Infertility and Fertility Preservation Form

Gonadotropins requiring prior authorization are: menotropins (Menopur®); follitropin alfa, recombinant (Gonal-f® multi-dose, Gonal-f® RFF, Gonal-f® RFF Redi-ject); follitropin beta, recombinant (Follistim® AQ); choriogonadotropin alfa (Ovidrel®); human chorionic gonadotropin (hCG; generic, Novarel®, Pregnyl®). Gonadotropin-releasing hormone (GnRH) antagonists requiring prior authorization are: ganirelix acetate; Cetrorelix (Cetrotide®). _ *Sections I.A., I.B., I.C., II.A., II.B.: Infertility/Fertility Preservation All lines of business: pharmacy benefit coverage is required. HIM line of business • AZ: Infertility - limited to diagnostic rendered for infertility evaluation; Fertility Preservation - medically necessary services and supplies for standard fertility preservation treatments are covered when a cancer treatment may directly or indirectly cause iatrogenic infertility. Iatrogenic infertility is infertility that is caused by a medical intervention, including reactions from prescribed drugs or from medical or surgical procedures that may be provided for cancer treatment.
• CA: Fertility Preservation – covers medically necessary services and supplies for established fertility preservation treatments in connection with iatrogenic Infertility; Infertility - with the exception of covered fertility preservation services, services or supplies that are intended to impregnate a woman are not covered. Excluded procedures include, but are not limited to:
o Conception by medical procedures, such as artificial insemination, in-vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), or any process that involves harvesting, transplanting or manipulating a human ovum. Also not covered are services and supplies (including injections and injectable medications) which prepare the covered person to receive these services; o Services and supplies for the purpose of diagnosing the cause of infertility. • KS: Limited to diagnostic testing to find the cause of infertility, such as diagnostic laparoscopy, endometrial biopsy and semen analysis. Benefits are included to treat the underlying medical conditions that cause infertility (such as endometriosis, obstructed fallopian tubes and hormone deficiency). • MI: Covered is available for medically necessary diagnostic and exploratory procedures to determine infertility, including surgical procedures and prescription drugs, to correct a medically diagnosed disease or condition of the reproductive organs including, but not limited to, treatment of the following endometriosis, collapsed/clogged fallopian tubes, or testicular failure. • NE: Coverage is available for diagnosis and services required to correct underlying medical causes of infertility • NJ: Subject to pre-approval, covered charges include: artificial insemination; and standard dosages, lengths of treatment and cycles of therapy of prescription drugs used to stimulate ovulation for artificial insemination or for unassisted conception • NM: Limited to diagnostic tests and services to treat the underlying medical condition that may cause infertility (e.g., endometriosis, obstructed fallopian tubes and hormone deficiency). • NC: Limited to diagnostic testing to find the cause of infertility, such as diagnostic laparoscopy, endometrial biopsy and semen analysis. Treatment of the underlying medical conditions that cause infertility (such as Page 1 of 16

CLINICAL POLICY Infertility and Fertility Preservation • endometriosis, obstructed fallopian tubes and hormone deficiency)are considered a separate benefit. Treatment for infertility is limited to a lifetime benefit maximum, per member, of three medical ovulation induction cycles. SC: Limited to medical services provided to the member which are medically necessary for the diagnosis of infertility and services required to correct underlying medical conditions that may cause infertility (e.g., endometriosis). This does not include treatment for infertility, including artificial insemination, in vitro fertilization and other types of artificial or surgical means of conception nor drugs administered in connection with these procedures.
• All other states: No benefits will be paid under this benefit provision for services provided or expenses incurred for infertility drugs, unless otherwise listed on the formulary.
FDA Approved Indication(s) Drugs Drug Name Brand Name Drug Class Indications, Female OI ART HH Indications, Male Prepubertal Cryptorchidism Menotropin Menopur Gonadotropin (hMG

