Ferring Pharmaceuticals Inc.
Reference Label Set Id: 46f7740f-c879-4a77-9a16-2821fd772641
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BRAVELLE ® safely and effectively. See full prescribing information for BRAVELLE ®
BRAVELLE ® (urofollitropin for injection, purified) for subcutaneous or intramuscular injection
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
BRAVELLE ® (urofollitropin for injection, purified) is a gonadotropin indicated for:
DOSAGE AND ADMINISTRATION
Ovulation Induction ( 2.2)
Assisted Reproductive Technology (ART) ( 2.3)
DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection: containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting, supplied as lyophilized powder in sterile vials with diluent vials. ( 3)
BRAVELLE ® is contraindicated in women who exhibit:
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
No drug/drug interaction studies have been conducted for BRAVELLE ® in humans ( 7)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Induction of Ovulation in Women who have Previously Received Pituitary Suppression
1.2 Development of Multiple Follicles as Part of an Assisted Reproductive Technology (ART) Cycle in Ovulatory Women Who Have Previously Received Pituitary Suppression
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Recommended Dosing for Induction of Ovulation
2.3 Recommended Dosing for Assisted Reproduction Technology (ART)
3 DOSAGE FORMS AND STRENGTHS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity and Anaphylactic Reactions
5.2 Abnormal Ovarian Enlargement
5.3 Ovarian Hyperstimulation Syndrome (OHSS)
5.4 Pulmonary and Vascular Complications
5.5 Ovarian Torsion
5.6 Multi-fetal Gestation and Birth
5.7 Congenital Malformations
5.8 Ectopic Pregnancy
5.9 Spontaneous Abortion
5.10 Ovarian Neoplasms
5.11 Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.3 Nursing Mothers
8.4 Pediatric Use
8.6 Renal and Hepatic Insufficiency
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Ovulation Induction
14.2 Assisted Reproductive Technologies [ART]
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1 Dosing and Use
17.2 Duration and Monitoring Required
17.3 Instructions Regarding a Missed Dose
17.4 Ovarian Hyperstimulation Syndrome (OHSS)
17.5 Multi-fetal Gestation and Birth
Prior to initiation of treatment with BRAVELLE ®:
Prior to initiation of treatment with BRAVELLE ®:
The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
The 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 ®).
Lyophilized powder for Injection containing 82.5 International Units of FSH, to deliver 75 International Units of FSH after reconstituting with the diluent, supplied in sterile vials with diluent vials and Q•Cap ® vial adapters.
BRAVELLE ® is contraindicated in women who exhibit:
BRAVELLE ® should only be used by physicians who are experienced in infertility treatment. BRAVELLE ® contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome [OHSS] with or without pulmonary or vascular complications [see Warnings and Precautions (5.3, 5.4)] and multiple births [see Warnings and Precautions (5.6)] . Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.11)] . Use the lowest effective dose.
Hypersensitivity/anaphylactic reactions associated with urofollitropins for injection, purified administration have been reported in some patients. These reactions presented as generalized urticaria, facial edema, angioneurotic edema, and/or dyspnea suggestive of laryngeal edema. The relationship of these symptoms to uncharacterized urinary proteins is uncertain.
In order to minimize the hazard associated with abnormal ovarian enlargement that may occur with BRAVELLE ® therapy, the lowest effective dose should be used [see Dosage and Administration (2.2, 2.3)]. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation [see Warnings and Precautions (5.11)] .
If the ovaries are abnormally enlarged on the last day of BRAVELLE ® therapy, hCG should not be administered in order to reduce the chances of development of the Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.3)] . Prohibit intercourse in women with significant ovarian enlargement because of the danger of hemoperitoneum resulting from rupture of ovarian cysts [see Warnings and Precautions (5.3)] .
OHSS: OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events [see Warnings and Precautions (5.4)]. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with OHSS.
OHSS occurs after treatment has been discontinued and reaches its maximum at about 7 to 10 days after treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration [see Warnings and Precautions (5.2)] , the hCG must be withheld.
Cases of OHSS are more common, more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore patients should be followed for at least two weeks after hCG administration.
If severe OHSS occurs, gonadotropins, including hCG, must be stopped and consideration should be given as to whether the woman needs be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows:
Do not remove ascitic, pleural, and pericardial fluid unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade.
OHSS increases the risk of injury to the ovary. Pelvic examination or intercourse may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should be avoided.
If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances, should be consulted.
