Bravelle

Last updated on RxList: 12/15/2016
Bravelle Side Effects Center

Last reviewed on RxList 1/29/2016

Bravelle (urofollitropin) for Injection is a purified form of a hormone called follicle-stimulating hormone (FSH) used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Bravelle also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization. Common side effects of Bravelle include headache, nausea, vomiting, mild stomach/abdominal pain, bloating, mild pelvic pain, cramps, constipation, injection site reactions (redness, pain, swelling, itching, or irritation), breast tenderness/pain, skin rash, hot flashes, or acne.

The dose of Bravelle to stimulate development of ovarian follicles is individualized for each patient. Bravelle may interact with other drugs. Tell your doctor all medications and supplements you use. Stop using Bravelle when you become pregnant. Bravelle must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Bravelle (urofollitropin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
Bravelle Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

  • stomach pain, bloating;
  • nausea, vomiting, diarrhea;
  • rapid weight gain, especially in your face and midsection;
  • little or no urinating; or
  • pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have signs of a stroke or blood clot, such as:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • stomach cramps or bloating;
  • headache, general pain;
  • nausea;
  • trouble breathing;
  • hot flashes; or
  • mild pelvic pain, pain after an egg is removed for in-vitro fertilization.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bravelle (Urofollitropin Injection)

QUESTION

What is pelvic inflammatory disease (PID)? See Answer
Bravelle Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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

Read the entire FDA prescribing information for Bravelle (Urofollitropin Injection)

© Bravelle Patient Information is supplied by Cerner Multum, Inc. and Bravelle Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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