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Follitropin (Follistim Aq)

Trade Name : Follistim AQ

Organon USA Inc.

INJECTION, SOLUTION

Strength 350 [iU]/.42mL

FOLLITROPIN Gonadotropin [EPC],Gonadotropins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Follitropin (Follistim Aq) which is also known as Follistim AQ and Manufactured by Organon USA Inc.. It is available in strength of 350 [iU]/.42mL per ml. Read more

Follitropin (Follistim Aq) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Follistim AQ (follitropin beta injection) Cartridge is indicated:
  • Arrayn- In Women for:
  • Follistim AQ Cartridge is a gonadotropin indicated:
  • In Women for:
  • In Men for:
  • See Dose Conversion Table 1 for Follistim AQ Cartridge with Pen Injector ()
  • In Anovulatory Women Undergoing Ovulation Induction
  • In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle
  • Induction of Spermatogenesis in Men
  • Injection: Follistim AQ Cartridge 175 international units per 0.210 mL
  • Injection: Follistim AQ Cartridge 350 international units per 0.420 mL
  • Injection: Follistim AQ Cartridge 650 international units per 0.780 mL
  • Injection: Follistim AQ Cartridge 975 international units per 1.170 mL
  • 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 ()
  • Follistim AQ Cartridge is contraindicated in women and men who exhibit:
  • Follistim AQ Cartridge is also contraindicated in women who exhibit:
  • Women and men who exhibit:
  • Women who exhibit:
  • 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 n
  • Treatment with Follistim AQ may result in:
  • Abnormal Ovarian Enlargement: Monitor ovarian response carefully. ()
  • Ovarian Hyperstimulation Syndrome (OHSS): Follow current clinical practice for reducing the risk of OHSS during IVF or ICSI. Adherence to recommended dose and treatment regimen and careful monitoring of ovarian response is important to reduce the risk. The OHSS risk increases with 18 or more follicles of 11 mm or more in diameter. If OHSS develops, standard management should be implemented. ()
  • Pulmonary and Vascular Complications: Before treatment with Follistim AQ Cartridge, weigh benefits versus risk in women with generally recognized risk factors for thromboembolic events. Pregnancy itself may increase this risk. ()
  • Ovarian Torsion: Diagnose and treat immediately. ()
  • Multi-fetal Gestation and Birth: Advise patients of the potential risks associated with multiple births. ()
  • Congenital Anomalies: Slightly higher incidence after IVF or ICSI than spontaneous conception that may be due to parental characteristics or multiple pregnancies. ()
  • Ectopic Pregnancy: Monitor for possible extrauterine pregnancy. ()
  • Spontaneous Abortion: Reported for all gonadotropin treatments, including Follistim AQ Cartridge. ()
  • Ovarian and Other Reproductive System Neoplasms: Reported for all gonadotropin treatments, including Follistim AQ Cartridge. Increased risk of these tumors in women undergoing infertility treatment has not been established. ()
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • The most common adverse reactions (u22652%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. ()
  • The most common adverse reactions (u22652%) in women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue. ()
  • The most common (u22652%) adverse reactions in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn
  • No drug-drug interaction studies have been performed.
  • Nursing Mothers: It is not known whether this drug is excreted in human milk. ()
  • 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.
  • 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 (u03b5: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.
  • No data
  • Long-term toxicity studies in animals have not been performed with Follistim to evaluate the carcinogenic potential of the drug. Follistim was not mutagenic in the Ames test using and tester strains and did not produce chromosomal aberrations in an in vitro assay using human lymphocytes.
  • No data
  • Follistim AQ Cartridge is supplied in a box containing disposable, 29 gauge, ultra-fine, u00bd-inch, sterile BD Micro-Fineu2122 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 Needles
  • NDC 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 Needles
  • NDC 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 Needles
  • NDC 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
  • Store refrigerated 2u00b0-8u00b0C (36u00b0-46u00b0F) until dispensed. Upon dispensing, the product may be stored by the patient at 2u00b0-8u00b0C (36u00b0-46u00b0F) until the expiration date, or at 25u00b0C (77u00b0F) for 3 months or until expiration date, whichever occurs first. Once the rubber inlay of the Follistim AQ Cartridge has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2u00b0-25u00b0C (36u00b0-77u00b0F). Protect from light. Do not freeze.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany
  • BD, BD Logo and BD Micro-Fine are trademarks of Becton, Dickinson and Company
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2004-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
  • Revised: 09/2019
  • uspi-mk8328-SOi-1909r013
  • PATIENT INFORMATION
  • Follistim (Fol'-lis-tim) AQ Cartridgen- (follitropin beta injection)
  • Read the Patient Information that comes with Follistim AQ Cartridge before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • What is Follistim AQ Cartridge?
  • Follistim AQ is a prescription medicine that contains follicle-stimulating hormone (FSH). The medicine is taken with the Follistim Pen.
  • Follistim AQ Cartridge is used:
  • In women:
  • In men:
  • Who should not take Follistim AQ Cartridge?
  • Do not take Follistim AQ Cartridge if you are a Woman or Man who:
  • Do not take Follistim AQ Cartridge if you are a Woman who:
  • Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.
  • What should I tell my healthcare provider before taking Follistim AQ Cartridge?
  • Before you take Follistim AQ, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.
  • How should I use Follistim AQ Cartridge?
  • Women:
  • Men:
  • What are the possible side effects of Follistim AQ Cartridge?
  • Follistim AQ Cartridge may cause serious side effects.
  • Serious side effects in women include:
  • The most common side effects of Follistim AQ Cartridge include:
  • In women:
  • In men:
  • These are not all the possible side effects of Follistim AQ Cartridge. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider immediately
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Follistim AQ Cartridge?
  • Keep Follistim AQ Cartridge and all medicines out of the reach of children.
  • General information about Follistim AQ Cartridge
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Follistim AQ for a condition for which it was not prescribed. Do not give Follistim AQ Cartridge to other people, even if they have the same condition that you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about Follistim AQ Cartridge. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Follistim AQ Cartridge that is written for healthcare professionals.
  • For more information, go to or call 1-866-836-5633.
  • What are the ingredients in Follistim AQ Cartridge?
  • Active ingredient: follitropin beta
  • Inactive ingredients: sucrose, sodium citrate, benzyl alcohol NF-10 mg/mL, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide.
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany
  • BD, BD Logo and BD Micro-Fine are trademarks of Becton, Dickinson and Company.
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2004-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
  • Revised: 09/2019
  • usppi-mk8328-SOi-1909r014
  • PATIENT INSTRUCTIONS FOR USE
  • Follistimu00ae (Folu0384-lis-tim) AQ Cartridge(follitropin beta injection)
  • Read the Patient Instructions for Use that comes with Follistim AQ Cartridge before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • Important: If you have a question, always mention the Lot number of your Follistim Pen as printed on the Pen Body. If you have a complaint, please do not discard any product or packaging.
  • For questions on information contained in this leaflet, call 1-866-836-5633.
  • www.follistim.com
  • How Do I Throw Away Used Cartridges and Needles?
  • How Do I Care for the Follistim Pen?
  • How should I store Follistim AQ Cartridge?
  • Keep Follistim AQ Cartridge, needles, and the disposal container, out of the reach of children.
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany
  • BD, BD Logo and BD Micro-Fine are trademarks of Becton, Dickinson and Company.
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2004-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
  • Revised: 09/2019
  • usppi-mk8328-SOi-1909r014
  • NDC 0052-0313-01 1 Sterile Prefilled 1.5 mL Cartridgecontaining 0.420 mL and5 BD Micro-Fineu2122 Pen Needlesn
  • Follistim AQ Cartridge 300 IU (follitropin beta injection)
  • For use only with Follistim Pen,available separately
  • For Subcutaneous Use
  • Rx only
  • 1 Sterile Prefilled 1.5 mL Cartridgecontaining 0.780 mL and7 BD Micro-Fineu2122 Pen Needles
  • Professional Sample u2013 Not For Sale
  • Follistim AQ Cartridge 600 IU (follitropin beta injection)
  • For use only with Follistim Pen, available separately
  • For Subcutaneous Use
  • Rx only
  • PRINCIPAL DISPLAY PANEL - 900 IU Kit Carton
  • NDC 0052-0326-01
  • 1 Sterile Prefilled 1.5 mL Cartridgecontaining 1.170 mL and10 BD Micro-Fineu2122 Pen Needles
  • Follistimn Cartridge 900 IU
  • For use only with Follistim Pen,available separately
  • For Subcutaneous Use
  • Rx only

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