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GONAL-F RFF
Overview
What is GONAL-F RFF?
Gonal-f RFF (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The biological activity of follitropin alfa has been calibrated against the first International Standard for recombinant human follicle stimulating hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f RFF contains no luteinizing hormone (LH) activity. Based on available data derived from physico-chemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.
Gonal-f RFF is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution.
Each Gonal-f RFF single-dose vial is filled with 82 IU (6 μg) follitropin alfa to deliver 75 IU (5.5 μg) and contains 30 mg sucrose, 1.11 mg dibasic sodium phosphate dihydrate, 0.45 mg monobasic sodium phosphate monohydrate, 0.1 mg methionine, and 0.05 mg polysorbate 20. Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. Vials are reconstituted with Sterile Water for Injection, USP.
Under current storage conditions, Gonal-f RFF may contain up to 10% of oxidized follitropin alfa.
Therapeutic Class: Infertility
What does GONAL-F RFF look like?
What are the available doses of GONAL-F RFF?
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What should I talk to my health care provider before I take GONAL-F RFF?
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How should I use GONAL-F RFF?
Gonal-f RFF (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f RFF is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Each Gonal-f RFF single-dose vial delivers 75 IU follitropin alfa.
What interacts with GONAL-F RFF?
- Gonal-f RFF (follitropin alfa for injection) is contraindicated in women who exhibit:
- Prior hypersensitivity to recombinant FSH preparations or one of their excipients.
- High levels of FSH indicating primary gonadal failure.
- Uncontrolled thyroid or adrenal dysfunction.
- Sex hormone dependent tumors of the reproductive tract and accessory organs.
- An organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin (see "").
- Ovarian cyst or enlargement of undetermined origin (see "").
- Pregnancy.
What are the warnings of GONAL-F RFF?
Throughout this labeling, epidemiological studies reported are of two types: retrospective casecontrol studies and prospective cohort studies. Case-control studies provide an estimate of the relative risk of a disease, which is defined as the of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk (or odds ratio) does not provide information about the actual clinical occurrence of a disease. Cohort studies provide a measure of both the relative risk and the attributable risk. The latter is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence or incidence of a disease in the subject population. For further information, the reader is referred to a text on epidemiological methods.
Overstimulation of the Ovary During FSH Therapy
Ovarian Enlargement
Ovarian Hyperstimulation Syndrome (OHSS)
Pulmonary and Vascular Complications
Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported. In addition, thromboembolic events both in association with, and separate from Ovarian Hyperstimulation Syndrome have been reported with gonadotropins including Gonal-f RFF. Intravascular thrombosis and embolism can result in reduced blood flow to critical organs or the extremities. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death.
Multiple Births
Reports of multiple births have been associated with Gonal-f RFF treatment. In Study 22240 for women receiving Gonal-f RFF over three treatment cycles, 20% of live births were multiple births. In Study 21884, 35.1% of live births were multiple births in women receiving Gonal-f RFF. The rate of multiple births is dependent on the number of embryos transferred. The patient should be advised of the potential risk of multiple births before starting treatment.
What are the precautions of GONAL-F RFF?
General
Careful attention should be given to the diagnosis of infertility in candidates for Gonal-f RFF (follitropin alfa for injection) therapy (see "").
Information for Patients
Prior to therapy with Gonal-f RFF, patients should be informed of the duration of treatment and monitoring of their condition that will be required. The risks of ovarian hyperstimulation syndrome and multiple births in women (see ) and other possible adverse reactions (see "") should also be discussed.
See PATIENT INSTRUCTIONS FOR USE OF GONAL-F RFF".
Laboratory Tests
- A rise in basal body temperature;
- Increase in serum progesterone; and
- Menstruation following a shift in basal body temperature.
- Fluid in the cul-de-sac;
- Ovarian stigmata;
- Collapsed follicle; and
- Secretory endometrium.
