Version May 2024
Note: Dose should be individualized. Use the lowest dose consistent with the expectation of good results. Over the course of treatment, doses may vary depending on individual patient response.
Multifollicular development during assisted reproductive technology (ART): SubQ:
Note: For the first treatment cycle, individual daily doses are based on serum anti-Mullerian hormone (AMH) levels and body weight (measured without shoes and coat just prior to start of stimulation). Individual daily dose should be maintained throughout the stimulation period. Adequate follicular development is generally achieved by the ninth day of treatment (range: 5 to 20 days).
First treatment cycle:
AMH <15 pmol/L (irrespective of body weight): 12 mcg/day.
AMH ≥15 pmol/L: Dose is dependent upon AMH levels (expressed in pmol/L); daily dose decreases from 0.19 to 0.1 mcg/kg by increasing AMH levels. Refer to manufacturer labeling for detailed dosing information.
Maximum dose: 12 mcg/day.
Note: As soon as ≥3 follicles ≥17 mm are observed, hCG should be administered to induce final follicular maturation. If patient has excessive ovarian response (>25 follicles with diameter ≥12 mm) do not induce final follicular maturation with hCG and cycle should be cancelled.
Subsequent treatment cycles: Note: Dose is based on ovarian response to previous cycle.
Adequate response: Maintain daily dose.
Hypo-response: May increase daily dose by 25% based on extent of response.
Hyper-response: Limited data; consult health care provider.
Maximum dose: 24 mcg/day.
Missed doses:Do not double the next dose; health care provider monitoring treatment should be notified.
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.
1% to 10%:
Central nervous system: Headache (1% to 5%), fatigue (2%), nipple pain (1%)
Endocrine & metabolic: Ovarian hyperstimulation syndrome (≤3%)
Gastrointestinal: Nausea (1% to 2%)
Genitourinary: Pelvic cramps (2% to 4%), pelvic pain (2%), uterine pain (1% to 2%)
Hematologic & oncologic: Polyp (1%, uterine)
Immunologic: Antibody development (1%)
<1%, postmarketing, and/or case reports: Abdominal distress, breast tenderness, constipation, diarrhea, dizziness, drowsiness, emotional lability, mastalgia, ovarian torsion, vaginal hemorrhage, vomiting
Hypersensitivity to follitropins or any component of the formulation; tumor of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; breastfeeding; gynecologic bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; primary ovarian failure; malformations of sexual organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy
Concerns related to adverse effects:
• Abortion: Risk of spontaneous abortion is increased with the use of gonadotropins; causal effect has not been established.
• Ectopic pregnancy: Risk for ectopic pregnancy may be increased in women with tubal abnormalities; intrauterine pregnancy should be confirmed early with ultrasound.
• Ovarian enlargement: 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: OHSS is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012) that may be life threatening. This syndrome may begin within 24 hours of treatment, but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, supportive care. and prevention of thromboembolic complications (ASRM 2016). Therapy with gonadotropins should be stopped.
• Ovarian neoplasms: Benign and malignant neoplasms have been reported in women receiving multiple-drug therapy for controlled ovarian stimulation; causal effect has not been established.
• 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 with gonadotropin therapy.
Disease-related concerns:
• Thromboembolic disorders: Women with a current or past history of thromboembolic disorders or with risk factors (eg, personal or family history, severe obesity, thrombophilia) may be at increased risk for occurrence or worsening of arterial or venous thromboembolic events during or following gonadotropin treatment; increased risks are also observed with pregnancy and OHSS.
Other warnings/precautions:
• Appropriate use: To minimize risks, use only at the lowest effective dose. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis.
• 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 the use of these medications; advise patient of the potential risk of multiple births before starting the treatment.
Not available in the US.
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Cartridge, Subcutaneous:
Rekovelle: 12 mcg/0.36 mL ([DSC]); 36 mcg/1.08 mL ([DSC]); 72 mcg/2.16 mL ([DSC]) [contains phenol]
Solution Pen-injector, Subcutaneous:
Rekovelle: 12 mcg/0.36 mL (0.36 mL); 36 mcg/1.08 mL (1.08 mL); 72 mcg/2.16 mL (2.16 mL) [contains phenol]
SubQ: Administer subQ preferably in the abdomen. The first injection should be administered under the supervision of a health care provider; self-administration of subsequent injections by the patient is at the discretion of the monitoring prescriber. Prefilled cartridges are to be used in conjunction with Rekovelle injection pen.
Note: Not approved in the US.
Multifollicular development during assisted reproductive technology: To stimulate the development of multiple follicles in women undergoing assisted reproductive technology (ART)
None known.
There are no known significant interactions.
Follitropin delta is used for the induction of ovulation. During the course of therapy, if ovaries become abnormally enlarged, treatment may be adjusted to reduce the risk of ovarian hyperstimulation syndrome (OHSS). In this situation, patients should be advised to abstain from intercourse or to use barrier contraceptive methods for at least 4 days.
Follitropin delta is used for the induction of ovulation; use is contraindicated in females who are already pregnant.
Ectopic pregnancy, congenital abnormalities, spontaneous abortion, and multiple births have been reported. The incidence of congenital abnormality may be slightly higher after assisted reproductive technology (ART) than with spontaneous conception; higher incidence may be related to parenteral characteristics (maternal age, sperm characteristics).
It is not known if follitropin delta is present in breast milk.
Follitropin delta is contraindicated with breastfeeding.
Prior to therapy: Rule out pregnancy and primary ovarian failure; endocrinologic and gynecologic assessment (including pelvic anatomy); fertility potential of partner; serum anti-Mullerian hormone (AMH) to determine initial dose (Note: Manufacturer recommends use of Elecsys AMH immunoassay to determine levels).
During therapy: Monitor sufficient follicular maturation. This may be directly estimated by sonographic visualization of the ovaries and endometrial lining or measuring serum estradiol levels. The combination of both ultrasonography and measurement of estradiol levels is useful for monitoring for the growth and development of follicles and timing hCG administration (ASRM 2008b).
Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks following hCG administration.
Mild/moderate OHSS symptoms may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012).
Follitropin delta is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin. Follitropins stimulate ovarian follicular growth in women who do not have primary ovarian failure (ASRM 2008a; ASRM 2008b).
Onset of action: Peak effect: Follicle development: Within cycle
Distribution: Vdss: 9 L
Bioavailability: SubQ: ~64%
Half-life elimination: SubQ: 40 hours (single dose); 28 hours (daily administration)
Time to peak: SubQ: 20 hours (single dose); 10 hours (once daily administration for 7 days)
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