Terms of Use

AGREEMENT BETWEEN USER AND ACERUS PHARMACEUTICALS CORPORATION

These Terms of Use apply to the Acerus Pharmaceuticals Corporation (“Acerus”) Web Site at natesto.com. Other sites owned and/or operated by Acerus may be subject to different Terms of Use.

The Acerus Web Site is offered to you conditioned on your acceptance without modification of the terms, conditions, and notices contained herein, as well as the Privacy Statement available at http://www.natestohcp.com/privacy-statement/. Your use of the Acerus Web Site constitutes your agreement to all such terms, conditions, and notices. If you do not agree to such terms, conditions, and notices, you may not use the Web Site.

MODIFICATION OF THESE TERMS OF USE

Acerus reserves the right to change the terms, conditions, and notices under which the Acerus Web Site is offered, including but not limited to the charges associated with the use of the Acerus Web Site.

LINKS TO THIRD PARTY SITES

The Acerus Web Site may contain links to other Web Sites ("Linked Sites"). The Linked Sites are not under the control of Acerus and Acerus is not responsible for the contents of any Linked Site, including without limitation any link contained in a Linked Site, or any changes or updates to a Linked Site. Acerus is not responsible for webcasting or any other form of transmission received from any Linked Site. Acerus is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Acerus of the site or any association with its operators.

NO UNLAWFUL OR PROHIBITED USE

As a condition of your use of the Acerus Web Site, you warrant to Acerus that you will not use the Acerus Web Site for any purpose that is unlawful or prohibited by these terms, conditions, and notices. You may not use the Acerus Web Site in any manner which could damage, disable, overburden, or impair the Acerus Web Site or interfere with any other party's use and enjoyment of the Acerus Web Site. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Acerus Web Sites.

HEALTH CARE INFORMATION

Any health care information included on the Acerus Web Site is not meant to replace the advice of medical professionals. The information provided on this site should not be used for diagnosis of any health condition—consult a medical professional for diagnosis and treatment options.

USE OF COMMUNICATION SERVICES

The Acerus Web Site may contain bulletin board services, chat areas, news groups, forums, communities, personal web pages, calendars, and/or other message or communication facilities designed to enable you to communicate with the public at large or with a group (collectively, "Communication Services"), you agree to use the Communication Services only to post, send and receive messages and material that are proper and related to the particular Communication Service. By way of example, and not as a limitation, you agree that when using a Communication Service, you will not:

  • Defame, abuse, harass, stalk, threaten or otherwise violate the legal rights (such as rights of privacy and publicity) of others.
  • Publish, post, upload, distribute or disseminate any inappropriate, profane, defamatory, infringing, obscene, indecent or unlawful topic, name, material or information.
  • Upload files that contain software or other material protected by intellectual property laws (or by rights of privacy of publicity) unless you own or control the rights thereto or have received all necessary consents.
  • Upload files that contain viruses, corrupted files, or any other similar software or programs that may damage the operation of another's computer.
  • Advertise or offer to sell or buy any goods or services for any business purpose, unless such Communication Service specifically allows such messages.
  • Conduct or forward surveys, contests, pyramid schemes or chain letters.
  • Download any file posted by another user of a Communication Service that you know, or reasonably should know, cannot be legally distributed in such manner.
  • Falsify or delete any author attributions, legal or other proper notices or proprietary designations or labels of the origin or source of software or other material contained in a file that is uploaded.
  • Restrict or inhibit any other user from using and enjoying the Communication Services.
  • Violate any code of conduct or other guidelines which may be applicable for any particular Communication Service.
  • Harvest or otherwise collect information about others, including e-mail addresses, without their consent.
  • Violate any applicable laws or regulations.

Acerus has no obligation to monitor the Communication Services. However, Acerus reserves the right to review materials posted to a Communication Service and to remove any materials in its sole discretion. Acerus reserves the right to terminate your access to any or all of the Communication Services at any time without notice for any reason whatsoever.

Acerus reserves the right at all times to disclose any information as necessary to satisfy any applicable law, regulation, legal process or governmental request, or to edit, refuse to post or to remove any information or materials, in whole or in part, in Acerus' sole discretion.

