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Ovidrel
Overview
What is Ovidrel?
Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated α and β - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the α - chain of r-hCG is identical to that of the α - chain of hCG, FSH and LH. The glycoform pattern of the α - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The β - chain has both O- and N-glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG.
The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity. The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the "Chorionic Gonadotrophins" monograph of the European Pharmacopoeia. The biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin.
Ovidrel PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection. Each Ovidrel PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5.
Therapeutic Class: Infertility
What does Ovidrel look like?
What are the available doses of Ovidrel?
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What should I talk to my health care provider before I take Ovidrel?
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How should I use Ovidrel?
Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as fertilization and embryo transfer. Ovidrel PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
For Subcutaneous Use Only
What interacts with Ovidrel?
- Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit:
- Prior hypersensitivity to hCG preparations or one of their excipients.
- Primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An uncontrolled organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin (see ).
- Ovarian cyst or enlargement of undetermined origin (see ).
- Sex hormone dependent tumors of the reproductive tract and accessory organs.
- Pregnancy.
What are the warnings of Ovidrel?
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What are the precautions of Ovidrel?
General
Careful attention should be given to the diagnosis of infertility in candidates for hCG therapy. (see ""). After the exclusion of pre-existing conditions, elevations in ALT were found in 10 (3%) of 335 patients receiving Ovidrel 250 µg, 9 (10%) of 89 patients receiving Ovidrel 500 µg and in 16 (4.8%) of 328 patients receiving urinary-derived hCG. The elevations ranged up to 1.2 times the upper limit of normal. The clinical significance of these findings is not known.
Information for Patients
Prior to therapy with hCG, 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.
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
- Secretory endometrium
In most instances, treatment of women with FSH 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 serum estrogens do not give an indication of the size or number of follicles.
Human chorionic gonadotropins can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on hCG if gonadotropin levels are requested.
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 ovulation require a physician who is experienced in the interpretation of these tests.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic potential of Ovidrel in animals have not been performed. genotoxicity testing of Ovidrel in bacteria and mammalian cell lines, chromosome aberration assay in human lymphocytes and in-vivo mouse micronucleus have shown no indication of genetic defects.
Pregnancy
Intrauterine death and impaired parturition were observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times the maximum human dose of 10,000 USP, based on body surface area.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if hCG is administered to a nursing woman.
Pediatric Patients
Safety and effectiveness in pediatric patients has not been established.
Geriatric Patients
Safety and effectiveness in geriatric patients has not been established.
What are the side effects of Ovidrel?
(see )
The safety of Ovidrel was examined in four clinical studies that treated 752 patients of whom 335 received Ovidrel 250 µg following follicular recruitment with gonadotropins. When patients enrolled in four clinical studies (3 in ART and one in OI) were injected subcutaneously with either Ovidrel or an approved urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel 250 µg group experienced application site disorders compared to 28% (92 of 328 patients) in the approved u-hCG group. Adverse events reported for Ovidrel 250 µg occurring in at least 2% of patients (regardless of causality) are listed in Table 9 for the 3 ART studies and in Table 10 for the single OI study.
Adverse events not listed in Table 9 that occurred in less than 2% of patients treated with Ovidrel 250 µg whether or not considered causally related to Ovidrel, included: injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma.
Additional adverse events not listed in Table 10 that occurred in less than 2% of patients treated with Ovidrel 250 µg, whether or not considered causally related to Ovidrel, included: breast pain, flatulence, abdominal enlargement, pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.
The following medical events have been reported subsequent to pregnancies resulting from hCG therapy in controlled clinical studies:
Of 125 clinical pregnancies reported following treatment with FSH and Ovidrel 250 µg or 500 µg, three were associated with a congenital anomaly of the fetus or newborn. Among patients receiving Ovidrel 250 µg, cranial malformation was detected in the fetus of one woman and a chromosomal abnormality (47, XXX) in another. These events were judged by the investigators to be of unlikely or unknown relation to treatment. These three events represent an incidence of major congenital malformations of 2.4%, which is consistent with the reported rate for pregnancies resulting from natural or assisted conception. In a woman who received Ovidrel 500 µg, one birth in a set of triplets was associated with Down's syndrome and atrial septal defect. This event was considered to be unrelated to the study drug.
