We know callbacks from patients are a common occurrence in your daily routine—and that you often hear the same questions time and time again. These answers to frequently asked questions will help explain medication usage during consults or respond to any follow-up calls with ease.
Gonal-f® RFF* Redi-ject® (follitropin alfa injection) is indicated for:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Primary ovarian failure and pregnancy should be excluded.
Patients ask: How will I be monitored when taking Gonal-f®?
Tell them: When taking Gonal-f®, your ovaries need to be monitored to see how they respond to treatment. Ultrasounds and hormone levels are used to:
Patients ask: Am I at increased risk for ovarian hyperstimulation syndrome (OHSS) after taking Gonal-f®?
Tell them: OHSS can occur after you’ve stopped taking Gonal-f®. It may develop quickly. In clinical trials with Gonal-f® RFF* Redi-ject®, OHSS occurred in 7.2% of ovulation induction cycles and 4.6% of assisted reproductive technology cycles.
If your ovaries are abnormally enlarged on the last day of Gonal-f® therapy, the ovulation trigger shot may not be given to reduce the chances of OHSS.
Patients ask: Does treatment with Gonal-f® increase my chance of multiples?
Tell them: Multifetal gestation and births have been reported with all gonadotropin therapy, including Gonal-f®.
In clinical trials for Gonal-f® RFF* Redi-ject, live births of multiples occurred in 20% of ovulation induction cycles and 35.1% of assisted reproductive technology cycles.
Patients ask: Can I still use my pen if I left it outside in a car during hot or cold weather?
Tell them: Gonal-f® RFF* Redi-ject® must be stored with the cap attached and away from light. New pens should be kept in the refrigerator between 36°F and 46°F until the expiration date, or at room temperature between 68°F and 77°F for up to 3 months or until the expiration date, whichever comes first.
If medicine is left in the pen after injecting, it may be stored in the refrigerator or at room temperature for up to 28 days before safely discarding.
Patients ask: How do I know the pen is totally empty?
Tell them: Gonal-f® RFF* Redi-ject® is available in 3 different dosage amounts: 300 IU/0.5 mL, 450 IU/0.75 mL, and 900 IU/1.5 mL. When your combined injected doses equal the number of IUs available in your pen, your device is empty.
Ask your healthcare provider about keeping a treatment diary to help you keep better track of your injections.
Patients ask: How do I finish an incomplete injection using a new pen?
Tell them: If you’ve finished your injection and the dose information display on your pen doesn’t read 0, your injection was incomplete. A second Gonal-f® RFF* Redi-ject® pen will be needed to finish your dose. On the new pen, dial the number that appears in the dose information display on the empty pen, then complete your dose.
Patients ask: How do I properly dispose of the pen?
Tell them: All used needles and empty pens should be discarded in an FDA-cleared sharps disposal container immediately after use.
If you do not have a sharps container, do not throw away loose needles and pens in your household trashcan. Instead, use a container that is:
For more information, visit fda.gov/safesharpsdisposal.
Gonal-f® Multi-Dose (follitropin alfa for injection) is indicated for:
In women
Prior to treatment complete an evaluation of female to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal- f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
In men
Prior to treatment perform thorough medical and endocrinologic evaluation, confirm hypogonadotropic hypogonadism, exclude primary testicular failure and serum testosterone levels should be normalized.
Patients ask: Am I at increased risk for ovarian hyperstimulation syndrome (OHSS) after taking Gonal-f®?
Tell them: OHSS can occur after you’ve stopped taking Gonal-f®. It may develop quickly. In clinical trials with Gonal-f® Multi-Dose, OHSS occurred in 3.9% of ovulation induction cycles and 0 assisted reproductive technology cycles.
If your ovaries are abnormally enlarged on the last day of Gonal-f® therapy, the ovulation trigger shot may not be given to reduce the chances of OHSS.
Patients ask: Does treatment with Gonal-f® increase my chance of multiples?
Tell them: Multifetal gestation and births have been reported with all gonadotropin therapy, including Gonal-f®.
In clinical trials for Gonal-f® Multi-Dose, live births of multiples occurred in 12.3% of ovulation induction cycles and 44% of assisted reproductive technology cycles.
Patients ask: Can I still use my medication if I left it outside in a car during hot or cold weather?
Tell them: Gonal-f® Multi-Dose must be stored away from light. Vials (mixed or unmixed) can be stored in the refrigerator or at room temperature between 36°F and 77°F. Safely discard any mixed solution after 28 days.
Patients ask: How do I properly dispose of medicine products?
Tell them: All used needles and vials should be discarded in an FDA-cleared sharps disposal container immediately after use.
