Legal Terms of Use

THIS WEBSITE, WHICH IS ACCESSIBLE UNDER THE DOMAIN NAME WWW.RASUVO.COM, IS MAINTAINED BY MEDAC PHARMA, INC., A DELAWARE CORPORATION. THE INFORMATION CONTAINED ON THIS WEBSITE, INCLUDING ANY INFORMATION REGARDING PRODUCTS OF MEDAC PHARMA, INC., IS INTENDED SOLELY FOR RESIDENTS OF THE UNITED STATES.

Your access to and use of the materials and information contained on this website are subject to the following terms and conditions. If you choose to access the website or make use of any of the information or materials it contains, you agree to be bound by these terms. If you do not accept these terms, do not use this website.

Proprietary Materials

The content appearing on this website is protected by copyright. You may view and copy materials and information on the website solely for your own non-commercial, personal and informational use. All copyright and other proprietary notices appearing on the website must be retained on any copies you make. No other use of the content provided on the website is authorized and is therefore expressly prohibited.

In addition, all trademarks and logos displayed on the website are the property of Medac Pharma, Inc. You are not permitted to use these trademarks or logos without the prior written permission of Medac Pharma, Inc.

Third-Party Websites

INFORMATION PERTAINING TO THE BUSINESS PARTNERS OF MEDAC PHARMA, INC., INCLUDING ITS PARENT COMPANY, MEDAC GMBH, IS AVAILABLE THROUGH THE SEPARATE WEBSITES OF THOSE PARTIES.

Medac Pharma, Inc., may provide links to websites operated by other parties, including the business partners of Medac Pharma, Inc., as a convenience to the users of this website. Such third-party websites are not under the control of Medac Pharma, Inc., and Medac Pharma, Inc., is not responsible for the content of any third-party website.

Disclaimers and Limitation of Liability

The statements and all materials contained on this website are provided for your general information only. The information is not intended to provide medical advice or patient-specific treatment advice. Users of this website should be aware that products described on this website have not yet been approved for use in the United States.

Although Medac Pharma, Inc., uses reasonable efforts to provide correct and current information on this website, the company assumes no responsibility for the accuracy or reliability of the information. The information and materials contained on the website at times may become out-of-date or may include omissions or other errors. Medac Pharma, Inc., may change the information provided on the website at any time without notice.

All information provided on this website is provided “AS IS” and without any warranty of any kind, either express or implied, including any implied warranties of merchantability, fitness for a particular purpose or non-infringement of third-party rights, in each case to the fullest extent permitted by law.

Medac Pharma, Inc., and its agents will not be liable for any direct, indirect, incidental, consequential, special or punitive damages arising out of your use of the website or the materials, information or links it contains.

Inquiries

Any information you choose to submit to Medac Pharma, Inc., through this website or by using an e-mail address appearing on this website will be treated by Medac Pharma, Inc., in accordance with the privacy policy for this website that is available through this link.

Updates

Medac Pharma, Inc., reserves the right to amend these terms of use from time to time, and an updated version of the applicable terms of use will reflect those changes. Medac Pharma, Inc., will provide prior notice of any changes to the terms of use and will update the effective date listed in the applicable terms of use.
Effective October 16, 2013

PRIVACY POLICY

Any information you choose to submit to Medac Pharma, Inc., through this website or by using an e-mail address appearing on this website will be treated by Medac Pharma, Inc., in accordance with the following privacy policy. Please read this entire privacy policy before submitting information to this website. By using this website and submitting information via this website, you agree with the terms of this privacy policy. Your use of this website is also subject to the Terms of Use for this website that are available through this link.

What We Collect

Medac Pharma, Inc., collects personally identifiable information from the users of this website only when such information is voluntarily provided by you through this website or by using an email address appearing on this website. This personally identifiable information may include your name and email address, any employment information submitted through the “Career Page” (including any personally identifiable information contained within a cover letter and resume submitted through the “Career Page”), and any other information that you submit that may be used to identify you individually.

How the Information Is Used

Medac Pharma, Inc., may use this personally identifiable information to respond to an email or other inquiry, to send news articles, updates or notices about our company and the products we offer that we think may be of interest to you or to respond regarding career opportunities that may be of interest to you. Personally identifiable information will not be sold, rented or exchanged with unaffiliated entities unless you are first notified and expressly consent to such transfer.

Medac Pharma, Inc., reserves the right to disclose personally identifiable information where required by applicable law (such as a search warrant, subpoena or court order). Any communication or material you provide to Medac Pharma, Inc., through this website or by using an email address appearing on this website will be treated by Medac Pharma, Inc., as non-confidential and non-proprietary. In the absence of a written agreement with Medac Pharma, Inc., to the contrary, you agree that you will not submit to the company any information or ideas that you consider to be confidential or proprietary.

