Version May 2024
Note: Follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome.
Infertility, ovulation induction: SUBQ: Follicle-stimulating hormone (FSH) 150 units/luteinizing hormone (LH) 75 units once daily. If an increase in FSH is necessary, dose may be adjusted in increments of FSH 37.5 to 75 units every 7 to 14 days using an approved follitropin alfa preparation. Duration of stimulation in any 1 cycle may be extended up to 5 weeks (treatment should be individualized based on response to prior cycle). Administer human chorionic gonadotropin 24 to 48 hours after the last dose of FSH/LH.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
Frequency not defined:
Gastrointestinal: Abdominal pain, constipation, flatulence, nausea
Genitourinary: Dysmenorrhea, mastalgia, ovarian cyst, pelvic pain
Local: Injection-site reaction
Nervous system: Fatigue, headache
Postmarketing:
Gastrointestinal: Abdominal distention, abdominal distress, diarrhea, vomiting
Genitourinary: Ovarian hyperstimulation syndrome
Hypersensitivity: Hypersensitivity reaction (including anaphylactic shock and anaphylaxis)
Respiratory: Exacerbation of asthma
Hypersensitivity to follitropin alfa, lutropin alfa or any component of the formulation; primary ovarian failure or anovulation with normal levels of LH and FSH; uncontrolled thyroid or adrenal dysfunction; tumors of the hypothalamus or pituitary gland; ovarian enlargement or cyst of undetermined origin; gynecological hemorrhages of undetermined origin; sex hormone dependent tumors of the reproductive tract and accessory organs; current pregnancy or lactation
Concerns related to adverse effects:
• Ectopic pregnancy: Risk for ectopic pregnancy may be increased in patients with tubal abnormalities.
• Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported.
• Ovarian enlargement: Mild or moderate uncomplicated ovarian enlargement may be accompanied by abdominal distention or abdominal pain in patients treated with gonadotropins. This generally regresses without treatment within 2 to 3 weeks.
• Ovarian hyperstimulation syndrome: Ovarian hyperstimulation syndrome (OHSS) is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate signs/symptoms of OHSS may include abdominal distention/discomfort, diarrhea, nausea, and mild/moderate enlargement of ovaries/ovarian cysts; severe signs/symptoms of OHSS may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012).
• Ovarian torsion: Has been reported following gonadotropin treatment; may be related to OHSS, prior ovarian torsion, prior or current ovarian cyst, polycystic ovaries, pregnancy, or prior abdominal surgery. Early diagnosis and prompt detorsion may limit the extent of ovarian damage.
• Pulmonary effects: Serious pulmonary conditions (atelectasis, acute respiratory distress syndrome, and exacerbation of asthma) have been reported.
• Thromboembolic events: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with thromboembolic disease or risk factors for thromboembolic events.
Disease-related concerns:
• Porphyria: Gonadotropins may increase the risk of an acute porphyric attack in patients with porphyria or a family history of porphyria; discontinuation of therapy may be necessary with onset or worsening of condition.
Other warnings/precautions:
• Appropriate use: To minimize risks, use only at the lowest effective dose.
• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.
• Multiple births: Multiple births may result from use; advise patients of the potential risk of multiple births before starting the treatment. Consider discontinuing or converting to assisted reproductive technology if >2 follicles are mature prior to triggering ovulation.
Not available in the US
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Subcutaneous:
Pergoveris: Follitropin alfa 150 units and lutropin alfa 75 units ([DSC])
SUBQ: Administer by SUBQ injection into the abdomen or upper thigh. Rotate injection site daily. Do not shake solution; allow any bubbles to settle prior to administration.
Infertility, ovulation induction: Stimulation of follicular development in patients with hypogonadotropic hypogonadism who have severe luteinizing hormone (LH) deficiency (LH <1.2 units/L) and follicle-stimulating hormone (FSH) deficiency (FSH ≤5 units/L) and are candidates for combination therapy with FSH and LH.
None known.
There are no known significant interactions.
This combination is intended for the treatment of infertility in patients with hypogonadotropic hypogonadism who have severe luteinizing hormone and follicle-stimulating hormone deficiency. If ovarian hyperstimulation syndrome develops and treatment is interrupted, barrier contraception is recommended for at least 4 days.
Use is contraindicated in patients who are pregnant.
Pregnancy rates following use of this formulation are similar to those reported to an in vitro pregnancy registry (Bühler 2014).
Refer to individual monographs for additional information.
Use is contraindicated in patients who are breastfeeding.
Refer to individual monographs for additional information.
Prior to initiation of therapy, a thorough gynecologic and endocrinologic evaluation must be performed; pregnancy should be ruled out. Confirm luteinizing hormone <1.2 units/L and follicle-stimulating hormone <5 units/L; patient should also have a negative progestin challenge test.
Monitor serum estradiol levels, as well as follicular growth, by transvaginal ultrasound to determine adequate ovarian response and timing of human chorionic gonadotropin (hCG) administration.
Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks following hCG administration. Initial symptoms of moderate to severe OHSS may include a sensation of bloating, abdominal pain, rapid weight gain, and decreased urine output (Shmorgun 2017).
Ovarian hyperstimulation syndrome: Monitoring of hospitalized patients should include serum albumin, degree of ascites, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, hydration status, serum creatinine, urine output, urine-specific gravity, signs of thromboembolism, vital signs, weight (daily or as necessary), and liver enzymes (weekly) (Shmorgun 2017).
See individual agents.
See individual agents.
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