Hizentra 1gm/5ml Inj, 5ml

Manufacturer CSL BEHRING Active Ingredient Immune Globulin Injection (Subcutaneous)(i MYUN GLOB yoo lin) Pronunciation Hye-ZEN-trah (Immune Globulin: ih-MYUN GLOB-yoo-lin)
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)
🀰
Pregnancy Category
Category C
βœ…
FDA Approved
Sep 2010
βš–οΈ
DEA Schedule
Not Controlled

Overview

ℹ️

What is this medicine?

Hizentra is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It is used to help people with certain immune system problems (like primary immunodeficiency) fight off infections, or to treat a nerve disorder called chronic inflammatory demyelinating polyneuropathy (CIDP). It is given as an injection under the skin (subcutaneously), usually by the patient or a caregiver at home.
πŸ“‹

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

Do not shake the solution before use.
Wash your hands before and after handling the medication.
If the medication has been stored in the refrigerator, allow it to reach room temperature before use. Do not heat the medication.
Inspect the solution before use: do not use if it is cloudy, leaking, or contains particles, or if the color has changed. Also, do not use if the medication 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

Dispose of used needles and syringes in a puncture-proof container, such as a needle/sharp disposal box. Do not reuse needles or other items.
When the container is full, follow local regulations for disposal.

Storage

Follow the storage instructions provided with the medication. Read the package insert for specific guidance.
If you have questions about storing this medication, consult your pharmacist.

Missed Dose

If you miss a dose, contact your doctor for instructions on what to do next.
πŸ’‘

Lifestyle & Tips

  • Maintain good hydration, especially before and during treatment.
  • Follow proper injection technique as instructed by your healthcare provider.
  • Rotate injection sites to prevent skin irritation.
  • Keep a diary of your injections, including date, time, dose, and injection sites.
  • Report any new or worsening symptoms to your doctor immediately.

Dosing & Administration

πŸ‘¨β€βš•οΈ

Adult Dosing

Standard Dose: Individualized based on patient's previous IVIG dose or clinical response. For Primary Immunodeficiency (PID): Initial weekly dose is 1.37 times the previous weekly IVIG dose. For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Initial loading dose of 0.2 g/kg (200 mg/kg) administered daily for 2 to 5 consecutive days, followed by a maintenance dose of 0.2 to 0.4 g/kg (200 to 400 mg/kg) administered weekly.
Dose Range: 100 - 400 mg

Condition-Specific Dosing:

Primary Immunodeficiency (PID): Initial weekly dose is 1.37 times the previous weekly IVIG dose. Subsequent doses adjusted to achieve desired IgG trough levels and clinical response, typically 100-200 mg/kg/week.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose: 0.2 g/kg daily for 2-5 days. Maintenance: 0.2-0.4 g/kg weekly.
πŸ‘Ά

Pediatric Dosing

Neonatal: Not established
Infant: Dosing for PID is individualized, similar to adults, based on previous IVIG dose or clinical response. Safety and efficacy in pediatric patients with CIDP not established.
Child: Dosing for PID is individualized, similar to adults, based on previous IVIG dose or clinical response. Safety and efficacy in pediatric patients with CIDP not established.
Adolescent: Dosing for PID is individualized, similar to adults, based on previous IVIG dose or clinical response. Safety and efficacy in pediatric patients with CIDP not established.
βš•οΈ

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor renal function.
Moderate: No specific dose adjustment recommended, but monitor renal function.
Severe: No specific dose adjustment recommended, but monitor renal function. Use with caution, especially in patients at risk for acute renal failure.
Dialysis: Not specifically studied. Immune globulins are large proteins and are not significantly removed by dialysis. Monitor clinical response and adverse events.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

Pharmacology

πŸ”¬

Mechanism of Action

Hizentra provides passive immunity through the administration of broad-spectrum IgG antibodies. In primary immunodeficiency, it replaces deficient IgG antibodies, helping to maintain protective antibody levels. In CIDP, the mechanism is not fully elucidated but is thought to involve immunomodulatory effects, including neutralization of pathogenic autoantibodies, modulation of Fc receptors, inhibition of complement activation, and suppression of inflammatory cytokines.
πŸ“Š

Pharmacokinetics

Absorption:

Bioavailability: Approximately 69% (relative to IVIG) for PID; not directly quantified for CIDP but absorbed slowly from subcutaneous tissue.
Tmax: 3 to 7 days (for IgG trough levels to stabilize after switching from IVIG to SCIG). Peak serum IgG levels are typically lower and broader than with IVIG.
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: Approximately 7.5 L (similar to endogenous IgG distribution)
ProteinBinding: Not applicable (IgG is a protein itself)
CnssPenetration: Limited (IgG does not readily cross the intact blood-brain barrier, though some penetration may occur in inflammatory conditions).