How You Can Update Your Information

You may choose at any time to remove your name and email address from the list Medac Pharma, Inc., uses to send correspondence by sending an email to info@medacpharma.com and requesting to be removed. You can also send an email to info@medacpharma.com to update your current email address in order to continue to receive correspondence from Medac Pharma, Inc.

Data Security

Medac Pharma, Inc., takes reasonable steps to protect your personally identifiable information from loss, misuse and unauthorized access. You should keep in mind, however, that no transmission over the Internet is 100% secure or error free and email sent to or from this website may not be secure. You should take care in deciding what information you send to us via email.

Third-Party Websites

Medac Pharma, Inc., may provide links to websites operated by other parties, including the business partners of Medac Pharma, Inc., as a convenience to the users of this website. This privacy policy does not apply to third-party sites, even if they are linked to this website. Websites operated by other parties may have their own privacy policies or no privacy policy at all. Medac Pharma, Inc., encourages you to review the privacy policies of any third-party website before providing any personally identifiable information.

Questions

If you have any questions about this privacy policy, please send all inquiries to info@medacpharma.com.

Updates

Medac Pharma, Inc. reserves the right to amend this privacy policy from time to time and an updated version of the applicable privacy policy will reflect those changes. Medac Pharma, Inc. will provide prior notice of any changes to the privacy policy and will update the effective date listed in the applicable privacy policy.
Effective October 16, 2013

Indications, Important Safety Information, Including Boxed Warning

What is Rasuvo (methotrexate) injection?

Rasuvo (methotrexate) injection is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:

  • Treat certain adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well.
  • Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.

Rasuvo should not be used for the treatment of cancer.

Rasuvo should not be used for the treatment of children with psoriasis.

Rasuvo is available in doses of 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, and 30 mg. Your doctor will prescribe a different way to take methotrexate if you need to take methotrexate by mouth or in some other way.

Important Safety Information, Including Boxed Warning, for Rasuvo

What is the most important information I should know about Rasuvo?

This product includes the following Boxed Warning:

Rasuvo can cause serious side effects that can lead to death, including:

Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or rheumatoid arthritis, have an increased risk of death from organ toxicity. Types of organ toxicity can include: gastrointestinal, nerve, bone marrow, lung, liver, kidneys, immune system, and skin.

Your doctor will do blood tests and other types of tests before you take and while you are taking Rasuvo to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any of the following symptoms of organ toxicity: vomiting, neck stiffness, diarrhea, paralysis, mouth sores, irritability, fever, sleepiness, confusion, problems with coordination, weakness, dry cough, temporary blindness, trouble breathing, seizures, severe skin rash, headache, and back pain.

Women who are pregnant are at increased risk for death of the baby and for birth defects in the baby. Women who are pregnant or who plan to become pregnant must not take Rasuvo. A pregnancy test should be performed before starting Rasuvo. Contraception should be used by both females and males while taking Rasuvo. Pregnancy should be avoided if either partner is receiving Rasuvo:

  • – for a minimum of 3 months after treatment with Rasuvo for males.
  • – during and for at least 1 menstrual cycle after treatment with Rasuvo for females.

What are the possible side effects of Rasuvo?

Rasuvo may cause serious side effects, including:

  • Fertility problems. Methotrexate, the active ingredient in Rasuvo, may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while taking Rasuvo and for a short period of time after you stop.
  • Certain cancers. Some people who have taken methotrexate have had a certain type of cancer called Non-Hodgkin's lymphoma and other tumors. Your doctor may tell you to stop taking Rasuvo if this happens.
  • Tissue and bone problems. Taking methotrexate while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.

Common side effects of Rasuvo include: nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash.

Who should not take Rasuvo?

Do not take Rasuvo if you:

  • Are pregnant or planning to become pregnant
  • Are breastfeeding; Rasuvo can pass into your breast milk and may harm your baby.
  • Have alcohol problems (alcoholism)
  • Have liver problems
  • Have problems fighting infection (immunodeficiency syndrome)
  • Have been told you have (or think you have) a blood disorder, such as low levels of white blood cells, red blood cells (anemia), or platelets
  • Have had an allergy to methotrexate or any of the ingredients in Rasuvo

What should I tell my doctor before taking Rasuvo?

Before you take Rasuvo, tell your doctor if you have any other medical conditions. Tell your doctor about all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Rasuvo may affect how other medicines work, and other medicines may affect how Rasuvo works, causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Rasuvo. For more information, ask your doctor or pharmacist.

For additional information about Rasuvo, please refer to the Patient Information Leaflet and Instructions for Use, which can be found at www.rasuvo.com or call 1-855-33MEDAC (1-855-336-3322).

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.