In most instances, treatment of women with Gonal-f RFF results only in follicular recruitment and development. In the absence of an endogenous LH surge, hCG is given when monitoring of the patient indicates that sufficient follicular development has occurred. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. The combination of both ultrasound and serum estradiol measurement are useful for monitoring the development of follicles, for timing of the ovulatory trigger, as well as for detecting ovarian enlargement and minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestation. It is recommended that the number of growing follicles be confirmed using ultrasonography because plasma estrogens do not give an indication of the size or number of follicles.
The clinical confirmation of ovulation, with the exception of pregnancy, is obtained by direct and indirect indices of progesterone production. The indices most generally used are as follows:
When used in conjunction with the indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following:
Accurate interpretation of the indices of follicle development and maturation require a physician who is experienced in the interpretation of these tests.
Drug Interactions
No drug/drug interaction studies have been performed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Gonal-f RFF. However, follitropin alfa showed no mutagenic activity in a series of tests performed to evaluate its potential genetic toxicity including, bacterial and mammalian cell mutation tests, a chromosomal aberration test and a micronucleus test.
Impaired fertility has been reported in rats, exposed to pharmacological doses of follitropin alfa (≥40 IU/kg/day) for extended periods, through reduced fecundity.
Pregnancy
See .
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Gonal-f RFF, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
What are the side effects of GONAL-F RFF?
The safety of Gonal-f RFF was examined in two clinical studies [one ovulation induction study (n=83) and one study in ART (n=237)].
Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 22240 (ovulation induction) are listed in Table 4.
Headache occurred in greater than 20% of patients receiving Gonal-f RFF in this study.
Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 21884 (ART) are listed in Table 5.
Headache and abdomen enlargement occurred in more than 10% of patients and abdominal pain occurred in more than 20% of patients.
The following medical events have been reported subsequent to pregnancies resulting from Gonadotropins in controlled clinical studies:
There are no indications that use of gonadotropins during ART is associated with an increased risk of congenital malformations.
The following adverse reactions have been previously reported during Gonal-f RFF therapy:
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
| Body SystemPreferred Term | Gonal-f RFF Patients (%) Experiencing EventsTreatment cycles=176 n=83 |
|---|---|
| Central and Peripheral Nervous System | |
| Headache | 22 (26.5%) |
| Dizziness | 2 (2.4%) |
| Migraine | 3 (3.6%) |
| Gastro-intestinal System | |
| Abdominal Pain | 10 (12.0%) |
| Nausea | 3 (3.6%) |
| Flatulence | 3 (3.6%) |
| Diarrhea | 3 (3.6%) |
| Toothache | 3 (3.6%) |
| Dyspepsia | 2 (2.4%) |
| Constipation | 2 (2.4%) |
| Stomatitis Ulcerative | 2 (2.4%) |
| Neoplasm | |
| Ovarian Cyst | 3 (3.6%) |
| Reproductive, Female | |
| Ovarian Hyperstimulation | 6 (7.2%) |
| Breast Pain Female | 5 (6.0%) |
| Vaginal Haemorrhage | 5 (6.0%) |
| Gynecological-related pain | 2 (2.4%) |
| Uterine haemorrhage | 2 (2.4%) |
| Respiratory System | |
| Sinusitis | 5 (6.0%) |
| Pharyngitis | 6 (7.2%) |
| Rhinitis | 6 (7.2%) |
| Coughing | 2 (2.4%) |
| Application Site | |
| Injection Site Pain | 4 (4.8%) |
| Injection Site Inflammation | 2 (2.4%) |
| Body as a Whole- General | |
| Back Pain | 3 (3.6%) |
| Pain | 2 (2.4%) |
| Fever | 2 (2.4%) |
| Hot Flushes | 2 (2.4%) |
| Malaise | 2 (2.4%) |
| Skin and Appendages | |
| Acne | 3 (3.6%) |
| Urinary System | |
| Micturition Frequency | 2 (2.4%) |
| Cystitis | 2 (2.4%) |
| Resistance Mechanism | |
| Infection viral | 2 (2.4%) | Body SystemPreferred Term | Gonal-f RFF Patients (%) Experiencing Eventsn=237 |
| Gastro-intestinal System | |
| Abdominal Pain | 55 (23.2%) |
| Nausea | 19 (8.0%) |
| Body as a Whole- General | |
| Abdomen Enlarged | 33 (13.9%) |
| Pain | 7 (3.0%) |
| Central and Peripheral Nervous System | |
| Headache | 44 (18.6%) |
| Dizziness | 5 (2.1)% |
| Application Site Disorders | |
| Injection site bruising | 23 (9.7%) |
| Injection site pain | 13 (5.5%) |
| Injection site inflammation | 10 (4.2%) |
| Injection site reaction | 10 (4.2)% |
| Application site edema | 6 (2.5)% |
| Reproductive, Female | |
| Ovarian Hyperstimulation | 11 (4.6%) |
| Intermenstrual Bleeding | 9 (3.8%) |
Postmarketing Experience
In addition to adverse events reported from clinical trials, the following events have been reported during postmarketing use of Gonal-f RFF. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to Gonal-f RFF can not be reliably determined.
