Gonal-f RFF Redi-ject 450 [iU]/.75mL
FOLLITROPIN · INJECTION, SOLUTION · EMD Serono, Inc.
Gonal-f RFF Redi-ject is a injection, solution containing follitropin at 450 [iU]/.75mL, taken subcutaneous. Manufactured by EMD Serono, Inc..
Key Facts
- Brand Name
- Gonal-f RFF Redi-ject
- Generic Name
- FOLLITROPIN
- NDC Code (Product)
44087-1116- Manufacturer
- EMD Serono, Inc.
- Strength
- 450 [iU]/.75mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA021684
- Drug Class
- Gonadotropin [EPC]
- Marketing Start
- 10/16/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GONAL-f ® RFF Redi-ject ® is a prefilled gonadotropin-containing auto-injection device indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure ( 1.1 ) Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle ( 1.2 ) 1.1 Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation Exclude primary ovarian failure Exclude the possibility of pregnancy Demonstrate tubal patency Evaluate the fertility status of the male partner 1.2 Development of Multiple Follicles in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility Exclude the possibility of pregnancy Evaluate the fertility status of the male partner
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Ovulation Induction ( 2.2 ) Initial starting dose of the first cycle - 75 International Units of GONAL-f ® RFF Redi-ject ® per day for 14 days, administered subcutaneously Individualization doses after 14 days Doses larger than 300 International Units of FSH per day are not recommended Assisted Reproductive Technology ( 2.3 ) Initial starting dose of the first cycle - 150 International Units per day, administered subcutaneously Dosage adjustments after 3-5 days and by 75-150 International Units at each adjustment Do not administer doses greater than 450 International Units per day 2.1 General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GONAL-f ® RFF Redi-ject ® is a pre-filled disposable auto-injection device intended for multiple dose use. GONAL-f ® RFF Redi-ject ® can be set in 12.5 International Units increments. Administer GONAL-f ® RFF Redi-ject ® subcutaneously in the abdomen as described in Instructions for Use Do not attempt to mix any other medications inside of the device with GONAL-f ® RFF Redi-ject ® . Instruc…
Contraindications
4 CONTRAINDICATIONS GONAL-f ® RFF Redi-ject ® is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH products High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1 , 1.2) ] Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome GONAL-f ® RFF Redi-ject ® is contraindicated in women who exhibit ( 4 ): Hypersensitivity to recombinant FSH preparations or one of their excipients High levels of FSH indicating primary gonadal failure Uncontrolled non-gonadal endocrinopathies Sex hormone dependent tumors of the reproductive tract and accessory organ. Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been performed.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions and Anaphylaxis [see Warnings and Precautions (5.1) ] Abnormal Ovarian Enlargement [see Warnings and Precautions (5.2) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.3) ] Atelectasis, acute respiratory distress syndrome and exacerbation of asthma [see Warnings and Precautions (5.4) ] Thromboembolic events [see Warnings and Precautions (5.4) ] Ovarian Torsion [see Warnings and Precautions (5.5) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.6) ] Congenital Malformations [see Warnings and Precautions (5.7) ] Ectopic Pregnancy [see Warnings and Precautions (5.8) ] Spontaneous Abortion [see Warnings and Precautions (5.9) ] Ovarian Neoplasms [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥5%) in ovulation induction include: headache, abdominal pain, ovarian hyperstimulation ( 6.1 ) The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, injection site bruising ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283…
Frequently Asked Questions
What is Gonal-f RFF Redi-ject used for?
Gonal-f RFF Redi-ject contains FOLLITROPIN. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Gonal-f RFF Redi-ject a controlled substance?
Gonal-f RFF Redi-ject is not classified as a controlled substance by the DEA.
What is the generic name for Gonal-f RFF Redi-ject?
The generic name for Gonal-f RFF Redi-ject is FOLLITROPIN. There are 4 other brand versions of FOLLITROPIN.
What is the NDC code for Gonal-f RFF Redi-ject 450 [iU]/.75mL?
The NDC (National Drug Code) for Gonal-f RFF Redi-ject 450 [iU]/.75mL is 44087-1116, listed by EMD Serono, Inc..