Elimination:

HalfLife: Approximately 25 to 30 days (similar to endogenous IgG)
Clearance: Variable, dependent on individual IgG catabolism rates.
ExcretionRoute: Primarily intracellular catabolism; minimal renal excretion of intact IgG.
Unchanged: Not applicable (catabolized)
⏱️

Pharmacodynamics

OnsetOfAction: Immediate (passive transfer of antibodies), but clinical effect for PID is sustained over time with regular dosing. For CIDP, clinical improvement may be observed within weeks of initiating therapy.
PeakEffect: Steady-state IgG levels are typically achieved after 2-3 months of regular weekly subcutaneous administration.
DurationOfAction: Maintained with weekly or bi-weekly dosing, reflecting the half-life of IgG.

Safety & Warnings

⚠️

BLACK BOX WARNING

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 central 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.
⚠️

Side Effects

Serious 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 vision
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 vision
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes

Severe Lung Problems and Aseptic Meningitis

This medication can 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, contact your doctor immediately:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused

Other Side Effects

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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

Reporting Side Effects

If you have 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:

  • Severe headache, stiff neck, fever, sensitivity to light, nausea, or vomiting (signs of aseptic meningitis syndrome)
  • Sudden pain, swelling, warmth, redness, or discoloration in an arm or leg (signs of a blood clot)
  • Sudden shortness of breath, chest pain, or coughing up blood (signs of a blood clot in the lungs)
  • Yellowing of the skin or eyes, dark urine, unusual tiredness (signs of hemolytic anemia)
  • Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, dizziness, feeling faint.
  • Signs of kidney problems: decreased urination, swelling in your legs or feet, unusual tiredness.
πŸ“‹

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 symptoms you experienced.
If you have IgA deficiency, a condition where your body lacks a specific antibody.
If you have hyperprolinemia, a condition characterized by elevated levels of proline in your blood.
If you have an excess of fluid in your body or have been advised to monitor your fluid intake.
* If you have low platelet levels, which can affect blood clotting.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 vaccines, discuss the potential risks with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.

Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so it is crucial to 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 viruses.

Some products may contain maltose, which can affect the accuracy of certain glucose tests. Inaccurate glucose test results can lead to improper treatment of high or low blood sugar, potentially resulting in long-term consequences or even death. Therefore, it is essential to consult your doctor about the most suitable blood sugar tests to use.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, if you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
πŸ†˜

Overdose Information

Overdose Symptoms:

  • Fluid overload (e.g., shortness of breath, swelling)
  • Hyperviscosity (e.g., headache, dizziness, visual disturbances)
  • Increased risk of adverse reactions

What to Do:

In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 911 or a poison control center (1-800-222-1222). Management is supportive, focusing on managing symptoms and monitoring vital signs and fluid balance.

Drug Interactions

πŸ”΄

Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): May interfere with the immune response to live virus vaccines. Defer vaccination for at least 3 months after Hizentra administration. For measles, defer for at least 6 months.
🟑

Moderate Interactions

  • Loop diuretics: Increased risk of renal dysfunction, especially in patients with pre-existing renal impairment or risk factors. Monitor renal function.

Monitoring

πŸ”¬

Baseline Monitoring

Serum IgG trough levels

Rationale: To establish baseline and guide initial dosing, especially when switching from IVIG, and to ensure adequate therapeutic levels.

Timing: Before initiation of therapy and periodically thereafter.

Renal function (BUN, serum creatinine)

Rationale: To assess baseline renal status, especially in patients with pre-existing renal impairment or risk factors for acute renal failure.

Timing: Before initiation of therapy.

Hydration status

Rationale: To ensure adequate hydration, which is important for preventing renal complications.

Timing: Before initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To assess general hematologic status.

Timing: Before initiation of therapy.

πŸ“Š

Routine Monitoring

Serum IgG trough levels

Frequency: Every 2-3 months initially, then every 6-12 months or as clinically indicated.

Target: Individualized, typically 700-1000 mg/dL or higher, aiming for levels associated with reduced infection rates for PID. For CIDP, clinical response is primary guide.

