Icatibant (Icatibant)

Trade Name : Icatibant

Teva Pharmaceuticals USA, Inc.

INJECTION, SOLUTION

Strength 10 mg/mL

ICATIBANT ACETATE Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Icatibant (Icatibant) which is also known as Icatibant and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 mg/mL per ml. Read more

Icatibant (Icatibant) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Icatibant Injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Icatibant Injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. ()

No data

30 mg injected subcutaneously in the abdominal area. ()
If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. ()
Do not administer more than 3 injections in 24 hours. ()
Patients may self-administer upon recognition of an HAE attack. ()

Icatibant Injection is supplied in a prefilled syringe delivering 30 mg icatibant. Each syringe delivers 3 mL solution with a concentration of 10 mg per mL.
Injection: 10 mg per mL ()

None.
None ()

Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with icatibant.

Laryngeal attacks: Following treatment of laryngeal attacks with icatibant, advise patients to seek immediate medical attention. ()

The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

No data

Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. ()

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.
In another clinical study, a dose of 3.2 mg/kg administered intravenously (approximately 8 times the therapeutic dose for HAE) caused erythema, itching and hypotension in healthy subjects. No therapeutic intervention was necessary.

Icatibant is a synthetic decapeptide with five non-proteinogenic amino acids. The chemical structure of icatibant acetate is presented in Figure 1.
Figure 1 Chemical Structure
Chemical name: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-Lu2011seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)-octahydroindol-2-ylcarbonyl]-Lu2011arginine, acetate saltn
Icatibant Injection is provided as a sterile, isotonic, and buffered solution of icatibant acetate in a single-dose, prefilled syringe for subcutaneous administration. Each mL of the solution contains 10 mg of icatibant (free base). Each prefilled syringe delivers 3 mL of solution equivalent to a 30 mg icatibant dose. The solution is clear and colorless.
The solution also contains sodium chloride, glacial acetic acid, sodium hydroxide and water for injection with a pH of approximately 5.5. The solution does not contain preservatives.
Pharmacological class:

No data

No data

The efficacy and safety of icatibant for the treatment of acute attacks of HAE in adults were studied in three controlled clinical trials. Among the 223 patients in these studies, the mean age was 38 years, 64% were female, and 95% were white. Approximately 57% of patients reported use of attenuated androgens, antifibrinolytic agents, or C1 inhibitors. Response to therapy was primarily assessed using visual analog scores on a 100 mm scale and patient- and physician-reported symptom scores for abdominal and cutaneous pain and swelling.
Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either icatibant 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label icatibant 30 mg. The primary endpoint was assessed using a 3-item composite visual analog score (VAS), comprised of averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pretreatment composite 3-itemVAS score (Figure 2). The median time to 50% reduction in symptoms for patients with cutaneous or abdominal attacks treated with icatibant (n=43) compared to placebo (n=45) was 2.0 hours [95% CI 1.5, 3.0] versus 19.8 hours [95% CI 6.1, 26.3], respectively (p<0.001).
Figure 2 Time to 50% reduction from baseline in 3-item VAS score.
Other evaluated endpoints included time to almost complete symptom relief (VAS<10 mm) and rescue medication use. In Trial 1, the median times to almost complete symptom relief were 8.0 versus 36.0 hours for icatibant and placebo, respectively. In terms of rescue medication use, 3/43 (7%) patients treated with icatibant used additional rescue medication in comparison to 18/45 (40%) patients treated with placebo.
In a second placebo-controlled trial and an active-controlled trial, a total of 26 and 35 patients, respectively, received icatibant 30 mg for the treatment of an acute HAE attack. Across the three trials, icatibant had a median time to 50% reduction from baseline symptoms ranging from 2.0 to 2.3 hours.
Recurrent attacks
In all three controlled trials, patients were eligible for treatment of subsequent attacks in an open-label extension. Patients were treated with icatibant 30 mg and could receive up to 3 doses of icatibant 30 mg administered at least 6 hours apart for each attack. A total of 225 patients were treated with 1,076 doses of 30 mg icatibant for 987 attacks of acute HAE in these trials. In an assessment of the first 5 icatibant-treated attacks (621 doses for 582 attacks), the median times to a 50% reduction from the pretreatment composite 3-itemVAS score were similar across attacks (2.0, 2.0, 2.4, 2.0, 1.5 hours). The majority (93%) of these attacks of HAE were treated with a single-dose of icatibant.
Laryngeal attacks
A total of 60 patients with laryngeal attacks were treated with icatibant in the controlled trials. Efficacy results were similar to those observed for non-laryngeal (cutaneous and abdominal) sites of attack.
Self-administration
Self-administration of icatibant by 56 patients was assessed in an open label trial. Patients who administered icatibant during an acute attack of HAE had a median time to 50% reduction from the pretreatment composite 3-itemVAS score of 2.6 hours.

