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Chorionic Gonadotropin (Recombinant)

Pronunciation

(kor ee ON ik goe NAD oh troe pin ree KOM be nant)

Index Terms

  • Choriogonadotropin Alfa
  • r-hCG

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Subcutaneous:

Ovidrel: 250 mcg/0.5 mL (0.5 mL)

Brand Names: U.S.

  • Ovidrel

Pharmacologic Category

  • Gonadotropin
  • Ovulation Stimulator

Pharmacology

Luteinizing hormone analogue produced by recombinant DNA techniques; stimulates late follicular maturation and initiates rupture of the ovarian follicle once follicular development has occurred

Distribution

Vd: 21.4L

Excretion

Urine (10% of dose)

Time to Peak

12-24 hours

Half-Life Elimination

Initial: 4 hours; Terminal: 29 hours

Use: Labeled Indications

As part of an assisted reproductive technology (ART) program, induces ovulation in infertile females who have been pretreated with follicle stimulating hormones (FSH); induces ovulation and pregnancy in infertile females when the cause of infertility is functional

Contraindications

Hypersensitivity to hCG preparations or any component of the formulation; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; uncontrolled organic intracranial lesion (ie, pituitary tumor); abnormal uterine bleeding, ovarian cyst or enlargement of undetermined origin; sex hormone dependent tumors; pregnancy

Dosing: Adult

Assisted reproductive technologies (ART) and ovulation induction in females: SubQ: 250 mcg given 1 day following the last dose of follicle stimulating agent. Use only after adequate follicular development has been determined. Hold treatment when there is an excessive ovarian response.

Dosing: Geriatric

Safety and efficacy have not been established.

Dosing: Renal Impairment

Safety and efficacy have not been established.

Dosing: Hepatic Impairment

Safety and efficacy have not been established.

Administration

For SubQ use only; inject into stomach area. Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).

Storage

Prefilled syringe: Prior to dispensing, store at 2°C to 8°C (36°F to 46°F). Patient may store at 25°C (77°F) for up to 30 days. Protect from light.

Drug Interactions

There are no known significant interactions.

Test Interactions

May interfere with interpretation of pregnancy tests; may cross-react with radioimmunoassay of luteinizing hormone and other gonadotropins

Adverse Reactions

2% to 10%:

Endocrine & metabolic: Ovarian cyst (3%), ovarian hyperstimulation (<2% to 3%)

Gastrointestinal: Abdominal pain (3% to 4%), nausea (3%), vomiting (3%)

Local: Pain at injection site (8%), bruising at injection site (3% to 5%), injection site reaction (<2% to 3%), inflammation at injection site (≤2%)

Miscellaneous: Postoperative pain (5%)

<2% (Limited to important or life-threatening): Abdominal swelling, albuminuria, back pain, breast pain, cardiac arrhythmia, cervical carcinoma, cervical lesion, cough, diarrhea, dizziness, dysuria, ectopic pregnancy, emotional lability, fever, flatulence, headache, heart murmur, herpes genitalis, hiccups, hot flash, hyperglycemia, hypersensitivity reaction, insomnia, intermenstrual bleeding, leukocytosis, leukorrhea, malaise, mastalgia, paresthesia, pharyngitis, pruritus, skin rash, upper respiratory tract infection, urinary incontinence, urinary tract infection, vaginal discomfort, vaginal hemorrhage, vaginitis, vulvovaginal candidiasis

Warnings/Precautions

Concerns related to adverse effects:

• Ovarian enlargement: May be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within 2 to 3 weeks. If ovaries are abnormally enlarged on the last day of treatment, withhold hCG to reduce the risk of ovarian hyperstimulation syndrome (OHSS).

• Ovarian hyperstimulation syndrome: Ovarian hyperstimulation syndrome (OHSS), an exaggerated response to ovulation induction therapy, is characterized by an increase in vascular permeability which causes a fluid shift from intravascular space to third space compartments (eg, peritoneal cavity, thoracic cavity) (ASRM, 2008; SOGC-CFAS, 2011). This syndrome may begin within 24 hours of treatment, but may become most severe 7 to 10 days after therapy (SOGC-CFAS, 2011). OHSS is typically self-limiting with spontaneous resolution, although it may be more severe and protracted if pregnancy occurs (ASRM, 2008). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include abdominal pain that is severe, acute respiratory distress syndrome, anuria/oliguria, ascites, dyspnea, hypotension, nausea/vomiting (intractable), pericardial effusions, tachycardia, or thromboembolism. Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM, 2008; Fiedler, 2012; SOGC-CFAS, 2011). If severe OHSS occurs, stop treatment and consider hospitalizing the patient. (ASRM, 2008; SOGC-CFAS, 2011). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM, 2008; SOGC-CFAS, 2011). The ascitic, pleural, and pericardial fluids may be removed if needed to relieve symptoms (eg, pulmonary distress or cardiac tamponade) (ASRM, 2008; SOGC-CFAS, 2011). Women with OHSS should avoid pelvic examination and/or intercourse (ASRM, 2008; SOGC-CFAS, 2011).

• Thromboembolism: In association with and separate from ovarian hyperstimulation syndrome (OHSS), arterial thromboembolic events have been reported.

Special populations:

• Elderly: Safety and efficacy have not been established in the elderly.

• Pediatric: Safety and efficacy have not been established in children.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).

Other warnings/precautions:

• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.

• Multiple births: May result from the use of these medications; advise patients of the potential risk of multiple births before starting the treatment.

Monitoring Parameters

Ultrasound and/or estradiol levels to assess follicle development; ultrasound to assess number and size of follicles; ovulation (basal body temperature, serum progestin level, menstruation, sonography)

OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary) and liver enzymes (weekly) (ASRM, 2008; SOGC-CFAS, 2011)

Pregnancy Risk Factor

X

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Ectopic pregnancy, premature labor, postpartum fever, and spontaneous abortion have been reported in clinical trials. Congenital abnormalities have also been observed, however, the incidence is similar during natural conception.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), breast pain, angina, vomiting blood, or signs of ovarian hyperstimulation syndrome (severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in amount of urine passed) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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