ICATIBANT injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ICATIBANT ACETATE (UNII: 325O8467XK) (ICATIBANT - UNII:7PG89G35Q7)

Commercializzato da:

Hikma Pharmaceuticals USA Inc.

Via di somministrazione:

SUBCUTANEOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Icatibant Injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. None. Risk Summary Available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (MRHD) and higher. Decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the MRHD. In a pre-and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the MRHD and higher, which resulted in deaths of dams at doses 2 times the MRHD and higher. Fetal death and early pup deaths were observed with doses 2 times the MRHD (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study with rats that received icatibant from gestation days 7 to 18, there was no evidence of any treatment-related structural abnormalities or effects on embryo-fetal survival with maternal doses up to 2.7 times the MRHD (on a mg/m 2 basis with maternal subcutaneous doses up to 25 mg/kg/day). In a fertility and early embryonic development study with rats, icatibant increased pre-implantation loss at a dose that was 7 times the MRHD (on an AUC basis at a maternal dose of 10 mg/kg/day). In an embryo-fetal development study with rabbits that received icatibant from gestation days 7 to 18, premature birth and abortion rates increased at doses approximately 0.025 times the MRHD and higher (on a mg/m 2 basis at maternal subcutaneous doses of 0.1 mg/kg and higher). Icatibant treatment resulted in dose-related decreases of total implantations and total number of live fetuses as well as dose-related increases of percent pre-implantation loss at a dose that was 13 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 10 mg/kg/day). There was no evidence of any treatment-related structural abnormalities with maternal doses up to 13 times the MRHD (on an AUC basis with maternal subcutaneous doses up to 10 mg/kg/day). In a pre-and post-natal development study in the rat, dams received icatibant by the subcutaneous route at doses of 1 mg/kg/day, 3 mg/kg/day, and 10 mg/kg/day from gestation day 6 to post-partum (PPD) day 20. Delayed parturition was observed at doses 0.5 times the MRHD and higher (on an AUC basis with maternal subcutaneous doses of 1 mg/kg/day and higher), which resulted in deaths of dams at doses 2 times the MRHD and higher (on an AUC basis with maternal subcutaneous doses of 3 mg/kg/day and higher). Fetal death and increased pup deaths through PPD 4 were observed with doses 2 times the MRHD (on an AUC with a maternal subcutaneous dose of 3 mg/kg/day and higher). Impairment of pup righting reflex and decreased pup hair growth were also observed at 7 times the MRHD (on an AUC basis with a maternal dose of 10 mg/kg). Icatibant and the M2 metabolite were found in maternal milk following subcutaneous administration of icatibant. The no effect dose for F1 pups was identified at a dose 0.5 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 1 mg/kg/day). A no effect dose was not identified for F 0 maternal toxicity. Risk Summary There are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. Icatibant and the M2 metabolite were found in rat milk following subcutaneous administration of icatibant (see Data) . When a drug is present in animal milk, it is likely that the drug will be present in human milk. However, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant and any potential adverse effects on the breastfed child from icatibant or from the underlying maternal condition. Data Animal Data Icatibant is excreted into the milk of lactating rats at concentrations that sometimes slightly exceeded those measured in the maternal plasma. Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Juvenile Toxicity Data Subcutaneous daily administration of icatibant to young rats during the juvenile period of development (postnatal days 22 to 70) delayed the sexual maturation of male reproductive tissues (atrophy of testes and epididymides) at exposures approximating one-third or greater the MRHD on a mg/m 2 basis. Impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period at exposures approximating the MRHD or greater on a mg/m 2 basis. No effects were observed in females at exposures approximating 3-fold the MRHD on a mg/m 2 basis. The observed tissue findings in males were consistent with those seen in sexually mature rats and dogs and are attributed to antagonism of the bradykinin B2 receptor and subsequent effects on gonadotropins. The observed effects may be a consequence of daily icatibant administration. Toxicity to the testis did not occur in dogs treated twice a week for 9 months [see Carcinogenesis, Mutagenesis, Impairment of Fertility (13.1)] . Clinical studies of icatibant did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are likely to have increased systemic exposure to icatibant compared to younger (18 to 45 years) patients [see Clinical Pharmacology (12.3)] . Since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended. Icatibant was studied in patients with mild to moderate (Child Pugh scores of 5 to 8) hepatic impairment. No change in systemic exposure is noted in these patient populations. No dose adjustment is required in patients with hepatic impairment [see Clinical Pharmacology (12.3)] . Although a formal renal impairment study has not been conducted, 10 of 37 patients treated with icatibant had hepatorenal syndrome with glomerular filtration rate (GFR) below 60 mL/min. Icatibant is cleared non-renally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. No dose adjustment is required in patients with renal impairment [see Clinical Pharmacology (12.3)] . 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 Injection is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. - It is not known if Icatibant Injection is safe or effective for children under 18 years of age. What should I tell my healthcare provider before using Icatibant Injection? Before you use Icatibant Injection, tell your healthcare provider about all your medical conditions including if you: - are pregnant or plan to become pregnant. It is not known if Icatibant Injection will harm your unborn baby. You and your healthcare provider will decide if Icatibant Injection is right for you. - are breastfeeding or plan to breastfeed. It is not known if Icatibant Injection passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use Icatibant Injection. Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. How should I use Icatibant Injection? - Read the Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use Icatibant Injection. - Use Icatibant Injection exactly as your healthcare provider tells you to use it. - Your healthcare provider will prescribe the right dose of Icatibant Injection for you and tell you when to use it. - Your healthcare provider will teach you or a caregiver how to give icatibant injections. - If your symptoms continue or come back, you may repeat your Icatibant Injection at least six hours apart. - Do not use more than 3 doses in 24 hours. - If you have a laryngeal attack, inject Icatibant Injection and then go to the nearest hospital emergency room right away. What should I avoid while using Icatibant Injection? Tiredness, drowsiness, and dizziness can happen in people who take Icatibant Injection. If this happens, 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: - redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site - fever - too much of an enzyme called transaminase in your blood - dizziness - nausea - headache - rash 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? - Store Icatibant Injection between 2°C to 25°C (36°F to 77°F). - Do not freeze. - Store Icatibant Injection in the original carton until you are ready to use it. 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 Injection for a condition for which it was not prescribed. Do not give Icatibant Injection 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, email [e-mail] or call 1-877-845-0689. What are the ingredients in Icatibant Injection? Active ingredient: icatibant acetate Inactive Ingredients: sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster), and water for injection Step 1. Preparing your dose of Icatibant Injection - Wash your hands with soap and water. - You will need the following supplies: Your Icatibant Injection carton that includes 1 single-dose Icatibant Injection prefilled syringe and 1 needle. 1 alcohol wipe The medicine inside your Icatibant Injection prefilled syringe should be clear and colorless. Do not use your Icatibant Injection prefilled syringe if the solution contains particles, is cloudy, or has an unusual color. - Your Icatibant Injection carton that includes 1 single-dose Icatibant Injection prefilled syringe and 1 needle. - 1 alcohol wipe - The medicine inside your Icatibant Injection prefilled syringe should be clear and colorless. Do not use your Icatibant Injection prefilled syringe if the solution contains particles, is cloudy, or has an unusual color. Figure A Step 2. Remove the prefilled syringe and needle from the carton. See Figure B. Figure B Step 3. Twist the needle cap lid to break the seal (the needle should remain inside the protective needle cap until ready to use) . 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 . Carefully attach the needle to the prefilled syringe containing the colorless Icatibant Injection solution. 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. The injection site should be a fold of skin on your stomach, about 2 to 4 inches (5 to 10 cm) below your belly button on either side. 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. Clean 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, for at least 30 seconds until no Icatibant Injection 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 your used Icatibant Injection syringe, with the needle attached, in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Figure O Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Revised: April 2024 19AUF08

