Bravelle® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
Bravelle® is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of Bravelle® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 IU of FSH. Bravelle® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in Bravelle®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
Directions for Using Bravelle®
Wash hands thoroughly with soap and water.
Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents.
To prepare the Bravelle® solution, inject 1 mL of Sterile Saline for Injection, USP into the vial of Bravelle®. DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the Bravelle® dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT.
For patients requiring a single injection from multiple vials of Bravelle®, up to 6 vials can be reconstituted with 1 mL of Sterile Saline for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Bravelle®. Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized Bravelle® into 1 mL of diluent.
Immediately ADMINISTER the reconstituted Bravelle® either SC (for ovulation induction or multifollicular development during ART) or IM (for ovulation induction). Any unused reconstituted material should be discarded.
Draw the reconstituted Bravelle® into an empty, sterile syringe.
Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top; then squeeze the plunger gently until all the air has been expelled and only Bravelle® solution is left in the syringe.
Bravelle® works if it is injected SC (for ovulation induction or multifollicular development during ART) or IM (for ovulation induction). The recommended sites for SC injection are either side of the lower abdomen in alternating fashion with the actual injection site varied a little with each injection. SC injection of Bravelle® into the thigh is not recommended unless the lower abdomen is not usable because of scarring, surgical deformity or other medical conditions.