Always use caution when giving out any personally identifying information about yourself or your children in any Communication Service. Acerus does not control or endorse the content, messages or information found in any Communication Service and, therefore, Acerus specifically disclaims any liability with regard to the Communication Services and any actions resulting from your participation in any Communication Service. Managers and hosts are not authorized Acerus spokespersons, and their views do not necessarily reflect those of Acerus.

Materials uploaded to a Communication Service may be subject to posted limitations on usage, reproduction and/or dissemination. You are responsible for adhering to such limitations if you download the materials.

MATERIALS PROVIDED TO ACERUS OR POSTED AT ANY ACERUS WEB SITE

Acerus does not claim ownership of the materials you provide to Acerus (including feedback and suggestions) or post, upload, input or submit to any Acerus Web Site or its associated services (collectively "Submissions"). However, by posting, uploading, inputting, providing or submitting your Submission you are granting Acerus, its affiliated companies and necessary sublicensees permission to use your Submission in connection with the operation of their Internet businesses including, without limitation, the rights to: copy, distribute, transmit, publicly display, publicly perform, reproduce, edit, translate and reformat your Submission; and to publish your name in connection with your Submission.

No compensation will be paid with respect to the use of your Submission, as provided herein. Acerus is under no obligation to post or use any Submission you may provide and may remove any Submission at any time in Acerus’ sole discretion.

By posting, uploading, inputting, providing or submitting your Submission you warrant and represent that you own or otherwise control all of the rights to your Submission as described in this section including, without limitation, all the rights necessary for you to provide, post, upload, input or submit the Submissions.

LIABILITY DISCLAIMER

THE INFORMATION, SOFTWARE, PRODUCTS, AND SERVICES INCLUDED IN OR AVAILABLE THROUGH THE ACERUS WEB SITE MAY INCLUDE INACCURACIES OR TYPOGRAPHICAL ERRORS. CHANGES ARE PERIODICALLY ADDED TO THE INFORMATION HEREIN. ACERUS AND/OR ITS SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN THE ACERUS WEB SITE AT ANY TIME. ADVICE RECEIVED VIA THE ACERUS WEB SITE SHOULD NOT BE RELIED UPON FOR PERSONAL, MEDICAL, LEGAL OR FINANCIAL DECISIONS AND YOU SHOULD CONSULT AN APPROPRIATE PROFESSIONAL FOR SPECIFIC ADVICE TAILORED TO YOUR SITUATION.

ACERUS AND/OR ITS SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, AND ACCURACY OF THE INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON THE ACERUS WEB SITE FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS ARE PROVIDED "AS IS" WITHOUT WARRANTY OR CONDITION OF ANY KIND. ACERUS AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL ACERUS AND/OR ITS SUPPLIERS BE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF USE, DATA OR PROFITS, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR PERFORMANCE OF THE ACERUS WEB SITE, WITH THE DELAY OR INABILITY TO USE THE ACERUS WEB SITE OR RELATED SERVICES, THE PROVISION OF OR FAILURE TO PROVIDE SERVICES, OR FOR ANY INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS OBTAINED THROUGH THE ACERUS WEB SITE, OR OTHERWISE ARISING OUT OF THE USE OF THE ACERUS WEB SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF ACERUS OR ANY OF ITS SUPPLIERS HAS BEEN ADVISED OF THE POSSIBILITY OF DAMAGES. BECAUSE SOME STATES/JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. IF YOU ARE DISSATISFIED WITH ANY PORTION OF THE ACERUS WEB SITE, OR WITH ANY OF THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE ACERUS WEB SITE.

SERVICE CONTACT: IR@ACERUSPHARMA.COM

TERMINATION/ACCESS RESTRICTION

Acerus reserves the right, in its sole discretion, to terminate your access to the Acerus Web Site and the related services or any portion thereof at any time, without notice. General to the maximum extent permitted by law, this agreement is governed by the laws of Ontario, Canada and you hereby consent to the exclusive jurisdiction and venue of courts therein in all disputes arising out of or relating to the use of the Acerus Web Site.