In a clinical study of induction of ovulation indication, 6 of 72 (8.33%) BRAVELLE ® treated women developed OHSS and 2 were classified as severe. In a clinical study for the development of multiple follicles as part of an IVF cycle, 3 of 60 women treated with BRAVELLE ® developed OHSS and 1 was classified as severe.
Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome) have been reported in women treated with gonadotropins. In addition, thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome have been reported in women treated with gonadotropins. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death. In women with recognized risk factors, the benefits of ovulation induction and assisted reproductive technology need to be weighed against the risks. Pregnancy also carries an increased risk of thrombosis.
Ovarian torsion has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multi-fetal gestation and births have been reported with all gonadotropin therapy including therapy with BRAVELLE ®.
In a controlled study of 72 patients undergoing induction of ovulation, 66.7% of pregnancies of women treated with subcutaneous BRAVELLE ® were multiples, while 28.6% of pregnancies in women treated with intramuscular BRAVELLE ® were multiples.
In a controlled study of 60 patients undergoing IVF, 34.8% of pregnancies of women treated with subcutaneous BRAVELLE ® were multiples.
Before beginning treatment with BRAVELLE ®, advise the woman and her partner of the potential risk of multi-fetal gestation and birth.
The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.
Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased. Early confirmation of intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.
The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility .
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation; however, a causal relationship has not been established.
In most instances, treatment of women with BRAVELLE ® will result only in follicular growth and maturation. In the absence of an endogenous LH surge, hCG is given when monitoring of the woman indicates that sufficient follicular development has occurred. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestation.
The clinical confirmation of ovulation is obtained by direct or indirect indices of progesterone production as well as sonographic evidence of ovulation.
Direct or indirect indices of progesterone production:
Sonographic evidence of ovulation:
The following serious adverse reactions are discussed elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of BRAVELLE ® was examined in four clinical studies that enrolled a total of 222 women who received BRAVELLE ®.
In a randomized, multi-center, active controlled study, a total of 72 women received BRAVELLE ® (35 in a subcutaneous administration arm and 37 in an intramuscular administration arm) for induction of ovulation. Adverse reactions occurring at an incidence of ≥2% incidence in women receiving BRAVELLE ® are shown in Table 1.
|All Patients with Adverse Events ≥ 2%|
|Adverse Events (%)||BRAVELLE ® subcutaneous||BRAVELLE ® intramuscular|
|OHSS||4 (11.4)||2 (5.4)|
|Vaginal Hemorrhage||3 (8.6)||0 (0.0)|
|Ovarian Disorder (Pain, Cyst)||1 (2.9)||3 (8.1)|
|Urinary tract infection||0||1 (2.7)|
|Cervix disorder||1 (2.9)||0|
|Nausea||2 (5.7)||0 (0.0)|
|Enlarged Abdomen||1 (2.9)||1 (2.7)|
|Abdominal Pain||1 (2.9)||2 (5.4)|
|Weight gain||1 (2.9)||0|
|Exfoliative dermatitis||0||1 (2.7)|
|Other Body Systems|
|Headache||4 (11.4)||3 (8.1)|
|Pain||2 (5.7)||0 (0.0)|
|Neck pain||0||1 (2.7)|
|Respiratory Disorder||2 (5.7)||0 (0.0)|
|Hot Flashes||2 (5.7)||0 (0.0)|
|Emotional lability||0||1 (2.7)|
|Accidental injury||0||1 (2.7)|
Assisted Reproductive Technology
Three studies examined the safety profile of BRAVELLE ® in ART. A total of 150 women received treatment with BRAVELLE ® in these studies. Adverse reactions occurring at an incidence of ≥2% incidence for this integrative assessment are presented in Table 2.
|All Patients with Adverse Events ≥ 2%|
|Adverse Events (%)||BRAVELLE ® subcutaneous|
|Vaginal hemorrhage||7 (4.7)|
|Post retrieval pain||12 (8.0)|
|Pelvic pain/cramps||10 (6.7)|
|Uterine spasms||4 (2.7)|
|Vaginal spotting||4 (2.7)|
|Urinary tract infection||5 (3.3)|
|Ovarian disorder||3 (2.0)|
|Breast tenderness||3 (2.0)|
|Vaginal Discharge||4 (2.7)|
|Infection fungal||3 (2.0)|
|Abdominal cramps||21 (14.0)|
|Abdominal pain||7 (4.7)|
|Abdominal fullness/enlargement||10 (6.7)|
|Other Body Systems|
|Respiratory disorder||6 (4.0)|
|Injection site reaction||6 (4.0)|
|Hot flash||6 (4.0)|
|Emotional lability||3 (2.0)|
The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to BRAVELLE ® cannot be reliably determined.
