urofollitropin (Rx)

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Brand and Other Names:Bravelle, Fertinorm HP

Dosing & Uses

AdultPediatric

Ovulation Induction

Initial: 150 International units IM/SC qDay x 5 days

Titrate by 75-150 International units qODay

Maximum dose 450 International units, maximum time 12 days

If patient's response satisfactory, administer hCG one day following the last dose of follitropin

ART (Assisted Reproductive Technology)

Begin on cycle day 2 or 3

Initial dose for women who have received a GnRH agonist for pituitary suppression is 225 IU SC qDay

May be coadministered with menotropins (Menopur), and the total initial dose when the products are combined should not exceed 225 IU (ie, urofollitropin 150 IU and menotropins 75 IU OR urofollitropin 75 IU and menotropins 150 IU)

In most cases, therapy should not exceed 12 days

Consider adjusting the dose after 5 days based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels

Do not make additional dosage adjustments more frequently than q2days or by >75 -150 IU at each adjustment

Continue treatment until adequate follicular development is evident, and then administer hCG

Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome on the last day of urofollitropin therapy

Do not administer daily doses of urofollitropin or urofollitropin in combination with menotropins that exceed 450 IU

Spermatogenesis

Pretreat with hCG until serum testosterone is in normal range

Administer 150 units follitropin 3 times/week with hCG 3 times/week

Continue with lowest dose needed to stimulate spermatogenesis; not to exceed 300 units 3 times/week; may administer for up to 18 months

Safety and efficacy not established

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Adverse Effects

>10%

Headache (11.1%)

OHSS (11.1%; severe pelvic pain, N/V, weight gain)

Frequency Not Defined

Hypertension

Ovarian enlargement

Abdominal cramps

Depression

Emotional lability

Fever

Pain

Breast tenderness

Hot flashes

Ovarian disorder (cyst, pain)

Abdomen enlarged

Abdominal pain

Nausea/vomiting

Weight gain

Uterine spasms

Vaginal discharge/hemorrhage/spotting

Injection site reaction

Postretrieval pain

Postmarketing Reports

Atelectasis

ARDS

Thromboembolic events

Anaphylaxis

Following pregnancy: spontaneous abortion, ectopic pregnancy, premature labor, postpartum fever, congenital abnormalities

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Warnings

Contraindications

Pregnancy; may cause fetal harm

Hypersensitivity

High levels of FSH indicating primary ovarian failure

Presence of uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders)

Sex hormone dependent tumors of the reproductive tract and accessory organ

Tumors of pituitary gland or hypothalamus

Abnormal uterine bleeding of undetermined origin

Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Cautions

Should be administered only by physicians thoroughly experienced in fertility disorders

Hypersensitivity/anaphylactic reactions reported

Ovarian hyperstimulation syndrome (OHSS) reported; OHSS is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event; characterized by dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium

Use lowest effect dose to minimize abnormal ovarian enlargement; if ovaries are enlarged on last day of therapy, do not administer hCG because of risk for OHSS

May cause pulmonary and vascular complications (eg, atelectasis, ARDS)

Ovarian torsion has been reported after treatment with gonadotropins

Multi-fetal gestation and births have been reported with all gonadotropin therapy

Incidence of congenital malformations after some ART (specifically IVF or ICSI) may be slightly higher than after spontaneous conception (likely due to parental characteristics)

Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased

Increased incidence of spontaneous abortion and ovarian neoplasms observed (without causality)

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: Not known if excreted in breast milk, avoid using in breast-feeding women

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Human FSH (obtained from urine of postmenopausal women); stimulates ovarian follicular growth in women with no primary ovarian failure

FSH is responsible for normal follicular growth, gonadal steroid production, spermatogenesis, and follicular maturation

Pharmacokinetics

Half-life: 32-37 hr (single dose regimen); 15.2-20.6 hr (multi-dose regimen)

Peak plasma: 17.4-20.5 hr (single dose regimen); 9.6-11.3 hr (multi-dose regimen)

Vd: 4.4 and 75.9 L

Clearance: Renal: 0.57 ml/min

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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