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FIRAZYR is a brand name for Icatibant, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FIRAZYR (icatibant injection) is indicated for: • the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase inhibitor deficiency. FIRAZYR is supplied through a controlled distribution program that is accessed by patients and pharmacies.…
Verbatim from this product's HC label. Tap a section to expand.
Takeda’s OnePath Patient Support Program FIRAZYR is supplied through a controlled distribution program that is accessed by patients and pharmacies. Patients should be enrolled in the OnePath Patient Support Program to receive FIRAZYR prefilled syringes and patient self-administration kits.
Physicians and dispensers should encourage their patients to register in the OnePath Patient Support Program to obtain FIRAZYR and additional training and educational materials. 1 Dosing Considerations Patients with laryngeal symptoms or any swelling causing breathing difficulties should seek medical attention immediately after administration of FIRAZYR and need to be managed in an appropriate medical institution after injection until the physician considers discharge to be safe.
2 Recommended Dose and Dosage Adjustment Adults: The recommended dose of FIRAZYR is 30 mg. Additional doses may be administered at intervals of at least 6 hours if response is inadequate or if symptoms recur. No more than 3 doses may be administered in any 24 hour period.
The safety of more than 8 injections in a month has not been investigated in clinical trials.
Pediatrics (aged 2 to 17 years):
The recommended dose of FIRAZYR based on body weight is provided in Table 1 below. 0 mL) In the clinical trial, not more than 1 injection of FIRAZYR per HAE attack was administered.
Pediatrics (< 2 years of age and in patients who weigh less than 12 kg):
No dosage regimen can be recommended as the safety and efficacy have not been established (see 14 CLINICAL TRIALS).
Geriatrics (≥65 years of age):
Patients are likely to have increased systemic exposure to FIRAZYR compared to younger patients. 3 Pharmacokinetics).
Hepatic Impairment:
No dosage adjustment is required.
Renal Impairment:
No dosage adjustment is required. 4 Administration FIRAZYR is recommended to be initiated under the supervision of a physician experienced in the treatment of HAE. FIRAZYR is supplied as a single-use prefilled syringe that delivers 3 mL of solution, equivalent to a 30 mg icatibant dose.
1 Adverse Reaction Overview Adult Population The majority of adult patients (97%) who were treated with subcutaneous FIRAZYR in clinical trials developed reactions at the site of injection including erythema, swelling, warm sensation, burning, itching and /or cutaneous pain.
These reactions were generally mild to moderate in severity, transient, and the majority (62%) resolved without intervention within 4 hours of FIRAZYR dosing. Other adverse reactions reported by patients treated with FIRAZYR (≥1% to <10% of patients) were dizziness, headache, nausea, rash, erythema, pruritus, pyrexia, and increased transaminases (ALT and AST).
The overall incidence of serious adverse events (SAEs) in adult trials was low in the clinical development program. In the Phase I and II studies, only 2 SAEs were reported within 14 days of FIRAZYR treatment (manic episode, HAE); these were judged as not related/probably not related to treatment.
In the controlled part of the three Phase III studies, only one SAE (cystitis) was reported within 14 days of FIRAZYR® (icatibant injection) Page 10 of 43 Unclassified / Non classifié dosing with FIRAZYR. This event was judged as not related to treatment.
In the repeated treatment part of the Phase III studies, safety was evaluated for up to 15 FIRAZYR-treated attacks for patients. Sixteen patients experienced a total of 22 SAEs that occurred within 14 days of FIRAZYR administration.
The only SAE that occurred in more than one patient was worsening or recurrence of HAE. Two SAEs were considered by the investigator as related to FIRAZYR treatment (events of arrhythmia and noncardiac chest pain). 6%) who were treated with subcutaneous FIRAZYR in the clinical trial developed reactions at the site of injection including erythema, swelling, burning sensation, warm sensation, cutaneous pain, and/or itching.
General FIRAZYR is recommended to be initiated under the supervision of a physician experienced in the treatment of HAE. Patients or a caregiver should be trained in subcutaneous injection techniques under the guidance of a healthcare professional before they can administer FIRAZYR.
The first self- administration of FIRAZYR should be performed under the guidance of a healthcare professional. 4 ADMINISTRATION). 1 Dosing Considerations). Asphyxia may occur more rapidly in children than adults due to smaller airway passages.
The safety and efficacy of FIRAZYR for the treatment of laryngeal symptoms is based on limited data in pediatric patients (see 14 CLINICAL TRIALS). 2 Pharmacodynamics). Use of FIRAZYR in patients with acute ischemic heart disease or unstable angina pectoris could theoretically lead to a decrease in coronary blood flow and a deterioration in cardiac function.