The following adverse reactions have been previously reported during menotropin 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 System | Ovidrel 250 µg(n=236) |
|---|---|
| Preferred Term | Incidence Rate% (n) |
| At Least One Adverse Event | 33.1% (78) |
| Application Site Disorders | 14.0% (33) |
| Injection Site Pain | 7.6% (18) |
| Injection Site Bruising | 4.7% (11) |
| Gastro-Intestinal System Disorders | 8.5% (20) |
| Abdominal Pain | 4.2% (10) |
| Nausea | 3.4% ( 8) |
| Vomiting | 2.5% ( 6) |
| Secondary Terms (Post-Operative Pain) | 4.7% (11) |
| Post-Operative Pain | 4.7% (11) |
| Body System | Ovidrel 250 µg(n=99) |
| Preferred Term | Incidence Rate% (n) |
| At Least One Adverse Event | 26.2% (26) |
| Application Site Disorders | 16.2% (16) |
| Injection site pain | 8.1% (8) |
| Injection site inflammation | 2.0% (2) |
| Injection site bruising | 3.0% (3) |
| Injection site reaction | 3.0% (3) |
| Reproductive Disorders, Female | 7.1% (7) |
| Ovarian cyst | 3.0% (3) |
| Ovarian hyperstimulation | 3.0% (3) |
| Gastro-Intestinal System Disorders | 4.0% (4) |
| Abdominal pain | 3.0% (3) |
Post-Marketing Experience
In addition to adverse events reported from clinical trials, the following events have been reported during post-marketing use of Ovidrel. Therefore, these events were reported from a population of uncertain size, the frequency or causal relationship to Ovidrel cannot be reliably determined.
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What should I look out for while using Ovidrel?
Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit:
Gonadotropins, including Ovidrel PreFilled Syringe (choriogonado-tropin alfa injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other hCG products, Ovidrel PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. The risks of gonadoptropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history. 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 induction of ovulation and use of Ovidrel PreFilled Syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.
What might happen if I take too much Ovidrel?
Sorry No Records found
How should I store and handle Ovidrel?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAOvidrel PreFilled Syringe (choriogonadotropin alfa injection) is supplied in a sterile, liquid single dose pre-filled 1 mL syringe. Each Ovidrel PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL.The following package combination is available:Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is supplied in a sterile, liquid single dose pre-filled 1 mL syringe. Each Ovidrel PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL.The following package combination is available:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
When given by intravenous administration, the pharmacokinetic profile of Ovidrel followed a biexponential model and was linear over a range of 25 µg to 1000 µg. Pharmacokinetic parameter estimates following SC administration of Ovidrel 250 µg to females are presented in Table 1.
Non-Clinical Toxicology
Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit:Gonadotropins, including Ovidrel PreFilled Syringe (choriogonado-tropin alfa injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other hCG products, Ovidrel PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. The risks of gonadoptropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history. 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 induction of ovulation and use of Ovidrel PreFilled Syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.
Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.
Careful attention should be given to the diagnosis of infertility in candidates for hCG therapy. (see ""). After the exclusion of pre-existing conditions, elevations in ALT were found in 10 (3%) of 335 patients receiving Ovidrel 250 µg, 9 (10%) of 89 patients receiving Ovidrel 500 µg and in 16 (4.8%) of 328 patients receiving urinary-derived hCG. The elevations ranged up to 1.2 times the upper limit of normal. The clinical significance of these findings is not known.
(see )
The safety of Ovidrel was examined in four clinical studies that treated 752 patients of whom 335 received Ovidrel 250 µg following follicular recruitment with gonadotropins. When patients enrolled in four clinical studies (3 in ART and one in OI) were injected subcutaneously with either Ovidrel or an approved urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel 250 µg group experienced application site disorders compared to 28% (92 of 328 patients) in the approved u-hCG group. Adverse events reported for Ovidrel 250 µg occurring in at least 2% of patients (regardless of causality) are listed in Table 9 for the 3 ART studies and in Table 10 for the single OI study.
Adverse events not listed in Table 9 that occurred in less than 2% of patients treated with Ovidrel 250 µg whether or not considered causally related to Ovidrel, included: injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma.
Additional adverse events not listed in Table 10 that occurred in less than 2% of patients treated with Ovidrel 250 µg, whether or not considered causally related to Ovidrel, included: breast pain, flatulence, abdominal enlargement, pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.
The following medical events have been reported subsequent to pregnancies resulting from hCG therapy in controlled clinical studies:
Of 125 clinical pregnancies reported following treatment with FSH and Ovidrel 250 µg or 500 µg, three were associated with a congenital anomaly of the fetus or newborn. Among patients receiving Ovidrel 250 µg, cranial malformation was detected in the fetus of one woman and a chromosomal abnormality (47, XXX) in another. These events were judged by the investigators to be of unlikely or unknown relation to treatment. These three events represent an incidence of major congenital malformations of 2.4%, which is consistent with the reported rate for pregnancies resulting from natural or assisted conception. In a woman who received Ovidrel 500 µg, one birth in a set of triplets was associated with Down's syndrome and atrial septal defect. This event was considered to be unrelated to the study drug.
The following adverse reactions have been previously reported during menotropin 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/"
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