Hizentra 1gm/5ml Inj, 5ml
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
Before Using This Medicine
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
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.
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
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
Baseline Monitoring
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.
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.
Rationale: To ensure adequate hydration, which is important for preventing renal complications.
Timing: Before initiation of therapy.
Rationale: To assess general hematologic status.
Timing: Before initiation of therapy.
Routine Monitoring
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.
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.
Frequency: With each administration and during follow-up.
Target: N/A
Action Threshold: Severe local reactions, systemic hypersensitivity, signs of thrombosis, aseptic meningitis, hemolysis.
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:
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 motherβs clinical need for Hizentra, and any potential adverse effects on the breastfed infant from Hizentra or from the underlying maternal condition.
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.
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
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.
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).