Cerebrovascular Accident Use of FIRAZYR in the weeks following a stroke could theoretically attenuate the positive late phase neuroprotective effects of bradykinin. Driving and Operating Machinery While taking FIRAZYR, patients should be cautioned not to drive, operate dangerous machinery or engage in activities that require alertness or physical coordination.
The following symptoms have been reported following the use of FIRAZYR and may occur as a result of an attack of HAE: Fatigue; lethargy; tiredness; somnolence; and dizziness.
Hepatic/Biliary/Pancreatic Hepatic impairment:
Data from subjects with a wide range of hepatic insufficiency suggest that FIRAZYR exposure is not influenced by hepatic impairment. 3 Pharmacokinetics). Monitoring and Laboratory Tests Monitoring reproductive hormone concentrations should be considered in children and adolescents receiving frequent FIRAZYR treatment (see 16 NON-CLINICAL TOXICOLOGY).
FIRAZYR is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The syringe and needle should be discarded in a sharps container after use. g. paresthesia or erythema). FIRAZYR should be inspected visually for particulate matter and discolouration prior to administration. FIRAZYR® (icatibant injection) Page 6 of 43 Unclassified / Non classifié The drug solution should be clear and colourless.
Do not administer if the product contains particulates or is discoloured. Adult Patients For adults, attach the provided 25 gauge needle to the prefilled syringe hub and screw on securely. Do not use a different needle. Disinfect the injection site and administer FIRAZYR by slow subcutaneous injection in the abdominal area over at least 30 seconds.
Adult patients (or their caregivers) may self-administer FIRAZYR upon recognition of symptoms of an HAE attack. They should be trained in subcutaneous injection techniques by a healthcare professional before they can administer FIRAZYR.
The first administration of FIRAZYR should be performed under the guidance of a healthcare professional before beginning the self-administration of FIRAZYR. Self- administration training is also available to adult patients and caregivers directly through Takeda’s OnePath Patient Support Program.
Pediatric Patients Pediatrics (aged 2 years and above who weigh between ≥ 12 kg and ≤ 65 kg): attach the provided 25 gauge needle to the graduated syringe hub containing the required injection volume (dose) and screw on securely. Do not use a different needle.
Disinfect the injection site and administer FIRAZYR by slow subcutaneous injection in the abdominal area over at least 30 seconds. Pediatrics (adolescents weighing > 65 kg): attach the provided 25 gauge needle to the prefilled syringe hub and screw on securely.
Do not use a different needle. Disinfect the injection site and administer FIRAZYR by slow subcutaneous injection in the abdominal area over at least 30 seconds. FIRAZYR may be administered to children and adolescents (≥2 to <18 years) by a healthcare professional.
FIRAZYR may also be self-administered, if appropriate, or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional. Self-administration may require measurement of the correct dose of FIRAZYR.
Ensure patients have received adequate training in the preparation of the empty graduated syringe, measurement of the correct dose of FIRAZYR, and transfer of the dose to the graduated syringe. Self-administration training is also available directly through Takeda’s OnePath Patient Support Program.
The required injection volume in mL (derived from Table 1) from the prefilled syringe should be transferred into an empty, 3 mL graduated syringe for subcutaneous injection. Supplies required for extracting the appropriate dose from the prefilled syringe for pediatric patients (3 mL graduated syringes and connectors), as well as alcohol wipes may be obtained through Takeda’s OnePath Patient Support Program.
5 Missed Dose Not applicable. 5 OVERDOSE In a clinical study evaluating a 90 mg dose (30 mg in each of 3 subcutaneous sites), the adverse event profile was similar to that seen with 30 mg administered in a single subcutaneous site. 2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects.
No […]
These reactions were generally mild-to-moderate in severity, transient, and the majority resolved within 6 hours of FIRAZYR dosing. Other adverse reactions reported by patients treated with FIRAZYR (≥1% to <10% of patients) and considered possibly related were dry mouth and fatigue.
1%. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
Adult Population In clinical studies, a total of 1,411 HAE attacks have been treated with 30 mg FIRAZYR administered subcutaneously. The safety of FIRAZYR was evaluated in three controlled Phase III trials that included 223 patients who received subcutaneous injection of FIRAZYR 30 mg (n=113), placebo (n=75), or tranexamic acid (n=38), administered by healthcare professionals.