Body as a Whole - General:
Respiratory System:
Vascular disorders:
What should I look out for while using GONAL-F RFF?
Gonal-f RFF (follitropin alfa for injection) is contraindicated in women who exhibit:
Gonal-f RFF (follitropin alfa for injection) should only be used by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f RFF is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see ""). Safe and effective use of Gonal-f RFF in women requires monitoring of ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used.
What might happen if I take too much GONAL-F RFF?
Aside from possible ovarian hyperstimulation and multiple gestations (see ), there is no information on the consequences of acute overdosage with Gonal-f RFF (follitropin alfa for injection).
How should I store and handle GONAL-F RFF?
Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6Gonal-f RFF (follitropin alfa for injection) is supplied in a sterile, lyophilized form in single-dose vials containing 82 IU with diluent (Sterile Water for Injection, USP) in a pre-filled syringe. Following reconstitution with the diluent as described, upon administration each vial will deliver a dose of 75 IU.Lyophilized vials may be stored refrigerated or at room temperature (2°- 25°C/36°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.Sterile Water for Injection, USP is provided in a pre-filled syringe. Separate needles are provided for reconstitution (18 G) and administration (29 G).Note: No antimicrobial or other substance has been added to the Sterile Water for Injection for the single-dose vials. Sterile Water for Injection is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.The following package combinations are available:1 vial Gonal-f RFF 75 IU and 1 pre-filled syringe Sterile Water for Injection, USP, 1 mL, 1 reconstitution needle (18 gauge), 1 administration needle (29 gauge), NDC 44087-9005-1 10 vials Gonal-f RFF 75 IU and 10 pre-filled syringes Sterile Water for Injection, USP, 1 mL, 10 reconstitution needles (18 gauge), 10 administration needles (29 gauge), NDC 44087-9005-6
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Single-dose pharmacokinetics of follitropin alfa were determined following subcutaneous administration of 300 IU Gonal-f RFF to 21 pre-menopausal healthy female volunteers who were pituitary down-regulated with a GnRH agonist.
The descriptive statistics for the pharmacokinetic parameters are presented in Table 1.
Non-Clinical Toxicology
Gonal-f RFF (follitropin alfa for injection) is contraindicated in women who exhibit:Gonal-f RFF (follitropin alfa for injection) should only be used by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f RFF is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see ""). Safe and effective use of Gonal-f RFF in women requires monitoring of ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used.
No drug/drug interaction studies have been performed.
Careful attention should be given to the diagnosis of infertility in candidates for Gonal-f RFF (follitropin alfa for injection) therapy (see "").
The safety of Gonal-f RFF was examined in two clinical studies [one ovulation induction study (n=83) and one study in ART (n=237)].
Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 22240 (ovulation induction) are listed in Table 4.
Headache occurred in greater than 20% of patients receiving Gonal-f RFF in this study.
Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 21884 (ART) are listed in Table 5.
Headache and abdomen enlargement occurred in more than 10% of patients and abdominal pain occurred in more than 20% of patients.
The following medical events have been reported subsequent to pregnancies resulting from Gonadotropins in controlled clinical studies:
There are no indications that use of gonadotropins during ART is associated with an increased risk of congenital malformations.
The following adverse reactions have been previously reported during Gonal-f RFF therapy:
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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