Use of the Acerus Web Site is unauthorized in any jurisdiction that does not give effect to all provisions of these terms and conditions, including without limitation this paragraph. You agree that no joint venture, partnership, employment, or agency relationship exists between you and Acerus as a result of this agreement or use of the Acerus Web Site. Acerus’ performance of this agreement is subject to existing laws and legal process, and nothing contained in this agreement is in derogation of Acerus' right to comply with governmental, court and law enforcement requests or requirements relating to your use of the Acerus Web Site or information provided to or gathered by Acerus with respect to such use. If any part of this agreement is determined to be invalid or unenforceable pursuant to applicable law including, but not limited to, the warranty disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of the agreement shall continue in effect. Unless otherwise specified herein, this agreement constitutes the entire agreement between the user and Acerus with respect to the Acerus Web Site and it supersedes all prior or contemporaneous communications and proposals, whether electronic, oral or written, between the user and Acerus with respect to the Acerus Web Site. A printed version of this agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. It is the express wish to the parties that this agreement and all related documents be drawn up in English.

COPYRIGHT AND TRADEMARK NOTICES:

All contents of the Acerus Web Site are: © 2021 by Acerus and/or its suppliers. All rights reserved.

TRADEMARKS

The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

The example companies, organizations, products, people and events depicted herein are fictitious. No association with any real company, organization, product, person, or event is intended or should be inferred.

Any rights not expressly granted herein are reserved.

SEVERABILITY

These Terms of Use incorporate any notices contained on the Web Site and Privacy Statement and constitute the entire agreement between you and Acerus governing access to the Web Site. If any provision of these Terms of Use is held to be unlawful, void, unenforceable, or in conflict with another applicable agreement, then the provision shall be deemed severable from the remaining provisions and shall not affect their validity and enforceability.

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Important Safety Information

Contraindications

Natesto is contraindicated in:

  • Men with carcinoma of the breast, or known or suspected carcinoma of the prostate
  • Women who are or who may become pregnant, or who are breastfeeding. Natesto may cause fetal harm when administered to a pregnant woman. Natesto may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. If a pregnant woman is exposed to Natesto, she should be apprised of the potential hazard to the fetus

Warnings And Precautions

Nasal Adverse Reactions and Limited Long-Term Information on Nasal Safety: Nasal adverse reactions, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort and nasal scabbing, were reported in the clinical trial experience with Natesto. All nasal adverse reactions except one (a single case of upper respiratory infection) were reported as mild or moderate in severity; however, long-term clinical trial data on nasal safety is available in a limited number of subjects. Patients should be instructed to report any nasal symptoms or signs to their healthcare professional. In that circumstance, healthcare professionals should determine whether further evaluation or discontinuation of Natesto is appropriate.

Use in Patients with Chronic Nasal Conditions and Alterations in Nasal Anatomy: Due to lack of clinical data on safety or efficacy, Natesto is not recommended for use in patients with a history of nasal disorders; history of nasal or sinus surgery; history of nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; mucosal inflammatory disorders (e.g., Sjogren’s syndrome); and sinus disease.

Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) treated with Natesto for worsening signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It would be appropriate to re-evaluate patients 3 to 6 months after initiation of treatment and then in accordance with prostate cancer screening practices.

Polycythemia: Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of Natesto. Check hematocrit prior to initiation. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism: Postmarketing reports of venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as Natesto. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a VTE is suspected, discontinue treatment with Natesto and initiate appropriate workup and management.

Cardiovascular Risk: Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Some studies, but not all, have reported an increased risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Natesto.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check testosterone levels to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Use in Women: Due to lack of controlled studies in women and potential virilizing effects, Natesto is not indicated for use in women.

Potential for Adverse Effects on Spermatogenesis: At large doses of exogenous androgens, including Natesto, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) that could lead to adverse effects on semen parameters, including sperm count.

Hepatic Adverse Effects: Prolonged use of high doses of orally active androgens (methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Natesto is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Natesto while the cause is evaluated.

