Follitropin Beta

Follitropin Beta is a hormone. Follitropin Beta is used in the treatment of female infertility due to anovulation in females not responded to therapy with clomiphene.

Follitropin Beta is primarily indicated in conditions like Infertility.

Follitropin Beta is contraindicated in conditions like Vaginal bleeding, Ovarian failure, Breast tumor, Uterine tumor, Pituitary tumor.

The symptomatic adverse reactions produced by Follitropin Beta are more or less tolerable and if they become severe, they can be treated symptomatically, these include Pain, Redness, Itching, Sweating, Bruising.

Concerns related to adverse effects: • Ovarian enlargement: The lowest effective dose should be used to decrease the risk of abnormal ovarian enlargement. If ovaries are abnormally enlarged on the last day of follitropin beta treatment, follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS). • Ovarian hyperstimulation syndrome: OHSS is a rare, exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of hCG treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; Shmorgun 2017). • Ovarian torsion: May occur in relation to OHSS, pregnancy, previous or current ovarian cyst and polycystic ovaries, previous abdominal surgery, and previous history of ovarian torsion. • Pulmonary effects: Serious pulmonary conditions, including acute respiratory distress syndrome, have been reported. • Thromboembolic events: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with a personal or family history of thromboembolic events, severe obesity, or thrombophilia. Dosage form specific issues: • Multiple dose injection pens: According to the Centers for Disease Control and Prevention, pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012). Other warnings/precautions: • Appropriate use: To minimize risks, use only at the lowest effective dose. Monitor ovarian response with transvaginal ultrasound; concurrent measurement of estradiol levels may also be useful. • Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management. • Multiple births: May result from the use of these medications; advise patient of the potential risk of multiple births before starting the treatment.

Concerns related to adverse effects: • Ovarian enlargement: The lowest effective dose should be used to decrease the risk of abnormal ovarian enlargement. If ovaries are abnormally enlarged on the last day of follitropin beta treatment, follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS). • Ovarian hyperstimulation syndrome: OHSS is a rare, exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of hCG treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; Shmorgun 2017). • Ovarian torsion: May occur in relation to OHSS, pregnancy, previous or current ovarian cyst and polycystic ovaries, previous abdominal surgery, and previous history of ovarian torsion. • Pulmonary effects: Serious pulmonary conditions, including acute respiratory distress syndrome, have been reported. • Thromboembolic events: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with a personal or family history of thromboembolic events, severe obesity, or thrombophilia. Dosage form specific issues: • Multiple dose injection pens: According to the Centers for Disease Control and Prevention, pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012). Other warnings/precautions: • Appropriate use: To minimize risks, use only at the lowest effective dose. Monitor ovarian response with transvaginal ultrasound; concurrent measurement of estradiol levels may also be useful. • Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management. • Multiple births: May result from the use of these medications; advise patient of the potential risk of multiple births before starting the treatment.

1.071 IU/kg (1.1 (1.071)) 24 hourly IM — - 1.071 IU/kg (1.1 (1.071)) 24 hourly SC — - Scraped Dose — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product Solution, Injection: Follistim AQ: 75 units/0.5 mL (0.5 mL [DSC]) Solution, Subcutaneous: Follistim AQ: 300 units/0.36 mL (0.42 mL); 600 units/0.72 mL (0.78 mL); 900 units/1.08 mL (1.17 mL) [contains benzyl alcohol]

( ) — Not recommended in this age group

( ) — Not recommended in this age group

There are no known significant interactions.

Inj Store at room temperature, Below 30°C. Do not Freeze. Protect from Sunlight.