FILSUVEZ- birch triterpenes gel

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

birch triterpenes (UNII: BX09B0RQR0) (birch triterpenes - UNII:BX09B0RQR0)

Dostupné z:

Amryt Pharmaceuticals DAC

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. None. Risk Summary There are no available data with use of FILSUVEZ in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, oral administration of birch triterpenes to pregnant rats during the period of organogenesis had no effects on reproductive or fetal parameters (see Data) . Systemic absorption of FILSUVEZ in humans is low following topical administration of FILSUVEZ, and maternal use is not expected to result in fetal exposure to the drug [see Pharmacokinetics (12.3)] . The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 embryofetal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. Birch triterpenes did not cause maternal toxicity or fetal malformations at doses up to 100 mg/kg/day. In a prenatal and postnatal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day from gestation day 5 through lactation day 20. Birch triterpenes did not affect development at doses up to 100 mg/kg/day. The available data do not support relevant comparisons of systemic birch triterpenes exposures achieved in the animal studies to exposures observed in humans after topical use of FILSUVEZ. Risk Summary There are no data on the presence of birch triterpenes or metabolites in human milk, the effects on the breastfed infant, or the effect on milk production. No effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman to FILSUVEZ would be low. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FILSUVEZ and any potential adverse effects on the breastfed infant from FILSUVEZ or from the underlying maternal condition [see Pharmacokinetics (12.3)]. The safety and effectiveness of FILSUVEZ for the treatment of wounds associated with dystrophic and junctional EB have been established in pediatric patients 6 months of age and older. Use of FILSUVEZ in this age group is supported by evidence from a single randomized, placebo-controlled trial in 156 subjects 6 months to 17 years of age [see Clinical Studies (14)] . The safety and effectiveness of FILSUVEZ have not been established in pediatric patients younger than 6 months of age. Clinical studies of FILSUVEZ did not include sufficient numbers of EB subjects 65 years of age and older to determine whether they respond differently from younger subjects. Important information: FILSUVEZ is for use on the skin (topical use) only. Do not use FILSUVEZ in or around your eyes or mucous membranes (for example, the mouth, vagina, or anus). This Instructions for Use contains information on how to apply FILSUVEZ. Read this Instructions for Use before you start using FILSUVEZ. Ask your healthcare provider if you have any questions. Important Information You Need to Know Before Applying FILSUVEZ - Use FILSUVEZ exactly as your healthcare provider tells you to use it. - Apply FILSUVEZ directly to the wound or to the dressing surface that will be in contact with the wound. - Clean wounds before applying FILSUVEZ as instructed by your healthcare provider. - Apply FILSUVEZ with a clean or gloved hand. - Apply FILSUVEZ at each dressing change until the wound is completely healed. - Do not get FILSUVEZ in or apply around the eyes, or mucous membranes (For example, mouth, vagina, or anus). If you get FILSUVEZ in your eyes or mucous membranes, rinse with clean water right away. Contact your healthcare provider if you have any discomfort. - Wash hands after applying FILSUVEZ and caring for wounds. - The tube of FILSUVEZ is for one-time use only. After the tube has been opened, apply the FILSUVEZ gel right away. Throw away any remaining gel and the tube after use. - Check the expiration date on the FILSUVEZ tube. Do not use FILSUVEZ if the expiration date has passed. Call your pharmacist or healthcare provider for instructions. Gather your supplies - a new tube of FILSUVEZ - gloves (if using) - sterile, non-adhesive dressing Applying FILSUVEZ - Wash your hands with soap and water or wear gloves. - Open a new tube of FILSUVEZ. Apply the gel right away. - You can apply FILSUVEZ in 2 ways, either directly to the wound or to the non-adhesive dressing surface that will be in contact with the wound. Option 1: Apply FILSUVEZ directly to wound. Apply a 1 mm layer of FILSUVEZ to the wound (See Step 1). Cover the entire wound surface with a 1 mm layer of FILSUVEZ (Step 2). Do not rub in the gel. Cover the wound with a sterile, non-adhesive wound dressing (see Step 3). Step 1 Step 2 Step 3 or Option 2: Apply FILSUVEZ directly to sterile, non-adhesive dressing. Apply a generous layer of FILSUVEZ directly to the sterile, non-adhesive dressing (see Step 1). Cover the entire non-adhesive dressing with FILSUVEZ (Step 2). Cover the wound with the dressing so that the gel is in direct contact with the wound (see Step 3). Secure the non-adhesive wound dressing as directed by your healthcare provider . Step 1 Step 2 Step 3 - Apply a 1 mm layer of FILSUVEZ to the wound (See Step 1). Cover the entire wound surface with a 1 mm layer of FILSUVEZ (Step 2). Do not rub in the gel. Cover the wound with a sterile, non-adhesive wound dressing (see Step 3). - Apply a generous layer of FILSUVEZ directly to the sterile, non-adhesive dressing (see Step 1). Cover the entire non-adhesive dressing with FILSUVEZ (Step 2). Cover the wound with the dressing so that the gel is in direct contact with the wound (see Step 3). Secure the non-adhesive wound dressing as directed by your healthcare provider . How should I store FILSUVEZ? Store FILSUVEZ at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze. Keep FILSUVEZ and all medicines out of the reach of children. How should I throw away (dispose of) FILSUVEZ? Throw away (dispose of) any remaining FILSUVEZ and the tube right away after use in household trash or through a drug take-back option, if available. Go to www.fda.gov/drugdisposal for more information on drug disposal. Manufactured by: Lichtenheldt GmbH, Pharmazeutische Fabrik, Werk 1, Industriestr. 7-11, 23812 Wahlstedt, Germany For more information, call 1-855-303-2347 or go to www.filsuvez.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: December-2023

Prehľad produktov:

FILSUVEZ (birch triterpenes) topical gel, 10% (w/w) is a colorless to slightly yellowish, opalescent, non-aqueous gel and is supplied in 25 mL white aluminum tubes containing 23.4 grams of gel per tube (NDC 76431-310-01). Each sterile tube is for one-time use only. Once opened, the product should be used immediately and discarded after use. Store at 20°C to 25°C (68° F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]). Do not freeze. Do not use beyond the expiration date.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

FILSUVEZ- BIRCH TRITERPENES GEL
AMRYT PHARMACEUTICALS DAC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FILSUVEZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FILSUVEZ.
FILSUVEZ (BIRCH TRITERPENES) TOPICAL GEL
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
FILSUVEZ topical gel is indicated for the treatment of wounds
associated with dystrophic and junctional epidermolysis bullosa in
adult
and pediatric patients 6 months of age and older. (1)
DOSAGE AND ADMINISTRATION
Apply a 1 mm layer of FILSUVEZ to the affected wound surface and cover
with wound dressing or apply FILSUVEZ directly to
dressing so that the topical gel is in direct contact with the wound.
Do not rub in the topical gel. (2)
Apply FILSUVEZ at wound dressing changes until the wound is healed.
(2)
Each tube of FILSUVEZ is for one-time use only. (2)
For topical use; not for oral, intravaginal, intra-anal, or ophthalmic
use. (2)
DOSAGE FORMS AND STRENGTHS
Topical gel: 10% birch triterpenes w/w supplied in 25 mL sterile tubes
(3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity Reactions:_ If signs or symptoms of hypersensitivity
occur, discontinue use immediately and initiate appropriate
therapy. (5.1)
ADVERSE REACTIONS
The most common (incidence ≥2%) adverse reactions are application
site reactions. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMRYT PHARMACEUTICALS
DAC AT 1-855-303-2347 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2023
®
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.