• FSH and LH) Gonadotropin (FSH) x x Gonal-f Follitropin alfa, recombinant Follitropin alfa, recombinant Follitropin alfa, recombinant Follitropin beta, recombinant Ganirelix acetate Cetrorelix Choriogonadotropin alfa Human chorionic gonadotropin Human chorionic gonadotropin Gonal-f RFF Gonadotropin (FSH) x Gonadotropin (FSH) x Gonal-f RFF Redi-ject Follistim-AQ Gonadotropin (FSH) x N/A Cetrotide Ovidrel x GnRH antagonist x GnRH antagonist Gonadotropin (hCG) x Novarel Gonadotropin (hCG) x Pregnyl Gonadotropin (hCG) x x x x x x x x x x x x x x x x x Abbreviations: ART: assisted reproductive technology; GnRH: gonadotropin-releasing hormone; HH: hypogonadotropic hypogonadism; hCG: human chorionic gonadotropin (produced by the placenta after implantation); hMG: human menopausal gonadotropin (combination of LH and FSH); OI: ovulation induction
  • Menopur is indicated for: o Development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology (ART) cycle. • Gonal-f is indicated for: o Induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure (known as primary ovarian insufficiency; POI).
  o Development of multiple follicles in the ovulatory infertile women as part of an ART cycle/program. o Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure (i.e. primary hypogonadism). Page 2 of 16

  CLINICAL POLICY Infertility and Fertility Preservation • Gonal-F RFF and Gonal-f RFF Redi-ject are indicated for: o Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to POI. o Development of multiple follicles in ovulatory infertile women as part of an ART cycle/program. • Follistim AQ is indicated for: o Induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to POI. o Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle [ART cycle]. o Induction of spermatogenesis in men with primary and secondary HH in whom the cause of infertility is not due to primary testicular failure. • Ganirelix is indicated for: o Inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH). • Cetrotide is indicated for: o The inhibition of premature LH surges in women undergoing COH. • Ovidrel is indicated for: o 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 (FSH) as part of an ART program such as IVF and embryo transfer. o Induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to POI. • Novarel and Pregnyl are indicated for: o Prepubertal cryptorchidism not due to anatomic obstruction. o Selected cases of HH secondary to a pituitary deficiency in males o Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to POI, and who has been appropriately pretreated with human menotropins. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
  It is the policy of health plans affiliated with Centene Corporation® that Menopur, Gonal-f, Gonal-f RFF, Gonal f RFF Redi-ject, Follistim-AQ, ganirelix acetate, Cetrotide, Ovidrel, Novarel, and Pregnyl are medically necessary when the following criteria are met:
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  CLINICAL POLICY Infertility and Fertility Preservation I. Initial Approval Criteria
  A. Infertility, Female (must meet all):

  1. Member must have infertility/fertility preservation coverage (optional pharmacy benefit);
  2. Diagnosis of infertility;
  3. Age ≥ 18 years;
  4. Prescribed by or in consultation with a reproductive endocrinologist;
  5. The requested drug(s) is for one of the following (a or b): a. OI, and both of the following (i and ii): i. Member has been diagnosed with an ovulatory disorder; ii. If the ovulatory disorder is secondary to hyperprolactinemia, failure of dopamine agonist treatment, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); b. ART, and both of the following (i and ii): i. If infertility is secondary to an ovulatory disorder, member has failed OI or is not a candidate for OI (e.g., member has been diagnosed with tubal blockage, uterine cavity abnormality, diminished ovarian reserve; member’s partner has been diagnosed with severe male factor infertility). ii. If unexplained infertility, failure of at least 3 cycles of clomiphene citrate or letrozole (see Appendix B) combined with intrauterine insemination, unless contraindicated or clinically significant adverse effects are experienced;
  6. Member does not have POI. Approval duration: 30 days or up to specified trial duration if available
     B. Fertility Preservation, Female (must meet all):
  7. Member must have infertility/fertility preservation coverage (optional pharmacy benefit);
  8. Request is for fertility preservation (embryo or oocyte cryopreservation) secondary to planned gonadotoxic therapy or gonadectomy;
  9. Member meets one of the following (a or b): a. Age ≥ 18 years and (i and ii): i. Member has received fertility preservation counseling (documented); ii. Member has executed an informed consent; b. Of reproductive age (peri/postpubertal - off-label use) and member meets both of the following (i and ii): i. All consent/assent signees have received fertility preservation counseling (documented); ii. Parent(s)/guardian(s) and member have executed informed consents and assents respectively;
  10. Prescribed by or in consultation with a reproductive endocrinologist;
  11. Member does not have POI. Approval duration: 30 days or up to specified trial duration if available
      C. Infertility, Male (must meet all):
  12. Member must have infertility/fertility preservation coverage (optional pharmacy benefit); Page 4 of 16

