Firazyr 30mg/3ml Inj 3ml
It is used to treat swelling attacks in people with hereditary angioedema (HAE).
Drug Class
Bradykinin B2 receptor antagonist
Pharmacologic Class
Selective bradykinin B2 receptor antagonist
Pregnancy Category
Category C
FDA Approved
Aug 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Firazyr (Icatibant) is a medicine used to treat sudden attacks of swelling (angioedema) in adults with a rare genetic condition called Hereditary Angioedema (HAE). HAE attacks happen when a chemical called bradykinin causes blood vessels to leak, leading to swelling in different parts of the body, like the skin, hands, feet, face, throat, or belly. Firazyr works by blocking the effects of this chemical, helping to reduce the swelling and other symptoms of 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 its color has changed. Inject the medication into the skin approximately 2 to 4 inches below the belly button, on either side. Avoid injecting into skin within 2 inches of a scar or into skin that is bruised, painful, or swollen.
Important Safety Precautions
Each prefilled syringe is intended 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 Limitations
Do not exceed three 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 its color has changed. Inject the medication into the skin approximately 2 to 4 inches below the belly button, on either side. Avoid injecting into skin within 2 inches of a scar or into skin that is bruised, painful, or swollen.
Important Safety Precautions
Each prefilled syringe is intended 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 Limitations
Do not exceed three 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 Firazyr with you, especially when traveling.
- Ensure you and your caregivers are trained on how to properly inject Firazyr.
- Do not delay treatment for an HAE attack, especially if it involves the throat, as this can be life-threatening.
- Keep a diary of your HAE attacks and treatments.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg (3 mL) administered subcutaneously
Dose Range:
30 - 90 mg
Condition-Specific Dosing:
acute HAE attack:
Administer 30 mg subcutaneously. If symptoms persist or recur, additional doses may be administered at intervals of at least 6 hours. No more than 3 doses should be administered in a 24-hour period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (FDA approval is for adults 18 years and older. Limited data in adolescents 12-17 years suggest similar pharmacokinetics and safety profile, but specific dosing not established for routine use.)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary, but caution is advised due to limited data in this population.
Dialysis:
Not available (Icatibant is not significantly renally excreted as unchanged drug.)
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary, but caution is advised due to limited data in this population.
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 of HAE attacks. By blocking the bradykinin B2 receptor, icatibant inhibits the effects of bradykinin, thereby reducing the symptoms of HAE attacks.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 85%
Tmax:
0.75 - 1.5 hours (subcutaneous)
FoodEffect:
Not applicable (administered subcutaneously)
Distribution:
Vd:
Approximately 29 L
ProteinBinding:
Approximately 90% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1-2 hours
Clearance:
Approximately 15 L/hr
ExcretionRoute:
Primarily via urine as inactive metabolites. Less than 1% excreted as unchanged drug.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 0.5-1 hour (symptom improvement)
PeakEffect:
Not precisely defined, but symptom resolution typically begins within 2-4 hours.
DurationOfAction:
Variable, typically sufficient to resolve an acute attack, but may require repeat dosing if symptoms recur (up to 3 doses in 24 hours).
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you notice any of the following or any other side effects that bother you or do not go away, contact your doctor:
- Pain, redness, swelling, or other reactions at the injection site
- Dizziness or headache
- Feeling sleepy
- Upset stomach
- Mild fever
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you notice any of the following or any other side effects that bother you or do not go away, contact your doctor:
- Pain, redness, swelling, or other reactions at the injection site
- Dizziness or headache
- Feeling sleepy
- Upset stomach
- Mild fever
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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:
- Injection site reactions (redness, swelling, pain, bruising, itching, warmth) are very common but usually mild and temporary.
- Rash
- Dizziness
- Fever
- Nausea
- Headache
- Elevated liver enzymes (rare, usually transient)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage 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. Before engaging in activities that require alertness, 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.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established, but may include exaggerated adverse effects such as severe injection site reactions, dizziness, or headache.
What to Do:
There is no specific antidote for icatibant overdose. Treatment should be symptomatic and supportive. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.
Drug Interactions
Monitoring
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 for subcutaneous injection.
Timing: Prior to first self-administration
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 additional dose (up to 3 doses in 24 hours).
Injection site reactions (e.g., redness, swelling, pain, bruising)
Frequency: After each injection
Target: Minimal or no reaction
Action Threshold: Manage symptomatically; educate patient that these are common and usually mild.
Symptom Monitoring
- Swelling (skin, subcutaneous, laryngeal, abdominal)
- 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 of Firazyr in pregnant women. Animal studies have shown adverse effects on embryo-fetal development at doses higher than human therapeutic doses. Firazyr should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; use only if clearly needed.
Second Trimester:
Potential risk based on animal data; use only if clearly needed.
Third Trimester:
Potential risk based on animal data; use only if clearly needed.
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 FIRAZYR, 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.
Infant Risk:
Potential for serious adverse reactions in nursing infants; risk unknown.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 18 years of age. Limited data in adolescents (12-17 years) suggest similar pharmacokinetics and safety profile to adults, but specific dosing recommendations are not available for routine use.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (âĨ65 years) and younger patients. No dose adjustment is required based on age alone.
Clinical Information
Clinical Pearls
- Firazyr is intended for self-administration or administration by a trained caregiver for acute HAE attacks.
- It is crucial to administer Firazyr at the first sign of an HAE attack to achieve the best outcome.
- Patients should always have at least one dose of Firazyr readily available.
- Laryngeal attacks are medical emergencies and require immediate treatment with Firazyr and potentially other supportive measures.
- Injection site reactions are very common (over 90% of patients) but are generally mild and transient.
Alternative Therapies
- C1 Esterase Inhibitor (human) products for acute attacks (e.g., Berinert, Ruconest)
- Kallikrein inhibitor (e.g., ecallantide - Kalbitor, for acute attacks, but has a Black Box Warning for anaphylaxis)
- Prophylactic treatments for HAE (not for acute attacks): C1 Esterase Inhibitor (human) products (e.g., Cinryze, Haegarda), Kallikrein inhibitors (e.g., lanadelumab - Takhzyro), Oral kallikrein inhibitors (e.g., berotralstat - Orladeyo).
Cost & Coverage
Average Cost:
$15,000 - $20,000 per 30mg/3ml pre-filled 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 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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.