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

FOLLISTIM® AQ Cartridge Instructions for Use

Watch the video to learn about self-injection with the FOLLISTIM Pen®

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Instructional Quick Guide for FOLLISTIM® AQ Cartridge (follitropin beta injection)

Directions provided here are abbreviated. They should be used only after receiving complete instructions from your health care professional.

To give yourself the injection, you will need:

A clean, dry surface, alcohol and cotton balls, or alcohol pads, sterile gauze, anti-bacterial soap, and a puncture-proof container to discard used supplies.

FOLLISTIM Pen®

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A FOLLISTIM AQ Cartridge

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A new BD Micro-Fine™ Needle

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Prepare your FOLLISTIM Pen

Pull the protective cap off the Pen Body (Figure 1A) and put it aside on a clean, dry surface.

  • Unscrew the entire Pen Body from the Cartridge Holder.
  • Place Pen Body and Cartridage Holder on a clean, dry surface.
  • Remove the FOLLISTIM AQ Cartridge from its package and clean the rubber inlay of the Cartridge with an alcohol pad.

Insert the Cartridge into the Cartridge Holder (Figure 1B), metal rimmed cap end first.

Screw Pen Body fully onto the Cartridge Holder containing the inserted Cartridge (Figure 1C), making sure there are no gaps.

  • Line up the arrow with the middle of the yellow alignment mark.

Clean the open end of the Cartridge Holder with an alcohol pad. Peel off the protective paper seal from the BD Micro-Fine Pen Needle that is in its Outer Needle Shield. Attach a new BD Micro-Fine Pen Needle after you make sure there is a FOLLISTIM AQ Cartridge in the FOLLISTIM Pen. Push the end of the Cartridge Holder into the Outer Needle Shield. Screw tightly together (Figure 1D).

Your FOLLISTIM Pen is now assembled and loaded.

Never touch the needle and never place an open needle on any surface.

You must use a new BD Micro-Fine Pen Needle with each injection. Use an alcohol pad to clean about a 2-inch area of skin where the needle will enter.

Set your dose

Gently pull off the Outer Needle Shield, leaving the Inner Needle Shield in place (Figure 2A), and set aside.

  • Use an alcohol pad to clean about a 2-inch area of skin where the needle will enter.
  • Do not discard the Outer Needle Shield.

Carefully remove the Inner Needle Shield (Figure 2B) and discard.

  • Do not touch the needle or let it touch any surface while uncapped.
  • Hold the FOLLISTIM Pen® with the needle pointing upwards. Tap the cartridge holder gently with your finger to force air bubbles to the top of the needle.

Dial the Dosage Knob until you hear one click. With the needle pointing upwards, push in the Injection Button.

Look for a droplet of medicine at the needle tip (Figure 2C). If you do not see a droplet, repeat steps above; otherwise you might not receive the correct dose.

If you have already used the FOLLISTIM® AQ Cartridge (follitropin beta injection) and you need to give yourself another dose, attach a new BD Micro-Fine™ Pen Needle and look for a droplet forming at the tip of the needle. If you do not see a droplet, repeat the previous 2 steps.

For doses of 50 International Units (IU) up to 450 IU, turn the Dosage Knob until the correct dosage aligns with the dosage markers on each side of the Dosage Window (Figure 2D).

If you dial past your dose, do not turn the Dosage Knob backward

(you will not damage the Pen, but medicine will be lost). Instead, continue turning until you pass the 450 IU mark, as far as it will turn. The Dosage Knob must move freely. Push the Injection Button in as far as it will go. Start dialing from “0” upwards until you reach the correct dosage.

Never try to correct a dose-dialing mistake while the needle is in your skin. This may result in an incorrect dose. If your prescribed dose exceeds the deliverable dose of the FOLLISTIM Pen or exceeds the amount remaining in the Cartridge, you will need to give yourself more than one injection.

You are now ready to complete your injection.

The best places to inject are just below your belly button or the upper outer area of your thigh.

Inject

Pinch the cleansed skin area between 2 fingers. With your other hand, insert the entire Pen Needle straight into the skin at a 90-degree angle (Figure 2E). Press the Injection Button all the way. Wait 5 seconds. The middle of the Dosage Window should display a dot next to the “0”. Pull the needle out quickly and apply pressure to the injection site with an alcohol pad.

If the number in the Dosage Window does not read “0” and you cannot push the Injection Button all the way in, do not try to force down the button. Your FOLLISTIM AQ Cartridge is probably empty. This means you have not received your full dose. Do not adjust the setting on the Dosage Scale. The number in the Dosage Window is the amount needed to complete your prescribed dose. Write down this number. Remove the needle and dispose of it properly. Reset the Dial Window to “0” by turning the Dosage Knob past the 450 IU mark as far as it will turn and pushing the injection button all the way in. Repeat instructions from “Ready (►) Prepare Your FOLLISTIM Pen to load a new Cartridge, attach a new needle and inject the remaining drug to complete your dose”.

Storage and Disposal

Each Pen Needle is for one injection only. Immediately following injection, remove and dispose of the used Pen Needle. The Pen Needle must be removed from the FOLLISTIM Pen prior to storage.

Storing the FOLLISTIM AQ Cartridge

Store refrigerated 2°-8°C (36°-46°F) until dispensed. Upon dispensing, the product may be stored by the patient at 2°-8°C (36°-46°F) until the expiration date, at or below 25°C (77°F) for 3 months or until expiration date, whichever occurs first. Once the rubber inlay of the FOLLISTIM AQ Cartridge has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2°-25°C (36°-77°F). Keep away from light. Do not freeze.

Patient support from Organon and ReUnite Rx

Support is available for eligible self-paying patients. Organon continues to collaborate with ReUnite Rx to assist eligible cash-paying fertility patients. If you need additional support for out-of-pocket costs for an Organon fertility medication, there may be other programs that can help.

Selected 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.

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 www.fda.gov/medwatch 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.