  CLINICAL POLICY Infertility and Fertility Preservation

  2. Request is for Gonal-f, Follistim-AQ, Novarel or Pregnyl;
  3. Diagnosis of infertility due to HH;
  4. Prescribed by or in consultation with a reproductive endocrinologist or urologist;
  5. Age ≥ 18 years;
  6. Product(s) are requested in one of the following ways (a or b): a. Novarel or Pregnyl as single-agent therapy to increase testosterone to the normal range (400 to 800 ng/dL); b. Gonal-f or Follistim-AQ in combination with either Novarel or Pregnyl to induce spermatogenesis once serum testosterone is within the normal range;
  7. Testosterone therapy is not prescribed concomitantly;
  8. Member does not have primary testicular failure. Approval duration: 6 months
     D. Prepubertal Cryptorchidism (undescended testes) (must meet all):
  9. Request is for Novarel or Pregnyl;
  10. Diagnosis of prepubertal cryptorchidism;
  11. Prescribed by or in consultation with a pediatric specialist in one of the following areas: endocrinology, urology, genetics, surgery;
  12. Age ≤ 9 years;
  13. One of the following (a or b): a. Member is not a candidate for corrective surgery; b. hCG will be used in coordination with surgery. Approval duration: 3 months E. Other diagnoses/indications (must meet 1 or 2):
  14. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
  15. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Infertility and Fertility Preservation, Female (must meet all):
  16. Member must have infertility/fertility preservation coverage (optional pharmacy benefit); Page 5 of 16

  CLINICAL POLICY Infertility and Fertility Preservation

  2. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  3. Member is responding positively to therapy;
  4. Request is for an OI or ART cycle currently underway. Approval duration: 30 days or up to specified trial duration if available
     (For additional reproductive attempts please refer to the initial criteria.) B. Infertility, Male (must meet all):
  5. Member must have infertility/fertility preservation coverage (optional pharmacy benefit);
  6. Request is for Gonal-f, Follistim-AQ, Novarel or Pregnyl;
  7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  8. Member is responding positively to therapy;
  9. If request is for Novarel or Pregnyl, one of the following (a or b): a. Pregnancy has not yet been achieved; b. Pregnancy has been achieved, and another pregnancy is being considered;
  10. If request is for Gonal-f or Follistim-AQ, both of the following (a and b): a. Prescribed in combination with Novarel or Pregnyl; b. Current reproductive attempt has not yet achieved pregnancy (if pregnancy has been achieved, refer to initial criteria for subsequent Gonal-F or Follistim-AQ requests). Approval duration: 6 months
      C. Prepubertal Cryptorchidism (undescended testes) (must meet all):
  11. Request is for Novarel or Pregnyl;
  12. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  13. Member is responding positively to therapy.
  14. Member has not received more than 3 months of therapy;
      Approval duration: 3 months Page 6 of 16

  CLINICAL POLICY Infertility and Fertility Preservation D. Other diagnoses/indications (must meet 1 or 2):

  1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
  2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
     III. Diagnoses/Indications for which coverage is NOT authorized:
     A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Treatment of obesity. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ART: assisted reproductive technology ASCO: American Society of Clinical Oncology AYA: adolescent and young adult COH: controlled ovarian hyperstimulation FDA: Food and Drug Administration FSH: follicle-stimulating hormone GnRH: gonadotropin-releasing hormone hCG: human chorionic gonadotropin HH: hypogonadotropic hypogonadism Appendix B: Therapeutic Alternatives
     Drug Name Dosing Regimen hMG: human menopausal gonadotropin
     ICSI: intracytoplasmic sperm injection IVF: in vitro fertilization LH: luteinizing hormone NCCN: National Comprehenswive Cancer Network OI: ovulation induction POI: primary ovarian insufficiency, primary ovarian failure Dose Limit/ Maximum Dose 1 mg twice weekly cabergoline Hyperprolactinemia (labeled): Initial: 0.25 mg PO twice weekly; may increase by 0.25 mg twice weekly (no more often than every 4 weeks) up to a maximum or 1 mg twice weekly according to the patient’s serum prolactin level. Page 7 of 16