Dettagli prodotto:

Icatibant Injection is supplied as a single-dose, prefilled syringe for subcutaneous administration. Each syringe delivers 3 mL of a sterile solution of icatibant 30 mg (as icatibant acetate). The solution is clear and colorless. Each glass syringe has a bromobutyl plunger stopper, which is not made with natural rubber latex. Icatibant Injection is available in cartons containing one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 24201-207-01. Icatibant Injection is also available in a pack containing 3 cartons; each carton contains one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 24201-207-03. Keep out of the reach of children. Store between 2°C to 25°C (36°F to 77°F). Do not freeze. Store in carton until time of administration.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ICATIBANT- ICATIBANT INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ICATIBANT INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ICATIBANT
INJECTION.
ICATIBANT INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
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. ( 1)
DOSAGE AND ADMINISTRATION
30 mg injected subcutaneously in the abdominal area. ( 2.1)
If response is inadequate or symptoms recur, additional injections of
30 mg may be administered at
intervals of at least 6 hours. ( 2.1)
Do not administer more than 3 injections in 24 hours. ( 2.1)
Patients may self-administer upon recognition of an HAE attack. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg per mL ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Laryngeal attacks: Following treatment of laryngeal attacks with
icatibant, advise patients to seek
immediate medical attention. ( 5.1)
ADVERSE REACTIONS
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. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT
[e-mail] OR CALL 1-877-845-0689 OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Elderly patients demonstrate increased systemic exposure to icatibant.
Differences in efficacy and
safety between elderly and younger patients have not been identified.
( 8.5)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2