Gonal-F Lyophilisate For Solution For Injection 1050iu Drug Medication Dosage Information
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Gonal-f: Lyophilisate for solution for injection (1050IU)

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What is this Medicine?

FOLLITROPIN ALFA (fol li TROE pin AL fa) helps stimulate the development of eggs within the ovary. It is used to treat women who have not been able to become pregnant because of problems with ovulation. This drug is also used in certain in vitro fertilization programs. For some men with infertility, this medicine helps to stimulate the production of sperm.

In-Depth Information

Gonal-f 1050unit Powder for Injection

NDC: 440879070
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Hypogonadism, Oligospermia, Infertility

Storage Information
Store unreconstituted product between 36 and 77 degrees F
Store reconstituted product in refrigerator (36 to 46 degrees F) or between 36 to 77 degrees F for use within 28 days
Protect from light
Gonal-f 1050unit Powder for Injection

Reported Side Effects for Gonal-f 1050unit Powder for Injection

Increased Urination Incidence:
<2.4%*
Severity: MILD
Onset: EARLY
Bladder Infection Incidence:
<2.4%*
Severity: MODERATE
Onset: DELAYED
Yeast Infection Incidence:
<2.5%*
Severity: MODERATE
Onset: DELAYED
Rhinitis Incidence:
0.8-7.2%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
1.0-2.0%*
Severity: MODERATE
Onset: EARLY
Vaginal Bleeding Incidence:
1.0-3.6%*
Severity: MODERATE
Onset: DELAYED
Paresthesias Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Vaginal Discharge Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
1.0-2.0%*
Severity: MILD
Onset: EARLY
Vaginal Discharge Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Injection Site Reaction Incidence:
1.0-6.7%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
1.0-2.5%*
Severity: MILD
Onset: EARLY
Chest Pain Incidence:
1.0-2.0%*
Severity: MODERATE
Onset: EARLY
Decreased Appetite Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Nervousness Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
1.0-2.0%*
Severity: MILD
Onset: RAPID
Tooth Pain Incidence:
1.0-3.6%*
Severity: MILD
Onset: DELAYED
Muscle Pain Incidence:
1.0-2.0%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
1.0-2.0%*
Severity: MODERATE
Onset: RAPID
Drowsiness Incidence:
1.0-2.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
1.0-2.3%*
Severity: MILD
Onset: EARLY
Cough Incidence:
1.7-2.4%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
1.7-2.4%*
Severity: MILD
Onset: EARLY
Constipation Incidence:
>2.0%*
Severity: MODERATE
Onset: DELAYED
Gynecomastia Incidence:
>2.0%*
Severity: MILD
Onset: DELAYED
Pelvic Pain Incidence:
2.0-7.1%*
Severity: MILD
Onset: DELAYED
Increase In Breast Size Incidence:
>2.0%*
Severity: MILD
Onset: DELAYED
Fever Incidence:
2.4-4.2%*
Severity: MILD
Onset: EARLY
Hot Flashes Incidence:
2.4%*
Severity: MODERATE
Onset: EARLY
Feeling Sick Incidence:
2.4%*
Severity: MILD
Onset: EARLY
Mouth Ulcers Incidence:
2.4%*
Severity: MODERATE
Onset: DELAYED
Menstrual Cramps Incidence:
2.5%*
Severity: MILD
Onset: DELAYED
Sore Throat Incidence:
2.5-7.2%*
Severity: MILD
Onset: DELAYED
Irregular Periods Incidence:
2.5%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
2.9-12.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
3.3%*
Severity: MILD
Onset: EARLY
Weight Gain Incidence:
3.6%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
3.6-13.6%*
Severity: MILD
Onset: EARLY
Fluid Retention Incidence:
3.6%*
Severity: MODERATE
Onset: EARLY
Migraine Incidence:
3.6%*
Severity: MODERATE
Onset: EARLY
Gas Incidence:
3.6-6.8%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
3.6-7.6%*
Severity: MILD
Onset: EARLY
Acne Incidence:
3.6-59.0%*
Severity: MILD
Onset: DELAYED
Ovarian Hyperstimulation Syndrome (OHSS) Incidence:
3.9-7.6%*
Severity: SEVERE
Onset: DELAYED
Breast Pain Incidence:
4.2-13.6%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
5.1%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
5.1-6.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
6.7-26.5%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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