Action Threshold: If infection rates are high or clinical response is inadequate, consider dose adjustment. If levels are excessively high, consider dose reduction.

Renal function (BUN, serum creatinine)

Frequency: Periodically, especially in patients with risk factors for renal dysfunction.

Target: Within normal limits for the patient.

Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or discontinuation if related to Hizentra.

Signs and symptoms of adverse reactions (e.g., infusion site reactions, systemic reactions)

Frequency: With each administration and during follow-up.

Target: N/A

Action Threshold: Severe local reactions, systemic hypersensitivity, signs of thrombosis, aseptic meningitis, hemolysis.

πŸ‘οΈ

Symptom Monitoring

  • Signs of allergic or anaphylactic reactions (e.g., hives, generalized urticaria, wheezing, hypotension, shock)
  • 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)
  • Signs of acute renal dysfunction (e.g., decreased urine output, swelling, fatigue)
  • Signs of hemolytic anemia (e.g., fatigue, pallor, dark urine, jaundice)
  • Signs of infection (e.g., fever, chills, malaise, localized pain or swelling at injection site)

Special Patient Groups

🀰

Pregnancy

Category C. Animal reproduction studies have not been conducted. It is not known whether Hizentra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hizentra should be given to a pregnant woman only if clearly needed. IgG antibodies are known to cross the placenta, particularly in the third trimester.

Trimester-Specific Risks:

First Trimester: Limited data. Risk of fetal harm is not established.
Second Trimester: Limited data. Risk of fetal harm is not established.
Third Trimester: IgG antibodies are actively transported across the placenta, potentially providing passive immunity to the fetus. Risk of fetal harm is not established.
🀱

Lactation

L3 (Moderately Safe). Endogenous IgG is excreted in human milk and may contribute to the transfer of antibodies to the neonate. The effects of orally ingested IgG on the infant are unknown. Consider the benefits of breastfeeding, the mother’s clinical need for Hizentra, and any potential adverse effects on the breastfed infant from Hizentra or from the underlying maternal condition.

Infant Risk: Low. IgG is a natural component of breast milk. Oral absorption of intact IgG by the infant is minimal. No known adverse effects on breastfed infants have been reported with immune globulin products.
πŸ‘Ά

Pediatric Use

Safety and efficacy for PID have been established in pediatric patients 2 years of age and older. Dosing is individualized. Safety and efficacy in pediatric patients with CIDP have not been established. Use with caution in infants and young children due to potential for fluid overload and renal considerations.

πŸ‘΄

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, caution should be exercised when administering Hizentra to patients aged 65 years and older due to the higher incidence of comorbidities (e.g., renal impairment, cardiovascular disease, diabetes) and concomitant medications, which may increase the risk of adverse reactions such as thrombosis and renal dysfunction.

Clinical Information

πŸ’Ž

Clinical Pearls

  • Hizentra is for subcutaneous use only; do NOT administer intravenously.
  • Patients can self-administer Hizentra at home after proper training by a healthcare professional.
  • Rotate injection sites (abdomen, thigh, upper arm, lateral hip) to minimize local reactions.
  • Multiple injection sites can be used simultaneously to accommodate larger volumes.
  • Ensure adequate hydration before administration to reduce the risk of renal dysfunction and thrombosis.
  • Patients should carry an emergency card or medical alert bracelet indicating their condition and treatment.
  • Monitor for signs of aseptic meningitis syndrome (AMS), which can occur hours to 2 days post-infusion and typically resolves spontaneously within several days.
  • Advise patients to report any signs of thrombosis immediately, especially if they have risk factors.
πŸ”„

Alternative Therapies

  • Other Subcutaneous Immune Globulin (SCIG) products (e.g., Cuvitru, Gamunex-C, Xembify, HyQvia)
  • Intravenous Immune Globulin (IVIG) products (e.g., Gammagard Liquid, Privigen, Octagam, Gamunex-C)
  • For PID: Prophylactic antibiotics (in some cases), hematopoietic stem cell transplantation (for severe cases).
  • For CIDP: Corticosteroids, plasma exchange (PLEX), other immunosuppressants (e.g., azathioprine, methotrexate, rituximab).
πŸ’°

Cost & Coverage

Average Cost: Highly variable, typically several thousand to tens of thousands USD per month depending on dose and frequency. per 5ml vial (1g)
Insurance Coverage: Specialty Tier (requires prior authorization, often covered by medical benefit or pharmacy benefit depending on plan)
πŸ“š

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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.