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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® .

Ovulation Induction

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%
BRAVELLE® subcutaneous
N=35
BRAVELLE® intramuscular
N=37
Genitourinary/Reproductive
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
Gastrointestinal
Nausea 2 (5.7) 0 (0.0)
Enlarged Abdomen 1 (2.9) 1 (2.7)
Abdominal Pain 1 (2.9) 2 (5.4)
Vomiting 0 1 (2.7)
Constipation 0 1 (2.7)
Diarrhea 0 1 (2.7)
Metabolic/Nutritional
Dehydration 0 1 (2.7)
Weight gain 1 (2.9) 0
Skin/Appendages
Acne 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)
Fever 0 1 (2.7)
Hypertension 0 1 (2.7)
Emotional lability 0 1 (2.7)
Depression 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 Safety Profile

All Patients with Adverse Events ≥ 2%
Adverse Events (%) BRAVELLE® subcutaneous
N=150
Genitourinary/Reproductive
Vaginal hemorrhage 7 (4.7)
Post retrieval pain 12 (8.0)
Pelvic pain/cramps 10 (6.7)
OHSS 9 (6.0)
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)
Gastrointestinal
Abdominal cramps 21 (14.0)
Nausea 13 (8.7)
Abdominal pain 7 (4.7)
Abdominal fullness/enlargement 10 (6.7)
Constipation 3 (2.0)
Other Body Systems
Headache 19 (12.7)
Pain 8 (5.3)
Rash 4 (2.7)
Respiratory disorder 6 (4.0)
Sinusitis 3 (2.0)
Injection site reaction 6 (4.0)
Hot flash 6 (4.0)
Emotional lability 3 (2.0)

Postmarketing Experience

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