Terms of Use / Privacy Policy

TERMS AND CONDITIONS

Please read the following terms and conditions before using the Kastle Therapeutics (INC, LLC, Etc.) website. By accessing and using this website, you acknowledge that you have read, understand and agree to comply with the following terms and conditions.

Kastle Therapeutics may amend these terms and conditions at any time. Your continued use of this website is conditioned on the terms and conditions stated at the time of your use. You should visit this page prior to using this website to determine the current terms and conditions to which you are bound.

Use Restriction

Kastle Therapeutics gives you permission to download or print one copy of all or any portion of this website for your personal use in learning about, or evaluating Kastle Therapeutics products or services; however, Kastle Therapeutics retains the copyright on all texts and graphics. This means that you do not have permission to engage in any other use of, including, but not limited to, to print, copy, reproduce, distribute, transmit, upload, download, store, display in public, alter or modify, the copyrighted materials, without Kastle Therapeutics prior written permission.

Corporate Identification and Trademarks

All trademarks, copyrights, content, information, business methods, graphic representations, designs and documentation posted on this website as well as the "look and feel" of this website are trademarks of Kastle Therapeutics and/or its affiliates. You may not copy, reproduce, republish, upload, post, transmit, distribute, modify or otherwise use these marks, including use on any other website, without Kastle Therapeutics prior written permission. The posting of these marks does not constitute a waiver, transfer or license of Kastle Therapeutics proprietary rights to you or to any third party.

Links

Kastle Therapeutics prohibits the use of its trademarks as a "link" on or to any other website unless Kastle Therapeutics has approved the link in writing in advance.

Disclaimer; Limitation of Liability

This website includes information related to or referenced in the offering documentation for certain products distributed by Kastle Therapeutics. This information is provided for your general information only and does not constitute an offer to sell or a solicitation of an offer to buy products. The information does not constitute a sufficient basis for making a decision with respect to the purchase of any products. Before purchasing any products, please consult your products advisor for information about and analysis of the products, its risks and its suitability in your particular circumstances.

Kastle Therapeutics makes reasonable efforts to place accurate information on this website; however, Kastle Therapeutics assumes no liability for any errors or omissions in the website content. Kastle Therapeutics does not warrant uninterrupted or error-free operation of the functions contained in this website or that the website or its server are free of viruses or other harmful components.

ALTHOUGH KASTLE THERAPEUTICS HAS TRIED TO BE AS ACCURATE, COMPLETE AND CURRENT AS POSSIBLE, KASTLE THERAPEUTICS DOES NOT WARRANT THAT THE CONTENT HEREIN IS ACCURATE, COMPLETE OR CURRENT. IT IS YOUR RESPONSIBILITY TO VERIFY ANY INFORMATION BEFORE RELYING ON IT. THE CONTENT OF THIS SITE MAY INCLUDE TECHNICAL INACCURACIES OR TYPOGRAPHICAL ERRORS. FROM TIME TO TIME CHANGES ARE MADE TO THE CONTENT HEREIN. KASTLE THERAPEUTICS MAY MAKE CHANGES IN THE PRODUCTS AND/OR THE SERVICES DESCRIBED HEREIN AT ANY TIME. WE RESERVE THE RIGHT TO MAKE CHANGES AND CORRECTIONS AT ANY TIME, WITHOUT NOTICE.

Unless expressly provided otherwise, KASTLE THERAPEUTICS provides this website and its contents "AS IS" and WITHOUT WARRANTIES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, TO THE FULLEST EXTENT ALLOWABLE BY LAW, INCLUDING ANY WARRANTIES OF TITLE OR ACCURACY OR ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