Pregnancy Category X [see Contraindications (4)] .
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from BRAVELLE ®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Aside from possible ovarian hyperstimulation [see Warnings and Precautions (5.3)] and multiple gestations [see Warnings and Precautions (5.6)] , little is known concerning the consequences of acute overdosage with BRAVELLE ®.
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
BRAVELLE ® administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with BRAVELLE ® in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.
Single doses of 225 International Units and multiple daily doses (7 days) of 150 International Units of BRAVELLE ® were administered to healthy volunteer female subjects while their endogenous FSH was suppressed. Sixteen subjects received BRAVELLE ® subcutaneously and 12 received the drug intramuscularly. Serum FSH concentrations were determined. Based on the steady state ratio of FSH C max and AUC, subcutaneous and intramuscular administration of BRAVELLE ® were not bioequivalent. Multiple doses of BRAVELLE ® intramuscular resulted in C max and AUC of 77.7% and 81.8% compared to multiple doses of BRAVELLE ® subcutaneous. The FSH pharmacokinetic parameters for single and multiple dose BRAVELLE ®, administered subcutaneously and intramuscularly are in Table 3.
|Single Dose (225 IU)||Multiple Dose × 7 (150 IU)|
|C max (mIU/mL)||6.0 (1.7)||8.8 (4.5)||14.8 (2.9)||11.5 (2.9)|
|T max (hrs)||20.5 (7.7)||17.4 (12.2)||9.6 (2.1)||11.3 (8.4)|
|AUC obs (mIU∙hr/mL)||379 (111)||331 (179)||234.7 (77.0)||192.1 (52.3)|
|t 1/2 (hrs)||31.8||37||20.6||15.2|
The subcutaneous route of administration trends toward greater bioavailability than the IM route for single and multiple doses of BRAVELLE ®.
The efficacy of BRAVELLE ® was examined in two clinical studies, one for in-vitro fertilization (IVF) and one for ovulation induction (OI).
In the randomized, multi-center, active-controlled, ovulation induction study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered BRAVELLE ® , intramuscularly-administered BRAVELLE ®, or a subcutaneously administered commercial recombinant FSH product. A total of 111 oligo-anovulatory women were randomized to both treatment arms, of which 72 received BRAVELLE ®, starting at a dose of 150 International Units daily for 5 days. Subsequently each woman received individual titration of the BRAVELLE ® dose from 75 to 450 International Units daily based on ultrasound and estradiol (E 2) levels. The total duration of dosing did not exceed 12 days. Results for the Intent-To-Treat Population are summarized in Table 4.
|BRAVELLE ® Subcutaneous||BRAVELLE ® Intramuscular|
|Ovulation (%)||24 (68.6)||26 (70.3)|
|Received hCG (%)||25 (71.4)||28 (75.7)|
|Mean Peak Serum E2 (pg/mL) (SD)||976.5 (680.6)||893.2 (815.2)|
|Chemical Pregnancy (%)||11 (31.4)||8 (21.6)|
|Clinical Pregnancy (%)||9 (25.7)||7 (18.9)|
|Continuing Pregnancy (%)||9 (25.7)||7 (18.9)|
|Pts. w/Live Births (%)||9 (25.7)||6 (16.2)|
In the randomized, multi-center, active-controlled, IVF study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered BRAVELLE ® or a subcutaneously administered commercial recombinant FSH product. A total of 120 patients were randomized to both treatment arms, of which 60 received BRAVELLE ®, starting at a dose of 225 International Units daily for 5 days. Subsequently each woman received individual titration of the dose from 75 to 450 International Units daily based on ultrasound and estradiol (E 2) levels. The total duration of dosing did not exceed 12 days. Results are summarized in Table 5 for the Intent-To-Treat population.
|BRAVELLE ® subcutaneous|
|Mean Total Oocytes Retrieved Per Patient (SD)||11.8 (6.3)|
|Mean Mature Oocytes Retrieved Per Patient (SD)||9.0 (5.7)|
|Patients with Oocyte Retrieval (%)||57 (95.0)|
|Patients with Embryo Transfer (%)||57 (95.0)|
|Patients with Chemical Pregnancy (%)||28 (46.6)|
|Patients with Clinical Pregnancy (%)||25 (41.7)|
|Patients with Continuing Pregnancy (%)||23 (38.3)|
BRAVELLE ® (urofollitropin for injection, purified) is supplied in a sterile, lyophilized, single dose vial containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting with the diluent.
Each vial is available with an accompanying vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride Injection, USP.
