Repronex


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menotropins

Menopur, Repronex

Pharmacologic class: Hormone

Therapeutic class: Exogenous gonadotropin

Pregnancy risk category X

Action

Simulates action of follicle-stimulating hormone (FSH) by promoting follicular growth and maturation

Availability

Injection (powder or pellet for reconstitution): 75 international units luteinizing hormone (LH); 150 international units LH and 150 international units FSH activity/vial

Indications and dosages

Controlled ovarian stimulation in patients with oligoanovulation

Women: Dosage individualized. Recommended dosage is 150 international units I.M. or subcutaneously daily during first 5 days of treatment, with subsequent dosages adjusted based on response. Adjust dosage no more often than every 2 days, and don't exceed 75 to 150 international units per adjustment. Maximum daily dosage is 450 international units. Dosing beyond 12 days is not recommended. If response is appropriate, human chorionic gonadotropin (hCG) should be given I.M. 1 day after last menotropins dose.

Assisted reproductive technologies

Women: In patients who've received gonadotropin-releasing hormone agonists or antagonist pituitary suppression, recommended initial dosage is 225 international units I.M. or subcutaneously, with subsequent dosage adjustments based on response. Adjust dosage no more often than every 2 days, and don't exceed 75 to 150 international units per adjustment. Maximum daily dosage is 450 international units. Dosing beyond 12 days isn't recommended. Once adequate follicular development appears, hCG is given to induce follicular maturation in preparation for oocyte retrieval.

Contraindications

• Hypersensitivity to drug
• High FSH levels (indicating primary ovarian failure)
• Abnormal bleeding of undetermined origin
• Uncontrolled thyroid or adrenal dysfunction
• Organic intracranial lesion (such as pituitary tumor)
• Causes of infertility other than anovulation (unless patient is candidate for in vitro fertilization)
• Ovarian cysts or enlargement not caused by polycystic ovarian syndrome
• Pregnancy

Precautions

Use cautiously in:
• renal or hepatic insufficiency (safety and efficacy not established)
• breastfeeding patients.

Administration

• Know that drug may be given either I.M. or subcutaneously.
• To reconstitute powder or pellet for injection, add accompanying 2 ml of 0.9% sodium chloride injection to vial.
• Inject immediately after reconstitution. Discard unused portion.
• Rotate injection sites.
• Use lower abdomen for subcutaneous injection.
• Withhold hCG if serum estradiol level exceeds 2,000 pg/ml or abdominal pain occurs.

Adverse reactions

CNS: headache, malaise, dizziness, cerebrovascular accident

CV: tachycardia, venous thrombophlebitis, arterial occlusion, arterial thromboembolism

GI: nausea, vomiting, diarrhea, abdominal cramps and distention, hemoperitoneum

GU: ovarian enlargement with pain, gynecomastia, ovarian cysts, multiple births, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy

Metabolic: electrolyte imbalances

Musculoskeletal: muscle aches, joint pain

Respiratory: dyspnea, tachypnea, atelectasis, adult respiratory distress syndrome, pulmonary embolism, pulmonary infarction

Skin: rash

Other: fever, hypersensitivity reaction, anaphylaxis

Interactions

None significant

Patient monitoring

• Know that before starting menotropins/hCG therapy to induce ovulation and pregnancy, patient should undergo gynecologic and endocrine evaluation with hysterosalpingogram to rule out pregnancy and neoplastic lesions.
• Assess patient to confirm anovulation. Obtain urinary gonadotropin levels as ordered to rule out primary ovarian failure. (Male partner's fertility should be evaluated, also).
• In older females (who have greater risk of anovulatory disorders and endometrial cancer), assess cervical dilation and curettage results.
• Evaluate patient for expected ovarian stimulation without hyperstimulation.

Monitor for early indications of OHSS-severe pelvic pain, nausea, vomiting, and weight gain. OHSS usually occurs 2 weeks after treatment ends, peaks 7 to 10 days after ovulation, and resolves with menses onset.

If OHSS occurs, drug is withdrawn and patient is hospitalized for bed rest, fluid and electrolyte management, and analgesics. Monitor daily fluid intake and output, weight, abdominal girth, hematocrit, serum and urinary electrolytes, urine specific gravity, blood urea nitrogen, and creatinine. Watch for hemoconcentration caused by fluid loss into peritoneal, pleural, and pericardial cavities.

Stay alert for pulmonary and thromboembolic complications.
• Assess male patient for pituitary insufficiency as possible cause of infertility.

