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The following serious adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity and Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
- Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
- Thromboembolic events [see WARNINGS AND PRECAUTIONS]
- Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
- Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
- Congenital Malformations [see WARNINGS AND PRECAUTIONS]
- Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
- Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
- Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
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.
Table 1: Ovulation Induction Safety Profile
|Adverse Events (%)||All Patients with Adverse Events ≥ 2%|
|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.
Table 2: Integrated IVF
|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.
Gastrointestinal disorders: Abdominal pain, Nausea, Vomiting, Abdominal distension, Abdominal discomfort, Diarrhea, Constipation
General disorders and administration site conditions: Pain, Injection site reactions (redness, bruising, swelling and/or pruritus)
Infections and infestations: Urinary tract infection, Nasopharyngitis
Musculoskeletal and connective tissue disorders: Muscle spasm
Nervous system disorders: Headache
Reproductive system disorders: Vaginal hemorrhage, OHSS [see WARNINGS AND PRECAUTIONS], Pelvic pain, Breast tenderness, Vaginal discharge. Ovarian enlargement, Multiple pregnancies [see WARNINGS AND PRECAUTIONS]
Skin and subcutaneous tissue disorders: Rash
Vascular disorders: Hot flushes
Read the Bravelle (urofollitropin injection) Side Effects Center for a complete guide to possible side effects
No drug/drug interaction studies in humans have been conducted for BRAVELLE® .This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/28/2014
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