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Drug overview for GONAL-F (follitropin alfa, recomb):
Generic name: FOLLITROPIN ALFA, RECOMB (FOL-i-TROE-pin AL-fa)
Drug class: Follicle-Stimulating Hormone (FSH)
Therapeutic class: Endocrine
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
Generic name: FOLLITROPIN ALFA, RECOMB (FOL-i-TROE-pin AL-fa)
Drug class: Follicle-Stimulating Hormone (FSH)
Therapeutic class: Endocrine
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
DRUG IMAGES
GONAL-F 1,050 UNITS VIAL
GONAL-F 450 UNITS VIAL
The following indications for GONAL-F (follitropin alfa, recomb) have been approved by the FDA:
Indications:
Follicle stimulation for assisted fertilization procedure
Hypogonadotropic hypogonadism
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
Multifollicular development for assisted reproductive technologies
Indications:
Follicle stimulation for assisted fertilization procedure
Hypogonadotropic hypogonadism
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
Multifollicular development for assisted reproductive technologies
The following dosing information is available for GONAL-F (follitropin alfa, recomb):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GONAL-F 450 UNITS VIAL | Maintenance | Adults inject 150 unit by subcutaneous route once daily |
| GONAL-F 1,050 UNITS VIAL | Maintenance | Adults inject 225 unit by subcutaneous route once daily |
No generic dosing information available.
The following drug interaction information is available for GONAL-F (follitropin alfa, recomb):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for GONAL-F (follitropin alfa, recomb):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 8 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Estrogen-dependent neoplasm |
| Hormone receptor positive breast cancer |
| Malignant neoplasm of the ovary |
| Malignant neoplasm of the uterus |
| Malignant tumor of testis |
| Pituitary neoplasm |
| Pregnancy |
| Tumor of hypothalamus |
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Abnormal uterine bleeding |
| Acute respiratory distress syndrome |
| Adrenocortical insufficiency |
| Pituitary insufficiency |
| Thromboembolic disorder |
| Thrombophilia |
| Torsion of ovary |
| Untreated hypothyroidism |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Morbid obesity |
| Ovarian hyperstimulation syndrome |
The following adverse reaction information is available for GONAL-F (follitropin alfa, recomb):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Ovarian cyst Ovarian enlargement Ovarian hyperstimulation syndrome |
Hypotension Migraine |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Anaphylaxis Arterial thrombosis Asthma exacerbation Cerebrovascular accident Dyspnea Hypersensitivity drug reaction Pulmonary thromboembolism Thromboembolic disorder Torsion of ovary |
There are 34 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Abnormal vaginal bleeding Acne vulgaris Acute abdominal pain Diarrhea Flatulence Flu-like symptoms Headache disorder Mastalgia Mood changes Nausea Pelvic pain Pharyngitis Sinusitis Upper respiratory infection |
Anorexia Candidiasis Chest pain Dizziness Drowsy Dysmenorrhea Dyspepsia Dysplasia of cervix Gynecomastia Injection site sequelae Nervousness Palpitations Polydipsia Pruritus of skin Vaginal discharge Vomiting Weight gain |
| Rare/Very Rare |
|---|
|
Facial edema Urticaria |
The following precautions are available for GONAL-F (follitropin alfa, recomb):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for GONAL-F (follitropin alfa, recomb):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GONAL-F (follitropin alfa, recomb)'s list of indications:
| Follicle stimulation for assisted fertilization | |
| Z31.83 | Encounter for assisted reproductive fertility procedure cycle |
| Z31.89 | Encounter for other procreative management |
| Z52.81 | Egg (oocyte) donor |
| Z52.810 | Egg (oocyte) donor under age 35, anonymous recipient |
| Z52.811 | Egg (oocyte) donor under age 35, designated recipient |
| Z52.812 | Egg (oocyte) donor age 35 and over, anonymous recipient |
| Z52.813 | Egg (oocyte) donor age 35 and over, designated recipient |
| Z52.819 | Egg (oocyte) donor, unspecified |
| Hypogonadotropic hypogonadism | |
| E23.0 | Hypopituitarism |
| Infertility associated with anovulation | |
| N97.0 | Female infertility associated with anovulation |
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