No data

See FDA-approved patient labeling (Patient Information and Instructions for Use).
Patients may self-administer icatibant upon recognition of an HAE attack after training under the guidance of a healthcare professional.
Patients with laryngeal symptoms should seek medical attention immediately in an appropriate healthcare facility after administration of icatibant .
Injection site reactions are reported in most patients after administration of icatibant. Other adverse reactions reported after administration of icatibant include pyrexia, increase in transaminases, dizziness, and rash .
Tiredness, drowsiness, and dizziness have been reported following the use of icatibant. Patients should be advised not to drive or use machinery if they feel tired or dizzy.
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Iss. 3/2019

Arrayn- Icatibant (eye ka' ti bant) Injection
Please read this Patient Information before you use Icatibant Injection and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Icatibant Injection?
Icatibant is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if icatibant is safe or effective for children under 18 years of age.
What should I tell my healthcare provider before taking Icatibant Injection?
Before you use Icatibant Injection, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
How should I use Icatibant Injection?
What should I avoid while using Icatibant Injection?
Tiredness, drowsiness, and dizziness can occur in people who take icatibant. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.
What are the possible side effects of Icatibant Injection?
The most common side effects of Icatibant Injection include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Icatibant Injection. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Icatibant Injection?
Keep Icatibant Injection and all medicines out of the reach of children.
General information about the safe and effective use of Icatibant Injection
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use icatibant for a condition for which it was not prescribed. Do not give icatibant to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Icatibant Injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Icatibant Injection that is written for health professionals.
For more information, go to www.tevaicatibant.com or call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
What are the ingredients in Icatibant Injection?
Active ingredient:
Inactive Ingredients:
Step-By-Step Instructions for your Icatibant Injection
Step 1. Preparing your dose of Icatibant Injection
Figure A
Step 2. Remove the prefilled syringe and needle from the carton. See Figure B.
Figure B
Step 3.tRemove the seal from the needle cap n- See Figure C.
Figure C
Step 4. Remove the protective cap from the end of the pre-filled syringe by unscrewing the cap. Hold the syringe firmly.n- See Figure D.
Figure D
Step 5. Firmly screw the needle on the prefilled syringe. Be careful not to remove the needle from the needle cap. See Figure E.
Figure E
Preparing the Injection Site
Step 6. Choose the injection site.n- See Figure F.
The area you choose for injection should be at least 2 inches (5 cm) away from any scars. Do not choose an area that is bruised, swollen, or painful.
Figure F
Step 7.tClean your Icatibant Injection site with an alcohol wipe and allow it to dry. See Figure G.
Figure G
Injecting your Icatibant Injection
Step 8. Remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. Do not pull up on the plunger. See Figure H.
Figure H
Step 9. Hold the Icatibant Injection prefilled syringe in 1 hand, between your fingers and thumb. See Figure I.
Figure I
Step 10. Use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. See Figure J.
Figure J
Step 11. Hold the syringe between a 45 to 90 degree angle to your skin with the needle facing the fold of skin you are holding. See Figure K.
Figure K
Step 12. Hold the fold of skin. Bring the syringe to the skin and quickly insert the needle into the skin fold. See Figure L.
Figure L
Step 13. Push the plunger, at the top of the syringe, over at least 30 seconds until no icatibant is in the syringe. See Figure M.
Figure M
Step 14. Release the skin fold and gently pull the needle out. See Figure N.
Figure N
Disposal of your used Icatibant Injection prefilled syringe
Step 15. Place the used Icatibant Injection syringe, with the needle attached, in a sharps container (such as a red biohazard container), a hard plastic container, (such as a detergent bottle), or a metal container (such as an empty coffee can). Seal the container and throw it away the right way. There may be state and local laws about the right way to throw away used syringes and needles. Ask your healthcare provider or pharmacist how to throw away used syringes and needles. See Figure O.
Figure O
This Patient Package Insert and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Iss. 3/2019

NDC 0093-3066-34
Rx only
Icatibant Injection
30 mg/3 mL
(10 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Prefilled Syringe
TEVA
Carton contains:One single-dose, single-use, prefilled syringe and one 25G hypodermic needle.Full prescribing information with patient injection instructions.The syringe is closed with a protective cap.For more information, go to www.tevaicatibant.com or call 1-888-838-2872.
Arrayn- Array

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Icatibant (Icatibant)

Trade Name : Icatibant

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Icatibant (Icatibant)

Trade Name : Icatibant

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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