Sajazir 30mg/3ml Inj 3ml
Overview
What is this medicine?
How to Use This Medicine
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via subcutaneous injection into the fatty tissue of the abdominal area.
Self-Administration
If you will be administering the injection yourself, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly.
Inspecting the Solution
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
Injection Site
Inject the medication into the skin approximately 2 to 4 inches below the belly button, on either side of the abdomen. Avoid injecting into skin within 2 inches of a scar, or into skin that is bruised, painful, or swollen.
Disposal and Safety Precautions
Each prefilled syringe is for single use only. Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Dosage Frequency
Do not exceed three doses within a 24-hour period.
Storage and Disposal
Store the medication at room temperature or in a refrigerator. Do not freeze the medication.
Missed Dose
If you miss a dose, seek medical attention immediately.
Lifestyle & Tips
- Always carry your medication with you, especially when traveling.
- Ensure you have an action plan for HAE attacks, including when to administer icatibant and when to seek emergency medical care.
- Properly dispose of used syringes in a sharps container.
Available Forms & Alternatives
Available Strengths:
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
Side Effects
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
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 discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Pain, redness, swelling, or other reactions at the injection site
- Dizziness or headache
- Feeling sleepy
- Upset stomach
- Mild fever
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for advice. 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 an HAE attack: sudden swelling of the face, lips, tongue, throat, hands, feet, genitals, or abdomen.
- Difficulty breathing or swallowing (indicates a laryngeal attack, which is a medical emergency).
- Severe abdominal pain, nausea, vomiting, or diarrhea (indicates a gastrointestinal attack).
- Any signs of allergic reaction after injection (though rare): rash, itching, severe dizziness, trouble breathing.
Before Using This Medicine
It is essential to inform your doctor about the following:
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 3.2 mg/kg (approximately 200 mg) have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Provide supportive care as clinically indicated. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Angiotensin-converting enzyme (ACE) inhibitors: Theoretical concern due to shared pathway (bradykinin). Co-administration is not recommended as ACE inhibitors increase bradykinin levels, which icatibant blocks. However, clinical data on this interaction are limited.
Monitoring
Baseline Monitoring
Rationale: Confirm appropriate indication for treatment.
Timing: Prior to first administration
Rationale: Ensure proper technique and understanding of when to use.
Timing: Prior to first administration
Routine Monitoring
Frequency: Continuously during and after administration
Target: Complete or significant resolution of symptoms
Action Threshold: If symptoms persist or recur after 6 hours, consider repeat dose (up to 3 doses in 24 hours).
Frequency: After each injection
Target: Minimal or no reaction
Action Threshold: Monitor for severity; advise patient on expected local reactions (redness, swelling, bruising).
Symptom Monitoring
- Swelling (skin, subcutaneous, laryngeal, gastrointestinal)
- Pain (especially abdominal pain)
- Difficulty breathing or swallowing (laryngeal edema)
- Nausea, vomiting, diarrhea (gastrointestinal edema)
- Injection site reactions (redness, swelling, bruising, pain, itching, warmth)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects at high doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
Lactation
Icatibant is excreted in the milk of lactating rats. It is unknown whether icatibant is excreted in human milk. Caution should be exercised when icatibant is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for icatibant and any potential adverse effects on the breastfed infant from icatibant or from the underlying maternal condition.
Pediatric Use
Approved for children 2 years of age and older. Dosing is weight-based. Safety and efficacy have not been established in children younger than 2 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. No dose adjustment is necessary based on age alone.
Clinical Information
Clinical Pearls
- Icatibant is for acute treatment of HAE attacks, not for prophylaxis.
- Patients should be trained on self-administration technique by a healthcare professional.
- Always have a second dose available if symptoms persist or recur, but do not exceed 3 doses in 24 hours.
- Laryngeal attacks are life-threatening and require immediate medical attention, even if icatibant is administered.
- Injection site reactions are common but usually mild and transient.
Alternative Therapies
- C1 esterase inhibitor (C1-INH) concentrates (e.g., Berinert, Cinryze, Haegarda, Ruconest)
- Kallikrein inhibitors (e.g., Ecallantide, Lanadelumab, Oral: Sebetralstat, Orladeyo)
- Fresh frozen plasma (FFP) - generally not recommended due to potential for worsening attack