Bravelle
Loading...Bravelle Recall
On February 23, 2011, the FDA published a nationwide recall of 6,434 Q-Cap cartons of Bravelle. Apparently, Ferring Pharmaceuticals, Inc. received several complains that sale units of Bravelle contained inner cartons mislabeled as Menopur - a different Ferring infertility drug. The Menopur cartons were imprinted with the correct lot number for the inner carton assembly of Bravelle and contained the correct lot of Bravelle vials. Ferring initiated a recall by telephone (Jan 7, 2011) and by letter (Jan 19, 2011). Manufacturer Draxis Specialty Pharmaceutical Inc. also initiated a recall of the drug. (fda.gov)
Recalled Bravelle Vial Numbers:
- Bravelle Vial Lot #: 0E534, Exp 7/12
- Bravelle Q-cap carton Lot #: 0E534A-1, Exp 02/12
- Incorrect Menopur inner cartons within the Bravelle Q-cap cartons Lot#: 0E534A, Exp 2/12
Other Resources
- Redditt thread discussing open Bravelle recall (10/11/15) - (redditt.com/r/intertility/...)
Questions & Answers
Question
** 2015 RECALL INFO ** – I just got off the phone with Ferring (manufacturer) and my local pharmacist. According the the Ferring rep I spoke with, this is a “pharmacy-level” recall (whatever that means. Pharmacist didn’t even know what that was) so maybe that’s why no info is showing up on the FDA. Supposedly there was a notification sent out to pharmacies in August and then another recent one last week. Again, according to the rep I spoke with, Ferring is recalling all of the Bravelle product because some were found to be less potent than they should be, ie – an efficacy problem. The Ferring rep told me that consumers were not notified because it is not a hazard and that anyone with Bravelle should go ahead and use it (consult doctor) but that there would be no more available on the market. I didn’t think to ask how long it would be before any it is produced or sold again, so maybe never. The Reddit thread cited here mentions Follistim and Gonal-F as possible alternatives or replacements for anyone using Bravelle.
I was told this is a “Class II” recall and involved all product nationwide. Hope that helps. If anyone has anything else to add, I’m eager to hear it.
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Prior to initiation of treatment with BRAVELLE®:
- Perform a complete gynecologic and endocrinologic evaluation
- Exclude a diagnosis of primary ovarian failure
- Exclude the possibility of pregnancy
- Demonstrate tubal patency
- Evaluate the fertility status of the male partner
Prior to initiation of treatment with BRAVELLE®:
- Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
- Exclude the possibility of pregnancy
- Evaluate the fertility status of the male partner
- Exclude women with primary ovarian failure
History
There is currently no drug history available for this drug.
Other Information
BRAVELLE® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
BRAVELLE® is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of BRAVELLE® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 International Units of FSH. BRAVELLE® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in BRAVELLE®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
FSH is a glycoprotein that is acidic and water-soluble.
BRAVELLE® has been mixed in vitro with MENOPUR® with no evidence of aggregation.
Therapeutic class: Infertility
Sources
Bravelle Manufacturers
-
Ferring Pharmaceuticals Inc.
![Bravelle (Urofollitropin) Kit [Ferring Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bravelle | Ferring Pharmaceuticals Inc.
2.1 General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer BRAVELLE® subcutaneously in the abdomen or intramuscularly as described in Instructions for Use. A healthcare provider should administer BRAVELLE® intramuscularly. 2.2 Recommended Dosing for Induction of OvulationThe dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
For women who have received GnRH agonist or antagonist pituitary suppression, a starting dose of 150 International Units per day of BRAVELLE® is administered subcutaneously or intramuscularly for 5 days in the first cycle of treatment. In subsequent cycles of treatment, the starting dose (and dosage adjustments) of BRAVELLE® should be determined based on the history of the ovarian response to BRAVELLE®. The following should be considered when planning the woman's individualized dose of BRAVELLE®: Appropriate BRAVELLE® dose adjustment(s), based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results), should be used to prevent multiple follicular growth and cycle cancellation. Do not make adjustments in dose more frequently than once every 2 days and do not exceed more than 75 to 150 International Units per adjustment. Use the lowest dose of BRAVELLE® that will achieve desired results. The maximum, individualized, daily dose of BRAVELLE® is 450 International Units per day. In general, do not exceed 12 days of treatment. When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation. Withhold hCG in cases where the ovarian monitoring on the last day of BRAVELLE® treatment suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) [see Warnings and Precautions (5.2, 5.3, 5.11)]. Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.
Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2, 5.3)]. 2.3 Recommended Dosing for Assisted Reproduction TechnologyThe recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of BRAVELLE® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. BRAVELLE® may be administered together with MENOPUR® (menotropins for injection, USP), and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of BRAVELLE® and 75 International Units of MENOPUR® or 75 International Units of BRAVELLE® and 150 International Units of MENOPUR®).
Beginning on cycle day 2 or 3, a starting dose of 225 International Units of BRAVELLE® is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 12 days. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 2 days or by more than 75 - 150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG. Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of BRAVELLE® therapy [see Warnings and Precautions (5.2, 5.3, 5.11)]. Do not administer daily doses of BRAVELLE® or BRAVELLE® in combination with MENOPUR® that exceed 450 International Units.
Login To Your Free Account