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MINT-ICATIBANT 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: AND CLINICAL USE................................................................................. 3 CONTRAINDICATIONS ............................................................................................... 3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
General MINT-ICATIBANT 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 MINT-ICATIBANT.
The first self- administration of MINT-ICATIBANT should be performed under the guidance of a healthcare professional. Administration of MINT-ICATIBANT to adolescents should be performed by a healthcare professional, caregiver, or through self-administration, if appropriate (see DOSAGE AND ADMINISTRATION).
Patients with laryngeal symptoms or any swelling causing breathing difficulties should seek medical attention immediately after administration of MINT-ICATIBANT (see DOSAGE AND ADMINISTRATION). 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 CLINICAL TRIALS). Cardiovascular Ischemic Heart Disease Icatibant has been shown to aggravate induced cardiac ischemia in several animal models by antagonising the cardioprotective effects of bradykinin (see DETAILED PHARMACOLOGY).
Use of MINT- ICATIBANT 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. Stroke Use of MINT-ICATIBANT in the weeks following a stroke could theoretically attenuate the positive late phase neuroprotective effects of bradykinin.
Special Populations Pregnant Women No formal studies of the use of icatibant in pregnant women have been conducted. MINT-ICATIBANT 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 TOXICOLOGY). Nursing Women Animal studies showed that icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood (see DETAILED PHARMACOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It is unknown whether icatibant is excreted in human breast milk. Many drugs are excreted in human milk, therefore caution should be exercised. MINT-ICATIBANT Product Monograph Page 5 of 39 Pediatrics (< 18 years of age) MINT-ICATIBANT is indicated for use in adolescents who weigh more than 65 kg.
Growth and Development Effects in Pediatric Patients The long-term effects of frequent treatment with icatibant in adolescents are unknown. Nonclinical studies administering icatibant at a high-frequency of high doses in rats and dogs, in which icatibant 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.
Monitoring reproductive hormone concentrations should be considered in adolescents receiving frequent icatibant treatment (see TOXICOLOGY). Geriatrics (> 65 years of age) Limited information is available for icatibant in patients older than 65 years of age.
Studies demonstrated that the total exposure to icatibant in geriatric patients was higher than in young adults (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). Hepatic impairment Data from subjects with a wide range of hepatic insufficiency suggest that icatibant exposure is not influenced by hepatic impairment.
No dosage adjustment is required in patients with hepatic impairment. Renal impairment Limited data from subjects with renal insufficiency suggest that icatibant exposure is not influenced by renal impairment. No dosage adjustment is required in patients with renal impairment.
ADVERSE REACTIONS Adverse Drug Reaction Overview Adult Population The majority of adult patients (97%) who were treated with subcutaneous icatibant 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 icatibant dosing. Other adverse reactions reported by patients treated with icatibant (≥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 icatibant 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 dosing with icatibant. 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 icatibant-treated attacks for patients.
Sixteen patients experienced a total of 22 SAEs that occurred within 14 days of icatibant 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 icatibant treatment (events of arrhythmia and noncardiac chest pain).
6%) who were treated with subcutaneous icatibant in the clinical trial developed reactions at the site of injection including erythema, swelling, burning sensation, warm […]