin (subcutaneously).
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 are 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. Rotate the injection site as directed by your doctor.
Disposal of Used Needles and Supplies
Dispose of used needles and other sharp objects 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 are 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. Rotate the injection site as directed by your doctor.
Disposal of Used Needles and Supplies
Dispose of used needles and other sharp objects 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
- Maintain adequate hydration before, during, and after administration to reduce the risk of adverse reactions, especially if you have kidney problems or are at risk for blood clots.
- Follow your healthcare provider's instructions for proper injection technique and site rotation to minimize local reactions.
- Keep a record of your injections, including date, time, dose, and injection sites.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's previous IVIG dose or body weight, and clinical response. Typically 100-200 mg/kg/week, administered weekly or bi-weekly. Dose adjustments are made to achieve desired IgG trough levels and clinical efficacy.
Condition-Specific Dosing:
Primary Immunodeficiency (PI):
Initial dose based on previous IVIG dose or calculated from body weight (e.g., 1.37 x prior IVIG dose in grams, divided by weekly frequency). Maintenance dose adjusted to achieve desired IgG trough levels and clinical response.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):
Initial dose of 0.2 g/kg weekly for 2-4 weeks, then maintenance dose of 0.2-0.4 g/kg weekly, adjusted based on clinical response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is individualized, similar to adults, based on body weight and clinical response for PI. Safety and efficacy in pediatric patients with CIDP have not been established.
Child:
Dosing is individualized, similar to adults, based on body weight and clinical response for PI. Safety and efficacy in pediatric patients with CIDP have not been established.
Adolescent:
Dosing is individualized, similar to adults, based on body weight and clinical response for PI and CIDP.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but monitor renal function.
Moderate:
No specific dose adjustment required, but monitor renal function. Use with caution in patients with pre-existing renal impairment.
Severe:
No specific dose adjustment required, but monitor renal function. Use with caution in patients with pre-existing renal impairment.
Dialysis:
Considerations: Not removed by dialysis. Monitor fluid status and renal function. Use with caution due to potential for acute renal dysfunction, though less common with SCIG than IVIG.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Hizentra provides passive immunity by increasing the circulating levels of IgG antibodies. It replaces missing or deficient IgG antibodies in patients with primary immunodeficiency (PI) and exerts immunomodulatory effects in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The exact mechanism of action in CIDP is not fully understood but is thought to involve modulation of immune responses.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 69% (compared to intravenous administration)
Tmax:
3 to 7 days (after subcutaneous administration)
FoodEffect:
Not applicable (administered subcutaneously)
Distribution:
Vd:
Approximately 7.5 L (similar to plasma volume)
ProteinBinding:
Not applicable (it is a protein itself)
CnssPenetration:
Limited (IgG crosses the blood-brain barrier to a limited extent)
Elimination:
HalfLife:
Approximately 20 to 30 days (highly variable among individuals)
Clearance:
Not readily quantifiable as a single rate due to complex catabolism; clearance is inversely proportional to serum IgG concentration.
ExcretionRoute:
Catabolized into amino acids and peptides, primarily eliminated via cellular degradation.
Unchanged:
Not applicable (it is a protein that is catabolized)
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow subcutaneous absorption, steady-state levels typically reached after 5-6 doses)
PeakEffect:
Not a distinct peak effect like small molecules; rather, it maintains steady-state IgG levels.
DurationOfAction:
Maintains therapeutic IgG levels for the duration of the dosing interval (e.g., 1 week or 2 weeks)
Confidence:
Medium
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 medical attention immediately:
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
Changes in eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes
Severe Lung Problems and Brain Inflammation
This medication may cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
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 attention immediately:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused
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 medical attention immediately:
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
Changes in eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes
Severe Lung Problems and Brain Inflammation
This medication may cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
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 attention immediately:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused
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, or throat, sudden dizziness or lightheadedness.
- Signs of a blood clot: pain, swelling, warmth, or redness in an arm or leg; shortness of breath, chest pain, rapid heart rate.
- Signs of kidney problems: decreased urine output, sudden weight gain, swelling in your legs or feet.
- Signs of aseptic meningitis syndrome: severe headache, neck stiffness, fever, sensitivity to light, nausea, vomiting.
- Signs of hemolytic anemia: unusual tiredness, pale skin, dark urine, yellowing of the skin or eyes.
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, including any symptoms that occurred.
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 can increase your risk of bleeding.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
* Any existing health problems or conditions
Your doctor will assess this information to determine if it is safe for you to take this medication with your other drugs and health conditions. Do not start, stop, or change the dose of any medication without first consulting 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, including any symptoms that occurred.
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 can increase your risk of bleeding.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
* Any existing health problems or conditions
Your doctor will assess this information to determine if it is safe for you to take this medication with your other drugs and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 with 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.
Regular blood tests and laboratory evaluations, as directed by your doctor, are crucial to monitor your condition. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
If you have a weakened immune system and have been exposed to measles, consult with your doctor to discuss the potential risks. It is also important to note that this medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease.
Some products may contain maltose, which can interfere with certain glucose tests, potentially leading to false results. This can have serious consequences, including long-term effects or even death, when treating high or low blood sugar levels. Therefore, it is crucial to discuss with your doctor which blood sugar tests are most suitable for you.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, if you are pregnant, planning to become pregnant, or breastfeeding, consult with 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.
Regular blood tests and laboratory evaluations, as directed by your doctor, are crucial to monitor your condition. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
If you have a weakened immune system and have been exposed to measles, consult with your doctor to discuss the potential risks. It is also important to note that this medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease.