USE OF THIS WEBSITE AND THE INFORMATION IS AT THE USER'S SOLE RISK. IN NO EVENT WILL KASTLE THERAPEUTICS OR ITS AFFILIATES OR SUPPLIERS BE LIABLE FOR ANY DAMAGES WHATSOEVER ARISING OUT OF OR RELATED TO THIS WEBSITE, ANY WEBSITE OPERATED BY A THIRD PARTY OR ANY INFORMATION CONTAINED IN THIS WEBSITE OR ANY OTHER WEBSITE, INCLUDING, BUT NOT LIMITED TO DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITATION LOST DATA, LOST REVENUE, OR LOST PROFITS, UNDER ANY THEORY, WHETHER UNDER A CONTRACT, TORT (INCLUDING NEGLIGENCE) OR ANY OTHER THEORY OF LIABILITY, EVEN IF KASTLE THERAPEUTICS IS AWARE OF THE POSSIBILITY OF SUCH DAMAGES. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY KASTLE THERAPEUTICS OR ANY OF ITS AFFILIATES, EMPLOYEES OR REPRESENTATIVES SHALL CREATE ANY WARRANTY IN ADDITION TO THOSE GIVEN HEREIN. TO THE EXTENT AN IMPLIED WARRANTY CANNOT BE EXCLUDED, SUCH WARRANTY IS LIMITED IN DURATION TO NINETY (90) DAYS. BECAUSE SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. YOU MAY ALSO HAVE OTHER RIGHTS PARTICULAR TO YOUR JURISDICTION. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE ABOVE STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. BECAUSE SOME JURISDICTIONS DO NOT ALLOW LIMITATION OR EXCLUSION OF CONSEQUENTIAL OR INCIDENTAL DAMAGES, SOME OR ALL OF THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

Jurisdiction and Governing Law

This site is intended and directed to residents of the United States. All advertising and claims contained in this site are valid only in the United States.

Any claim relating to this website and the materials contained in this website is governed by the laws of the State of Illinois, without reference to its conflicts of law rules. Your use of this website constitutes your consent to jurisdiction in courts of competent jurisdiction in the State of Illinois to resolve any interpretation or dispute arising from your use of this website.

Copyright

ONLINE PRIVACY POLICY

Kastle Therapeutics supports the highest standards of integrity for every online visitor. When you register at the Kastle Therpeutics website, our goal is to respect your privacy. This Privacy Policy sets forth how we handle information we obtain from you and learn about you when you visit our website, including:

the information we collect;
the choices that are available to you regarding how the information is used and to whom it is disseminated;
your rights to access and correct or update your personally-identifiable information; and
the security procedures that are in place to protect against the loss, misuse or alteration of information under our control.

If you have any questions or comments about Kastle Therapeutics Privacy Policy, please contact us at: info@kastletx.com.

Information We Collect and How We Use It

Kastle Therapeutics collects two types of information about you when you visit our website:

personal information (including, by way of example only, your name, address, telephone number and e-mail address); and
non-personal, aggregate information (such as information regarding the pages on our site that you have visited and your IP address).

1. Personally-Identifiable Information

What We Collect: The only personally identifying information we collect and store about you is the information that you choose to provide to us.

Electronic Mail: We will also gather your personally identifiable information when you send us an e-mail. We will use this information to respond to your e-mail. We may also use the information to send you notifications about our products or services.

Business Partners/Professional Visitors: Business partners and professional visitors requesting access to specialized content areas of this website may be required to provide identifying information.

Sharing Your Information: We may share your personally identifiable information within Kastle Therapeutics and its affiliated companies. By using the Kastle Therapeutics website, you agree that we will have right to use and disclose any information that you submit to us across Kastle Therapeutics-owned business entities, as appropriate, without compensation or acknowledgment of its source. We may acquire businesses or assets in the future to which customer's personal information may be transferred in the course of such transactions. We may transmit the information to another country for purposes such as for storage, or because of where our servers are located. In addition, we will release customer's personally-identifiable information if required to do so by law or by search warrant, subpoena or court order.

