Sajazir 30mg/3ml Inj 3ml

Manufacturer CYCLE PHARMACEUTICALS Active Ingredient Icatibant(eye KAT i bant) Pronunciation eye-KAT-i-bant
It is used to treat swelling attacks in people with hereditary angioedema (HAE).
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Drug Class
Hereditary Angioedema (HAE) Agent
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Pharmacologic Class
Bradykinin B2 Receptor Antagonist
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Pregnancy Category
Category C
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FDA Approved
Aug 2009
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Icatibant is a medicine used to treat sudden attacks of hereditary angioedema (HAE). HAE is a rare genetic condition that causes episodes of severe swelling in different parts of the body, like the skin, throat, or gut. Icatibant works by blocking a natural substance in your body called bradykinin, which is responsible for causing this swelling during an HAE attack.
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How to Use This Medicine

Proper Administration of This Medication

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.
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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.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg (1 pre-filled syringe) administered subcutaneously into the abdominal area.
Dose Range: 30 - 90 mg

Condition-Specific Dosing:

acute_hae_attack: A second dose of 30 mg may be administered at least 6 hours after the first dose if symptoms persist or recur. A third dose of 30 mg may be administered at least 6 hours after the second dose if symptoms persist or recur. No more than 3 doses should be administered within a 24-hour period.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for infants under 2 years of age.
Child: For children 2 years of age and older: Dosing is weight-based. Refer to specific prescribing information for detailed weight-based dosing tables (e.g., 10-20 kg: 10 mg; 20-30 kg: 15 mg; 30-40 kg: 20 mg; 40-50 kg: 25 mg; >50 kg: 30 mg). May repeat dose once if symptoms persist or recur after 6 hours.
Adolescent: For adolescents 12 years and older weighing >50 kg: 30 mg subcutaneously. May repeat dose once if symptoms persist or recur after 6 hours.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment necessary.
Moderate: No dose adjustment necessary.
Severe: No specific dose adjustment recommended, but use with caution due to limited data.
Dialysis: Not available

Hepatic Impairment:

Mild: No dose adjustment necessary.
Moderate: No dose adjustment necessary.
Severe: No specific dose adjustment recommended, but use with caution due to limited data.
Confidence: Medium

Pharmacology

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Mechanism of Action

Icatibant is a selective and competitive antagonist of the bradykinin B2 receptor. In hereditary angioedema (HAE), attacks are caused by uncontrolled production of bradykinin, which leads to increased vascular permeability and localized edema. By blocking the bradykinin B2 receptor, icatibant inhibits the effects of bradykinin, thereby reducing vascular permeability and alleviating HAE symptoms.
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Pharmacokinetics

Absorption:

Bioavailability: 97%
Tmax: 0.75-1 hour (subcutaneous)
FoodEffect: Not applicable (subcutaneous injection)

Distribution:

Vd: 20-25 L
ProteinBinding: 90%
CnssPenetration: Limited

Elimination:

HalfLife: 1-2 hours
Clearance: 15.3 L/hour
ExcretionRoute: Renal (primarily as metabolites), Fecal
Unchanged: 10% (renal)
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Pharmacodynamics

OnsetOfAction: Within 0.5-1 hour (symptom improvement)
PeakEffect: Not precisely defined for symptom resolution, but Tmax of drug is ~1 hour.
DurationOfAction: Variable, typically sufficient to resolve acute HAE attack symptoms, but may require repeat dosing.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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.
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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.
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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:

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.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you. If you are using this medication to treat swelling in your neck or throat, seek immediate emergency medical attention after administration. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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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

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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

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Baseline Monitoring

Diagnosis of Hereditary Angioedema (HAE)

Rationale: Confirm appropriate indication for treatment.

Timing: Prior to first administration

Patient education on self-administration

Rationale: Ensure proper technique and understanding of when to use.

Timing: Prior to first administration

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Routine Monitoring

Resolution of HAE attack symptoms (e.g., swelling, pain, abdominal symptoms)

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).

Injection site reactions

Frequency: After each injection

Target: Minimal or no reaction

Action Threshold: Monitor for severity; advise patient on expected local reactions (redness, swelling, bruising).

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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

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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:

First Trimester: Limited data, theoretical risk based on animal studies.
Second Trimester: Limited data, theoretical risk based on animal studies.
Third Trimester: Limited data, theoretical risk based on animal studies.
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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 mother’s clinical need for icatibant and any potential adverse effects on the breastfed infant from icatibant or from the underlying maternal condition.

Infant Risk: L3 (Moderate risk) - Due to unknown excretion in human milk and potential for bradykinin B2 receptor antagonism in infant.
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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.

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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

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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.
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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
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Cost & Coverage

Average Cost: High (Specialty drug) per 30mg/3ml pre-filled syringe
Insurance Coverage: Specialty Tier (requires prior authorization)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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.