If you do not have a sharps container, do not throw away loose needles and vials in your household trashcan. Instead, use a container that is:
For more information, visit fda.gov/safesharpsdisposal.
Gonal-f® RFF* 75 IU (follitropin alfa for injection) is indicated for:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
Patients ask: Am I at increased risk for ovarian hyperstimulation syndrome (OHSS) after taking Gonal-f®?
Tell them: OHSS can occur after you’ve stopped taking Gonal-f®. It may develop quickly. In clinical trials with Gonal-f® RFF* 75 IU, OHSS occurred in 7.2% of ovulation induction cycles and 4.6% assisted reproductive technology cycles.
If your ovaries are abnormally enlarged on the last day of Gonal-f® therapy, the ovulation trigger shot may not be given to reduce the chances of OHSS.
Patients ask: Does treatment with Gonal-f® increase my chance of multiples?
Tell them: Multifetal gestation and births have been reported with all gonadotropin therapy, including Gonal-f®.
In clinical trials for Gonal-f® RFF* 75 IU, live births of multiples occurred in 20% of ovulation induction cycles and 35.1% of assisted reproductive technology cycles.
Patients ask: Can I still use my medication if I left it outside in a car during hot or cold weather?
Tell them: Gonal-f® RFF* 75 IU must be stored away from light. Unmixed vials can be stored in the refrigerator or at room temperature between 36°F and 77°F. Medication should be used immediately after mixing.
Patients ask: How do I properly dispose of medicine products?
Tell them: All used needles and vials should be discarded in an FDA-cleared sharps disposal container immediately after use.
If you do not have a sharps container, do not throw away loose needles and vials in your household trashcan. Instead, use a container that is:
For more information, visit fda.gov/safesharpsdisposal.
Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Cetrotide® should only be prescribed by physicians who are experienced with infertility problems and their management.
Patients ask: Am I at increased risk for ovarian hyperstimulation syndrome (OHSS) after taking Cetrotide®?
Tell them: OHSS can occur after treatment with Cetrotide®. In clinical trials, OHSS occurred in 3.5% of patients.
Patients ask: Can I still use my medication if I left it outside in a car during hot or cold weather?
Tell them: Cetrotide® must be stored away from light and in the refrigerator between 36 ºF and 46ºF.
Patients ask: How do I properly dispose of medicine products?
Tell them: All used needles and vials should be discarded in an FDA-cleared sharps disposal container immediately after use.
If you do not have a sharps container, do not throw away loose needles and vials in your household trashcan. Instead, use a container that is:
For more information, visit fda.gov/safesharpsdisposal.
Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the 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 as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization (IVF) and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
Patients ask: How will I be monitored when taking Ovidrel®?
Tell them: When taking Ovidrel®, your ovaries need to be monitored to see how they respond to treatment. Ultrasounds and hormone levels are used to:
Patients ask: Am I at increased risk for ovarian hyperstimulation syndrome (OHSS) after taking Ovidrel®?
Tell them: OHSS can occur after you’ve stopped taking gonadotropin treatments. They may develop quickly. In women receiving Ovidrel® 250 μg treatment, OHSS occurred in 1.7% of patients in ART clinical trials and 3.0% of patients in OI clinical trials. OHSS occurred in 9.0% of patients receiving Ovidrel® 500 μg.
If your patient’s ovaries are abnormally enlarged on the last day of FSH therapy, Ovidrel® should not be administered to reduce the chances of OHSS.
Patients ask: Does treatment with Ovidrel® increase my chance of multiples?
Tell them: Reports of multiple births have been associated with Ovidrel® treatment. During ART, the risk of multiples correlates to the number of embryos transferred.
In ART clinical studies of Ovidrel® 250 μg treatment, multiple births occurred in 30.9% of live deliveries. In an OI clinical trial, 13.3% of women experienced multiples.
Patients ask: Can I still use my medication if I left it outside in a car during hot or cold weather?
Tell them: Ovidrel® must be stored away from light. Store your prefilled syringe in the refrigerator between 36ºF and 46ºF to allow it to be used until the expiration date shown on the carton. If kept at room temperature (up to 77ºF), Ovidrel® PreFilled Syringe must be discarded after 30 days.
Patients ask: How do I properly dispose of medicine products?
Tell them: All used needles and vials should be discarded in an FDA-cleared sharps disposal container immediately after use.
If you do not have a sharps container, do not throw away loose needles and vials in your household trashcan. Instead, use a container that is:
For more information, visit fda.gov/safesharpsdisposal.