2. Non Personally-Identifiable Information

What We Collect: The Kastle Therapeutics website may collect non-personally identifiable information during your visit, such as type of browser, operating system, domain name, or IP address. An IP address is a number that is automatically assigned to your computer whenever you're surfing the Web. Web servers -- the big computers that "serve" up Web pages -- automatically identify your computer by its IP address. When you visit pages on Kastle Therapeutics website, our servers log your IP address. We do not link IP addresses to any personally identifiable information. This means that your session will be logged, but you remain anonymous to us. IP address information is used only to improve the service of the Kastle Therapeutics website and is then discarded at the end of each session on our site.

Referrers: Kastle Therapeutics also collects information through "referrers" and various environmental variables. A "referrer" is information the web browser passes along to Kastle Therapeutics web server that references the URL from which you came. "Environmental variables" include, among other things, the domain from which you access the Internet, the time you accessed our website, type of web browser and operating system or platform used, the Internet address of the website you left to visit Kastle Therapeutics, the names of the pages you visit while at our website, and the Internet address of the website you visit afterward. We collect all of this information to allow us to detect broad demographic trends, to provide information tailored to your interests and to enhance your experience on Kastle Therapeutics website. Kastle Therapeutics may store "referrer" information for a limited period of time prior to deleting this information.

Profiling: To help us improve our website and to ensure that we make every effort to provide you with information and offers that are of interest to you, we may merge your personally-identifiable information with click-stream data and other data we have (including cookies and offline data). We will provide notice of this, as well as an opportunity to opt-out of it, at the time and place of information collection and before data is entered onto our system. We may also develop a non-identifiable profile on you based on the pages within our site that you visit.

Links: This website may contain links to other websites. Please be aware that we are not responsible for the privacy practices of such other sites. We encourage our users to read the privacy statements of each and every website that they visit. This privacy statement applies solely to information collected when you visit the Kastle Therapeutics website.

Notification of Changes: If we decide to change our privacy policy, we will post those changes on our Homepage so that you will always be aware of what information we collect, how we use it and under what circumstances we disclose it. We will use information in accordance with the privacy policy under which the information was collected.

Special Policy Regarding Information from Children Under Thirteen: This website is not targeted to children under the age of 13, and we do not knowingly request personally identifiable information from any child under the age of 13 without parental consent. When we do receive such information, we delete it as soon as we discover it and do not use it or share it with third parties.

Choices: Kastle Therapeutics provides the following choices regarding the use of your information. You may choose not to provide us with any contact information.

Security: We make every effort to have reasonable security procedures in place to protect the loss, misuse or alteration of information under our control. If you have any questions about the security at our website, you can send an email to info@kastletx.com.

Anchor 1

KYNAMRO® (mipomersen sodium) Injection 200 mg/mL

INDICATIONS AND USAGE

KYNAMRO® (mipomersen sodium) Injection 200 mg/ml is a prescription medicine used along with other lipid-lowering medications and diet in people with homozygous familial hypercholesterolemia (HoFH) to reduce:

Low-density lipoprotein (LDL) cholesterol, commonly known as “bad” cholesterol
Total cholesterol
A protein that carries LDL cholesterol in the blood (apolipoprotein B)
Non–high-density lipoprotein cholesterol (non–HDL-C)

LIMITATIONS OF USE

It is not known if KYNAMRO is safe and effective in people with high cholesterol but who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
It is not known whether KYNAMRO can decrease problems from high cholesterol, such as heart attack, stroke, death, or other health problems
The safety and effectiveness of KYNAMRO as a treatment given in addition to LDL apheresis, a dialysis-like procedure that removes cholesterol from the blood, is not known or recommended

IMPORTANT SAFETY INFORMATION

KYNAMRO (mipomersen sodium) Injection 200 mg/mL may cause serious side effects, including liver problems. KYNAMRO can cause liver problems such as increased liver enzymes or increased fat in the liver.

In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO (compared with 0% of the 17 patients treated with placebo) had at least 1 elevation in levels of liver enzymes that was at least 3 times higher than normal. There were no important changes in other measures of liver function.

KYNAMRO also increases liver fat, with or without accompanying increases in liver enzymes. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and high cholesterol, the median absolute increase in liver fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Fatty liver is a risk factor for advanced liver disease.