Edema: Androgens, including Natesto, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia: Gynecomastia may develop and may persist in patients being treated with androgens, including Natesto, for hypogonadism.

Sleep Apnea: The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease.

Lipids: Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting testosterone therapy. Changes in serum lipid profile may require discontinuation of testosterone therapy.

Hypercalcemia: Androgens, including Natesto, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

Decreased Thyroxine-binding Globulin: Androgens, including Natesto, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Adverse Reactions

Natesto was evaluated in a 90-day clinical study that included a 90-day extension period and a subsequent 180-day extension period. Among the 78 patients who received Natesto three times daily in the 90-day clinical study, 69 of those patients received Natesto treatment during the 90-day extension period. A total of 18 patients received Natesto treatment in all three treatment periods, including the 90-day clinical study, the first 90-day extension period, and the second 180-day extension period.

The most common adverse reactions (incidence ≥3%) in the 90-day clinical study were prostate-specific antigen (PSA) increased (5.1%), headache (3.8%), rhinorrhea (3.8%), epistaxis (3.8%), nasal discomfort (3.8%), nasopharyngitis (3.8%), bronchitis (3.8%), upper respiratory tract infection (3.8%), sinusitis (3.8%), and nasal scab (3.8%). Among the 69 patients who received Natesto during the 90-day extension period, the most common adverse reactions were: nasopharyngitis (8.7%), PSA increased (5.8%), parosmia (5.8%), nasal discomfort (5.8%), rhinorrhea (7.2%), and nasal scab (5.8%).

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90- and 180-day extension periods, a total of 6 subjects withdrew from treatment for the following adverse reactions (reported by 1 subject each): nasal discomfort, headache, dysgeusia, PSA increased, allergic reaction (hives, swollen lips and tongue), and 1 patient with myalgia, arthralgia, fever, chills, and petechiae.

Drug Interactions

Insulin: Natesto can cause changes in insulin sensitivity or glycemic control. In diabetic patients, androgens may decrease blood glucose and may necessitate a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants: Anticoagulant activity may be affected by androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.

Corticosteroids: Use of testosterone and corticosteroids concurrently may increase fluid retention and requires careful monitoring, particularly in patients with cardiac, renal, or hepatic disease.

Oxymetazoline: A 2.6% decrease in mean 24-hour bioavailability of testosterone and 3.6% decrease in mean maximum observed concentration of total testosterone was observed in males with symptomatic seasonal rhinitis when treated with oxymetazoline 30 minutes prior to Natesto compared to when left untreated. Oxymetazoline does not impact the absorption of testosterone when concomitantly administered with Natesto. Drug interaction potential with other nasally administered drugs other than oxymetazoline has not been studied.

Use In Specific Populations

Pregnancy: Pregnancy Category X – Natesto is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers: Although it is not known how much testosterone transfers into human milk, Natesto is contraindicated in nursing women because of the potential for serious adverse reactions in nursing mothers.

Pediatric Use: Safety and efficacy of Natesto has not been established in pediatric patients less than 18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses.

Geriatric Use: There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing Natesto to determine whether efficacy in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients using Natesto to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Renal Impairment: No studies were conducted in patients with renal impairment.

Hepatic Impairment: No studies were conducted in patients with hepatic impairment.

Use in Men with Body Mass Index Greater than 35 kg/m2: Safety and efficacy of Natesto in males with body mass index greater than 35 kg/m2 has not been established.

Allergic Rhinitis: Serum total testosterone concentrations decreased by 21% to 24% in males with symptomatic allergic rhinitis, whether treated with nasal decongestants such as oxymetazoline or left untreated.

Drug Abuse And Dependence

Natesto contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders.

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression.

The following adverse reactions have been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications have not been documented.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, visit www.natestohcp.com, or call 1-833-698-3786.

Indication

Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range

Limitations of use:

  • Safety and efficacy of Natesto in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established
  • Safety and efficacy of Natesto in males less than 18 years old have not been established

Please see Full Prescribing Information.

NAT-US-0095  09/21