Safety Information for FOLLISTIM® AQ Cartridge (follitropin beta injection)

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Safety Information

INDICATIONS: FOLLISTIM AQ Cartridge is indicated for the induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure.

SELECTED SAFETY INFORMATION: CONTRAINDICATIONS: FOLLISTIM AQ Cartridge is contraindicated in women who exhibit any of the following: prior hypersensitivity to recombinant human follicle-stimulating hormone (hFSH) products; high levels of FSH indicating primary gonadal failure; presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders); hypersensitivity reactions to streptomycin or neomycin (FOLLISTIM AQ may contain traces of these antibiotics.); tumors of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; or ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS).

INDICATIONS

FOLLISTIM AQ Cartridge is indicated for the induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure.

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS: FOLLISTIM AQ Cartridge is contraindicated in women who exhibit any of the following: prior hypersensitivity to recombinant human follicle-stimulating hormone (hFSH) products; high levels of FSH indicating primary gonadal failure; presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders); hypersensitivity reactions to streptomycin or neomycin (FOLLISTIM AQ may contain traces of these antibiotics.); tumors of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; or ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS).

Patient Information Prescribing Information

INDICATIONS

FOLLISTIM AQ Cartridge is indicated for the induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure.

FOLLISTIM AQ Cartridge is also indicated for pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Prior to initiation of treatment with FOLLISTIM AQ Cartridge for OI or IVF/ICSI:

Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of the cause of infertility.
The possibility of pregnancy should be excluded.
The fertility status of the male partner should be evaluated.

Additionally, for women undergoing OI:

Primary ovarian failure should be excluded.
Tubal patency should be demonstrated.

Selected Safety Information About FOLLISTIM AQ Cartridge

CONTRAINDICATIONS

FOLLISTIM AQ Cartridge is contraindicated in women who exhibit any of the following: prior hypersensitivity to recombinant human follicle-stimulating hormone (hFSH) products; high levels of FSH indicating primary gonadal failure; presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders); hypersensitivity reactions to streptomycin or neomycin (FOLLISTIM AQ may contain traces of these antibiotics.); tumors of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; or ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS).

WARNINGS AND PRECAUTIONS

FOLLISTIM AQ Cartridge should be prescribed only by physicians who are experienced in infertility treatment. FOLLISTIM AQ Cartridge contains a potent gonadotropic substance capable of causing ovarian hyperstimulation syndrome (OHSS) with or without pulmonary or vascular complications and multiple births. Gonadotropin therapy requires the availability of appropriate monitoring facilities.

Abnormal Ovarian Enlargement

In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with FOLLISTIM AQ therapy, treatment should be individualized and the lowest effective dose should be used. Intercourse should be prohibited in patients with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from ruptured ovarian cysts.

Ovarian Hyperstimulation Syndrome

OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical condition. OHSS occurs after gonadotropin treatment has been discontinued, and it can develop rapidly, reaching its maximum about 7 to 10 days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is a risk for OHSS evident prior to human chorionic gonadotropin (hCG) administration, the hCG must be withheld. Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least 2 weeks after hCG administration. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the patient needs to be hospitalized. During clinical trials with FOLLISTIM or FOLLISTIM AQ Cartridge therapy, OHSS occurred in 7.6% of 105 women (ovulation induction) and 6.4% of 751 women (IVF or ICSI) treated with FOLLISTIM and FOLLISTIM AQ Cartridge, respectively.

Pulmonary and Vascular Complications

Serious pulmonary conditions (eg, atelectasis, acute respiratory distress syndrome) have been reported in women treated with gonadotropins. In addition, thromboembolic reactions, both in association with and separate from OHSS, have been reported following gonadotropin therapy. Women with generally recognized risk factors for thrombosis, such as a personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb, and rarely, in myocardial infarction. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulation induction, IVF, or ICSI need to be weighed against the risks. It should be noted that pregnancy itself also carries an increased risk of thrombosis.

Ovarian Torsion

Ovarian torsion has been reported after treatment with FOLLISTIM AQ Cartridge and after intervention with other gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst, and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

Multifetal Gestation and Births

Multifetal gestation and births have been reported with all gonadotropin treatments including treatment with FOLLISTIM AQ Cartridge. The woman and her partner should be advised of the potential risk of multifetal gestation and births before starting treatment.

Congenital Anomalies

The incidence of congenital malformations after IVF or ICSI may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (eg, maternal age, sperm characteristics) and to the higher incidence of multifetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.

Ectopic Pregnancy

Since infertile women undergoing IVF and ICSI often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early confirmation of an intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.

Spontaneous Abortion

The risk of spontaneous abortions (miscarriage) is increased with gonadotropin products; however, causality has not been established. The increased risk may be a factor of the underlying infertility.

Ovarian Neoplasms

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for controlled ovarian stimulation; however, a causal relationship has not been established.

Laboratory Tests – For Women

In most instances, treatment with FOLLISTIM AQ Cartridge will result only in follicular growth and maturation. In order to complete the final phase of follicular maturation and to induce ovulation, hCG must be given following the administration of FOLLISTIM AQ Cartridge or when clinical assessment indicates that sufficient follicular maturation has occurred. The degree of follicular maturation and the timing of hCG administration can both be determined with the use of sonographic visualization of the ovaries and endometrial lining in conjunction with measurement of serum estradiol levels. The combination of transvaginal ultrasonography and measurement of serum estradiol levels is also useful for minimizing the risk of OHSS and multifetal gestations.

FOLLISTIM Pen

The FOLLISTIM Pen is intended only for use with FOLLISTIM AQ Cartridge. The FOLLISTIM Pen is not recommended for the blind or visually impaired without the assistance of an individual with good vision who is trained in the proper use of the injection device.

ADVERSE REACTIONS

Adverse reactions occurring in ≥2% of patients in a clinical trial undergoing ovulation induction with FOLLISTIM included: abdominal discomfort (2.9%), abdominal pain (2.9%), abdominal pain lower (2.9%), ovarian cyst (2.9%), OHSS (7.6%), headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage, and injection site reaction.
Adverse reactions occurring in ≥2% of patients in a clinical trial undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle with FOLLISTIM AQ Cartridge included: headache (7.3%), nausea (3.9%), OHSS (6.4%), pelvic discomfort (8.3%), pelvic pain (5.5%), and fatigue (2.3%).

USE IN SPECIFIC POPULATIONS

Lactation

Risk Summary

It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FOLLISTIM AQ Cartridge and any potential adverse effects on the breastfed child from FOLLISTIM AQ Cartridge or from the underlying maternal condition.

PATIENT COUNSELING INFORMATION

Prior to beginning therapy, inform women about the time commitment and monitoring procedures necessary to undergo treatment. Also inform women that if they miss or forget to take a dose of FOLLISTIM AQ Cartridge, the next dose should not be doubled and they should call the health care provider for further instruction.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Please read the accompanying Patient Information and Instructions for Use for FOLLISTIM AQ Cartridge and discuss them with your healthcare provider. The physician Prescribing Information also is available.

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