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Summary of Contraindications Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU are contraindicated in patients with prior hypersensitivity to rhFSH or excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled thyroid, adrenal or pituitary disorders, sex hormone dependent tumors of the reproductive tract/accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin and ovarian cyst or enlargement of undetermined origin. Please scroll for full IMPORTANT RISK INFORMATION or see full Prescribing Information for Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU. * RFF: Revised Formulation Female
Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection) Contraindications:
Warnings and Precautions:
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Patient Counseling: In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF* Redi-ject®, not share the device or reuse needles, and to ask their Healthcare Provider about questions. Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female
Important Risk Information for Gonal-f® Multi-Dose (follitropin alfa for injection) Contraindications:
WARNINGS Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications
Multiple Births
PRECAUTIONS
Adverse Reactions: Indications and Usage:
Prior to treatment complete an evaluation of female to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded. Men
Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection) Contraindications:
WARNINGS For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used. Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications:
Multiple Births
PRECAUTIONS
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female |
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Cetrotide® is contraindicated in women who are pregnant, are nursing, or have severe renal impairment. Cetrotide® is also contraindicated in women who exhibit or have known hypersensitivity to cetrorelix acetate, mannitol, extrinsic peptide hormone, GnRH or any other GnRH analogs. Treatment with Cetrotide® is not advised in women with severe allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions have been reported. Other adverse events reported include ovarian hyperstimulation syndrome, nausea, headache, and local injection site reactions. Multiple births and congenital abnormalities have been reported. Indication
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Important Risk Information for Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) Ovidrel® PreFilled Syringe should only be used by physicians who are experienced with infertility problems, their management and appropriate selection and monitoring of patients. Ovidrel® PreFilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations, mannitol, or one of their other excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled intracranial lesion, abnormal uterine bleeding of an undetermined origin, an ovarian cyst or enlargement of an undetermined origin. Women who are pregnant or nursing should not use Ovidrel® PreFilled Syringe. Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) and ovarian enlargement with or without pulmonary and vascular complications. Adverse reactions reported include injection site reactions, GI disorders, abdominal pain, nausea, vomiting, ovarian cyst, ovarian hyperstimulation, and thromboembolic events. Multiple births and congenital abnormalities have been reported. Indication
|
Summary of Contraindications Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU are contraindicated in patients with prior hypersensitivity to rhFSH or excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled thyroid, adrenal or pituitary disorders, sex hormone dependent tumors of the reproductive tract/accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin and ovarian cyst or enlargement of undetermined origin. Please scroll for full IMPORTANT RISK INFORMATION or see full Prescribing Information for Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and Gonal-f® RFF* 75 IU. * RFF: Revised Formulation Female
Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection) Contraindications:
Warnings and Precautions:
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Patient Counseling: In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF* Redi-ject®, not share the device or reuse needles, and to ask their Healthcare Provider about questions. Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female
Important Risk Information for Gonal-f® Multi-Dose (follitropin alfa for injection) Contraindications:
WARNINGS Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications
Multiple Births
PRECAUTIONS
Adverse Reactions: Indications and Usage:
Prior to treatment complete an evaluation of female to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded. Men
Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection) Contraindications:
WARNINGS For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used. Overstimulation of the Ovary During FSH Therapy:
Pulmonary and Vascular Complications:
Multiple Births
PRECAUTIONS
Adverse Reactions: The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Indications and Usage:
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
* RFF: Revised Formulation Female |
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Cetrotide® is contraindicated in women who are pregnant, are nursing, or have severe renal impairment. Cetrotide® is also contraindicated in women who exhibit or have known hypersensitivity to cetrorelix acetate, mannitol, extrinsic peptide hormone, GnRH or any other GnRH analogs. Treatment with Cetrotide® is not advised in women with severe allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions have been reported. Other adverse events reported include ovarian hyperstimulation syndrome, nausea, headache, and local injection site reactions. Multiple births and congenital abnormalities have been reported. Indication
|
Important Risk Information for Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) Ovidrel® PreFilled Syringe should only be used by physicians who are experienced with infertility problems, their management and appropriate selection and monitoring of patients. Ovidrel® PreFilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations, mannitol, or one of their other excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled intracranial lesion, abnormal uterine bleeding of an undetermined origin, an ovarian cyst or enlargement of an undetermined origin. Women who are pregnant or nursing should not use Ovidrel® PreFilled Syringe. Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) and ovarian enlargement with or without pulmonary and vascular complications. Adverse reactions reported include injection site reactions, GI disorders, abdominal pain, nausea, vomiting, ovarian cyst, ovarian hyperstimulation, and thromboembolic events. Multiple births and congenital abnormalities have been reported. Indication
|