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Follistim AQ
Overview
What is Follistim AQ?
Follistim AQ Cartridge contains human follicle-stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology. The active drug substance, follitropin beta, has a dimeric structure containing two glycoprotein subunits (alpha and beta). Both the 92 amino acid alpha-chain and the 111 amino acid beta-chain have complex heterogeneous structures arising from two N-linked oligosaccharide chains. Follitropin beta is synthesized in a Chinese hamster ovary (CHO) cell line that has been transfected with a plasmid containing the two subunit DNA sequences encoding for hFSH. The purification process results in a highly purified preparation with a consistent hFSH isoform profile and high specific activity [as determined by the Ph. Eur. test for FSH bioactivity and on the basis of the molar extinction coefficient at 277 nm (ε:mgcm) = 1.066].
The biological activity is determined by measuring the increase in ovary weight in female rats. The intrinsic luteinizing hormone (LH) activity in follitropin beta is less than 1 international unit per 40,000 international units FSH. The compound is considered to contain no LH activity.
The amino acid sequence and tertiary structure of the product are indistinguishable from that of hFSH of urinary source. Also, based on available data derived from physico-chemical tests and bioassay, follitropin beta and follitropin alfa, another recombinant follicle-stimulating hormone product, are indistinguishable.
Follistim AQ Cartridge is a ready for use, prefilled with solution, disposable cartridge containing either 175 IU of follitropin beta in 0.210 mL (833 IU/mL), 350 IU in 0.420 mL (833 IU/mL), 650 IU in 0.780 mL (833 IU/mL) or 975 IU in 1.170 mL (833 IU/mL) of aqueous solution for multiple dose use, with a maximal deliverable dose of either 150 IU, 300 IU, 600 IU or 900 IU, respectively. Inactive ingredients in the cartridges include: benzyl alcohol NF 10 mg/mL; L-methionine USP 0.5 mg/mL; polysorbate 20 NF 0.2 mg/mL; sodium citrate (dihydrate) USP 14.7 mg/mL; sucrose NF 50 mg/mL; and water for injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7.
Follistim AQ Cartridge is for use only with the Follistim Pen, which features an adjustable dosing system for administering the drug in a microvolume of solution. The Follistim Pen with Follistim AQ Cartridge is intended for SUBCUTANEOUS USE ONLY. The recombinant protein in Follistim AQ Cartridge has been standardized for FSH bioactivity in terms of the WHO International Standard for Follicle Stimulating Hormone (FSH) Recombinant, Human for Bioassay (code 92/642), issued by the World Health Organization Expert Committee on Biological Standardization (1995). Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.
In clinical trials with Follistim, serum antibodies to FSH or anti-CHO cell derived proteins were not detected in any of the treated patients after exposure to Follistim for up to three cycles.
What does Follistim AQ look like?
What are the available doses of Follistim AQ?
Injection: Follistim AQ Cartridge 175 IU per 0.210 mL ()
Injection: Follistim AQ Cartridge 350 IU per 0.420 mL ()
Injection: Follistim AQ Cartridge 650 IU per 0.780 mL ()
Injection: Follistim AQ Cartridge 975 IU per 1.170 mL ()
What should I talk to my health care provider before I take Follistim AQ?
Nursing Mothers: It is not known whether this drug is excreted in human milk. ()
How should I use Follistim AQ?
Follistim AQ (follitropin beta injection) Cartridge is indicated:
In Women for:
Starting daily dose of 50 international units of Follistim AQ Cartridge is administered subcutaneously for at least the first 7 days. The dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response.
What interacts with Follistim AQ?
Sorry No Records found
What are the warnings of Follistim AQ?
Sorry No Records found
What are the precautions of Follistim AQ?
Sorry No Records found
What are the side effects of Follistim AQ?
Sorry No records found
What should I look out for while using Follistim AQ?
Follistim AQ Cartridge is contraindicated in women and men who exhibit:
Follistim AQ Cartridge is also contraindicated in women who exhibit:
What might happen if I take too much Follistim AQ?
Aside from the possibility of Ovarian Hyperstimulation Syndrome and multiple gestations , there is no additional information concerning the consequences of acute overdosage with Follistim AQ Cartridge.
How should I store and handle Follistim AQ?
Follistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) packaged with one disposable prefilled 1.5 mL colorless glass cartridge, with grey rubber piston and an aluminum crimp-cap with black rubber inlay and in the following presentations:NDC 0052-0303-01 Follistim AQ Cartridge 175 international units per 0.210 mL (delivering 150 international units) with orange crimp-caps and 3 BD Micro-Fine Pen NeedlesNDC 0052-0313-01 Follistim AQ Cartridge 350 international units per 0.420 mL (delivering 300 international units) with silver crimp-caps and 5 BD Micro-Fine Pen NeedlesNDC 0052-0316-01 Follistim AQ Cartridge 650 international units per 0.780 mL (delivering 600 international units) with gold crimp-caps and 7 BD Micro-Fine Pen NeedlesNDC 0052-0326-01 Follistim AQ Cartridge 975 international units per 1.170 mL (delivering 900 international units) with blue crimp-caps and 10 BD Micro-Fine Pen NeedlesFollistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) packaged with one disposable prefilled 1.5 mL colorless glass cartridge, with grey rubber piston and an aluminum crimp-cap with black rubber inlay and in the following presentations:NDC 0052-0303-01 Follistim AQ Cartridge 175 international units per 0.210 mL (delivering 150 international units) with orange crimp-caps and 3 BD Micro-Fine Pen NeedlesNDC 0052-0313-01 Follistim AQ Cartridge 350 international units per 0.420 mL (delivering 300 international units) with silver crimp-caps and 5 BD Micro-Fine Pen NeedlesNDC 0052-0316-01 Follistim AQ Cartridge 650 international units per 0.780 mL (delivering 600 international units) with gold crimp-caps and 7 BD Micro-Fine Pen NeedlesNDC 0052-0326-01 Follistim AQ Cartridge 975 international units per 1.170 mL (delivering 900 international units) with blue crimp-caps and 10 BD Micro-Fine Pen NeedlesFollistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) packaged with one disposable prefilled 1.5 mL colorless glass cartridge, with grey rubber piston and an aluminum crimp-cap with black rubber inlay and in the following presentations:NDC 0052-0303-01 Follistim AQ Cartridge 175 international units per 0.210 mL (delivering 150 international units) with orange crimp-caps and 3 BD Micro-Fine Pen NeedlesNDC 0052-0313-01 Follistim AQ Cartridge 350 international units per 0.420 mL (delivering 300 international units) with silver crimp-caps and 5 BD Micro-Fine Pen NeedlesNDC 0052-0316-01 Follistim AQ Cartridge 650 international units per 0.780 mL (delivering 600 international units) with gold crimp-caps and 7 BD Micro-Fine Pen NeedlesNDC 0052-0326-01 Follistim AQ Cartridge 975 international units per 1.170 mL (delivering 900 international units) with blue crimp-caps and 10 BD Micro-Fine Pen NeedlesFollistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) packaged with one disposable prefilled 1.5 mL colorless glass cartridge, with grey rubber piston and an aluminum crimp-cap with black rubber inlay and in the following presentations:NDC 0052-0303-01 Follistim AQ Cartridge 175 international units per 0.210 mL (delivering 150 international units) with orange crimp-caps and 3 BD Micro-Fine Pen NeedlesNDC 0052-0313-01 Follistim AQ Cartridge 350 international units per 0.420 mL (delivering 300 international units) with silver crimp-caps and 5 BD Micro-Fine Pen NeedlesNDC 0052-0316-01 Follistim AQ Cartridge 650 international units per 0.780 mL (delivering 600 international units) with gold crimp-caps and 7 BD Micro-Fine Pen NeedlesNDC 0052-0326-01 Follistim AQ Cartridge 975 international units per 1.170 mL (delivering 900 international units) with blue crimp-caps and 10 BD Micro-Fine Pen NeedlesFollistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) packaged with one disposable prefilled 1.5 mL colorless glass cartridge, with grey rubber piston and an aluminum crimp-cap with black rubber inlay and in the following presentations:NDC 0052-0303-01 Follistim AQ Cartridge 175 international units per 0.210 mL (delivering 150 international units) with orange crimp-caps and 3 BD Micro-Fine Pen NeedlesNDC 0052-0313-01 Follistim AQ Cartridge 350 international units per 0.420 mL (delivering 300 international units) with silver crimp-caps and 5 BD Micro-Fine Pen NeedlesNDC 0052-0316-01 Follistim AQ Cartridge 650 international units per 0.780 mL (delivering 600 international units) with gold crimp-caps and 7 BD Micro-Fine Pen NeedlesNDC 0052-0326-01 Follistim AQ Cartridge 975 international units per 1.170 mL (delivering 900 international units) with blue crimp-caps and 10 BD Micro-Fine Pen Needles
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Follistim AQ Cartridge is contraindicated in women and men who exhibit:Follistim AQ Cartridge is also contraindicated in women who exhibit:
Drug Interactions:
There is usually complete cross-resistance between mercaptopurine and thioguanine.
The dosage of mercaptopurine may need to be reduced when this agent is combined with other drugs whose primary or secondary toxicity is myelosuppression. Enhanced marrow suppression has been noted in some patients also receiving trimethoprim-sulfamethoxazole.
Inhibition of the anticoagulant effect of warfarin, when given with mercaptopurine, has been reported.
As there is evidence that aminosalicylate derivatives (e.g., olsalazine, mesalazine, or sulphasalazine) inhibit the TPMT enzyme, they should be administered with caution to patients receiving concurrent mercaptopurine therapy (see ).
Follistim AQ Cartridge should be used 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 .
Careful attention should be given to the diagnosis of infertility and in the selection of candidates for Follistim AQ Cartridge therapy .
Switching to Follistim AQ Cartridge from other brands (manufacturer), types (recombinant, urinary), and/or methods of administration (Follistim Pen, conventional syringe) may necessitate an adjustment of the dose
The following serious adverse reactions are discussed elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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