Urofollitropin-injection

Headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: clomiphene, gonadorelin.

Do not share this medication with others.Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol level, liver tests, ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

Your pharmacist can provide more information about urofollitropin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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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

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