75 International Units FSH activity, supplied as:
NDC 55566-8505-6: Box of 5 vials + 5 vials diluent + 5 Q•Cap ® vial adaptors.
See FDA-approved patient labeling (Patient Information and Instructions for Use)
Instruct women on the correct usage and dosing of MENOPUR ® [see Dosage and Administration (2.2)] . Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider.
Prior to beginning therapy with BRAVELLE ®, inform women about the time commitment and monitoring procedures necessary for treatment.
Inform the woman that if she misses or forgets to take a dose of BRAVELLE ®, the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.
Inform women regarding the risks of OHSS [see Warnings and Precautions (5.3)] and OHSS-associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.4)] and ovarian torsion [see Warnings and Precautions (5.5)] with the use of BRAVELLE ®.
Inform women regarding the risk of multi-fetal gestation and birth with the use of BRAVELLE ® [see Warnings and Precautions (5.6)] .
Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP, manufactured for Ferring Pharmaceuticals Inc.
(urofollitropin for injection, purified)
for subcutaneous use
Read this Patient Information before you start using BRAVELLE ® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is BRAVELLE ®?
BRAVELLE ® is a prescription medicine that contains follicle stimulating hormone (FSH). BRAVELLE ® is used to treat women:
Who should not use BRAVELLE ®?
Do not use BRAVELLE ® if you:
What should I tell my healthcare provider before using BRAVELLE ®?
Before using BRAVELLE ®, tell your healthcare provider if you:
Tell your healthcare provider all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use BRAVELLE ®?
What are possible side effects of BRAVELLE ®?
BRAVELLE ® may cause serious side effects, including:
If you have a serious allergic reaction, stop using BRAVELLE ® and call your healthcare provider or go to the nearest hospital emergency room right away.
The most common side effects of BRAVELLE ® include:
These are not all the possible side effects of BRAVELLE ®. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
How should I store BRAVELLE ®?
Keep BRAVELLE ® and all medicines out of the reach of children.
General information about the safe and effective use of BRAVELLE ®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BRAVELLE ® for a condition for which it was not prescribed. Do not give BRAVELLE ® to other people, even if they have the same condition you have. It may harm them.
This Patient Information summarizes the most important information about BRAVELLE ®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BRAVELLE ® that is written for health professionals.
For more information go to www.bravelle.com, or call 1-888-FERRING (1-888-337-7464).
What are the ingredients in BRAVELLE®?
Active ingredient: urofollitropin
Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate dibasic, heptahydrate and phosphoric acid
(urofollitropin for injection, purified)
for subcutaneous use
Your healthcare provider should show you how to mix and inject BRAVELLE ® or BRAVELLE ® mixed with MENOPUR ® before you do it for the first time. Before using BRAVELLE ® or BRAVELLE ® mixed with MENOPUR ® for the first time, read this Instructions for Use carefully. Keep this leaflet in a safe place and read it when you have questions.
Supplies you will need to give your injection of BRAVELLE ® or BRAVELLE ® mixed with MENOPUR ®. See Figure A.
Step 1. Preparing your BRAVELLE ® or BRAVELLE ® mixed with MENOPUR ®.
If your healthcare provider tells you to use more than 1 vial of BRAVELLE ® or tells you to mix your BRAVELLE ® with MENOPUR ® in the same syringe:
Step 2. Removing the Q•Cap ® and adding your needle for injection.
Step 3. Prepare Injection site for BRAVELLE ® or with BRAVELLE ® mixed with MENOPUR ®.
Step 6. Disposing of your used needles and syringes.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
FERRING PHARMACEUTICALS INC.
PARSIPPANY, NJ 07054
Revised: July 2015
Bravelle® 75 IU
(urofollitropin for injection, purified)
5 single dose vials of urofollitropin for injection, purified
5 single dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL
FOR SUBCUTANEOUS OR
INTRAMUSCULAR INJECTION ONLY
Reconstitute with 1 mL 0.9% Sodium Chloride Injection, USP.
Administer SC or IM immediately after reconstitution.
Discard unused portion.
Usual Dosage: See package insert for dosage and complete
Lyophilized powder may be stored refrigerated or at room
temperature (3° to 25° C / 37° to 77° F). Protect from light.
|Labeler - Ferring Pharmaceuticals Inc. (103722955)|
|Ferring Production Inc.||079510999||label(55566-8505) , pack(55566-8505)|
|Jubilant HollisterStier General Partnership||246762764||manufacture(55566-8505) , pack(55566-8505)|
|F. M. Howell & Company||962888116||pack(55566-8505)|