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Terms and Conditions

Please carefully review the following terms and conditions of use (“Terms and Conditions”), which apply to everyone who visits this Tolmar* website. By accessing and using this website, you are agreeing to abide by, and be bound by, the following Terms and Conditions and any amendments in effect at the time of your visit. Tolmar may modify these Terms and Conditions at any time without notice by updating these legal notices, and we encourage you to review the Terms and Conditions because any such modifications will be binding on you.

Trademarks and service marks on this Tolmar website, including but not limited to product names, are registered and unregistered trademarks of Tolmar and others. The contents of this Tolmar website (including, without limitation, the arrangement and layout of the websites; names and logos; and text, illustrations and artwork) are the copyrighted and/or trademarked property of Tolmar (or the original creator of the material) and are protected under applicable copyright and trademark laws. Nothing contained on the websites should be construed as granting any license or right to use any such marks or copyrighted material without the written permission of Tolmar or such other party who may own such mark(s) or copyrighted material. Any unauthorized use of the trademarks, copyrights or other contents of this Tolmar website may violate civil or criminal laws.

Product Catalog

The product catalog on the Tolmar website has been designed as a quick reference for Tolmar products. Some products-either brand or generic-may no longer be available on the market due to discontinuations from product portfolios. This product catalog may not represent our complete product portfolio due to additional product launches or product discontinuations. The products displayed on this website are intended as a reference source only and not for prescribing or dispensing purposes.

Patients should always obtain complete medical information about their prescription medicines (beneficial medical uses and possible adverse effects) from the product’s approved package insert and/or by discussing the appropriate use of any medicine(s) directly with their prescribing physician. Consumers should not construe any information herein as medical advice. Tolmar and its affiliates are not responsible for any reliance on or use of any information included herein.

No Advice

Nothing contained in Tolmar’s website should be construed as medical, legal, investment, financial or other advice. Without limitation, nothing contained in the sites should replace medical advice, medical visits or recommendations from health care providers. Patients should always consult with a doctor or other health care provider for medical advice.

Tolmar’s website contains links to third-party websites, which are provided as a convenience to users of our site. Tolmar makes no claim or warranty of, and is not responsible for, any information found in a linked website. We encourage you to check the disclaimers and other legal notices provided on such linked sites.

No Representation or Warranty

While Tolmar uses reasonable efforts to include up-to-date and accurate information on its website, Tolmar does not make, and expressly disclaims, any representations or warranties of any kind, either express or implied (including without limitation any implied warranties of merchantability, fitness for a particular purpose or non-infringement) with regard to any such information, its accuracy or completeness or the frequency that it is updated. Everything on Tolmar’s website is provided “AS IS.” Tolmar assumes no liability or responsibility for any errors or omissions in the content of its websites.

Limitation of Liability

Your use of Tolmar’s website is at your own risk. In no event shall Tolmar or any of its officers, directors, employees or affiliates, be liable, directly or indirectly, for any damages of any kind or nature, including, without limitation, direct, incidental, punitive or consequential, or any claims or losses, resulting from or in connection with the creation or use of, or reliance on, this site or any information contained herein, any other Tolmar website or any linked website contained in any such sites, or any of the information accessed through any such site or from the inability to use any such site. This limitation includes damage to your computer equipment or any viruses that may infect your computer equipment or other property.

Governing Law

These Terms and Conditions of use and your use of this website shall be governed by the laws of the State of Colorado without regard to conflict of laws principles. Any legal action or proceeding related to the Terms and Conditions or your use of this website shall be brought exclusively in the courts of the State of Colorado or the United States District Court for the District of Colorado.

*Tolmar refers to Tolmar Holdings, Inc. and its wholly owned operating subsidiaries, Tolmar, Inc. (product development and manufacturing), Tolmar Therapeutics, Inc. (licensing), and Tolmar Pharmaceuticals, Inc. (sales and marketing).

IMPORTANT SAFETY INFORMATION

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FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) has been reported in pediatric patients treated with GnRH agonists.  Patients should be monitored for headache, papilledema and blurred vision.

The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush. 

Please see Full Prescribing Information for FENSOLVI for additional important safety information. 

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.