Patient teaching

• Before therapy, teach patient about duration of treatment and necessary monitoring.
• Inform patient about risk of multiple births with menotropins and hCG use.
• For infertile females, encourage daily intercourse starting on day before hCG administration.
• As appropriate, review all other significant and life-threatening adverse reactions.

menotropins

(men-oh-troe-pins) ,

HMG

(trade name),

Menopur

(trade name),

Pergonal

(trade name),

Repronex

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: gonadotropins
Pregnancy Category: X

Indications

Used in conjunction with chorionic gonadotropin to stimulate ovulation in patients with ovarian dysfunction and resultant infertility.Used in conjunction with chorionic gonadotropin to stimulate spermatogenesis in male patients with hypogonadotropic hypogonadism and resultant infertility.As part of assisted reproductive technologies (ART) to stimulate the production of multiple oocytes in ovulatory patients.

Action

A purified form of human pituitary gonadotropins consisting of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). In women, FSH causes growth and maturation of the ovarian follicle. LH causes ovulation and development of the corpus luteum. In men, LH causes spermatogenesis.

Therapeutic effects

Ovulation or spermatogenesis, with resultant fertility.

Pharmacokinetics

Absorption: Appears to be well absorbed after IM administration.
Distribution: Unknown.
Metabolism and Excretion: 8% excreted unchanged in the urine.
Half-life: FSH—70 hr; LH—4 hr.

Time/action profile (effects on reproductive function†)

ROUTEONSETPEAKDURATION
IM, subcut (women)unknown18 hrunknown
IM (men)unknown4 mounknown
†Women—peak = ovulation after chorionic gonadotropins; men—peak = increased spermatogenesis

Contraindications/Precautions

Contraindicated in: Vaginal bleeding of unknown cause; Uterine fibroid tumors; Ovarian cysts; Pregnancy.
Use Cautiously in: Asthma; CV disease; Seizure disorders; Migraine headaches; Polycystic ovaries; Pituitary hypertrophy or tumor; Severe renal impairment.

Adverse Reactions/Side Effects

Cardiovascular

  • thromboembolism (life-threatening)
  • edema
  • thrombophlebitis

Gastrointestinal

  • abdominal pain (most frequent)
  • bloating (most frequent)
  • diarrhea
  • nausea
  • vomiting

Genitourinary

  • pelvic pain (most frequent)
  • multiple births
  • ovarian enlargement

Endocrinologic

  • gynecomastia (men)

Miscellaneous

  • fever

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Subcutaneous Intramuscular (Adults) Repronex—Infertile patients with oligo-anovulation—150 units FSH and 150 units LH daily for first 5 days of treatment after GnRH agonist or antagonist pituitary suppression, dosage adjustments may be made every 2 days and should not exceed 75–150 units/adjustment (not to exceed 450 units/day or more than 12 days of therapy). If response is appropriate, hCG should be given after discontinuation of menotropins. Assisted reproduction technologies—225 units FSH and 225 units LH daily after GnRH agonist or antagonist pituitary suppression, dosage adjustments may be made every 2 days and should not exceed 75–150 units/adjustment (not to exceed 450 units/day or more than 12 days of therapy) followed by chorionic gonadotropin.
Intramuscular (Adults —females) Pergonal—75 units FSH and 75 units LH/day for 7–12 days followed by hCG if ovaries are not enlarged. If pregnancy does not occur, dose may be doubled for 2–3 more courses.
Intramuscular (Adults —males) Pergonal—following pretreatment with hCG alone, 75 units FSH activity and 75 units LH 3 times weekly concurrently with hCG, dose may be doubled if ineffective after 4 mo.

Availability

Powder for injection: 75 units FSH activity and 75 units LH activity in vial, 150 units FSH activity and 150 units LH activity in vial

Nursing implications

Nursing assessment

  • Female Infertility: Gynecologic and endocrine examinations to determine the cause of infertility should be completed before therapy. The patient’s partner should also be evaluated for possible decreased fertility. An endometrial biopsy should be performed in older patients to rule out the presence of endometrial carcinoma.
  • Ultrasound exams are recommended during menotropin therapy and before administration of chorionic gonadotropin.
  • Male Infertility: Urologic and endocrine examinations to determine the cause of infertility should be completed before therapy.
  • Lab Test Considerations: In female infertility, cervical mucus volume and character, serum estradiol levels, serum or urine progesterone concentrations, and ultrasound may be used to determine whether follicular maturation has occurred.
    • In male infertility, serum testosterone, sperm count, and motility should be evaluated before and after course of therapy.

