Icatibant 30mg/3ml Inj 3ml
It is used to treat swelling attacks in people with hereditary angioedema (HAE).
Drug Class
Hereditary Angioedema (HAE) Agent
Pharmacologic Class
Bradykinin B2 Receptor Antagonist
Pregnancy Category
Category C
FDA Approved
Aug 2011
DEA Schedule
Not Controlled
Overview
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 face, hands, feet, throat, or belly. Icatibant works by blocking a substance in your body called bradykinin, which is responsible for causing this swelling during an attack.
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 via injection into the fatty tissue of the skin in the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before and after handling the medication, wash your hands thoroughly. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. 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 that is:
Within 2 inches of a scar
Bruised
Painful
Swollen
Each prefilled syringe is intended for single use only. Dispose of used needles in a designated needle/sharp disposal container. Do not reuse needles or other items. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Dosage Frequency
Do not administer more than 3 doses of this medication within a 24-hour period.
Storage and Disposal
Store this medication at room temperature or in a refrigerator. Do not freeze the medication.
Missed Dose
If you miss a dose, seek medical attention immediately.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin in the abdominal area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before and after handling the medication, wash your hands thoroughly. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. 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 that is:
Within 2 inches of a scar
Bruised
Painful
Swollen
Each prefilled syringe is intended for single use only. Dispose of used needles in a designated needle/sharp disposal container. Do not reuse needles or other items. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Dosage Frequency
Do not administer more than 3 doses of this medication within a 24-hour period.
Storage and Disposal
Store this 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 icatibant injection with you, especially when traveling.
- Administer the injection as soon as symptoms of an HAE attack begin.
- Do not exceed 3 doses in a 24-hour period.
- Keep a diary of your HAE attacks and medication use.
- Discuss with your doctor if you are taking ACE inhibitors, as these medications are generally not recommended for HAE patients.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg (3 mL) administered as a subcutaneous injection
Dose Range:
30 - 90 mg
Condition-Specific Dosing:
acuteHAEAttack:
A single 30 mg subcutaneous injection. If symptoms persist or recur, additional injections may be administered at intervals of at least 6 hours. No more than 3 doses (90 mg) should be administered in a 24-hour period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and effectiveness have not been established in pediatric patients. Limited data suggest potential benefit in adolescents 12-17 years old, but specific dosing is not FDA approved for this age group.)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary (Limited data, caution advised)
Dialysis:
No specific recommendations, caution advised due to limited data
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary (Limited data, caution advised)
Confidence:
Medium
Pharmacology
Mechanism of Action
Icatibant is a selective and competitive antagonist of the bradykinin B2 receptor. Hereditary angioedema (HAE) is caused by a deficiency or dysfunction of C1-esterase inhibitor (C1-INH), leading to uncontrolled activation of the kallikrein-kinin system and excessive production of bradykinin. Bradykinin is a potent vasodilator that increases vascular permeability, leading to the characteristic swelling, pain, and inflammation seen in HAE attacks. By blocking the bradykinin B2 receptor, icatibant inhibits the effects of bradykinin, thereby reducing the symptoms of HAE attacks.
Pharmacokinetics
Absorption:
Bioavailability:
97%
Tmax:
0.75 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
20-29 L
ProteinBinding:
90%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-2 hours
Clearance:
15 L/h
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<1% (urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (symptom improvement)
PeakEffect:
Not precisely defined, but symptom resolution typically within 4-6 hours
DurationOfAction:
Up to 6 hours (based on dosing interval)
Confidence:
Medium
Safety & Warnings
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. If you have questions or concerns about side effects, consult your doctor. For medical advice 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, 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. If you have questions or concerns about side effects, consult your doctor. For medical advice 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 or persistent injection site reactions (e.g., large area of swelling, blistering, infection)
- Signs of allergic reaction (e.g., rash, itching, hives, difficulty breathing, swelling of face/lips/tongue/throat, severe dizziness)
- Worsening or non-resolving HAE symptoms after appropriate dosing
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 allergic reaction you experienced, including any symptoms that occurred.
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 you have, 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. Never start, stop, or change the dose of any medication without first consulting 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 allergic reaction you experienced, including any symptoms that occurred.
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 you have, 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. Never 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. To ensure your safety, avoid operating a vehicle or engaging in any activities that require alertness until you are aware of how this drug affects you. If you are using this medication to treat swelling in your neck or throat, seek immediate emergency medical attention at the emergency room (ER) after administration. Additionally, if you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Limited information on overdose. Expected symptoms would be an exaggeration of known side effects, primarily injection site reactions.
What to Do:
Seek immediate medical attention. Treatment is supportive and symptomatic. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Angiotensin-converting enzyme (ACE) inhibitors: Theoretical interaction due to both drugs affecting bradykinin levels. Concomitant use is not recommended as ACE inhibitors increase bradykinin levels, which could theoretically reduce the efficacy of icatibant or exacerbate HAE symptoms. However, clinical data are limited.
Monitoring
Baseline Monitoring
Diagnosis of Hereditary Angioedema (HAE)
Rationale: Icatibant is indicated only for acute HAE attacks.
Timing: Prior to first administration
Patient education on self-administration
Rationale: To ensure proper and safe use at home.
Timing: Prior to first self-administration
Routine Monitoring
Resolution of HAE symptoms (e.g., swelling, pain, abdominal symptoms)
Frequency: Continuously during and after an attack
Target: Complete or significant resolution
Action Threshold: If symptoms persist or recur after 6 hours, consider a second dose (up to 3 doses in 24 hours).
Injection site reactions (e.g., redness, swelling, bruising, pain)
Frequency: After each injection
Target: Minimal to mild
Action Threshold: Severe or persistent reactions may require medical attention.
Symptom Monitoring
- Swelling (face, extremities, larynx, abdomen)
- Pain (abdominal, affected area)
- Nausea/vomiting (abdominal attacks)
- Difficulty breathing/swallowing (laryngeal attacks)
- Injection site reactions (redness, swelling, bruising, pain, itching, warmth)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential risk, but human data are lacking.
Second Trimester:
Potential risk, but human data are lacking.
Third Trimester:
Potential risk, but human data are lacking.
Lactation
It is not known whether icatibant is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from icatibant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. (L3: Moderately safe, but caution advised)
Infant Risk:
Unknown, potential for serious adverse reactions. Monitor infant for adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Limited clinical experience in adolescents (12-17 years) suggests potential benefit, but specific dosing is not approved. Not recommended for children under 12 years.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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 proper subcutaneous self-administration technique.
- Administer at the first sign of an HAE attack, especially for laryngeal attacks which can be life-threatening.
- Injection site reactions are very common (over 70% of patients) and typically mild to moderate.
- Avoid concomitant use with ACE inhibitors due to theoretical concerns about efficacy and potential for exacerbating HAE symptoms.
Alternative Therapies
- C1 Esterase Inhibitor (human) products (e.g., Cinryze, Berinert, Haegarda, Ruconest) - different mechanism (replaces deficient protein)
- Lanadelumab (Takhzyro) - kallikrein inhibitor (prophylaxis)
- Oral kallikrein inhibitors (e.g., Orladeyo - prophylaxis)
Cost & Coverage
Average Cost:
Approximately $15,000 - $18,000 per 30mg/3ml prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.