Bravelle
Bravelle Uses, Dosage, Side Effects, Food Interaction and all others data.
FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Used for the treatment of female infertility, urofollitropin or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of urofollitropin is the primary hormone responsible for follicular recruitment and development.
| Trade Name | Bravelle |
| Availability | Prescription only |
| Generic | Urofollitropin |
| Urofollitropin Other Names | Follitropin human, Urofollitrophin, Urofollitropin |
| Related Drugs | progesterone, clomiphene, Clomid, chorionic gonadotropin (hcg), Pregnyl, Menopur, Gonal-f, Follistim, Follistim AQ |
| Weight | 75iu, , 75intlunits |
| Type | Injection, Powder, For Solution, Injectable Powder For Injection |
| Formula | C42H65N11O12S2 |
| Weight | 980.162 Da |
| Groups | Approved, Vet approved |
| Therapeutic Class | Trophic Hormones & Related Synthetic Drugs |
| Manufacturer | Ferring Pharmaceuticals Pvt Ltd, Ferring Pharmaceuticals Ltd |
| Available Country | India, United Kingdom, Canada, Saudi Arabia, United States, Netherlands, Spain |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Bravelle 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
Bravelle is a gonadotropin used for:
- Induction of ovulation in women who have previously received pituitary suppression: intramuscular and subcutaneous administration
- Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression
Bravelle is also used to associated treatment for these conditions: Infertility, Assisted Reproductive Technology therapy, Ovulation induction therapy
How Bravelle works
FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Dosage
Bravelle dosage
Ovulation Induction:
- Initial starting 150 International Units per day for 5 days, administered subcutaneously or intramuscularly
- Individualization of dosing after 5 days
- Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
- Do not administer greater than 450 International Units per day
Assisted Reproductive Technology (ART):
- Initial starting dose of the first cycle-225 International Units per day for 5 days, administered subcutaneously
- Individualization of dosing after 5 days
- Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
- Do not administer greater than 450 International Units per day
Side Effects
The most common adverse reactions (≥5% incidence) in ovulation induction include headache, hot flashes, OHSS, pain, and respiratory disorder.
The most common adverse reactions (≥2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, OHSS, pain, pelvic pain, and post retrieval pain
Precaution
- Abnormal Ovarian Enlargement
- Ovarian Hyperstimulation Syndrome
- Pulmonary and Vascular Complications
- Ovarian Torsion
- Multi-fetal Gestation and Birth
- Congenital Malformations
- Ectopic Pregnancy
- Spontaneous Abortion
- Ovarian Neoplasms
Interaction
No drug/drug interaction studies have been conducted for Bravelle in humans
Food Interaction
No interactions found.Bravelle Disease Interaction
Major: adrenal dysfunction, thyroid dysfunction, tumors, thromboembolism, intracranial tumorsModerate: pulmonary conditions
Volume of Distribution
Time to peak in plasma: IM: 17 hours (single dose), 11 hours (multiple doses) SubQ: 21 hours (single dose), 10 hours (multiple doses)
Elimination Route
74%
Half Life
Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Elimination Route
Via liver and kidneys
Pregnancy & Breastfeeding use
Pregnancy Category X. Do not use Bravelle in pregnant women. It is not known whether Bravelle is excreted in human milk
Contraindication
Bravelle is contraindicated in women who exhibit:
- Prior hypersensitivity to urofollitropins
- High levels of FSH indicating primary ovarian failure
- Pregnancy
- Presence of uncontrolled non-gonadal endocrinopathies
- Sex hormone dependent tumors of the reproductive tract and accessory organ
- Tumors of pituitary gland or hypothalamus
- Abnormal uterine bleeding of undetermined origin
- Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome
Special Warning
Pediatric Use: Safety and efficacy not established.
Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of Urofollitrophin in women with renal or hepatic insufficiency have not been established.
Storage Condition
Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C). Protect from light. Use immediately after reconstitution. Discard unused material.
Innovators Monograph
You find simplified version here Bravelle
FAQ
What is Bravelle used for?
Bravelle injection is used to treat infertility in women. This medicine is a man-made hormone called follicle-stimulating hormone.follicle-stimulating hormone is produced in the body by the pituitary gland.follicle-stimulating hormone helps to develop eggs in the ovaries of women.
What are the common side effects of Bravelle?
May common side effects are include;
Is Bravelle safe during pregnancy?
Do not use Bravelle if you are pregnant. Bravelle may also increase your risk of tubal pregnancy
When should not I take Bravelle?
You should not use Bravelle if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, breast cancer, uterine or ovarian cancer, a pituitary gland tumor, or infertility that is not caused by lack of ovulation.
How do I take Bravelle?
Inject Bravelle under the skin or into a muscle, usually once a day or as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking.
Is Bravelle safe during breastfeeding?
It is not known whether Bravelle passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I use Bravelle?
Bravelle is usually given in combination with a medication called human chorionic gonadotropin. This medication causes ovulation to occur by mimicking a natural hormone called luteinizing hormone .
Who should not take Bravelle?
Do not use Bravelle if you:
- are allergic to urofollitropin or any ingredients of this medication
- are infertile for any other cause than lack of follicular development or ovulation (unless you are a candidate for IVF)
- are pregnant or breast-feeding
- have abnormal uterine bleeding of unknown cause
- have an ovarian cyst or enlargement not due to polycystic ovary syndrome
- have certain brain lesions (such as a pituitary tumour)
- have high levels of FSH
- have tumours of the reproductive tract that depend on sex hormones
- have uncontrolled thyroid or adrenal dysfunction
Does Bravelle causes allergic reactions?
This medication may cause a serious allergic reaction in some people. If you develop hives, difficulty breathing, or swelling of the face or throat, stop using the medication and seek medical attention immediately.
Is Bravelle safe during breastfeeding?
It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking Bravelle, it may affect your baby. This medication should not be used by breast-feeding women.