Some products may contain maltose, which can interfere with certain glucose tests, potentially leading to false results. This can have serious consequences, including long-term effects or even death, when treating high or low blood sugar levels. Therefore, it is crucial to discuss with your doctor which blood sugar tests are most suitable for you.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, if you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Fluid overload (e.g., shortness of breath, swelling)
- Hyperviscosity (e.g., headache, dizziness, visual disturbances)
- Increased risk of adverse events
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is supportive, focusing on fluid management and monitoring for complications. Call 1-800-222-1222 for poison control.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella, rotavirus): May interfere with the immune response to live virus vaccines. Vaccination with live virus vaccines should be deferred for at least 3 months after Hizentra administration. For measles, the interval may be up to 11 months depending on the dose of immune globulin.
Monitoring
Baseline Monitoring
Serum IgG trough levels
Rationale: To establish baseline and guide initial dosing, especially when transitioning from IVIG, and to ensure adequate therapeutic levels.
Timing: Prior to initiation of therapy.
Renal function (BUN, serum creatinine)
Rationale: To assess baseline renal status, especially in patients with pre-existing renal impairment, as acute renal dysfunction can occur with IG products (though less common with SCIG).
Timing: Prior to initiation of therapy.
Hydration status
Rationale: To ensure adequate hydration before and during therapy, especially in patients at risk for renal dysfunction or thrombosis.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess for baseline hematologic abnormalities, as hemolytic anemia can occur.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (e.g., frequency of infections for PI, neurological symptoms for CIDP)
Frequency: Regularly, at each follow-up visit.
Target: Reduction in infection rate, improvement in neurological function.
Action Threshold: Lack of clinical improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Serum IgG trough levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated) after steady-state is achieved.
Target: Individualized, typically >500-700 mg/dL for PI, or as determined by clinical response for CIDP.
Action Threshold: Consistently low trough levels or inadequate clinical response may warrant dose increase.
Signs and symptoms of adverse reactions (e.g., infusion site reactions, systemic reactions, signs of thrombosis, renal dysfunction, hypersensitivity)
Frequency: During and after each administration, and at follow-up visits.
Target: Absence of severe reactions.
Action Threshold: Occurrence of severe reactions requires immediate medical attention and potential discontinuation or modification of therapy.
Symptom Monitoring
- Infusion site reactions (pain, redness, swelling, itching, bruising)
- Systemic reactions (headache, fatigue, fever, chills, nausea, vomiting, dizziness)
- Signs of hypersensitivity/anaphylaxis (hives, rash, difficulty breathing, wheezing, swelling of face/lips/tongue/throat, sudden drop in blood pressure)
- Signs of thrombosis (pain, swelling, warmth, redness in an arm or leg; shortness of breath, chest pain, rapid heart rate)
- Signs of renal dysfunction (decreased urine output, sudden weight gain, swelling)
- Signs of aseptic meningitis syndrome (severe headache, neck stiffness, fever, photophobia, nausea, vomiting)
- Signs of hemolytic anemia (fatigue, pallor, dark urine, jaundice)
Special Patient Groups
Pregnancy
Immune globulins, including Hizentra, are known to cross the placenta, particularly during the third trimester. Clinical experience with immune globulins suggests that no adverse effects on the course of pregnancy, the fetus, or the neonate are to be expected. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk; IgG transfer is minimal.
Second Trimester:
Low risk; increasing IgG transfer.
Third Trimester:
Low risk; significant IgG transfer, providing passive immunity to the neonate.
Lactation
Immune globulins are naturally present in human milk. No adverse effects on the breastfed infant are expected. Considered compatible with breastfeeding.
Infant Risk:
Low risk; provides passive immunity to the infant.
Pediatric Use
Hizentra is approved for use in pediatric patients 2 years of age and older with PI. Safety and efficacy in pediatric patients with CIDP have not been established. Dosing is individualized based on body weight and clinical response. Close monitoring for adverse reactions is important.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, caution should be exercised in elderly patients with pre-existing cardiovascular risk factors, renal impairment, or diabetes due to the increased risk of thrombosis and acute renal dysfunction with immune globulin products. Monitor hydration status and renal function closely.
Clinical Information
Clinical Pearls
- Hizentra is for subcutaneous administration only. Do NOT administer intravenously.
- Patients should be trained by a healthcare professional on proper subcutaneous administration technique, including aseptic technique, injection site rotation, and proper disposal of supplies.
- Rotate injection sites (e.g., abdomen, thigh, upper arm) to minimize local reactions. Do not inject into areas where the skin is tender, bruised, red, or hard.
- Multiple injection sites can be used simultaneously to administer larger volumes or to reduce injection time.
- Ensure adequate hydration before and during administration, especially in patients at risk for renal dysfunction or thrombosis.
- Pre-medication is generally not required for subcutaneous immune globulin administration, unlike some intravenous formulations.
- Patients should carry an emergency medical identification card or wear a medical alert bracelet indicating their condition and treatment.
Alternative Therapies
- Other Subcutaneous Immune Globulin (SCIG) products: Cuvitru (Immune Globulin Infusion 20% (Human)), Xembify (Immune Globulin Infusion 20% (Human)), Gamunex-C (Immune Globulin Injection 10% (Human), used off-label SC), HyQvia (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase)
- Intravenous Immune Globulin (IVIG) products: Gammagard Liquid, Privigen, Octagam, Gamunex-C, Flebogamma DIF, Panzyga (various concentrations and brands available)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month depending on dose and frequency. per 20ml vial (4gm)
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by medical benefit)
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 emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.