  CLINICAL POLICY Infertility and Fertility Preservation Drug Name Dosing Regimen bromocriptine (Parlodel®) clomiphene citrate letrozole (Femara®) Hyperprolactinemia (labeled):
  Initial: 1.25 to 2.5 mg PO daily; may be increased by 2.5 mg daily as tolerated every 2 to 7 days until optimal response (range: 2.5 to 15 mg/day). Treatment of ovulatory dysfunction in women desiring pregnancy (labeled): Initial: 50 mg PO once daily for 5 days. Begin on or about the fifth day of cycle if progestin-induced bleeding is scheduled or spontaneous uterine bleeding occurs prior to therapy. Therapy may be initiated at any time in patients with no recent uterine bleeding. Subsequent doses may be increased to 100 mg once daily for 5 days only if ovulation does not occur at the initial dose. If needed, the 5-day cycle may be repeated as early as 30 days after the previous one. Exclude the presence of pregnancy. The lowest effective dose should be used. Maximum dose: 100 mg once daily for 5 days for up to 6 cycles. Infertility - ovulation stimulation in anovulatory females (off-label): Initial: 2.5 mg PO once daily for 5 days, starting on day 3, 4, or 5 following menses or progestin induced bleed; may increase to 5 mg/day for 5 days in subsequent cycles if ovulation does not occur.
  Dose Limit/ Maximum Dose 15 mg/day 150 mg/day
  per expert review Durations: 5 to 7 days per expert review 7.5 mg/day Durations: 5 to 7 days per expert review Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): pregnancy; for additional contraindications, please refer to the product package inserts • Boxed warning(s): none reported Appendix D: General Information • Female Infertility o OI refers to pharmacological treatment of anovulation with fertility medications to induce ovulation. OI is used in conjunction with intercourse or intrauterine insemination. o ART procedures include but are not limited to 1) in vitro fertilization (IVF), 2) intracytoplasmic sperm injection (ICSI), and 3) assisted reproductive hatching. IVF is the most common type of ART. An IVF interval generally is two weeks in length and includes 1) ovarian stimulation with fertility medications to induce development of multiple ovarian follicles/oocytes (i.e., COH), 2) aspiration and fertilization of oocyte(s) in the laboratory setting ("in vitro"), and then 3) transfer of the embryo(s) into the uterine cavity.
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  CLINICAL POLICY Infertility and Fertility Preservation • Male Infertility o Male infertility secondary to HH is amendable to treatment with fertility drugs. Once reproductive attempts are complete, transition to testosterone replacement therapy is an option if needed for long-term treatment. • Prepubertal Males: cryptorchidism o Corrective surgery for cryptorchidism (orchidopexy) is considered first-line therapy. Surgery and/or gonadotropin therapy typically would be completed by 24 months of age to avoid potential negative fertility and cancer risk sequelae. • Fertility Medications o Fertility medications are used together in coordinated individualized regimens. The regimens in Section V: Dosage and Administration are presented as general guidelines drawn from FDA labels and expert input. Care should be taken not to interrupt a reproductive attempt currently underway. • Fertility Preservation o For females, ART may be preferable to OI in cases of fertility preservation (embyro or oocyte cryopreservation) secondary to planned gonadotoxic therapy or gonadectomy.
  Gonadotoxic therapies or gonadectomy may be undertaken as treatment for cancer as well as benign autoimmune or hematologic conditions such as systemic lupus erythematosus, multiple sclerosis, autoimmune thrombocytopenia, rheumatoid arthritis, Wegener’s granulomatosis and Behçet’s disease. o For males, various fertility preservation strategies are available but do not typically involve the medications central to the present policy. *See Practice Committee of the American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril, 2019;112:1022-33, for more information in this regard.
  o The American Society of Clinical Oncology (ASCO, 2018), American Society for Reproductive Medicine (ASRM, 2018/2019), Society for Assisted Reproductive Technology (SART)/ASRM (2007), and National Comprehensive Cancer Network (NCCN, 2023) provide guidance for fertility preservation prior to gonadotoxic medical treatment for patients of reproductive age as well as prepubertal patients. Selected ASCO recommendations are listed below:
   Adult women • Recommendation 3.1. Embryo cryopreservation is an established fertility preservation method, and it has routinely been used for storing surplus embryos after in vitro fertilization.
  • Recommendation 3.2. Cryopreservation of unfertilized oocytes is an option, and may be especially well suited to women who do not have a male partner, do not wish to use donor sperm, or have religious or ethical objections to embryo freezing. • Recommendation 3.5 (updated). There is conflicting evidence to recommend GnRH agonists and other means of ovarian suppression for fertility preservation. The Panel recognizes that, when proven fertility preservation methods such as oocyte, embryo, or ovarian tissue cryopreservation are not feasible, and in the setting of young women with breast cancer, GnRH agonists may be offered to patients in the hope of reducing the likelihood of chemotherapy-induced ovarian insufficiency. However, GnRH agonists should not be used in place of proven fertility preservation methods. Page 9 of 16