Potential Nursing Diagnoses

Sexual dysfunction (Indications)
Disturbed body image (Indications)

Implementation

  • Female infertility—chorionic gonadotropin is usually administered 1 day after course of human menotropins. Male infertility—chorionic gonadotropin is administered alone until secondary sex characteristics develop, then administered concurrently with menotropins.
  • Subcutaneous: Alternating sites in the lower abdomen should be used for subcut injection.
  • Intramuscular: Reconstitute powder with 2-mL vial of 0.9% NaCl for injection provided by manufacturer. Use immediately; discard any unused portion of dose.

Patient/Family Teaching

  • Instruct patient in correct technique for medication reconstitution and administration of IM injection. Ensure that patient understands medication administration schedule.
  • Female Infertility: Instruct patient in the correct method for measuring basal body temperature. A record of the daily basal body temperature should be maintained before and throughout course of therapy.
    • Reinforce physician’s instructions regarding timing of sexual intercourse (usually daily beginning 1 day after administration of chorionic gonadotropin).
    • Emphasize the importance of close monitoring by the physician throughout course of therapy (daily pelvic examinations are indicated after estrogen levels rise and for 2 wk after chorionic gonadotropin therapy).
    • Inform patient before therapy of the potential for multiple births.
    • Instruct patient to notify physician immediately if pregnancy is suspected (menses do not occur when expected and basal body temperature is biphasic).
    • Advise patient to report to physician signs and symptoms of fluid retention (swelling of ankles and feet, weight gain), thromboembolic disorders (pain, swelling, tenderness in extremities, headache, chest pain, blurred vision), or abdominal or pelvic pain or bloating.
  • Male Infertility: Inform patient that breast enlargement may occur. Physician should be consulted if this is problematic.

Evaluation/Desired Outcomes

  • Follicular maturation in women. Menotropin therapy is followed by human chorionic gonadotropin, which should lead to ovulation with subsequent pregnancy. If ovulation does not occur after any cycle, therapeutic regimen should be re-evaluated. If ovulation does not occur after 3 cycles, appropriateness of continuation of menotropin therapy should be reconsidered.
  • Increased spermatogenesis after 4 mo of therapy in men.

Repronex®

CenterWatch, menotropins PA, Repronal Gynecology A proprietary generic equivalent of Pergonal® for treating infertility. See Infertility.
References in periodicals archive ?
I had major allergic reaction to the Repronex and then to discover it is derived by menopausal women's urine I was floored
Following the initiation of Lupron, ovarian stimulation drugs, called gonadotropins, such as follicle stimulating hormone (FSH; Fertinex, Gonal-F, Serono Laboratories, Randolph, MA) and possibly, human menopausal gonadotropin (hMG; Repronex, Ferring Pharmaceuticals Inc.
CHAPTER 5 METHODS OF TREATMENT 63 FERTILITY PHARMACEUTICALS 63 INTRODUCTION AND TYPES 63 Antagon 64 Bravelle 65 Cetrotide 65 Clomid 65 Crinone and Prometrium 66 Fertinex 67 Follistim 67 Gonal-F 67 Humegon 68 Lupron 68 Novarel 68 Ovidrel 69 Parlodel 69 Pregnyl 69 Profasi 69 Prometrium 69 Repronex 69 Serophene 70 TABLE 8 SELECTED PRESCRIPTION FERTILITY DRUGS 70 MARKET REVENUES AND FORECAST 71 TABLE 9 MARKET SIZE OF GLOBAL INFERTILITY PHARMACEUTICALS AT U.
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), NOVAREL (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, LYSTEDA (tranexamic acid tablets), FIRMAGON (degarelix for injection), and EUFLEXXA (1% sodium hyaluronate).
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR and REPRONEX (menotropins for injection, USP), Novarel (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, LYSTEDA(TM) (tranexamic acid tablets), FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), Novarel (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, LYSTEDA(TM) (tranexamic acid tablets), FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), and EUFLEXXA (1 percent sodium hyaluronate).
They include: LYSTEDA tablets, BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), NOVAREL (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), NOVAREL (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), NOVAREL (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, LYSTEDA(TM) (tranexamic acid) tablets, FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).
They include: BRAVELLE (urofollitropin for injection, purified), MENOPUR (menotropins for injection, USP) and REPRONEX (menotropins for injection, USP), NOVAREL (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).
They include: LYSTEDA(TM) (tranexamic acid), BRAVELLE (urofollitropin for injection, purified), MENOPUR and REPRONEX (menotropins for injection, USP), Novarel (chorionic gonadotropin for injection, USP), ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, FIRMAGON (degarelix for injection), PROSED DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA (1% sodium hyaluronate).