Follitropin

4 CONTRAINDICATIONS FOLLISTIM AQ Cartridge is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant hFSH products or any component of FOLLISTIM AQ Cartridge. Reactions including anaphylaxis have been reported [see Adverse Reactions ] High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1 , 1.2 , 1.3) ] Hypersensitivity reactions to streptomycin or neomycin.

OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of OHSS developing are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS.

Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows: Acute Phase: Management should be directed at preventing hemoconcentration due to loss of intravascular volume to the third space and minimizing the risk of thromboembolic phenomena and kidney damage.

Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized. Diuretics may be indicated during the resolution phase, if necessary, to combat pulmonary edema. OHSS increases the risk of injury to the ovary. The ascitic, pleural, and pericardial fluid should not be removed unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade.

If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the dose may be increased to 3,000 international units twice a week. After normalization of serum testosterone levels, administer 450 international units per week (225 international units twice weekly or 150 international units three times weekly) of FOLLISTIM AQ Cartridge subcutaneously with the same pre-treatment hCG dose used to normalize testosterone levels. 2.1 General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

If the solution is not clear and colorless or has particles in it, the solution should not be used. Do not add any other medicines into the FOLLISTIM AQ Cartridge. FOLLISTIM AQ Cartridge with the pen injector device delivers on average an 18% higher amount of follitropin beta when compared to reconstituted FOLLISTIM delivered with a conventional syringe and needle.

When administering FOLLISTIM AQ Cartridge, a lower starting dose and lower dose adjustments (as compared to reconstituted FOLLISTIM) should be considered. For that purpose the following Dose Conversion Table is provided: [See table below.] 300 IU 450 IU 375 IU 2.2 Recommended Dosing in Anovulatory Women Undergoing Ovulation Induction The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies ] .