Study drug treatment occurred within 6 hours of the attack becoming at least moderate in severity for abdominal or cutaneous attacks. The mean age at study entry was 38 years (range 18 to 83 years), 64% were female, and 95% were Caucasian.
, unstable angina pectoris, severe coronary heart disease or congestive heart failure [New York Heart Association class 3 and 4]) that in the investigator’s judgment would be a contraindication for participation in the trial; or were pregnant or breastfeeding.
The safety data described below represent adverse reactions observed from the two placebo- controlled Phase III trials, consisting of 77 patients who were randomized to receive FIRAZYR at a dose of 30 mg SC, and 75 who were randomized to receive placebo.
The safety data represent events occurring within 14 days of treatment of the patient’s first attack. The most frequently reported adverse reactions occurring in greater than 2% of FIRAZYR-treated patients (2 or more patients), and at a higher frequency with FIRAZYR compared to placebo, are shown in Table 1.
The severity of adverse reactions was assessed by the investigator based on the following definitions: mild - no limitation of usual activities; moderate - some limitation of usual activities; and severe – inability to carry out usual activities.
The majority of adverse reactions reported following FIRAZYR treatment were judged to be mild or moderate in severity. FIRAZYR® (icatibant injection) Page 11 of 43 Unclassified / Non classifié Table 3 - Adverse reactions observed in >2% of Adult FIRAZYR-treated patients (≥2 patients) and at a higher rate with FIRAZYR compared to placebo in the placebo-controlled trials System Organ Class / Preferred Term FIRAZYR (N = 77) (%) Placebo (n = 75) (%) Gastrointestinal disorders Abdominal distension 2 (3) 0 (0) Abdominal pain 2 (3) 0 (0) Diarrhea 2 (3) 0 (0) General disorders and administration site conditions Injection site reactionb 75 (97) 25 (33) Pyrexia 3 (4) 0 (0) Infections and infestations Nasopharyngitis 2 (3) 0 (0) Sinusitis 2 (3) 1 (1) Urinary tract infection 2 (3) 1 (1) Investigations Transaminases increasedc 3 (4) 0 (0) Nervous System Disorders Dizziness 2 (3) 1 (1) Respiratory, thoracic and mediastinal disorders Nasal congestion 2 (3) 0 (0) a Events occurring within 14 days of study drug administration.
Five patients who experienced laryngeal attacks (mild to moderate in severity) were randomized in Study 1 and are included in this table (3 in the FIRAZYR group and 2 in the placebo group); patients with laryngeal attacks were not randomized in Studies 2 and 3 and are excluded from this table.
b Injection site reactions include any of the following: injection site burning, injection site erythema, injection site swelling, injection site pain, injection site pruritus, and injection site warmth. c Alanine aminotransferase (ALT), […]
Renal Renal impairment:
Limited data from subjects with renal insufficiency suggest that FIRAZYR exposure is not influenced by renal impairment. 3 Pharmacokinetics). Reproductive Health • Fertility The long-term effects of frequent treatment with FIRAZYR in children and adolescents are unknown.
Nonclinical studies administering FIRAZYR at a high-frequency of high doses in rats and dogs, in which FIRAZYR was administered on a daily basis for 7 and 13 weeks, respectively, demonstrated treatment-related, reversible impairment of sexual maturation and degeneration in sexual organs (See 16 NON-CLINICAL TOXICOLOGY).
1 Pregnant Women No formal studies of the use of FIRAZYR in pregnant women have been conducted. FIRAZYR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 5 and 2-fold the maximum recommended human dose (MRHD) (on an AUC basis at maternal doses of 1 and 3 mg/kg, respectively).
Increased fetal distress and perinatal death were observed at high doses (at 7-fold the MRHD, on an AUC basis at a maternal daily dose of 10 mg/kg/day). The potential risk for humans is unknown (see 16 NON-CLINICAL TOXICOLOGY). 2 Breastfeeding Animal studies showed that FIRAZYR is excreted in the milk of lactating rats at concentrations similar to those in maternal blood.
It is unknown whether FIRAZYR is excreted in human breast milk. Many drugs are excreted in human milk, therefore caution should be exercised. 3 Pediatrics Pediatrics (< 18 years of age): FIRAZYR is indicated for use in adolescents and children aged 2 years and older.
1 Clinical Trials by Indication, 7 Reproductive Health, Fertility). 4 Geriatrics Geriatrics (> 65 years of age): Limited information is available for FIRAZYR in patients older than 65 years of age. 3 PharmacokineticsError! ).