Your doctor will measure your liver enzyme levels and liver function before starting treatment and then regularly during treatment, as recommended. If enzyme levels or liver function are abnormal, treatment will be withheld or discontinued depending on severity.

Because of the risk of liver problems, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS. Your doctor must be enrolled in the program in order for you to be prescribed KYNAMRO. KYNAMRO is only for patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia.

CONTRAINDICATIONS

Do not take KYNAMRO if you:

Have moderate or severe liver problems or active liver disease, including unexplained abnormal liver tests
Are allergic to mipomersen or any of the ingredients in KYNAMRO

WARNINGS AND PRECAUTIONS

KYNAMRO can cause increases in liver enzymes and liver fats. Monitor transaminases during treatment with KYNAMRO as described in Warnings and Precautions.

Prior to starting your therapy with KYNAMRO, your doctor should perform liver tests including measurements of liver enzymes called alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase. If the results of any of these tests are abnormal, your doctor may perform additional tests to explain or resolve these abnormalities before starting your treatment with KYNAMRO.

During the first year of therapy, your doctor will conduct liver-related tests on a monthly basis.

After the first year, these tests should be conducted at least once every 3 months. Your doctor should stop your treatment with KYNAMRO if the tests show significant or constant increases in levels.

If liver enzyme levels are elevated and you are showing symptoms of liver injury or liver disease (e.g,, nausea, vomiting, fever, loss of appetite, feeling more tired than usual, yellowing of your eyes or skin, dark urine, itching, or stomach pain), your physician should stop treatment and identify the possible cause.

Drinking alcohol may increase your chance of having liver problems or make your liver problems worse. You should not have more than 1 alcoholic drink each day while using KYNAMRO.

Caution should be exercised when KYNAMRO is used with other medications that may cause liver problems as the effect of these combinations is unknown. More frequent liver-related tests may be necessary.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before starting a new medicine while taking KYNAMRO, even if you will only be taking it for a short time, ask your doctor or pharmacist if it is safe to take while you are using KYNAMRO.

The effect of taking KYNAMRO at the same time as other LDL-lowering drugs that can increase liver fat has not been studied. Therefore, it is not recommended.

Skin reactions at the site of injection were reported at least once in 84% of patients, including redness or discoloration of the skin, pain, tenderness, itching, and swelling around the injection site. Proper injection technique is recommended to help minimize the potential for reactions at the site of injection. These reactions did not occur on all injections. A total of 5% of patients discontinued therapy due to injection site reactions.

Flu-like symptoms, including fever, chills, aches, and tiredness, have been reported in 30% of patients taking KYNAMRO. These symptoms did not occur with all injections. These symptoms usually happen within 2 days after an injection. A total of 3% of patients discontinued therapy due to flu-like symptoms.

USE IN SPECIFIC POPULATIONS

Before you take KYNAMRO tell your doctor if you are pregnant or plan to become pregnant. KYNAMRO may cause harm to your unborn baby. If you are a female who can get pregnant, you should use effective birth control while using KYNAMRO. Talk with your doctor to find the best method of birth control for you. If you become pregnant while taking KYNAMRO, stop taking KYNAMRO and call your doctor right away.

Before you take KYNAMRO tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if KYNAMRO passes into your breast milk. You and your doctor should decide if you will use KYNAMRO or breastfeed. You should not do both.

The safety and effectiveness of KYNAMRO in children under the age of 18 has not been established.

It is not known whether KYNAMRO is safe and effective in people with kidney problems, including people who are receiving kidney dialysis.

SIDE EFFECTS

In drug trials the most commonly reported side effects were injection site reactions (84%), flu-like symptoms (30%), nausea (14%), headache (12%), and elevations in liver enzymes, specifically ALT (10%).

Call your doctor right away about any side effect that bothers you or that does not go away.

See full Prescribing Information and Medication Guide, including Boxed Warning, for more details.

Important Safety Information