  CLINICAL POLICY Infertility and Fertility Preservation • Recommendation 3.6 (updated). Ovarian tissue cryopreservation for the purpose of future transplantation does not require ovarian stimulation and can be performed immediately. In addition, it does not require sexual maturity and hence may be the only method available in children. Finally, this method may also restore global ovarian function. However, it should be noted further investigation is needed to confirm whether it is safe in patients with leukemias.  Adult men • Recommendation 2.1. Sperm cryopreservation is effective, and health care providers should discuss sperm banking with postpubertal males receiving cancer treatment.
  • Recommendation 2.2. Hormonal gonadoprotection: Hormonal therapy in men is not successful in preserving fertility. It is not recommended.
  • Recommendation 2.3. Other methods, such as testicular tissue cryopreservation and reimplantation or grafting of human testicular tissue, should be performed only as part of clinical trials or approved experimental protocols.
   Special Considerations: Children:
  • Recommendation 5.1. Suggest established methods of fertility preservation (eg, semen or oocyte cryopreservation) for postpubertal children, with patient assent and parent or guardian consent. For prepubertal children, the only fertility preservation options are ovarian and testicular cryopreservation, which are investigational.
  V. Dosage and Administration
  Dosing Regimen Maximum Dose Drug Name Infertility, Female
  Follicle stimulating agents Menopur (menotropins) Gonal-f, Gonal-f RFF, Gonal-f RFF Redi-ject (follitropin alpha, recombinant) Follistim-AQ (follitropin beta, recombinant) Pituitary suppression agents Ganirelix acetate Cetrotide (cetrorelix) Ovulatory “trigger” agents Ovidrel (choriogonadotropin alfa; recombinant hCG) hCG (Novarel, Pregnyl; urinary hCG) Up to 450 IU SC per day Up to 450 SC IU per day Up to 500 IU SC per day 250 mcg SC per day 0.25 mg SC per day 250 mcg SC once 5,000 to 10,000 USP Units IM once • Doses are individualized. • Duration typically would not exceed one month per reproductive attempt; there may be exceptions. • Doses and durations as noted above. • Doses are individualized. • An agent from this category is typically Page 10 of 16

  CLINICAL POLICY Infertility and Fertility Preservation Drug Name Dosing Regimen Infertility, Male: Due to hypogonadotropic hypogonadism Novarel, Pregnyl (hCG) Gonal-f (follitropin alfa, recombinant) Follistim-AQ (follitropin beta, recombinant) Dosing may range from 500 to 4,000 USP Units IM on BIW/TIW schedules for up to 12 months to achieve/maintain normal testosterone levels. 150 to 300 IU SC TIW up to 18 months in combination with hCG at the dose required to maintain normal testosterone levels. 150 to 225 IU SC on BIW/TIW schedules up to 12 months in combination with hCG at the dose required to maintain normal testosterone levels.
  Prepubertal Cryptorchidism
  Novarel, Pregnyl (hCG) Dosing may range from 500 to 5,000 IM USP Units with varying schedules (e.g., every 2nd/3rd day, TIW) with prn repeat courses up to 3 months.
  Maximum Dose given once per reproductive attempt. Regimens and maximum doses/durations vary; single agent hCG therapy followed by follitropin/hCG combination therapy may extend up to 24 months or at times longer.
  Regimens and maximum doses vary. Maximum duration: 3 months. VI. Product Availability
  Drug Name Menopur Gonal-F multi dose vial Gonal-F RFF single dose vial: Gonal-F RFF Redi-ject Follistim-AQ Ganirelix acetate Cetrotide
  Ovidrel Novarel Pregnyl Chorionic gonadotropin (hCG) Availability Injection: 75 U FSH and 75 U LH/vial Injection: 450 U/vial; 1,050 U/vial Injection: 75 U/vial Prefilled auto-injection device: 300 U/0.5 mL, 450 U/0.75 mL, 900 U/1.5 mL Injection cartridge: 150 U, 300 U, 600 U, 900 U Prefilled syringe: 250 mcg/0.5 mL Injection: 0.25 mg/vial Prefilled syringe: 250 mcg/0.5 mL Injection: 5,000 U/vial, 10,000 U/vial Injection: 10,000 U/vial Injection: 10,000 U/vial VII.