icatibant

eye-KAT-i-bant

Therapeutic Classification: hereditary angioedema agents

Pharmacologic Classification: bradykinin B2 receptor antagonists

REMS

Treatment of attacks of hereditary angioedema (HAE).

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.

Absorption: 97% absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Metabolized systemically by proteolytic enzymes to metabolites that are renally excreted; <10% excreted unchanged in urine.

Half-Life: 1.4 hr.

(reduction of symptoms)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 1 hr	2.0–2.6 hr‡	6–8 hr

‡50% reduction in baseline symptoms.

Contraindicated in:

None noted.

Use Cautiously in:

OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

GI: ↑transaminases

Local: injection site reactions

Neuro: dizziness

Misc: fever

Drug-drug:

May ↓ antihypertensive response to ACE inhibitors.

SC (Adults ): 30 mg may be repeated in 6 hr, not to exceed 3 injections/24 hr.

(Generic available)

Solution for injection: 10 mg/mL

Assess for symptoms of hereditary angioedema (submucosal or SUBQ swelling) before and following treatment.

Lab Test Considerations:

May cause ↑ serum transaminases.

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.
SC: 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.

Instruct patient in recognizing symptoms of hereditary angioedema and correct technique for self-administration and disposal of equipment. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
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.

Resolution of signs and symptoms of an acute attack of hereditary angioedema.

Firazyr

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3066- Icatibant
  - 0093-3066-34- 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3066- Icatibant
  - 0093-3066-93- 3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE

24201- Hikma Pharmaceuticals USA Inc.
- 24201-207- Icatibant
  - 24201-207-01- 1 SYRINGE, GLASS in 1 CARTON (24201-207-01) / 3 mL in 1 SYRINGE, GLASS

24201- Hikma Pharmaceuticals USA Inc.
- 24201-207- Icatibant
  - 24201-207-03- 3 CARTON in 1 CARTON (24201-207-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

32861- Chengdu Shengnuo Biopharm Co. Ltd.
- 32861-0004-
  - 32861-0004-1- 1 kg in 1 BOTTLE (32861-0004-1)

35207- BCN PEPTIDES SA
- 35207-0008-
  - 35207-0008-5- 500 g in 1 BOTTLE (35207-0008-5)

41524- AmbioPharm, Inc.
- 41524-0008-
  - 41524-0008-1- 1 g in 1 BOTTLE (41524-0008-1)

46708- Alembic Pharmaceuticals Limited
- 46708-654- Icatibant
  46708-654-03- 1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS

46708- Alembic Pharmaceuticals Limited
- 46708-654- Icatibant
  - 46708-654-09- 3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 3 mL in 1 SYRINGE, GLASS

54092- Takeda Pharmaceuticals America, Inc.
- 54092-702- Firazyr
  - 54092-702-01- 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS

54092- Takeda Pharmaceuticals America, Inc.
- 54092-702- Firazyr
  - 54092-702-02- 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS

54092- Takeda Pharmaceuticals America, Inc.
- 54092-702- Firazyr
  - 54092-702-03- 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS

55111- Dr.Reddy's laboratories Limited
- 55111-994-
  - 55111-994-00- 1 kg in 1 DRUM (55111-994-00)

55150- Eugia US LLC
- 55150-351- Icatibant
  55150-351-01- 1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS

55150- Eugia US LLC
- 55150-351- Icatibant
  - 55150-351-03- 3 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

55463- Bachem AG
- 55463-0033-
  - 55463-0033-0- 200 g in 1 BOTTLE, GLASS (55463-0033-0)

59651- Aurobindo Pharma Limited
- 59651-363-
  59651-363-37- 1 kg in 1 BOTTLE, GLASS (59651-363-37)

60505- Apotex Corp.
- 60505-6214- ICATIBANT
  60505-6214-1- 1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) / 3 mL in 1 SYRINGE, GLASS

62147- USV Private Limited
- 62147-0277-
  - 62147-0277-0- 1 kg in 1 DRUM (62147-0277-0)

62332- Alembic Pharmaceuticals Inc.
- 62332-654- Icatibant
  62332-654-03- 1 SYRINGE, GLASS in 1 CARTON (62332-654-03) / 3 mL in 1 SYRINGE, GLASS

62332- Alembic Pharmaceuticals Inc.
- 62332-654- Icatibant
  - 62332-654-09- 3 SYRINGE, GLASS in 1 CARTON (62332-654-09) / 3 mL in 1 SYRINGE, GLASS

63323- Fresenius Kabi USA, LLC
- 63323-574- Icatibant
  - 63323-574-86- 1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)

63323- Fresenius Kabi USA, LLC
- 63323-574- Icatibant
  - 63323-574-93- 3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE

63415- Assia Chemical Industries Ltd - Teva Tech Site
- 63415-0526-
  - 63415-0526-0- 1 kg in 1 CARTON (63415-0526-0)

66529- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
- 66529-0002-
  66529-0002-1- 300 g in 1 BAG (66529-0002-1)

66558- FRESENIUS KABI IPSUM SRL
- 66558-0197-
  66558-0197-1- 10 g in 1 JAR (66558-0197-1)

66558- FRESENIUS KABI IPSUM SRL
- 66558-0197-
  66558-0197-2- 50 g in 1 JAR (66558-0197-2)

66558- FRESENIUS KABI IPSUM SRL
- 66558-0197-
  66558-0197-3- 75 g in 1 JAR (66558-0197-3)

66558- FRESENIUS KABI IPSUM SRL
- 66558-0197-
  66558-0197-4- 150 g in 1 JAR (66558-0197-4)

69097- Cipla USA Inc.
- 69097-664- ICATIBANT
  69097-664-34- 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASS

69097- Cipla USA Inc.
- 69097-664- ICATIBANT
  - 69097-664-68- 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 3 mL in 1 SYRINGE, GLASS

69766- MSN Life Sciences Private Limited
- 69766-014-
  - 69766-014-06- 1 kg in 1 DRUM (69766-014-06)

70709- Cycle Pharmaceuticals Ltd-Uk
- 70709-013- SAJAZIR
  70709-013-01- 1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS

70709- Cycle Pharmaceuticals Ltd-Uk
- 70709-013- SAJAZIR
  - 70709-013-03- 3 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASS

72162- Bryant Ranch Prepack
- 72162-2106- ICATIBANT
  - 72162-2106-2- 1 SYRINGE, GLASS in 1 CARTON (72162-2106-2) / 3 mL in 1 SYRINGE, GLASS

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