icatibant


Also found in: Acronyms, Wikipedia.

icatibant

(eye-kat-i-bant) ,

Firazyr

(trade name)

Classification

Therapeutic: hereditary angioedema agents
Pharmacologic: bradykinin b2 receptor antagonists
Pregnancy Category: C

Indications

Treatment of attacks of hereditary angioedema (HAE) in patients >18 yr.

Action

Antagonizes the effects of bradykinin which are responsible for symptoms of HAE.

Therapeutic effects

Decreased manifestations of HAE including skin swelling, skin pain and abdominal pain with decreased progression to laryngeal edema.

Pharmacokinetics

Absorption: 97% absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Metabolized systemically by proteolytic enzymes to metabolites that are renally excreted; <10% excreted unchanged in urine.
Half-life: 1.4 hr.

Time/action profile (reduction of symptoms)

ROUTEONSETPEAKDURATION
Subcutwithin 1 hr2.0–2.6 hr†6–8 hr
† 50% reduction in baseline symptoms.

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Obstetric: Use during pregnancy only if potential benefit justifies potential risk to fetus; Lactation: Use cautiously during lactation; Pediatric: Safe and effective use in patients <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Gastrointestinal

  • ↑ transaminases

Local

  • injection site reactions (most frequent)

Miscellaneous

  • fever

Interactions

Drug-Drug interaction

May ↓ antihypertensive response to ACE inhibitors.

Route/Dosage

Subcutaneous (Adults >18yr) 30 mg may be repeated in 6 hr, not to exceed 3 injections/24 hr.

Availability

Solution for subcutaneous injection: 10 mg/mL in 3 mL syringe (30 mg/syringe)

Nursing implications

Nursing assessment

  • Assess for symptoms of hereditary angioedema (submucosal or subcutaneous swelling) before and following treatment.
  • Lab Test Considerations: May cause ↑ serum transaminases.

Potential Nursing Diagnoses

Ineffective breathing pattern (Indications)

Implementation

  • Additional doses may be administered with at least 6 hrs between injection if response is inadequate or symptoms recur. Do not administer more that 3 doses in 24 hr.
  • Subcutaneous: Inject into abdominal area using the 25 gauge needle provided. Pinch fold of skin about 2–4 inches from belly button and inject at a 45°–90° angle. Avoid areas with scars or that are bruised, swollen, or painful. Do not use a different needle. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter.

Patient/Family Teaching

  • Instruct patient in recognizing symptoms of hereditary angioedema and correct technique for self-administration and disposal of equipment.
  • Caution patient to seek medical attention immediately after injection if laryngeal swelling occurs.
  • May cause tiredness, drowsiness, and dizziness. Caution patient to avoid driving, and other activities requiring alertness until response to medication is known.
  • Advise patient to notify health care professional if fever, dizziness, or rash occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of an acute attack of hereditary angioedema.
References in periodicals archive ?
Phase 3 studies involving icatibant have shown promising results for treatment of acute attacks of angioedema.
Continued strong revenue growth driven by the anticipated launch of the first phase of a new range of Niaspan products in early 2007, and Icatibant, coupled with a significant reduction in royalty expenses, should result in earnings growth per fully diluted share in the range of 30% - 40% over 2006 guidance.
Shire has recently submitted data from the Phase IIIb EASSI (Evaluation of the Safety of Self-Administration With Icatibant) study of icatibant to the European Medicines Agency (EMA) for a proposed label amendment to include self-administration of subcutaneous icatibant to treat acute attacks of HAE.
Previous episodes in which icatibant wasn't used lasted a mean of 41.
A Phase IIIb Evaluation of the Safety of Self-Administration with Icatibant (EASSI) study showed that self-administration of FIRAZYR for acute attacks of HAE was generally well-tolerated.
Nasdaq:KOSP) announced today preliminary results from two pivotal Jerini AG (FSE: JI4) Phase III Icatibant clinical trials, FAST-1 and FAST-2 (For Angioedema Subcutaneous Treatment), for the subcutaneous treatment of hereditary angioedema (HAE), a debilitating and potentially life-threatening genetic disease.
The results for laryngeal attacks treated with icatibant were similar to the results for abdominal and cutaneous attacks treated with icatibant.
We are pleased to receive the FDA's orphan drug designation for Icatibant in a second indication," said Jens Schneider-Mergener, Chief Executive Officer of Jerini.
Icatibant has shown unambiguous clinical efficacy for treatment of acute attacks of hereditary angioedema.
With Icatibant, we can help patients suffering from hereditary angioedema", stated Jens Schneider-Mergener, CEO of Jerini.
The new investment will allow Jerini to strengthen its clinical and preclinical pipeline," explains Jens Schneider-Mergener, CEO and founder of Jerini, adding, "The proceeds will be particularly used to create market readiness for our lead product Icatibant in the indication Angioedema in 2006.